The World Health Organization (WHO) estimates that 80 percent of the population of some Asian and African countries presently use herbal medicine for some aspect of primary health care.Pharmaceuticals are prohibitively expensive for most of the world's population, half of whom lived on less than $2 U.S. per day in 2002. In comparison, herbal medicines can be grown from seed or gathered from nature for little or no cost patent (/ˈpætənt/ or /ˈpeɪtənt/) is a set of exclusive rights granted by a sovereign state to an inventor or assignee for a limited period of time in exchange for detailed public disclosure of an invention. An invention is a solution to a specific technological problem and is a product or a process. Patents are a form of intellectual property.

1. REGULATORY
REQUIREMENT FOR
SETTING HERBAL DRUG
INDUSTRY
BY: RAGHAV DOGRA
M .PHARM (PHARMACEUTICAL ANALYSIS)
2ND SEMESTER
1

2. 2
GLOBAL
MARKETING
MANAGEMENT

3. INTRODUCTION
3
 Medicinal plants (MPs) as a group comprises approx. 8,000 species and which is
around 50% of all the higher flowering plant species of India.
 More than 15 lakh practitioners use MPs in preventive, promotive and curative
applications.
 There are over 7,800 manufacturing units of herbal product in India according to
Planning Commission, 2000.
 The growing demand for herbal products has led to a big leap in volume of plant
materials traded within and across the countries.
 The EXIM Bank (2003) puts the international market of medicinal plants related
trade 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.

4. BENEFITS OF MEDICINAL
PLANTS
4
 Different kinds of subsistence, cultural and monetary benefits are provided
by MPs to people.
 In China, Nepal and India, they are an important revenue generating
resources and provides income to economically marginalized and native
people.
 Medicinal plants can also relax the chronic problem of global poverty and
hunger.
 Poverty Reduction Strategy and Programs will require interventions which
are grass roots-based, poor-centered and livelihood focused.
 Medicinal plants can meet the basic needs of the poor rural people.

5. EMERGING MARKETS
5
 Multinational pharmaceutical companies and domestic manufacturers of herbal-
based medicines increased interest had significantly contributed to the economic
growth of the Medicinal plant sector.
 The global market potential of Aloe Vera used to treat burns and added to skin
creams and cosmetics was estimated in the billions of dollars.
 Devil’s Claw, is a major exports from Namibia for use in the treatment of
arthritis and other inflammatory diseases.
 India is the hub of the regional trade, at national level the 40% of the state
forest-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$ 18-20
millions are traded and about 90% of this collection is exported mainly to India
in raw form.

6. 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 .

7. GLOBAL MARKETTING
OPPORTUNITY
7
 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.

8. EXPORTS
8
 India is one of the major exporters of crude drugs mainly to the 6
developed countries i.e. USA, Germany, France, Switzerland, UK and
Japan and about 75% to 80% of crude drug import market is taken
over 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 chief
demand.
 The total value of exports of crude drugs has increased from Rs.394
crores in 1996-97 to Rs.446 crores in 1998-99.
 Chinese exports of herbal medicines worth $10 billion a year as
compared to India’s Rs 700 crore showing vast scope of increasing our
advantage to take over large share of the world market.

9. Contd..
9
 Out of the Rs 700 crore exports of herbal medicines, only 40 per cent is
value addition and 60 per cent is export of raw medicinal plants.
 Western countries can add value if India is to depend on exports of raw
medicinal plants .
 Neither domestic farmers be ever given better prices nor tribal people be
given 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 forest
wealth to contract farming where there is a link between the producer and
the grower for better livelihood.
 It is more worrisome that in crops, which are grown only in India such as
isabgul, psyllium, there are 848 patents in the last two decades in the USPTO
and only four out of these are by Indians.

10. IMPORTS
10
 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 drugs
come 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 from
CHEMEXCIL, 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),

11. 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 the
requirements.
 According to a survey conducted by Mac Alpine Thorpe Warrier, Commonwealth
Consultants, (1997), the global market for herbal products was estimated of US $ 9
billion (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 is
substantial scope for the country to exploit this opportunity.

12. CHALLENGES
12
 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.

13. Contd..
13
 The followings are the major challenges in trading of Medicinal Plants both
at domestic and international level:
 Inadequate knowledge and incomplete information on products, markets and
prices on the part of collectors/producers.
 Difficult to No proper recognition access appropriate markets and market
information of environmentally and commercially sound MPs.
 Lack of standardization and consistency in quality for international
marketing.
 Astringent phyto-sanitary regulations such as requirement of microbiological
test, pesticides and heavy metal test by international markets.
 Uneven distribution of benefits.

14. MARKETING STATERGIES
14
 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.

15. 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. 16
INDIAN PATENT
LAW

17. Legislative Framework of IP
Administration17
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. 18
CONTROLLER GENERAL OF PATENTS, DESIGNS
AND TRADEMARKS
(CGPDTM)
T M REGISTRY
DESIGN OFFICE
G.I. REGISTRY
Head Office
KOLKATA
Branch
DELHI
Branch
CHENNAI
Branch
MUMBAI
Head Office
MUMBAI
DELHI
KOLKATA
CHENNAI
A’BAD
IPTI ,NIIPM,
P.I.S. Nagpur
KOLKATA
PATENT OFFICE
CHENNAI

19. Patent Law - Salient Features
19
 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 traditional
knowledge.
 Publication of applications after 18 months with facility for
early publication.
 Substantially reduced time-lines.

20. Safeguards in the Patent Law and
Legislative Measures -Patents20
 Compulsory license to ensure availability of drugs at reasonable
prices.
 Provision to deal with public health emergency.
 Revocation of patent in public interest and also on security
considerations.
 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

21. What is Patentable?
21
Sec.2(1)(J)
“Invention” means a new product or process involving an inventive
step 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, n
prior public knowledge or prior public use with in India, claimed
before in any specification in India.
involves an inventive step: Should involves technical advance as
compared to the existing knowledge or have economic significance
or both and makes the invention not obvious to a person skilled in
the art.
be Capable of industrial application: Invention is capable of
being made or used in any kind of industry.
not fall under Section 3 and 4:

22. Section 3 and 4
22
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 is
contrary public order or Morality e.g. Gambling machine, Device for
house-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 cell
Excludes 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 environment
Effect : Only genetically modified micro-organisms (GMOs) which do
not fall under section 3 (b) are patentable.

23. 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

24. Contd..
24
Section 3 (d)Effect: Salts, esters, ethers, polymorphs, metabolite, pure forms,
particle size, isomers, complexes, combinations and derivatives of a known
substance with enhanced efficacy are patentable.
Section3 (d)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. e.g. New use of Aspirin for heart
ailments, Mere new uses of Neem.
Section 3(e)Substance obtained by mere admixture resulting only
in the aggregation of the properties of the components thereof or a
process for producing such substance
e.g Combiflam [Paracetamol (Antipyretic) + Brufen (analgesic)],
Solution of sugar and color additives in water to form a soft drink
However, A mixture resulting into synergistic properties of
mixture of ingredients however, may be patentable - Soap,

25. 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 of
known devices, each functioning independently of one another in a
Known way e.g. A Bucket fitted with torch, An umbrella with fan ,A
clock 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, Preparation
of an improved soil. However, Agricultural Equipments are patentable

26. Contd..
26
Section 3(i) Any process for medicinal, surgical, curative, prophylactic,
diagnostic, therapeutic or other treatment of human beings or a
similar treatment of animals to render them free of disease or to
increase their economic value or that of their
Products e.g. Removal of cancer tumor, Removal of dental plaque and
carries, Surgical processes, Processes relating to therapy, Method of
vaccination, Blood transfusion. However Treatment performed on
tissues 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

27. Contd..
27
Section 3(k) mathematical method or business method or
algorithms or computer programme e.g. Computer program by itself or
as a record on a carrier. However New calculating machine
combination of hardware and software is patentable.
Section 3(l) A literary, dramatic, musical or artistic work or any other
aesthetic creation including cinematographic work and television
productions. These subject-matters fall under the copyright
protection.
Section 3(m) A mere scheme or rule or method of performing mental
act 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 playing
game 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

28. Contd…
28
Section 3 (o) Topography of integrated circuits. e.g. Mask works -
circuits layout.
Section 3 (p) Inventions which are Traditional Knowledge or an
aggregation or duplication of known properties of traditionally known
component or components e.g. Traditional Knowledge already in public
domain. Wound healing property of Haldi .However, Any value-
addition using Traditional Knowledge leading to a new process or
product ,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.

29. How to file a Patent
29
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 fee
Is 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 .

30. 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 this
journal is made available on the website weekly.
 Other option to get his application published before 18 months is via
publishing 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 party
in a period 48 months, from the date of filing, is available for making request for
examination.
 EXAMINATION:
 Application is sent to an Examiner within 1 month from the date of request
for examination.
 Examiner undertakes examination w.r.t. whether the claimed invention is not
prohibited for grant of patent ,whether the invention meets the criteria of
patentability.

31. 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

32. 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

33. VARIOUS STAGES
33
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

34. FEE FOR RENEWAL
34
 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. 35
INTERNATION
AL PATENT
LAW

36. PATENT COOPERATION TREATY
36
 PCT as it is typically referred to, came into existence in 1970. It is open to
States party to the Paris Convention for the Protection of Industrial Property
(1883).
 The Treaty, which like any other Treaty is a legal agreement entered into
between various countries. The purpose of the PCT is to streamline the
initial filing process, making it easier and initially cheaper to file a patent
application 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 national
or resident of a Member Country. A Member Country, also referred to
sometimes as Contracting States, are simply those countries that are
members to the international Treaty.

37. Contd…
37
 It is, however, important to understand that obtaining international patent
protection is not cheap. It is also important to understand that the
international patent application you file will not mature into an international
patent.
 it is probably worth explaining that there is no such thing as an international
patent, which is one of the things that causes international protection to be
quite costly. It is necessary to seek patent protection in each country because
individual countries issue patents.
 The international process is just a convenient, uniform process that allows
applicants to start down the road toward patent protection in any number of
jurisdictions without the need to make a unique application filing in multiple
countries.
 The PCT procedure consists of two main phases. there is said to be an
“international phase” and a “national phase” to the PCT process.

38. Contd..
38
 The second phase begins with the international application entering into any
number of countries to be evaluated under the patent laws in force in each
particular country where you want a patent.
 The international application may be filed with the International Bureau as
the Receiving Office.
 When no corresponding national or international application has been filed
in the United States and you want to use the International Bureau as the
Receiving Office and the invention was conceived in the United States, you
must 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 a
patent. Had you filed first in United States, for example, you could have
filed an international application claiming the benefit of that earlier filed
U.S. application for up to 12 months.
 the PCT process is most popular with and best suited for large multi-national
corporations who routinely seek patents in many jurisdictions, such as
Pharmaceutical companies

39. STEPS IN FILLING A PATENT
39
 If an invention is thought to be marketable, applying for a patent it should be
considered . In the United States, for a domestic patent is applied in United
States Patent and Trademark Office (USPTO).
 First step is to apply for a domestic patent if thought for an international
patent, known as a PCT patent. If your invention’s market is thought to be
abroad, you should consider applying for an international patent to protect
your 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.

40. APPLYING INTERNATIONAL PCT
PATENT:40
 Be mindful of the 12-month deadline for filing an international
patent under the Patent Cooperation Treaty.
The PCT is single international patent application recognized by the
other 148 member countries. This patent application must be filed
within 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 have
between 18 and 30 months to then file your patent in individual
countries. This is called “nationalizing” your patent and is discussed
below. Before you file your PCT patent, you should be aware of the
deadlines so that you can plan your patent application timeline
accordingly.
You can review a list of country-specific deadlines for nationalizing
patents at: http://www.wipo.int/pct/en/texts/time_limits.html

41. 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/

42. Contd..
42
 The Description must explain the invention in a clear and complete
manner. The description should include the following parts:
“Technical Field,” “Background Art,” “Disclosure of Invention,”
“Brief Description of Drawings,” “Best Mode for Carrying Out the
Invention” or, where appropriate “Mode(s) for Carrying Out the
Invention,” “Industrial Applicability,” and, if applicable, “Sequence
Listing” and “Sequence Listing Free Text.”
 The Claims section must define the protection that is being sought
for the invention.
 The Drawings section include any technical drawings, perspectives,
sections, cross-sections, or other diagrams that are necessary for a
reviewer to understand the invention.
 For applications filed via EFS-Web the application must be in PDF
format and on paper size A4.

43. 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

44. 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.

45. 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.

46. 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.

47. Contd…
47
 Certain international treaties, such as the North American Free
Trade Agreement (NAFTA) or the International treaties such
as the North American Free Trade Agreement (NAFTA) and
the Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS), have provisions to enforce patents
and provide remedies for patent infringement. However, these
treaties are only relevant if the country where the infringement
occurred is a party to the treaty.
 If you believe that your patent was infringed, ask your
domestic attorney speak with the local attorney who you used
for the nationalization process. They should be able to help
you bring a patent enforcement case.

48. PATENTABLE NATURAL
PRODUCTS48
1.Formulation of new composition or improved formulation is
patented
 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.

49. 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.

50. 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

51. 51
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

52. 52