UNNI NALSAR

The Fascinating World of Patents

Seminar on Industrial Property 25th January 2007At Hotel International KochiOrganised by EU-India TIDP amp CUSAT

VK UnniAsst Professor - Law

NALSAR University of Law Hyderabadwwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Patent law deals with new industrially applicable inventions

It envisages a very powerful and special mode of protection for inventions

The patentee is given a monopoly to work the invention for a period of around 20 years

Compared to other streams of IPR the property right granted is very strong

A patent is never granted in an automatic way there is a structured procedure for obtaining a patent

UNNI NALSAR

The Fascinating World of Patents

Patents can be given for products as well as processes

Here a monopoly is granted to the patentee for disclosing the details of the invention which he would have kept as a secret

The disclosure made by the patentee should enable a person skilled in the art to workmake the invention once the patent expires

This would mean that an adequate and enabling disclosure is a condition precedent for obtaining a patent

UNNI NALSAR

ldquoPatentsrdquo How it all started

The origins of patent law can be traced from the medieval times

It all started with the granting of ldquoLetters Patentrdquo which were in effect open letters with kingrsquos seal

The Letters Patent granted the rights to foreign weavers craftsmen so that they can practise their trade

The first letters patent was granted to a weaver who wanted to practise his trade in England

UNNI NALSAR

The Fascinating World of Patents

Justification for Patents It encourages research and invention Induces inventors to reveal their inventions

instead of keeping them as a secret It offers a reward for the effort of

developing inventions to the stage where it is commercially viable

Provides inducement to invest money in new lines of production which may not be profitable if too many people venture into it

UNNI NALSAR

The Fascinating World of Patents

The patent system guarantees a limited term of protection in return for the inventorrsquos willingness to disclose details of his invention and finally to abandon his property right in it

The conventional justification is that in a patent system inventors are rewarded for their time work and risk of capital by the grant of a patent

The society is also benefited by stimulating investment and employment because details of the invention are added to the store of available knowledge

UNNI NALSAR

The Fascinating World of Patents

Patentability Requirements The invention has to be novel It should involve an inventive step ie it

should be non-obvious It should be capable of industrial

application It should not be excluded specifically by the

statute

UNNI NALSAR

The Fascinating World of Patents

Novelty Invention must be new it must not already

have been available to the public An invention can be new only if it does not

form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made

available to the public before the date of the invention whether by written oral description by use or in any manner

Prior publication could have occurred anywhere in the world

UNNI NALSAR

But disclosures that are made in confidence will not be considered as prior publication

Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention

Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral

disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty

UNNI NALSAR

The Fascinating World of Patents

How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great

Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used

in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent

Thus even a single act of disclosure can destroy the novelty of an invention

UNNI NALSAR

The Fascinating World of Patents

Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107

Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public

The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public

When a prototype is kept in public it is irrelevant whether a skilled person examined it or not

In such cases there is prior disclosure consequently there is loss of novelty

UNNI NALSAR

The Fascinating World of Patents

Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not

In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329

Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty

UNNI NALSAR

The Fascinating World of Patents

Inventive Step Inventive step means a feature of an invention

that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art

The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Patent law deals with new industrially applicable inventions

It envisages a very powerful and special mode of protection for inventions

The patentee is given a monopoly to work the invention for a period of around 20 years

Compared to other streams of IPR the property right granted is very strong

A patent is never granted in an automatic way there is a structured procedure for obtaining a patent

UNNI NALSAR

The Fascinating World of Patents

Patents can be given for products as well as processes

Here a monopoly is granted to the patentee for disclosing the details of the invention which he would have kept as a secret

The disclosure made by the patentee should enable a person skilled in the art to workmake the invention once the patent expires

This would mean that an adequate and enabling disclosure is a condition precedent for obtaining a patent

UNNI NALSAR

ldquoPatentsrdquo How it all started

The origins of patent law can be traced from the medieval times

It all started with the granting of ldquoLetters Patentrdquo which were in effect open letters with kingrsquos seal

The Letters Patent granted the rights to foreign weavers craftsmen so that they can practise their trade

The first letters patent was granted to a weaver who wanted to practise his trade in England

UNNI NALSAR

The Fascinating World of Patents

Justification for Patents It encourages research and invention Induces inventors to reveal their inventions

instead of keeping them as a secret It offers a reward for the effort of

developing inventions to the stage where it is commercially viable

Provides inducement to invest money in new lines of production which may not be profitable if too many people venture into it

UNNI NALSAR

The Fascinating World of Patents

The patent system guarantees a limited term of protection in return for the inventorrsquos willingness to disclose details of his invention and finally to abandon his property right in it

The conventional justification is that in a patent system inventors are rewarded for their time work and risk of capital by the grant of a patent

The society is also benefited by stimulating investment and employment because details of the invention are added to the store of available knowledge

UNNI NALSAR

The Fascinating World of Patents

Patentability Requirements The invention has to be novel It should involve an inventive step ie it

should be non-obvious It should be capable of industrial

application It should not be excluded specifically by the

statute

UNNI NALSAR

The Fascinating World of Patents

Novelty Invention must be new it must not already

have been available to the public An invention can be new only if it does not

form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made

available to the public before the date of the invention whether by written oral description by use or in any manner

Prior publication could have occurred anywhere in the world

UNNI NALSAR

But disclosures that are made in confidence will not be considered as prior publication

Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention

Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral

disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty

UNNI NALSAR

The Fascinating World of Patents

How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great

Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used

in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent

Thus even a single act of disclosure can destroy the novelty of an invention

UNNI NALSAR

The Fascinating World of Patents

Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107

Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public

The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public

When a prototype is kept in public it is irrelevant whether a skilled person examined it or not

In such cases there is prior disclosure consequently there is loss of novelty

UNNI NALSAR

The Fascinating World of Patents

Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not

In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329

Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty

UNNI NALSAR

The Fascinating World of Patents

Inventive Step Inventive step means a feature of an invention

that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art

The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Patents can be given for products as well as processes

Here a monopoly is granted to the patentee for disclosing the details of the invention which he would have kept as a secret

The disclosure made by the patentee should enable a person skilled in the art to workmake the invention once the patent expires

This would mean that an adequate and enabling disclosure is a condition precedent for obtaining a patent

UNNI NALSAR

ldquoPatentsrdquo How it all started

The origins of patent law can be traced from the medieval times

It all started with the granting of ldquoLetters Patentrdquo which were in effect open letters with kingrsquos seal

The Letters Patent granted the rights to foreign weavers craftsmen so that they can practise their trade

The first letters patent was granted to a weaver who wanted to practise his trade in England

UNNI NALSAR

The Fascinating World of Patents

Justification for Patents It encourages research and invention Induces inventors to reveal their inventions

instead of keeping them as a secret It offers a reward for the effort of

developing inventions to the stage where it is commercially viable

Provides inducement to invest money in new lines of production which may not be profitable if too many people venture into it

UNNI NALSAR

The Fascinating World of Patents

The patent system guarantees a limited term of protection in return for the inventorrsquos willingness to disclose details of his invention and finally to abandon his property right in it

The conventional justification is that in a patent system inventors are rewarded for their time work and risk of capital by the grant of a patent

The society is also benefited by stimulating investment and employment because details of the invention are added to the store of available knowledge

UNNI NALSAR

The Fascinating World of Patents

Patentability Requirements The invention has to be novel It should involve an inventive step ie it

should be non-obvious It should be capable of industrial

application It should not be excluded specifically by the

statute

UNNI NALSAR

The Fascinating World of Patents

Novelty Invention must be new it must not already

have been available to the public An invention can be new only if it does not

form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made

available to the public before the date of the invention whether by written oral description by use or in any manner

Prior publication could have occurred anywhere in the world

UNNI NALSAR

But disclosures that are made in confidence will not be considered as prior publication

Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention

Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral

disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty

UNNI NALSAR

The Fascinating World of Patents

How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great

Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used

in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent

Thus even a single act of disclosure can destroy the novelty of an invention

UNNI NALSAR

The Fascinating World of Patents

Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107

Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public

The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public

When a prototype is kept in public it is irrelevant whether a skilled person examined it or not

In such cases there is prior disclosure consequently there is loss of novelty

UNNI NALSAR

The Fascinating World of Patents

Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not

In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329

Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty

UNNI NALSAR

The Fascinating World of Patents

Inventive Step Inventive step means a feature of an invention

that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art

The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

ldquoPatentsrdquo How it all started

The origins of patent law can be traced from the medieval times

It all started with the granting of ldquoLetters Patentrdquo which were in effect open letters with kingrsquos seal

The Letters Patent granted the rights to foreign weavers craftsmen so that they can practise their trade

The first letters patent was granted to a weaver who wanted to practise his trade in England

UNNI NALSAR

The Fascinating World of Patents

Justification for Patents It encourages research and invention Induces inventors to reveal their inventions

instead of keeping them as a secret It offers a reward for the effort of

developing inventions to the stage where it is commercially viable

Provides inducement to invest money in new lines of production which may not be profitable if too many people venture into it

UNNI NALSAR

The Fascinating World of Patents

The patent system guarantees a limited term of protection in return for the inventorrsquos willingness to disclose details of his invention and finally to abandon his property right in it

The conventional justification is that in a patent system inventors are rewarded for their time work and risk of capital by the grant of a patent

The society is also benefited by stimulating investment and employment because details of the invention are added to the store of available knowledge

UNNI NALSAR

The Fascinating World of Patents

Patentability Requirements The invention has to be novel It should involve an inventive step ie it

should be non-obvious It should be capable of industrial

application It should not be excluded specifically by the

statute

UNNI NALSAR

The Fascinating World of Patents

Novelty Invention must be new it must not already

have been available to the public An invention can be new only if it does not

form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made

available to the public before the date of the invention whether by written oral description by use or in any manner

Prior publication could have occurred anywhere in the world

UNNI NALSAR

But disclosures that are made in confidence will not be considered as prior publication

Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention

Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral

disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty

UNNI NALSAR

The Fascinating World of Patents

How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great

Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used

in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent

Thus even a single act of disclosure can destroy the novelty of an invention

UNNI NALSAR

The Fascinating World of Patents

Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107

Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public

The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public

When a prototype is kept in public it is irrelevant whether a skilled person examined it or not

In such cases there is prior disclosure consequently there is loss of novelty

UNNI NALSAR

The Fascinating World of Patents

Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not

In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329

Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty

UNNI NALSAR

The Fascinating World of Patents

Inventive Step Inventive step means a feature of an invention

that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art

The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Justification for Patents It encourages research and invention Induces inventors to reveal their inventions

instead of keeping them as a secret It offers a reward for the effort of

developing inventions to the stage where it is commercially viable

Provides inducement to invest money in new lines of production which may not be profitable if too many people venture into it

UNNI NALSAR

The Fascinating World of Patents

The patent system guarantees a limited term of protection in return for the inventorrsquos willingness to disclose details of his invention and finally to abandon his property right in it

The conventional justification is that in a patent system inventors are rewarded for their time work and risk of capital by the grant of a patent

The society is also benefited by stimulating investment and employment because details of the invention are added to the store of available knowledge

UNNI NALSAR

The Fascinating World of Patents

Patentability Requirements The invention has to be novel It should involve an inventive step ie it

should be non-obvious It should be capable of industrial

application It should not be excluded specifically by the

statute

UNNI NALSAR

The Fascinating World of Patents

Novelty Invention must be new it must not already

have been available to the public An invention can be new only if it does not

form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made

available to the public before the date of the invention whether by written oral description by use or in any manner

Prior publication could have occurred anywhere in the world

UNNI NALSAR

But disclosures that are made in confidence will not be considered as prior publication

Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention

Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral

disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty

UNNI NALSAR

The Fascinating World of Patents

How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great

Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used

in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent

Thus even a single act of disclosure can destroy the novelty of an invention

UNNI NALSAR

The Fascinating World of Patents

Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107

Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public

The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public

When a prototype is kept in public it is irrelevant whether a skilled person examined it or not

In such cases there is prior disclosure consequently there is loss of novelty

UNNI NALSAR

The Fascinating World of Patents

Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not

In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329

Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty

UNNI NALSAR

The Fascinating World of Patents

Inventive Step Inventive step means a feature of an invention

that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art

The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

The patent system guarantees a limited term of protection in return for the inventorrsquos willingness to disclose details of his invention and finally to abandon his property right in it

The conventional justification is that in a patent system inventors are rewarded for their time work and risk of capital by the grant of a patent

The society is also benefited by stimulating investment and employment because details of the invention are added to the store of available knowledge

UNNI NALSAR

The Fascinating World of Patents

Patentability Requirements The invention has to be novel It should involve an inventive step ie it

should be non-obvious It should be capable of industrial

application It should not be excluded specifically by the

statute

UNNI NALSAR

The Fascinating World of Patents

Novelty Invention must be new it must not already

have been available to the public An invention can be new only if it does not

form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made

available to the public before the date of the invention whether by written oral description by use or in any manner

Prior publication could have occurred anywhere in the world

UNNI NALSAR

But disclosures that are made in confidence will not be considered as prior publication

Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention

Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral

disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty

UNNI NALSAR

The Fascinating World of Patents

How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great

Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used

in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent

Thus even a single act of disclosure can destroy the novelty of an invention

UNNI NALSAR

The Fascinating World of Patents

Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107

Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public

The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public

When a prototype is kept in public it is irrelevant whether a skilled person examined it or not

In such cases there is prior disclosure consequently there is loss of novelty

UNNI NALSAR

The Fascinating World of Patents

Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not

In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329

Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty

UNNI NALSAR

The Fascinating World of Patents

Inventive Step Inventive step means a feature of an invention

that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art

The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Patentability Requirements The invention has to be novel It should involve an inventive step ie it

should be non-obvious It should be capable of industrial

application It should not be excluded specifically by the

statute

UNNI NALSAR

The Fascinating World of Patents

Novelty Invention must be new it must not already

have been available to the public An invention can be new only if it does not

form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made

available to the public before the date of the invention whether by written oral description by use or in any manner

Prior publication could have occurred anywhere in the world

UNNI NALSAR

But disclosures that are made in confidence will not be considered as prior publication

Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention

Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral

disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty

UNNI NALSAR

The Fascinating World of Patents

How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great

Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used

in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent

Thus even a single act of disclosure can destroy the novelty of an invention

UNNI NALSAR

The Fascinating World of Patents

Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107

Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public

The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public

When a prototype is kept in public it is irrelevant whether a skilled person examined it or not

In such cases there is prior disclosure consequently there is loss of novelty

UNNI NALSAR

The Fascinating World of Patents

Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not

In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329

Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty

UNNI NALSAR

The Fascinating World of Patents

Inventive Step Inventive step means a feature of an invention

that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art

The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Novelty Invention must be new it must not already

have been available to the public An invention can be new only if it does not

form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made

available to the public before the date of the invention whether by written oral description by use or in any manner

Prior publication could have occurred anywhere in the world

UNNI NALSAR

But disclosures that are made in confidence will not be considered as prior publication

Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention

Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral

disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty

UNNI NALSAR

The Fascinating World of Patents

How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great

Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used

in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent

Thus even a single act of disclosure can destroy the novelty of an invention

UNNI NALSAR

The Fascinating World of Patents

Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107

Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public

The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public

When a prototype is kept in public it is irrelevant whether a skilled person examined it or not

In such cases there is prior disclosure consequently there is loss of novelty

UNNI NALSAR

The Fascinating World of Patents

Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not

In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329

Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty

UNNI NALSAR

The Fascinating World of Patents

Inventive Step Inventive step means a feature of an invention

that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art

The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

But disclosures that are made in confidence will not be considered as prior publication

Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention

Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral

disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty

UNNI NALSAR

The Fascinating World of Patents

How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great

Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used

in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent

Thus even a single act of disclosure can destroy the novelty of an invention

UNNI NALSAR

The Fascinating World of Patents

Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107

Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public

The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public

When a prototype is kept in public it is irrelevant whether a skilled person examined it or not

In such cases there is prior disclosure consequently there is loss of novelty

UNNI NALSAR

The Fascinating World of Patents

Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not

In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329

Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty

UNNI NALSAR

The Fascinating World of Patents

Inventive Step Inventive step means a feature of an invention

that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art

The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great

Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used

in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent

Thus even a single act of disclosure can destroy the novelty of an invention

UNNI NALSAR

The Fascinating World of Patents

Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107

Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public

The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public

When a prototype is kept in public it is irrelevant whether a skilled person examined it or not

In such cases there is prior disclosure consequently there is loss of novelty

UNNI NALSAR

The Fascinating World of Patents

Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not

In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329

Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty

UNNI NALSAR

The Fascinating World of Patents

Inventive Step Inventive step means a feature of an invention

that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art

The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107

Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public

The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public

When a prototype is kept in public it is irrelevant whether a skilled person examined it or not

In such cases there is prior disclosure consequently there is loss of novelty

UNNI NALSAR

The Fascinating World of Patents

Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not

In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329

Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty

UNNI NALSAR

The Fascinating World of Patents

Inventive Step Inventive step means a feature of an invention

that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art

The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not

In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329

Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty

UNNI NALSAR

The Fascinating World of Patents

Inventive Step Inventive step means a feature of an invention

that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art

The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Inventive Step Inventive step means a feature of an invention

that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art

The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

Patents would not be available on the following grounds the mere discovery of a known substance which does not result

in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a

known substance the mere use of a known process machine or apparatus unless

such known process results in a new product or employs at least employs one new reactant

One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel

International Ltd (1999) FSR 683 what was the problem which the invention

addressed how long had the problem existed how significant was the problem how widely known was the problem and

how many were likely to be seeking a solution

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

what prior art would have been known to those in the field

what other solutions were proposed prior to publication of the patent

what other factors were there that held back exploitation of the solution

how well has the product been received has the commercial success of the product been due

to its technical merits This decision leads to the position that commercial

success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Industrial Application Industrial application is another

requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from

copyright An invention is capable of industrial

application if it can be made or used in any kind of industry including agriculture

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies

The above said exclusion doesnrsquot extend to products consisting of substances used in any such method

The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of PatentsWhat are not patentable Sec 3

an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)

an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)

the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature

Sec 3[c]

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)

ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy

Inserted by the 2005 amendment

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)

the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)

Sec 3(g) has been omitted by the 2002 amendment

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative

prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)

Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)

A mathematical or business method or a computer programme per se or algorithms Sec 3(k)

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)

Method of performing a mental act or method of playing a game Sec 3(m)

Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional

knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Ownership of patents Normally it is the inventor who owns the

patent Incase the inventor has assigned the

patent the owner of the patent will be different

Disputes mainly arise over ownership of inventions between employees and employers

In India there is no provision which deals with employee-employer inventions

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Rights of a patent holder (Sec 48) When a patent is for a product the patent

holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license

A patent is always territorial in nature In case of a process patent the patent

holder has the exclusive right to use or exercise the methodprocess in India

If any person violates any of these rights then there will be infringement

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

The following can be considered as the public interest provisions vis a vis the patent monopoly

Opposition of patents 1048710The Indian law provides for both pre grant and post

grant opposition As per Sec 25 (1) when an application for a patent has

been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a

period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)

The grounds can be many like lack of novelty obviousness insufficient description of the invention etc

Then the Controller of patents has to constitute an opposition board to consider this opposition

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

The opposition board has to hear both the parties and give its opinion to the controller

1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Compulsory Licensing The aim or purpose of this provision is to ensure hat

the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention

Grounds for compulsory licensing can be classified the grounds into two categories (private and public)

Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents Sec 84 deals with compulsory licensing on private

grounds After 3 years from the grant of the patent any person

shall apply to the controller to issue him a compulsory license to work the patent

The grounds for making such application are The reasonable requirement of the public with respect

to the invention are not satisfied Patented invention is not available to the public at a

reasonably affordable price Invention is not worked in the territory of India

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents Thus if the controller is satisfied that

these conditions are not being met he will grant a compulsory license upon the terms he may think fit

Sections 86-89 deals with the procedures to be followed while granting a compulsory license

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market

The license shall be for the balance term of the patent or for a shorter term

Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory

license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents If the controller feels that because of national

emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act

This beneficial provision can be really helpful in the case of emergencies

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)

However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India

Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without

running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or

any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid

Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the

general rules of patent infringement This research exception enables a manufacturer of generic

drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires

Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule

The generic drug maker can then market their own version of the patented drug as soon as the patent expires

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a

patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product

Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Revocation of patents These proceedings can be instituted at any time after

the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a

counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in

public interest]

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Revocation of Patents (Sec 85) When a compulsory license has been granted after 2

years from the date of such grant any interested person central govt can apply before the controller to revoke the patent

The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg

UNNI NALSAR

The Fascinating World of Patents

Thank You Very Much

VK Unni

Asst Professor - Law

NALSAR University of Law Hyderabad

wwwnalsaracin

E-mail unninalsarlawunivorg