IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre

8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre

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Intellectual Property Rights

& Generic PharmaceuticalIndustry

By

Dr. Mahendra B. Thakre

IPDO-IPM

St. Peter's Institute of Pharmaceutical

Sciences- 1st July 2011


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Overview of GATT and WTO

TRIPS and Intellectual Property Rights

Patents and its importance

Developing concept of Patentability

Patents and its enforcement

Status of Patent Act

Pharmaceutical Industry as an case study

ROAD MAP


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General Agreement on Tariff and Trade(GATT)

It was singed on Oct. 30, 1947 at Geneva

The fundamental principles of GATT includes:-Trade should be carried on non-discriminatory

basis

Domestic industry should be protected by meansof custom tariff and not through commercial means

The aim of consultations should be avoidance ofdamage to members interest

GATT served as a frame work within whichnegotiations could be held to reduce tariff and

other trade barriers


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WORLD TRADE ORGANISATION (WTO)

WTO came into effect on Jan 1, 1995

Currently 146 countries are membersIt is full fledged international organization

It contains much improved version of the original

GATT rules plus a lot more

It administers a unified package of agreements towhich all members are committed.

TRIPs agreements


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INTELLECTUAL PROPERTY RIGHTS

Patents

Copyright

Trademark

Design

Trade Secrets

Geographical indicationIntegrated Circuits


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WHAT IS NOT PATENTABLE

Discoveries are not patentable

Ideas are not patentable

Laws of nature

Physical Phenomena

Abstract ideas


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WHAT CAN BE PATENTED

New and useful

Process

Machine

Manufacture

Composition of matter

Or any new and useful improvement thereof


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Developing concept of what can bepatented

Diamond Vs. Chakrabarty, 206 USPQ 193 (1980), held

that microorganisms produced by genetic engineering arenot excluded from patent protection.

Test was not whether they were living, but whether theywere produced by human intervention.


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PATENT RIGHTS

Right to exclude others

A patent is not a grant of a right to make use or sell.

Quid pro quo of Patent protection- grant of patent in

return for full disclosure


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Why are patents valuable to an

organization?

Experience has shown that rivals are less likely to go to

court when they know that their opponent can also wield

a patent

IPR protection is key for companies to recoup costs and

generate returns (active ingredient, formulation, process)

Asserting your patent back in an infringement action

A good patent portfolio can affect the market valuation of

a company and used as a bargaining chip


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COCEPTS OF PATENTABILITY

Utility

AnticipationObviousness

Enablement

Best mode


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UTILITYLevel of utility to be disclosed by pharmaceuticals

patents

In vitro activity

Animal tests

Does not have to prove safety or efficacy of the drug in

human beings

Reasonable correlation between the activity in question

and the asserted utility

Function of the FDA and patent office are distinct


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OBVIOUSNESSIf the difference between the subject matter sought to patented

and the prior art are such that the subject matter as a whole

would have been obvious at the time the invention was made

to a person having ordinary skill in the art to which said subject

matter pertains

Definition of one of Ordinary skill in the art

Combining two or more prior art references

Motivation to combine

Some teaching, suggestions, or motivation to modify or combinefound either in the references themselves or in the knowledge

generally available to one of ordinary skill in the art


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ENABLEMENT

35 U.S.C. 112

The specification shall contain a written description ofthe invention, and of the manner and process of

making and using it, in such full, clear, concise, and

exact terms as to enable any person skilled in the art

to which it pertains, or with which it is most nearly

connected, to make and use the same, and shall setfor the the best mode contemplated by the inventor of

carrying out his invention


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INFRINGEMENT

Making, using, selling or offering for sale

Importing

Experimental use defense

Bolar exemption is not an experimental use defense


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STATUS OF PATENT ACT

In India

Recognition of Product

20 years from date of filing

In US

Patent filed before June 8th 1995 20 years from

the date of filing or 17 years from the date ofgranting whichever is more

After 1995 20 years form the date of filing


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FDA

Regulatory approval-time and cost

Focus of FDA approval process-safety and efficacyDifference between the conditions for patentability

and approval

Only one out of every 2,500 patents make it to the

market


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HATCHW

AXMAN ACT

Commonly known as The Drug price competition and

patent term restoration Act of 1984.

The Act deals with approval of generic drugs and

conditions for getting approvals from FDA, market

exclusivity, Patent term extension and orange book listing


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Patent challenges and generic exclusivityOverview of the legal process

ANDA Requirements:

i. Information to show that the listed drug is

approved;

ii. That the listed drug has the same active ingredient as

the new drug;

iii. That the route of administration, the dosage

forms, the strength of new drug etc. Are the same asthe listed drug;

iv.That the new drug is bio-equivalentto the listed drug.


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PARA CERTIFICATIONSSection 505(j)(2)(A)(vii)

(I) That such patent information has not been filed;

(II) That such patent has expired;

(III) That the proposed drug will not be marketed until

expiration of the patent.

(IV) That either the proposed generic drug does not infringe

the patent or the patent is invalid (known as

Paragraphs IV certification)


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CONCLUSION

Protection of Intellectual property is at most

important for knowledge based industry

Exploitation of patent landscape would be a

driving factor for expanding business.


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CARRIER OPPORTUNITIES IN IP

Intellectual Property Management Generic

business IPM - Drug discovery

Business Development

Strategic Development

IP Law firms

KPO (Knowledge Processing Organization)


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THANKS ..

[email protected]

IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre

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