REGULATORY

REQUIREMENT FOR

SETTING HERBAL DRUG

INDUSTRY

BY: RAGHAV DOGRA

M .PHARM (PHARMACEUTICAL ANALYSIS)

2ND SEMESTER

1

2

GLOBAL

MARKETING

MANAGEMENT

INTRODUCTION3

Medicinal plants (MPs) as a group comprises approx. 8,000 species and which isaround 50% of all the higher flowering plant species of India.

More than 15 lakh practitioners use MPs in preventive, promotive and curativeapplications.

There are over 7,800 manufacturing units of herbal product in India according toPlanning Commission, 2000.

The growing demand for herbal products has led to a big leap in volume of plantmaterials traded within and across the countries.

The EXIM Bank (2003) puts the international market of medicinal plants relatedtrade as US$ 60 billion per year growing at the rate of 7% only .

80% of the population of developing countries relies on traditional medicines,mostly plant drugs, for their primary health care needs acc. to WHO.

BENEFITS OF MEDICINAL

PLANTS4

Different kinds of subsistence, cultural and monetary benefits are providedby MPs to people.

In China, Nepal and India, they are an important revenue generatingresources and provides income to economically marginalized and nativepeople.

Medicinal plants can also relax the chronic problem of global poverty andhunger.

Poverty Reduction Strategy and Programs will require interventions whichare grass roots-based, poor-centered and livelihood focused.

Medicinal plants can meet the basic needs of the poor rural people.

EMERGING MARKETS5

Multinational pharmaceutical companies and domestic manufacturers of herbal-based medicines increased interest had significantly contributed to the economicgrowth of the Medicinal plant sector.

The global market potential of Aloe Vera used to treat burns and added to skincreams and cosmetics was estimated in the billions of dollars.

Devil’s Claw, is a major exports from Namibia for use in the treatment ofarthritis and other inflammatory diseases.

India is the hub of the regional trade, at national level the 40% of the stateforest-based revenues and 70% of forest export revenues come from MAPs &Non-Timber Forest Products (NTFPs), mostly in unprocessed and raw forms.

In Nepal it is estimated that every year 20,000 tons of MAPs worth US$ 18-20millions are traded and about 90% of this collection is exported mainly to Indiain raw form.

DEMAND FOR MEDICINAL

PLANTS6

From 2002 to 2005 the demand for medicinal plants in India to meet both domestic

and export markets was projected to increase at about 15−16 percent annually.

If properly organized, the cultivation and management of medicinal plants becomes

highly remunerative both in financial and economic terms for the small-scale growers.

The annual revenue stream from the three major Indian systems of medicine, is

estimated at more than half a billion dollars annually.

In 2000 demand and supply of MAPs was estimated to be about 40,000 to 2, 00,000

tons; by 2005 the gap was expected to increase from 1, 52, 000 to 4, 00, 000 tons

(Planning Commission, 2000 & CRPA, 2001).

MAP-based industries create employment opportunities in poor, job-starved states,

thereby increasing the cash earnings of local people .

GLOBAL MARKETTING

OPPORTUNITY7

Export opportunities of natural products are remarkable as the world market is

looking towards natural sources for the purposes of therapeutic use as well as

nutritional dietary supplements.

The global herbal remedies market can be classified into five strategic areas:

(i) Phyto-Pharmaceuticals -the plant based drugs containing isolated pure active

compounds used to treat diseases.

(ii) Medicinal Botanicals / Dietary Supplements -the whole plant or plant-part

extracts used for maintenance of health by affecting a body structure and its

function;

(iii) Nutraceuticals-the food containing supplements from natural (botanical)

sources, that deliver a specific health benefit, including prevention and

treatment of disease;

(iv) Cosmeceuticals-the cosmetic products which contain biologically active

ingredients having an effect on the user and

(v) Herbal raw material.

EXPORTS8

India is one of the major exporters of crude drugs mainly to the 6developed countries i.e. USA, Germany, France, Switzerland, UK andJapan and about 75% to 80% of crude drug import market is takenover by INDIA alone.

Aconite, Aloe, Belladonna, Cassia, Cinchona,Dioscorea, Digitalis,Ephedra, Ergot, Hyoscymus, Ipecac, Liquorice, Opium, Podophyllum,Rauwolfia, Senna, Stramonium, Isabgol seeds/husk are in chiefdemand.

The total value of exports of crude drugs has increased from Rs.394crores in 1996-97 to Rs.446 crores in 1998-99.

Chinese exports of herbal medicines worth $10 billion a year ascompared to India’s Rs 700 crore showing vast scope of increasing ouradvantage to take over large share of the world market.

Contd..9

Out of the Rs 700 crore exports of herbal medicines, only 40 per cent isvalue addition and 60 per cent is export of raw medicinal plants.

Western countries can add value if India is to depend on exports of rawmedicinal plants .

Neither domestic farmers be ever given better prices nor tribal people begiven more returns for collection of these medicinal plants.

In India, medicinal plants are registered as a Minor Forest Produce (MFP)and there is a need to move away from unsustainable exploitation of forestwealth to contract farming where there is a link between the producer andthe grower for better livelihood.

It is more worrisome that in crops, which are grown only in India such asisabgul, psyllium, there are 848 patents in the last two decades in the USPTOand only four out of these are by Indians.

IMPORTS10

All the raw materials used by the Pharmacies are not of indigenous origin.

Substantial supplies are received from Nepal, Bhutan, Bangladesh, Pakistan,Afghanistan, Singapore, etc. often through informal routes.

For instance most of the 'Chiraita' and other Himalayan medicinal plant crude drugscome from Nepal and Bhutan, 'Oleoresin guggul' of best quality from Pakistan,'Liquorice' from Afganistan etc.

7, 180 tons raw material demand is met through import According to the data fromCHEMEXCIL, of the total estimated annual demand of 31, 780 tons.

The requirements of Akkalkada- Glycrrhiza glabra(Pakistan, Iran, Afghanistan),

Dalchini- Cinnamomum zeylanica(China),

Kankol- Piper cubeba(Indonesia),

Contd..11

Maiphal- Quercus infectoria mostly met through imports.

About 90% requirement of Guggul(Commiphora wightii) is imported from Pakistan.

Clove (Syzygium aromaticum), Nutmeg mace (Myristica fragrence aril), Ginger(Zingiber officinale) are the other raw materials partially imported to fulfill therequirements.

According to a survey conducted by Mac Alpine Thorpe Warrier, CommonwealthConsultants, (1997), the global market for herbal products was estimated of US $ 9billion (Rs.36,000 Crores) which is expected to grow to US $ 40 billion (Rs.1,60,000 Crores) by 2010.

Of this European market is of the size of US $ 2.7 billion i.e.,Rs.10,800 crores.

India's share of this market is less than one per cent revealing the fact that there issubstantial scope for the country to exploit this opportunity.

CHALLENGES12

Collectors, processors and traders face problems in finding favorable

markets due to price factors, quality and quantity considerations.

Local and regional price fluctuations as well as the lack of current

market and price information affect the income of the actual local

collectors who are dependent on the middlemen or village traders.

Financial and logistic constraints make it difficult for local producers

and collectors to interact more closely with prospective clients.

Contd..13

The followings are the major challenges in trading of Medicinal Plants bothat domestic and international level:

Inadequate knowledge and incomplete information on products, markets andprices on the part of collectors/producers.

Difficult to No proper recognition access appropriate markets and marketinformation of environmentally and commercially sound MPs.

Lack of standardization and consistency in quality for internationalmarketing.

Astringent phyto-sanitary regulations such as requirement of microbiologicaltest, pesticides and heavy metal test by international markets.

Uneven distribution of benefits.

MARKETING STATERGIES14

The current increase in the worldwide consumption and use of 'green'

products, especially drugs, flavors and fragrances of natural origin, has

indeed amplified the scope of the use of indigenous flora and collection &

trade of exotic species.

The identification of the ultimate suppliers and buyers is also big issue in

this sector.

The gaps between the producers/collectors and traders or buyers need to be

minimized as these are at present very wide and often inequitable.

Linkages should be developed in order to have better understanding about

the NTFPs business & between the businesses and the producers/collectors.

Contd..15

A holistic management action plan is necessary to formulate for

assessment and management of resource base, best harvesting and

processing practices, trade issues and aspects dealing with the intellectual

property rights on the traditional medicines by the tribal people.

Investments are needed for the development of appropriate conversation,

cultivation harvesting strategies, which will simultaneously meet the

demand for low-cost and locally available medicines.

At the same time, there must be immediate efforts to ensure the

conservation of diverse biological resources and the preservation and

application of local and cultural knowledge on the use of these resources.

16

INDIAN PATENT

LAW

Legislative Framework of IP Administration

17

Department of IP &P covers

The Patents Act, 1970 (as amended in 1999,2002, 2005)

The Patents Rules, 2003 (as amended in 2005 2006)

The Designs Act, 2000

The Designs Rules, 2001 (as amended in 2008)

The Trade Marks Act 1999

The Trade Marks Rules 2002

The Geographical Indications of Goods (Registration & Protection) Act, 1999

The Geographical Indications of Goods (Registration & Protection) Rules, 2002,

Department of Education covers

The Copyrights Act 1957 (amended in 1999)

18

CONTROLLER GENERAL OF PATENTS, DESIGNS AND TRADEMARKS

(CGPDTM)

T M REGISTRY

DESIGN OFFICE

G.I. REGISTRY

Head OfficeKOLKATA

BranchDELHI

BranchCHENNAI

BranchMUMBAI

Head OfficeMUMBAI

DELHI

KOLKATA

CHENNAI

A’BAD

IPTI ,NIIPM,P.I.S. Nagpur

KOLKATA

PATENT OFFICE

CHENNAI

Patent Law - Salient Features19

Patent provided are Both product and process.

Term of patent – 20 years.

Examination on request.

Both pre-grant and post-grant opposition .

Fast track mechanism for disposal of appeals.

Provision for protection of bio-diversity and traditionalknowledge.

Publication of applications after 18 months with facility forearly publication.

Substantially reduced time-lines.

Safeguards in the Patent Law and

Legislative Measures -Patents20

Compulsory license to ensure availability of drugs at reasonableprices.

Provision to deal with public health emergency.

Revocation of patent in public interest and also on securityconsiderations.

From 1.1.1995 Mail-Box for pharmaceutical and agrochemicals products Exclusive Marketing Rights

From 1.1.2000 Patent term increased to 20 years Definition of invention – inclusion of inventive step Reversal of burden of proof – on the infringer Mandatory compulsory licence provision for food, drugs and

chemicals removed Right of patentee (importation also included)

From 1.1.2005 Product patents for food, chemical and pharmaceutical

What is Patentable?21

Sec.2(1)(J)

“Invention” means a new product or process involving an inventivestep and capable of industrial application.

Invention must

relates to a Process or Product or both

be new (Novel): Must not be published in India or elsewhere, nprior public knowledge or prior public use with in India, claimedbefore in any specification in India.

involves an inventive step: Should involves technical advance ascompared to the existing knowledge or have economic significanceor both and makes the invention not obvious to a person skilled inthe art.

be Capable of industrial application: Invention is capable ofbeing made or used in any kind of industry.

not fall under Section 3 and 4:

Section 3 and 422

Section 3(a)

Frivolous inventions, Inventions contrary to well established natural laws

e.g. Machine that gives more than 100% performance, Perpetul machine.Section 3(b)Commercial exploitation or primary use of inventions which iscontrary public order or Morality e.g. Gambling machine, Device forhouse-breaking.Commercial exploitation or primary use of inventions , which causes serious prejudice to health or human, animal, plant life or to the environment e.g. Biological warfare material or device, weapons of mass destruction Terminator gene technology, Embryonic stem cellExcludes patents on**** GMOs – exploitation of which could be contrary public order or morality or prejudicial to human, animal or plant life or health or to the environmentEffect : Only genetically modified micro-organisms (GMOs) which donot fall under section 3 (b) are patentable.

Contd..23

Section 3 ( c )

Mere Discovery of a Scientific Principle or formulation of an abstract

theory or discovery of any living thing or discovery of non living

substance occurring in nature e.g. Newton’s Laws ,Superconducting

Phenomenon as such Property of certain material to withstand

mechanical shock Discovery of micro-organism Discovery of natural

gas or a mineral.

Section3 (d)

Salts, esters, ethers, polymorphs, metabolites, pure form, particle size,

isomers, mixture of isomers, complexes, combinations and other

derivatives of known substances shall be considered to be the same

substance, unless they differ significantly in properties with regard to

efficacy e.g. Crystalline forms of known substance

Contd..24

Section 3 (d)Effect: Salts, esters, ethers, polymorphs, metabolite, pure forms,particle size, isomers, complexes, combinations and derivatives of a knownsubstance with enhanced efficacy are patentable.

Section3 (d)Mere discovery of any new property or new use for aknown substance or of the mere use of a known process, machine orapparatus, unless such known process results in a new product oremploys at least one new reactant. e.g. New use of Aspirin for heartailments, Mere new uses of Neem.

Section 3(e)Substance obtained by mere admixture resulting onlyin the aggregation of the properties of the components thereof or aprocess for producing such substancee.g Combiflam [Paracetamol (Antipyretic) + Brufen (analgesic)],Solution of sugar and color additives in water to form a soft drinkHowever, A mixture resulting into synergistic properties ofmixture of ingredients however, may be patentable - Soap,Detergents, lubricants etc

Contd…25

Section 3 ( e )Effect Substance obtained by mere admixture resulting

only in the aggregation of the properties of the components thereof or a

process for producing such substance are not patentable However

Synergistic formulations are patentable.

Section 3 ( f )Mere arrangement or re-arrangement or duplication ofknown devices, each functioning independently of one another in aKnown way e.g. A Bucket fitted with torch, An umbrella with fan ,Aclock and radio in a single cabinet, A flour mill provided with Sieving

Section 3(h) Method of Agriculture or Horticulture e.g.Cultivation of algae ,Producing new form of a known plant, Preparationof an improved soil. However, Agricultural Equipments are patentable

Contd..26

Section 3(i) Any process for medicinal, surgical, curative, prophylactic,diagnostic, therapeutic or other treatment of human beings or asimilar treatment of animals to render them free of disease or toincrease their economic value or that of theirProducts e.g. Removal of cancer tumor, Removal of dental plaque andcarries, Surgical processes, Processes relating to therapy, Method ofvaccination, Blood transfusion. However Treatment performed ontissues or fluids permanently removed from the body Surgical,therapeutic or diagnostic Apparatus or instruments are patentable.

Section 3(j) Plants & animals in whole or any part thereof other than

microorganisms, but including seeds, varieties an d species an

essentially biological process for production or propagation of plants &

animals.

Section 3(j) Plants & animals in whole Parts of plants & animals seeds

varieties & species essentially biological processes for propagation or

production of the animals & plants

Contd..27

Section 3(k) mathematical method or business method oralgorithms or computer programme e.g. Computer program by itself oras a record on a carrier. However New calculating machinecombination of hardware and software is patentable.Section 3(l) A literary, dramatic, musical or artistic work or any otheraesthetic creation including cinematographic work and televisionproductions. These subject-matters fall under the copyrightprotection.Section 3(m) A mere scheme or rule or method of performing mentalact or method of playing game e.g. Scheme for learning a language,Method for solving a crossword puzzle, Method of learning a language ,Method of teaching /learning However, Novel apparatus for playinggame or carrying out a scheme is patentable .

Section 3 (n) Presentation of information e.g. Any manner or method

of expressing information whether by spoken words, Visual display,

symbols, diagrams ,Information recorded on a carrier

However

Contd…28

Section 3 (o) Topography of integrated circuits. e.g. Mask works -

circuits layout.Section 3 (p) Inventions which are Traditional Knowledge or anaggregation or duplication of known properties of traditionally knowncomponent or components e.g. Traditional Knowledge already in publicdomain. Wound healing property of Haldi .However, Any value-addition using Traditional Knowledge leading to a new process orproduct ,which is novel with inventive step and industrial applicability,Extraction of Azadirachtin from Neem can be patented.

Section 4 Inventions falling within Section 20(1) of the Atomic

EnergAct,1962 are not patentable Effect Inventions relating to

compounds of Uranium, Beryllium, Thorium, Plutonium, Radium,

Graphite, Lithium and more asnotified by Central Govt. from time to

time.

How to file a Patent29

Application is filed for patent in one of the patent offices based on

territorial jurisdiction of the place of office or residence of the

Applicant Agent by paying the required fee

Information concerning application form and details of fee

and Guidelines for applicants available at www.ipindia.nic.in .

FORMALITY CHECK:

the formal requirements before accepting the application and the feeIs checked by the examiner– this is done immediately.

on the same day Issue of application number and the cash receipt.

The cash receipt, application number is sent by post within 2-3 days,In case of receipt of application by post .

Contd..30

FORMALITY CHECK:

Application is kept secret for a period of 18 months from the date of filing

the application is published in the official journal in the 19th month thisjournal is made available on the website weekly.

Other option to get his application published before 18 months is viapublishing within one month of the request.

REQUEST FOR EXAMINATION:

Application is examined on request.

Request for examination can be made either by the applicant or by a third partyin a period 48 months, from the date of filing, is available for making request forexamination.

EXAMINATION:

Application is sent to an Examiner within 1 month from the date of requestfor examination.

Examiner undertakes examination w.r.t. whether the claimed invention is notprohibited for grant of patent ,whether the invention meets the criteria ofpatentability.

Contd….31

ISSUE OF FIRST EXAMINATION REPORT:

Examiner is having a period 1 to 3 months to submit report to controller.

Controller is having 1 month’s time to review the Examiner’s report

First Examination Report (FER) containing gist of the objections is issued within 6 months from the date of filing of request.

RESPONSE FROM THE APPLICANT:

12 months’ time, from the date of issue of FER is available to the applicant to meet the objections

If objections are met, grant of patent is approved by the Controller within a period of 1 month.

PRE-GRANT OPPOSITION:

After publication, an opposition can be filed within a period of 6 months

Opportunity of hearing the opponent is also available

Contd…32

EXAMINATION OF PREGRANT OPPOSITION:

Opposition (documents) is sent to the applicant .

A period of 3 months is allowed for receipt of response.

CONSIDERATION OF PRE GRANT OPPOSITION:

After examining the opposition and the submissions made

during the hearing, Controller may Either reject the

opposition and grant the patent Or accept the opposition

and modify/reject the patent application.

This is to be done within a period of 1 month from the date of completion of opposition proceedings.

GRANT OF PATENT:

A certificate of patent is issued within 7 days

Grant of patent is published in the official journal

VARIOUS STAGES33

PUBLICATION OF APPLICATION

REQUEST FOR EXAMINATION

GRANT OF PATENT

3rd Party Representation

Revocation/Amendment

OPPOSITION

• PROMPTLY AFTER 18 MONTHS FROM P.D.

• WITHIN 48 MONTHS FROM F.D.

• ALL OBJECTIONS TO BE COMPLIED WITHIN 12

MONTHS

• WITHIN 12 MONTHS

FILING OF APPLICATION

PROVNL. / COMPLETE

Decision of

Controller

EXAMINATION-ISSUE OF FER

Appeal

Appellate Board

• IF P.S.IS FILED C.S. TO BE FILED WITHIN

12MONTHS

FEE FOR RENEWAL34

To be paid within 3+6 months from date of

recording in the register [sec 142 (4) ]

No fee for 1st and 2nd year

Renewal fee, on yearly basis, is required to be paid

for 3rd to 20th for keeping the patent in force

Delay upto six months from due date permissible on

payment of fee for extension of time

Patent lapses if renewal fee is not paid within the

prescribed period

35

INTERNATION

AL PATENT

LAW

PATENT COOPERATION TREATY36

PCT as it is typically referred to, came into existence in 1970. It is open toStates party to the Paris Convention for the Protection of Industrial Property(1883).

The Treaty, which like any other Treaty is a legal agreement entered intobetween various countries. The purpose of the PCT is to streamline theinitial filing process, making it easier and initially cheaper to file a patentapplication in a large number of countries.

You accomplish this by filing an “international patent application.” Indeed,the term PCT is largely synonymous with “international patent application.

An international patent application may be filed by anyone who is a nationalor resident of a Member Country. A Member Country, also referred tosometimes as Contracting States, are simply those countries that aremembers to the international Treaty.

Contd…37

It is, however, important to understand that obtaining international patentprotection is not cheap. It is also important to understand that theinternational patent application you file will not mature into an internationalpatent.

it is probably worth explaining that there is no such thing as an internationalpatent, which is one of the things that causes international protection to bequite costly. It is necessary to seek patent protection in each country becauseindividual countries issue patents.

The international process is just a convenient, uniform process that allowsapplicants to start down the road toward patent protection in any number ofjurisdictions without the need to make a unique application filing in multiplecountries.

The PCT procedure consists of two main phases. there is said to be an“international phase” and a “national phase” to the PCT process.

Contd..38

The second phase begins with the international application entering into anynumber of countries to be evaluated under the patent laws in force in eachparticular country where you want a patent.

The international application may be filed with the International Bureau asthe Receiving Office.

When no corresponding national or international application has been filedin the United States and you want to use the International Bureau as theReceiving Office and the invention was conceived in the United States, youmust petition for a foreign filing license under 37 C.F.R. 5.13.

you have 30 months to enter the national stage in countries where you want apatent. Had you filed first in United States, for example, you could havefiled an international application claiming the benefit of that earlier filedU.S. application for up to 12 months.

the PCT process is most popular with and best suited for large multi-nationalcorporations who routinely seek patents in many jurisdictions, such asPharmaceutical companies

STEPS IN FILLING A PATENT39

If an invention is thought to be marketable, applying for a patent it should beconsidered . In the United States, for a domestic patent is applied in UnitedStates Patent and Trademark Office (USPTO).

First step is to apply for a domestic patent if thought for an internationalpatent, known as a PCT patent. If your invention’s market is thought to beabroad, you should consider applying for an international patent to protectyour legal rights to your product.

DETERMINATION WHETHER AN INVENTION IS PATENTABLE:

It must be invented or discovered by a person;

It must be a new and useful process, machine, manufacture, or composition

of matter; or

If not new, it must be an improvement on a useful process, machine,manufacture, or composition of matter.

APPLYING INTERNATIONAL PCT

PATENT:40

Be mindful of the 12-month deadline for filing an internationalpatent under the Patent Cooperation Treaty.

The PCT is single international patent application recognized by theother 148 member countries. This patent application must be filedwithin 12 months of the date that you filed your provisional or non-provisional application with the USTPO or Indian patent office etc.

Check foreign country deadlines.

Typically, once you submit your PCT patent application you will havebetween 18 and 30 months to then file your patent in individualcountries. This is called “nationalizing” your patent and is discussedbelow. Before you file your PCT patent, you should be aware of thedeadlines so that you can plan your patent application timelineaccordingly.

You can review a list of country-specific deadlines for nationalizingpatents at: http://www.wipo.int/pct/en/texts/time_limits.html

Contd…41

Draft a PCT patent application. The PCT patent application requires

information for it to be deemed complete. You should consider hiring

an attorney that specializes in patent law and is experienced in PCT

patents to assist you in drafting your application. Your PCT

application must include the following:

A PCT Request form that sets forth many of the requirements of the

PCT application. The request contains: a petition that the application

be processed; the title of the invention; the name of the inventor and/or

agent; the inventor’s residence and address; and the inventor’s choice

of which international searching agencies he or she wants to conduct

the international patent search. The form is located

at: http://www.wipo.int/pct/en/forms/

Contd..42

The Description must explain the invention in a clear and completemanner. The description should include the following parts:“Technical Field,” “Background Art,” “Disclosure of Invention,”“Brief Description of Drawings,” “Best Mode for Carrying Out theInvention” or, where appropriate “Mode(s) for Carrying Out theInvention,” “Industrial Applicability,” and, if applicable, “SequenceListing” and “Sequence Listing Free Text.”

The Claims section must define the protection that is being soughtfor the invention.

The Drawings section include any technical drawings, perspectives,sections, cross-sections, or other diagrams that are necessary for areviewer to understand the invention.

For applications filed via EFS-Web the application must be in PDFformat and on paper size A4.

Contd..43

All documents must have a minimum resolution of 300 dpi.

File PCT patent application. A PCT patent application can be

filed with the International Bureau of the World Intellectual

Property Organization (WIPO) in the following ways:

Electronically via the e PCT system located at

https://pct.wipo.int/LoginForms/epct.jsp; or on the PCT-SAFE

system located at http://www.wipo.int/pct-safe/en/

By fax to (41-22) 910 06 10 (or (41-22) 338 70 60 in case of

transmission difficulties). You must forward the original

document within 14 days. By mail or hand delivery to:

International Bureau of WIPO, PCT Receiving Office

Contd…44

Pay required fees. In order got your patent application to be reviewed,

you must pay the required fees.

The fees can be paid in Swiss francs, US dollars, or Euros.

A list of required fees can be found

at: http://www.wipo.int/pct/guide/en/gdvol1/annexes/annexc/ax_c_ib.pdf

Application fees can be paid by credit card, account debit, bank transfer

or by check made payable to the World Intellectual Property

Organization.

Wait for international patent search to be conducted. Once you have

submitted your PCT application, one of the international patent search

companies will perform a patent search and write a report as to the

patentability of your invention. If your patent is accepted, your

application will be published along with the patentability opinion. You

also have the option to withdraw your application.

Contd..45

Nationalize your foreign patent. submission and receiving a favorable

opinion on patentability, you must “nationalize” your PCT application in

any country that you want to grant you a patent. For example, if you want

France and China to grant you a patent, you must submit your PCT

application to each of those countries.

As discussed above, each jurisdiction has specific deadlines for when you

must nationalize your application. You must file your application before

the deadline passes.

Typically for nationalization you will have to pay a fee, submit some

documentation and potentially translate your application. Since each

country has different rules, it is wise to hire a local attorney in the

country that you are seeking patent protection. Your U.S. attorney should

be able to set up this arrangement and work with local lawyers to ensure

the application is filed correctly.

Contd…46

You want to nationalize your application where you have expected or

actual sales of your invention. The cost for nationalization can run

between $4000 and $7000 per country.

Enforce your patent. If someone uses your patented invention

without permission. This is called patent infringement. In order to

secure the right to sue for patent infringement, you must have

nationalized your patent in the foreign jurisdiction where your patent

was used unlawfully.

Even though countries may allow a lawsuit for patent infringement,

not all countries have the legal mechanisms in place to actually

enforce the decision.

Contd…47

Certain international treaties, such as the North American FreeTrade Agreement (NAFTA) or the International treaties suchas the North American Free Trade Agreement (NAFTA) andthe Agreement on Trade-Related Aspects of IntellectualProperty Rights (TRIPS), have provisions to enforce patentsand provide remedies for patent infringement. However, thesetreaties are only relevant if the country where the infringementoccurred is a party to the treaty.

If you believe that your patent was infringed, ask yourdomestic attorney speak with the local attorney who you usedfor the nationalization process. They should be able to helpyou bring a patent enforcement case.

PATENTABLE NATURAL

PRODUCTS48

1.Formulation of new composition or improved formulation ispatented

E.g: Patented herbal anti- allergic composition which comprises a

synergistic mixture of extracts from the fruits of Terminalia chebula,

bark of Albizia lebbeck, Terminalia bellerica and Embelica

officinalis and process of preparation of such composition.

The present invention also contains the fruits of Piper longum, Piper

nigrum and rhizomes of Zinger officinalae and thoroughly mixed to

get the final composition which has potent anti-allergic activity. The

preparation is useful for the treatment of allergic conditions.

Contd..49

2.Patent for new use of the herbal constituents

Eg: The weight loss properties of Forskohlin (obtained from the roots of Coleus

forskohlli ) were discovered by the firm ( Sabinsa corporation), in humans, which is

not a traditional use of the Coleus active. For this, the company was grated a patent for

its use and composition in promotion of lean body mass, reduction of adipose tissue

(fat) and weight loss.

3. Modification or Synthesis of the natural compounds

Eg: The novel steroidal glycosides compounds which are extracted and isolated from

the extracts of plant of the genus Trichocaulon or Hoodia containing an appetite

suppressant agent and the derivatives of such compounds are synthesized with the aim

of increasing the activity of the active ingredient. Also, this invention provides novel

intermediates for the synthesis of active compound.

Contd..50

The active ingredient in the Hoodia gordonil plant is called P57 and is responsible for its appetite suppressant qualities. Phyto-pharm, a British pharmaceutical company, has the exclusive patent on P57

4. A Novel isolation process ;

E.g.; For the process of isolation of Azadirachtin (fungicidal activity) from the

seeds of neem and also its storage. N.C.L, Pune, Indian patent.

5. A new application of an isolated compound

E.g.; For the use of turmeric as a stabilizing agent for menadione, an antifungal

agent Japanese patent.

6. The inventions with novelties: E.g.; Bio-pesticides

7. Biotechnology related products

8. Purification of the natural products

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9. Patents for new chemical components from natural products. An example of such a case is that of a new substance, which is discovered as being produced by a microorganism. Higher value for a patent is placed on a compound with structural novelty and with some derivatives produced which offer information regarding structure–activity relationships and the biological mechanism of action is unique

10.Patents for known compounds from natural products. For example, the patenting of betulinic acid, which exhibits specific cytotoxicity against melanoma cells, and also possesses in vivo anti-proliferative and cancer chemopreventive activities.

11.Patents for traditional herbal medicines and herbal medicinal products.

12.New Indication of Herbal Drug and Herbal Medicine. As an example, an herbal medicine could have an unknown effect of curing breast cancer discovered by a scientist. In such a case the new indication can be protected by Patent Law

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