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CLEA (ASIA-INDIA) MOOTING COMPETITION -2019

TEAM CODE :117

CLEA (ASIA-INDIA) MOOTING COMPETITION -2019

JANUARY 12th-13th

BEFORE THE PATENT TRIAL AND APPEAL BOARD OF PARSINIA

ON SUBMISSION FOR HEARING

Jaiv Sanskruti Avagat (State Of Toqoi)…..……….PETITIONER


v.
Ojibwe Industries Inc., (State Of Parsinia).,……...RESPONDENT

MEMORIAL FOR PETITIONER

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TABLE OF CONTENTS

1. List of Abbreviations………….…………………………………………………...3-4

2. Index of Authorities…………….………………………………………….………5-7

 Table of Cases

 Books

 Websites

 Statutes

3. Statement of Jurisdiction …………….………………………………….……......8

4. Statement of Facts …………………….……………………………..…................9-10

5. Statement of Issues…………………….…………………………………….…….11

6. Summary of Arguments……………….……………………………………….….12

7. Arguments Advanced………………….…………………………………………..13-34

Issue-1: Whether The Patenting Of “Rausilux” Amounts to Bio Piracy And

Misappropriation Of Traditional Knowledge Of Kehuar Community?

Issue-2: Whether the granted patent for ‘Rausilux’ can be revoked on the basis of

anticipation and prior art?

8. Conclusion………………………………………………………...…………….….36-37

9. Prayer …………………………………………………………..…………...……...38

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ABBREVIATIONS

CBD Convention On Biological Diversity

CCPA Court Of Customs And Patent Appeals

E.P.O European Patent Office

E.T.C Erosion, Technology, And Concentration

Ibid Ibidem

Id., Ibid

Inc. Incorporation

IPR Intellectual property Rights

NBA National Biodiversity Authority

OII Ojibwe Industries Incorporation

PPTO Parsinia Patent and trade mark Office

RAFI Research Affiliates Fundamental Indexes

S. Section

TK Traditional Knowledge

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TM Traditional Medicine

TRIPS Trade-Related Aspects of Intellectual Property Rights

U.S.A Unites States Of America

U.S.C United States Code

UN United Nations

US United Sates

USPTO US Patent and Trade Mark Office

WIPO World Intellectual property Organization

WTO World Trade Organization

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INDEX OF AUTHORITIES

 TABLE OF CASES

1. Ayahuasca Case , Re-examination no:90/005307

2. Bishwananth Prasad Radhey Shyam v. Hindustan Metal Industries, (1979) 2 S.C.C.

511

3. Franz Xaver Huemer v. New Yash Engineers, AIR 1997 Del 79

4. In re Bergstrom, 427 F.2d 1394, 1401 (C.C.P.A. 1970).

5. India-US Basumathi Rice Dispute, Trade and Environment Database (TED),Case

No.493

6. Maca Plant Case, US20040137131A1

7. Neem Case, USPTO Reexam. No. 90/004,050, Dec. 8, 1995

8. Novartis Ag. vs Adarsh Pharma And Anr. on 28 April, 2004, 2004 (3) CTC 95

9. Pfizer, Inc v. Apotex, Inc ,488 F.3d 1377 (Fed. Cir. 2007)

10. Quinoa plant extract case, US9125879B2

11. Reserpine case, US2788309A

12. Turmeric Case, Alyon Slack, Turmeric,TED, Case No.770,2004.

13. United States v. Adams, 383 U.S. 39, 148 U.S.P.Q. (BNA) 479 (1966)

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 BOOKS

1. V. SHIVA, Protect or Plunder? Understanding Intellectual Property Rights, London,

Zed Books, 2001, 49

2. Medicinal Plants: Pills in a Haystack, ECONOMIST, Feb 24, 1990, at 87

3. V. SHIVA, Protect or Plunder? Understanding Intellectual Property Rights, London,

Zed Books, 2001, 49.

4. Graham Dutfield, Trade Related Aspects of Traditional Knowledge, 33 CASE W.

RES. J. INT’L. L. 239 (2001).

5. Emily Marden, The Neem Tree Patent: International Conflict over the

Commodification of Life, 22 B.C. INT’L & COMP. L. REV. 279 (1999).

6. Bennett, Bradley C. Hallucinogenic plants of the Shuar and related indigenous groups

in Amazonian Ecuador and Peru, 44(4) Brittonia (1992) p. 483

 WEBSITES

1. en.oxforddictionaries.com – ‘Biopiracy

2. ETC Group on Biopiracy, available at: http://www.etcgroup.org/issues/biopiracy

3. http://ipindia.nic.in/ipr/patent/Patent_Manual_Feedback/ FICCI%27s_comments.pdf

4. http://www.biodiv/org/doc/legal/cbd-un-en(last visited JAN 5, 2019).

5. https://www.lawteacher.net/free-law-essays/commercial-law/section-3-of-the-indian-

patents-act-commercial-law-essay.php#ftn36

6. https://www.researchgate.net/publication/324312963_Biopiracy_and_its_impact_on_

Biodiversity_A_special_review_on_Sri_Lankan_context [accessed Jan 05 2019].

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 STATUTES

1. The Biological Diversity Act ,2002

2. The Convention on Biological Diversity

3. The Indian Patents Act, 1970

4. The Marrakesh Agreement Establishing WTO

5. The Munich Convention

6. The U.S Patent Act

7. United Nations Declaration On The Rights Of Indigenous Peoples Of 1994

8. WIPO

9. TRIPS Agreement

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STATEMENT OF JURISDICTION

The Petitioner has the honor to submit the memorial of the present case for Post Grant Review

filed under the U.S Patent Act before the Patent Trial and Appeal Board of Parsinia under S.282

of the U.S Patent Act. It sets forth the facts and the laws on which the claims are based.

35 U.S. Code § 321 - Post-grant review

(a)IN GENERAL: Subject to the provisions of this chapter, a person who is not the owner of a

patent may file with the Office a petition to institute a post-grant review of the patent.

The Director shall establish, by regulation, fees to be paid by the person requesting the review, in

such amounts as the Director determines to be reasonable, considering the aggregate costs of the

post-grant review.

(b)SCOPE:A petitioner in a post-grant review may request to cancel as unpatentable 1 or more

claims of a patent on any ground that could be raised under paragraph (2) or (3) of section 282(b)

(relating to invalidity of the patent or any claim).

(c)FILING DEADLINE:A petition for a post-grant review may only be filed not later than the date

that is 9 months after the date of the grant of the patent or of the issuance of a reissue patent (as

the case may be).

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STATEMENT OF FACTS

The eco-social culture of the Kehuar community in Mahagir mountain range in the Democratic

Republic of Toqoi has generated a powerful heritage of Kehamani knowledge, which includes

the knowledge of plant and genetic resources that has extraordinary medical and commercial

value.

The community firmly believes in traditional ethno medicines and treatment methods. The

members of the community share their ethno medical knowledge only through oral traditions. A

council of elder community members lead by a hereditary chief decides the treatment which

involves the use of any traditional medicine. The traditional medicines are being prepared by

Kehuars from the medicinal plants which they conserve, nurture and preserve for centuries. One

of the key traditional medicines, community use is a combination of (i) Strychnos nux-vomica

(ii) Rauwolfia Serpentina and (iii) Limonia Acidissima, for curing blood pressure related heart

diseases. All three species are listed in the endangered plant species list of the state of Toqoi. The

concoction is prepared using various parts of the plants, by indigenous methods. The concoction

needs to be consumed by the patient immediately as the toxic properties of the plant parts will be

active after 2 hours of its preparation.

Mr. Arikara Hopo and Mr. Bannock Hopo after completing their post graduation from TIEBS,

later got admission in a prestigious research programme of Inter University Centre for Bio-

Diversity and Ethno Medicine (IUCBEM). As part of their academic activities and the terms of

the Adsila-Ojibwe Scholarship, Ms. Arikara and Mr.Bannock were required to complete a

project in the field of medicine. Ms. Arikara and Mr. Bannock worked on the scientific aspects

of bio-ethnic medicine concoction of their indigenous community, which involved the use of

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Strychnos nux-vomica, Rauwolfia Serpentina and Limonia Acidissima. Instead of indigenous

method they used advanced bio-chemical distilling method and included tools like genomics,

proteomics and bio informatics in the process. The biological pathways such as gene and protein

expression, modulation and regulation and cell signaling were also applied by them and they

created a drug Rausilux which is an anticoagulant to be used for Deep Vein Thrombosis (DVT)

and helps in preventing blood clots after a stroke or pulmonary embolism, which also makes it a

life saving drug. Due to these pharmaceutical processes, the shelf life of the drug increased to six

months compared to the requirement of immediate consumption of the concoction in its

traditional use. The biogenetic materials of the plants were gathered from ex situ collections in

three countries where these plants do not exit naturally. OII applied for patent for the drug

Rausilux in 2015 in Parsinia. Parsinia Patent and Trademark Office (PPTO) granted patent for

the drug Rausilux in February 2018 to OII. It was an unopposed patent.

Jaiv Sanskruti Avagat (JSA), a non-profit organization based on the state of Toqoi focused

mainly on the documentation and protection of traditional knowledge. JSA became aware of the

patent grant for Rausilux immediately after its grant by PPTO in 2018 and has accused Ojibwe

(OII) of bio-piracy and misappropriation of the traditional knowledge of Kehuar community,

JSA representing the Kehuar community decided to file a post-grant review at the Patent Trial

and Appeal Board of Parsinia which is akin to that of USPTO model. The State of Toqoi is a

party to the United Nation’s Convention on Biological Diversity (CBD) and has enacted the

National Bio-Diversity Act. The authority appointed under the Act grants permits and licenses

for the same. However, the State of Parsinia is not a member to CBD. Both Toqoi and Parsinia

are parties to the Marrakesh Agreement establishing the (WTO) agreement and have completed

their transition period and compliance obligations.

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STATEMENT OF ISSUES

Issue-1: Whether The Patenting Of “Rausilux” Amounts to Bio Piracy And

Misappropriation Of Traditional Knowledge Of Kehuar Community?

A. Whether the application of patent is barred by the TK under National Biological

Diversity Act and Convention on Biological Diversity?

B. Whether the respondent has committed bio piracy under National Biodiversity Act

and convention on biological diversity?

Issue-2: Whether the granted patent for ‘Rausilux’ can be revoked on the basis of

anticipation and prior art?

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SUMMARY OF ARGUMENTS

ISSUE 1: Whether the Patenting Of “Rausilux” Amounts to Bio Piracy And

Misappropriation Of Traditional Knowledge Of Kehuar Community?

It is submitted that the patenting of “Rausilux” amounts to Bio-piracy and misappropriation of

knowledge because the state of Toqoi has immense provisions under National Biodiversity Act

and UN Convention on Biological Diversity (CBD) to protect the indigenous knowledge of their

community. It was only thorough the CBD that the protection of Traditional Knowledge (TK)

came in to focus. There have been several high profile cases involving Indian TK in the US. The

main issue is that non-US oral traditions are no bar to novelty in a US patent application. India

has reacted defensively to American patents based on their TK. The Indian Biological Diversity

Act has introduced a number of provisions that will make foreign companies deal with a central

authority in order to gain access to Indian biological materials, including TK.

ISSUE 2: Whether the granted patent for ‘Rausilux’ can be revoked on the basis of

anticipation and prior art?

It is submitted that the element of novelty has been challenged by anticipation and prior art. So

the basic requirement for granting patent is not fulfilled; thereby the patent can be subjected to

revocation. It is pertinent to mention that the principles of anticipation by previous publication

and by prior claim are to be investigated under the Indian Patent Act and if found against the

patent claim, it would form a ground for revocation under the Act and when there are materials

on record to show that there was prior publication of the claim, the patent claim is liable to be

rejected. Further, The Marrakesh Agreement Establishing WTO between State of Parsinia and

Toqoi also provides an opportunity for judicial review of any decision to revoke or forfeit a

patent.
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ARGUMENTS ADVANCED

I. The Patenting Of “Rausilux” Amounts to Bio Piracy And

Misappropriation Of Traditional Knowledge Of Kehuar Community.

It is submitted that the patenting of “Rausilux” amounts to Bio-piracy and misappropriation

of knowledge because the state of Toqoi has immense provisions under National Biodiversity

Act and UN Convention on Biological Diversity (CBD) to protect the indigenous knowledge

of their community. It was only thorough the CBD that the protection of Traditional

Knowledge (TK) came in to focus. There have been several high profile cases involving

Indian TK in the US. The main issue is that non-US oral traditions are no bar to novelty in a

US patent application. India has reacted defensively to American patents based on their TK.

The Indian Biological Diversity Act has introduced a number of provisions that will make

foreign companies deal with a central authority in order to gain access to Indian biological

materials, including TK.

A. The application of patent is barred by the TK under National Biological

Diversity Act and Convention on Biological Diversity.

Traditional knowledge is typically defined either as knowledge developed by indigenous

communities1 or "tradition-based literary, artistic or scientific works, performances, inventions,

scientific discoveries, designs, marks, names, symbols, undisclosed information and all other

tradition-based innovations and creations resulting from intellectual activity in the industrial,

1
Gervais 2005 Mich St L Rev 140.

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literary or artistic fields."2 The State of Toqoi is ecologically and culturally rich in biodiversity.

This range is also designated to be protected as a representative ecosystem and the natural or

cultural sceneries by the Ministry of Forest and Environment of the Sate of Toqoi. The Kehuars,

the indigenous community firmly believes in traditional ethno medicines and treatment methods.

Their traditional medicines are being prepared by the Kehuars from the medicinal plants which

they conserve, nurture and preserve for centuries. Traditional medicine includes knowledge and

practices either codified in writing or transmitted orally. T K is thus the totality of all knowledge

and practices, whether explicit or implicit, used in the management of socio-economic and

ecological facets of life. This knowledge is established on past experiences and observation. It is

usually a collective property of a society. Many members of the particular society contribute to it

over time, and it is modified and enlarged as it is used over time. This knowledge is transmitted

from generation to generation.

 Traditional knowledge Under U.N Convention On Biological Diversity

The State of Toqoi is a part to the United Nations Convention On Biological Diversity and has

enacted the National Biodiversity Act, which sets the regulation of biological resources in any

commercial processes, and its transportation and uses in other countries. The authority appointed

under the Act grants the permits and licenses for the same. The primary goal of the convention is

to conserve biological diversity, promote sustainable use of its components, and promote a fair

and equitable sharing of benefits from the use of genetic resources. The CBD established that

sovereign nations have ownership of their TK and biological resources. Thus, State of Toqoi has

the entire ownership over its genetic resources as well as the knowledge regarding the same.

2
WIPO "Intellectual Property Needs" 25.

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The Preamble of the CBD states: “Recognizing the close and traditional dependence of many

indigenous and local communities embodying traditional lifestyles on biological resources, and

the desirability of sharing equitably benefits arising from the use of traditional knowledge,

innovations and practices relevant to the conservation of biological diversity and the sustainable

use of its components.”3

Articles 8(j), 10(c) and 18(4)4 make reference to the rights of indigenous and local people.

 “Each contracting party shall, as far as possible and as appropriate, subject to its national

legislation, respect, preserve and maintain knowledge, innovations and practices of

indigenous and local communities embodying traditional lifestyles relevant for the

conservation and sustainable use of biological diversity and promote their wider

application with the approval and involvement of the holders of such knowledge,

innovations and practices and encourage the equitable sharing of the benefits arising from

the utilization of such knowledge, innovations and practices.” 5

 Each Contracting Party “shall protect and encourage customary use of biological

resources in accordance with traditional cultural practices that are compatible with

conservation or sustainable use requirements.” 6

 CBD defines “technologies” broadly to include “indigenous and traditional

technologies.”7

3
The Convention on Biological Diversity came into force on 29 December 1993. Text available at
http://www.biodiv/org/doc/legal/cbd-un-en.pdf (last visited JAN 5, 2019).
4
Convention on Biological Diversity
5
Article 8(j) of CBD

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The provision under Article 8(j) of CBD provides a two face definition. The first deals with the

dependence on certain lifestyles on biological resources while the other deals explicitly with

rights. Instead of using the broad term ‘traditional knowledge’ alone, the document qualifies it

with the terms ‘innovations and practices.’ TM is not specifically mentioned in the 1982 model

provisions, but there is little doubt that it is included in the CBD as a ‘practice.’ The CBD also

draws a distinction between indigenous and local communities. However, TK from either source

is considered equivalent. The use of the term ‘traditional’ however, carries with it a major

assumption. It suggests that there has been a period of cultural transmission that remains faithful

to the past.8 The CBD, in including local communities in the same formulation, effectively

sidesteps the issue of faithfulness to the past.

This provision tries not to restrict exploitation of resources by either the sovereign national

government or the international community. Elements of the CBD, including provision 8(j) has

had a significant impact on the laws of some countries. The Indian Biological Diversity Act

,2002 clearly follows the CBD. While the US is not a signatory, there is increasing international

pressure to recognize benefit sharing as an objective.

Convention on Biological diversity9 provides that Each Contracting Party shall, as far as possible

and as appropriate:

a) Integrate consideration of the conservation and sustainable use of biological resources into

national decision-making;

6
Id., Article 10
7
Id., Article 18(4)
8
See Tony Simpson, The Protection of Cultural and Intellectual Property Rights of Indigenous Peoples
INTERNATIONAL WORK GROUP FOR INDIGENOUS AFFAIRS 18-22 (1997).
9
Supra note 4 @ Article 10

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b) Adopt measures relating to the use of biological resources to avoid or minimize adverse

impacts on biological diversity;

c) Protect and encourage customary use of biological resources in accordance with traditional

cultural practices that are compatible with conservation or sustainable use requirements;

d) Support local populations to develop and implement remedial action in degraded areas where

biological diversity has been reduced;

Recognizing the sovereign rights of States over their natural resources, the authority to determine

access to genetic resources rests with the national governments and is subject to national

legislation.10 The Sate of Toqoi has the sovereign national authority to deal with its traditional

resources. The provisions dealing with the National powers for the protection of TK are as

follows.

 Traditional knowledge Under National Biodiversity Act,2002

The Indian Biodiversity Act in its preamble provides “for conservation of biological diversity,

sustainable use of its components and fair and equitable sharing of the benefits arising out of the

use of biological resources, knowledge and for matters connected therewith or incidental

thereto.” It is also considered necessary to provide for conservation, sustainable utilization and

equitable sharing of the benefits arising out of utilization of genetic resources and also to give

effect to the said Convention.

No person shall apply for any intellectual property right (IPR), by whatever name called, in or

outside India for any invention based on any research or information on a biological resource

10
Id., Article 15

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obtained from India without obtaining the previous approval of the National Biodiversity

Authority (NBA) before making such application. 11

Any person referred to in sub-section (2) of section 3 who intends to obtain any biological

resource occurring in India or knowledge associated thereto for research or for commercial

utilization or for bio-survey and bio-utilization or transfer the results of any research relating to

biological resources occurring in, or obtained from, India, shall make application in such form

and payment of such fees as may be prescribed, to the NBA. 12

No person who has been granted approval under section 19 shall transfer any biological resource

or knowledge associated thereto which is the subject matter of the said approval except with the

permission of the NBA.13

The NBA may, on behalf of the Central Government, take any measures necessary to oppose the

grant of intellectual property rights in any country outside India on any biological resource

obtained from India or knowledge associated with such biological resource which is derived

from India.14

No person shall, without the previous approval of the National Biodiversity Authority, transfer

the results of any research relating to any biological resources occurring in, or obtained from,

India for monetary consideration or otherwise to any person who is not a citizen of India or

citizen of India who is non-resident as defined in clause (30) of section 2 of the Income-tax Act,

11
Section 6(1) of Biological diversity Act,2002
12
Id., S. 19(1)
13
Id., S. 20(1)
14
Id., S. 18(4)

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1961 or a body corporate or organization which Is not registered or incorporated in India or

which has any non-Indian participation in its share capital or management. 15

The product was invented by two members of the Kehaur community itself. Access to their

genetic resources is perhaps justified by Section 3 of CBD. However by virtue of Section 4, the

Ojibwe Industries Inc., was prevented from taking the ownership of the invention for commercial

purposes as it is a body corporate or organization not registered within India.

Thus from the purview of CBD and National Biological Diversity Act, it is clear that there is a

clear-cut interference in to the traditional knowledge of the indigenous community without their

informed consent.

B. The respondent has committed bio piracy under National Biodiversity

Act and CBD

Bio-piracy means the practice of commercially exploiting naturally occurring biochemical or

genetic material, especially by obtaining patents that restrict its future use, while failing to pay

fair compensation to the community from which it originates. 16

The indigenous people in tropical countries did not use their traditional knowledge for

commercial purposes as such, they were able to maintain their indigenous knowledge without

any damage within past centuries. But today, as biological resources and related knowledge

become a source of high priced assets in the capital market, biodiversity is now transformed into

a valuable commodity worldwide. Although there are many legal frameworks in internationally

and locally to prevent the Bio-piracy, cause the mal-functioning of these existing legal elements.

15
Id., S.4

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Bio-piracy becomes one of a most serious environmental issue in the world. 17

The patenting of (often spurious) inventions based on biological resources and/or traditional

knowledge that are extracted without adequate authorization and benefit-sharing from other

(usually developing) countries, indigenous or local communities is termed as patent based

biopiracy.

To check misappropriation of Indian biological resources, the Act provides that access to Indian

biological resources and associated knowledge are subject to terms and conditions, which secure

equitable sharing of benefits. Further, it would be required to obtain the approval of the NBA

before seeking any IPR based on biological material and associated knowledge obtained from

India. 18

A number of cases relating to traditional knowledge have attracted international attention. As a

result, the issue of traditional knowledge has been brought to the fore of the general debate

surrounding intellectual property. These cases involve what is often referred to as “biopiracy”.

The examples of turmeric, neem and ayahuasca illustrate the issues that can arise when patent

protection is granted to inventions relating to traditional knowledge which is already in the

public domain. In these cases, invalid patents were issued because the patent examiners were not

aware of the relevant traditional knowledge. In another example, a patent was granted on a plant

species called Hoodia. Here, the issue was not whether the patent should or should not have been

granted, but rather on whether the local people known as the San, who had nurtured the

16
en.oxforddictionaries.com – ‘Biopiracy
17
Bio-piracy and its impact on Biodiversity: A special review on Sri Lankan context.. Available from:
https://www.researchgate.net/publication/324312963_Biopiracy_and_its_impact_on_Biodiversity_A_special_revie
w_on_Sri_Lankan_context [accessed Jan 05 2019].
18
The Biological Diversity Act,2002 , S. 13

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traditional knowledge underpinning the invention, were entitled to receive a fair share of any

benefits arising from commercialisation.

Indigenous peoples have the right to practice and revitalize their cultural traditions and customs.

This includes the right to maintain, protect, and develop the past, present and future

manifestations of their cultures, such as . . . ceremonies and technologies . . . as well as the right

to the restitution of cultural, intellectual, religious and spiritual property taken without their free

and informed consent or in violations of their laws, traditions, or customs. 19

In the recent past, there have been several cases of bio-piracy of TK from India. First it was the

patent on wound-healing properties of haldi (turmeric); now patents have been obtained in

other countries on hypoglycaemic properties of karelu (bitter gourd), brinjal, etc. An

important criticism in this context relates to foreigners obtaining patents based on Indian

biological materials without acknowledging the source of their Knowledge or sharing the

benefits. There is also the view that the TRIPS Agreement is aiding the exploitation of

biodiversity by privatizing biodiversity expressed in life forms and knowledge. Thus the unjust

superiority of TRIPS agreement over National Biological Diversity should be curtailed for the

effective protection of indigenous knowledge.

So it can be concluded that though several provisions of Biological Diversity Act are

progressive, yet there remain important weaknesses in various sectors. The Act does not provide

a comprehensive framework for the conservation and sustainable use of biological resources. Its

response to the current challenges is to assert the country’s sovereign rights over natural

resources. It therefore proposes to put stringent limits on access to biological resources or related

19
Article 12 of United Nations declaration on the rights of indigenous peoples of 1994

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knowledge for all foreigners. In fact, it focuses mainly on the question of access to resources. As

far as the issue of IPR is concerned, the Act is primarily defensive in its intent, enacted to

prevent the bio piracy of India’s natural resources.

In the current case the knowledge used by the kehuar community was willfully misappropriated

for commercial purposes by the OII. The requirements under the Biological Diversity Act and

the CBD were not followed by the patent applicant. The main issue is that there is no prior

informed consent from the community. Further the ex-situ cultivation of the three species of

plants cannot be justified. Because these plants are endemic to the region where the State of

Toqoi is geographically located and is listed in the endangered plant species list of the State of

Toqoi. The contracting parties shall Establish and maintain facilities for ex-situ conservation of

and research on plants, animals and micro-organisms, preferably in the country of origin of

genetic resources.20 The contracting parties shall further adopt measures for the recovery and

rehabilitation of threatened species and for their reintroduction into their natural habitats under

appropriate conditions.21 Even though ex-situ cultivation has been carried out in three countries

who are parties to CBD, it was not their natural habitat.

Each natural product has its own method of preparation that has been developed from generation

to generation within these communities. It is this specialized knowledge that is now sought by

bioprosepecting companies. Thus it is clear that there is an invasion by misappropriating the

traditional knowledge of indigenous communities for the purpose of seeking exclusive patent

ownership over the knowledge.

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II. The granted patent for ‘Rausilux’ can be revoked on the basis of

anticipation and prior art .

It is submitted that the element of novelty has been challenged by anticipation and prior art. So

the basic requirement for granting patent is not fulfilled; thereby the patent can be subjected to

revocation. It is pertinent to mention that the principles of anticipation by previous publication

and by prior claim are to be investigated under the Indian Patent Act and if found against the

patent claim, it would form a ground for revocation under the Act and when there are materials

on record to show that there was prior publication of the claim, the patent claim is liable to be

rejected. Further, The Marrakesh Agreement Establishing WTO between State of Parsinia and

Toqoi also provides an opportunity for judicial review of any decision to revoke or forfeit a

patent.

 Novelty under Indian law

India follows the principle of absolute novelty which may be construed by a joint reading of

sections 2 (1) and 13 of the Indian Patents Act, 1970. For a patent to qualify the test of absolute

novelty, it must be determined that it is not anticipated by previous publication in India and

elsewhere 22
and or by prior claiming in India .23It is pertinent to mention that the principles of

anticipation by previous publication and by prior claim are to be investigated under section 13 of

the Act and if found against the patent claim, it would form a ground for revocation under the

20
Article9(b) of CBD
21
Id., Article 9(c)
22
S. 13(1)(a) and S.13(2) of Indian Patent Act, 1970
S. 13 (1)(b).of Indian Patent Act, 1970
2323

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Act24 and when there are materials on record to show that there was prior publication of the

claim, the patent claim is liable to be rejected. 25

The Patent Act,1970 26


provides the grounds of opposition to patents and states that a patent

could be opposed on the ground that complete specification does not disclose or wrongly

mention the source or geographical origin of the biological material used for the invention 27.

This provision should have included traditional knowledge. The statute provides that an

invention may also be opposed when the invention so far as claimed in any claim of the complete

specification is anticipated having regard to the knowledge, oral or otherwise, available within

any local or indigenous community in India or elsewhere. 28 The object of Patent Act, 1970 is to

reward the genuine inventor by enabling him to commercially exploit the fruits of his labor by

conferring patent for his invention. It is possible that any dishonest person may hunt records and

present a published invention picked up from such records for patent. The act of presenting of

such invention, accepted or rejected by the Controller, for patent by an applicant is called

“anticipation”.

Sections 2(1)(j)29 and 2(1)(ja)30 of the Patents Act highlight the difference between a new

invention and an invention. A ‘new invention’ is defined as: “any invention or technology which

has not been anticipated by publication in any document or used in the country or elsewhere in

24
S. 64(1)(e) of Indian Patent Act, 1970
25
Novartis Ag. vs Adarsh Pharma And Anr. on 28 April, 2004, 2004 (3) CTC 95
26
S. 25 , Indian Patent Act,1970
27
Id.,S. 25(1)(j)
28
Id., S. 25(1)(k)
29
"invention" means a new product or process involving an inventive step and capable of industrial application;
30
"inventive step" means a feature of an invention that involves technical advance as compared to the existing
knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in
the art;

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the world before the date of filing of patent application with complete specification, i.e., the

subject matter has not fallen in public domain or that it does not form part of the state of the art.

In order to proceed for patent it is necessary to check whether the said invention is patentable or

not. For that three essential requirements have to be fulfilled.

1) Novelty (i.e. the invention should be new and should not be anticipated by any prior

published document(s) (prior art)).

2) Inventiveness (i.e. the invention should be non-obvious to a person skilled in the art).

3) Industrial Application (i.e. the invention should be capable of use industrially)

Among them the most prominent one is that of novelty.

In the case of Bishwananth Prasad Radhey Shyam v. Hindustan Metal Industries, the Supreme

Court observed: “The fundamental principle of Patent Law is that a patent is granted only for an

invention which is new and useful.”31

Mere Discovery Of A New Form Of Known Substance

A mere discovery of a new property of known substance is not considered patentable. For

instance, the paracetamol has antipyretic property. Further discovery of new property of

paracetamol as analgesic cannot be patented. Similarly, ethyl alcohol is used as solvent but

further discovery of its new property as anti knocking, thereby making it usable as fuel, cannot

be considered patentable.32

31
Bishwananth Prasad Radhey Shyam v. Hindustan Metal Industries, (1979) 2 S.C.C. 511.
32
http://ipindia.nic.in/ipr/patent/Patent_Manual_Feedback/ FICCI%27s_comments.pdf

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For 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.”

Thus, the provision aims to restrict the scope of patent protection in pharmaceuticals by

excluding incremental innovation which does not meet the criteria of enhanced efficacy. In other

words, the provision can be viewed as heightened non-obviousness standard which must be

satisfied by a new form to be eligible for patentability, in addition to the non-obviousness test

used for measuring the inventive step criteria. For instance, in Pfizer Inc v. Apotex, Inc 33,

Pfizer’s patent on a hypertension drug was invalidated as its active ingredient was a salt form of

a known substance. Increasingly, evidence of TM can be used to destroy novelty in some

jurisdictions, but in the US the situation is much more difficult.

 Novelty Under U.S Patent Law

Even in countries like US, the courts very often use double patenting doctrine and the patent

misuse doctrine to prevent patenting of new forms of already known substances and curb

evergreening. Double patenting doctrine like Section 3(d) prevents an inventor from claiming

more than one patent on the same invention or obvious modifications or alterations of the

same. 34 The Patent Act governs what can be protected via patents in the US. 35 The invention

must fall in one of three categories: ‘manufacture,’ ‘process,’ or a ‘composition of matter.’ 36 In

33
488 F.3d 1377 (Fed. Cir. 2007)
34
https://www.lawteacher.net/free-law-essays/commercial-law/section-3-of-the-indian-patents-act-commercial-law-
essay.php#ftn36
35
35 U.S.C. Ss. 101-104 (1988)
36
Id., s. 101

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practice, not all categories offer the same level of protection. For instance, a drug may not be

protected by a utility patent because it is not possible to prove it is a ‘manufacture’ or

‘composition of matter’. In this case, the process itself could be patented. This was the case with

“Reserpine”, a drug used to treat hypertension, which was derived from the plant Rauvolfia

serpentnia. 37
Process patents can protect the method used to produce (either manufacture or

isolate) a drug. These patents are regarded as fairly weak in relation to a patent on the product

itself. An alternative way to make a substance could be found that it would not infringe. In

contrast, even if a producer found a way to make a substance in a different way and protected by

a ‘composition of matter’ patent, it would infringe.

The US patent law specifies the general field of subject matter that can be patented and the

conditions under which a patent may be obtained. In the language of the statute, any person who

“invents or discovers any new and useful process, machine, manufacture, or composition of

matter, or any new and useful improvement thereof, may obtain a patent,” subject to the

conditions and requirements of the law. The word “process” is defined by law as a process, act,

or method, and primarily includes industrial or technical processes. The term “composition of

matter” relates to chemical compositions and may include mixtures of ingredients as well as new

chemical compounds. These classes of subject matter taken together include practically

everything that is made by man and the processes for making the products.

A successful patent, of whatever category, must also be useful 38, novel39 and be non-obvious.

Utility is a test to make sure that the public can benefit, which is easy to satisfy in the case of

most drugs. Novelty makes sure that the claimed inventor has patented something that is new.

37
U.S. Patent No. 2,833,771 (filed 1958)
38
35 U.S.C. S.101

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Increasingly, evidence of TM can be used to destroy novelty in some jurisdictions, but in the US

the situation is much more difficult.

An overview of United States patent law is compulsory given its impact on international patent

standards. Additionally, the strength of US patent protections has led many foreigners to patent

in the United States. 40


The United States Patent Act requires an inventor to meet three

conditions when applying for a patent: (1) novelty, (2) non-obviousness, and (3) utility. 41 Each of

these requirements is analyzed below.

The novelty requirement of the US Patent Act is presented in section 101 and 102. 42 Section

101 requires that the invention be "new," while section 102 requires the invention be "novel." 43

However, case law has established that section 102 encompasses section 101; thus, if an

invention satisfies the novelty requirement, the new requirement is also met. 44 The novelty

requirement is generally met unless the invention is patented or depicted in a publication in the

US or a foreign country.45 To determine novelty, patent examiners inquire into the current state

of the art as a basis for comparison.46 This is done by comparing the invention to other patents

and publications under section 102, including any evidence of uses or sales of the invention

within the US; the sum of these references is considered "prior art." 47
Once prior art is

established, an inquiry is made to determine whether the invention described in a patent

39
Id., Ss.101-102
40
R. Carl Moy, The History of the Patent Harmonization Treaty: Economic Self-Interest as an Influence, 26 J.
MARSHALL L. Rev. 457, 491 (1993)
41
35 U.S.C. Ss. 101-103.
42
Supra note 39
43
Ibid
44
See In re Bergstrom, 427 F.2d 1394, 1401 (C.C.P.A. 1970).
45
35 U.S.C. S. 102(a)
46
Ibid
47
ROGER E. SCHECTER & JOHN R. THOMAS, PRINCIPLES OF PATENT LAW: CONCISE HORNBOOK
SERIES 1, 74 (2004).

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application is indistinguishable from any of the prior 48


art references. If the purported invention

is identical 49to any one of those prior art references, it lacks novelty and no patent will be issued.

The United States Patent Act also requires that inventions or discoveries be non-obvious. 50 As

with section 102, prior art is also used to determine if an invention is obvious 51. Prior art is used

to determine if an invention is obvious to a person skilled in the art. 52 If so, the invention is

obvious and unpatentable. 53

In order for an invention to be patentable it must be new as defined in the patent law, which

provides that an invention cannot be patented if:

“(1) the claimed invention was patented, described in a printed publication, or in public use, on

sale, or ‘otherwise available to the public’ before the effective filing date of the claimed

invention” or

“(2) the claimed invention was described in a patent issued [by the U.S.] or in an application for

patent published or deemed published [by the U.S.], in which the patent or application, as the

case may be, names another inventor and was effectively filed before the effective filing date of

the claimed invention.”

In patent prohibition (1), the term “otherwise available to the public” refers to other types of

disclosures of the claimed invention such as, for example, ‘an oral presentation’ at a scientific

48
Ibid
49
Ibid
50
35 U.S.C. S. 103.
51
Supra note 47 @151.
52
Ibid
53
Ibid

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meeting, a demonstration at a trade show, a lecture or speech, a statement made on a radio talk

show, a YouTube™ video, or a website or other on-line material.

“A person shall be entitled to a patent unless: “the invention was known or used by others in this

country, or patented or described in a printed publication54 in this or foreign country, before the

invention thereof by the applicant for a patent.” 55


If an invention were known or used56 in the

USA, there is no need for it to be in a printed publication in order to bar a subsequent patent by

another party. ‘Knowledge’ does not refer to what is known or understood in an abstract sense. 57

Even if a TM practice were ancient, and published without the permission of the community,

there could be a bar to a patent application under 35 U.S.C. S.102 (b). 58 Even academics with no

thought of financial gain could be considered bio-pirates.

In the absence of any accessible written record, a patent examiner in another country is unable to

access documentation that would challenge the novelty or inventiveness of an application based

on traditional knowledge. The only option for an aggrieved party, be it the holders of the

knowledge, or someone representing them, is to challenge the patent during the granting process

or after grant, where national laws permit. For instance, this is what the Indian Government

achieved by overturning the patents on basmati and turmeric in the US. The presence of

administrative or quasi-judicial patent opposition or re-examination procedures has facilitated the

overturning of these patents. In the absence of such procedures it would have been necessary to

instigate proceedings before the relevant court with the inherent cost and time implications. Even

54
See Steven J. Rothschild & Thomas P. White, Printed Publication: What is it Now?, 70 J. PAT & TRADEMARK
OFF. SOC’Y 42 (1988).
55
Supra Note 16 @ s.102(a)
56
See DONALD CHISUM, PATENTS: A TREATISE ON THE LAW OF PATENTABILITY, VALIDTY AND
INFRINGEMENT
57
United States v. Adams, 383 U.S. 39, 148 U.S.P.Q. (BNA) 479 (1966).

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with such procedures, it is extremely difficult and costly for developing countries to monitor and

challenge IPRs issued all around the world.

Prior art is any evidence that your invention is already known. Prior art does not need to exist

physically or be commercially available. It is enough that “someone, somewhere, sometime

previously has described or shown or made something that contains a use of technology that is

very similar to your invention.”59

Anything already in the public domain is not considered novel as it is “prior art.” 60 Since

traditional knowledge generally has been public within the society for centuries, it falls within

the public domain.61 The US Patent Act specifies that the invention should not be obvious to one

skilled in the art.62 Traditional knowledge will not qualify for this test either—making patent

protection of this knowledge difficult.

Patent laws generally require an invention to be universally novel if it is to qualify for a patent.

Where a product or process already forms part of the state of art at the time of the filing of the

first patent application, a patent may not be granted as the subject matter lacks the required

novelty. Here in this case, the knowledge about this medicine and its use are part of the state of

art and the patent grant was completely wrong and it need to be revoked. Much TK is

customarily transmitted orally, and is not normally reduced to a written or fixed form. This has

led to concerns that, to the extent that any patent law system specifically recognizes documented

or written knowledge when determining the validity of patent claims, there is the possibility of

58
See Gelvina Rodriguez Stevenson, Trade Secrets: The Secret to Protecting Indigenous Ethnological (Medicinal)
Knowledge, 32 N.Y.U. INT’L. L. & POL. 1119, 1137 (2000).
59
European Patent Office
60
See 35 U.S.C. S. 102 (2000).
61
Article 54 of the European Patent Treaty also refuses to grant patents to things that fall within the purview of “the
state of art.”

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claimed inventions being deemed valid, even when they may involve the appropriation of orally

disclosed TK. The concern is that this would prejudice the interests of those communities with a

stronger oral tradition. From the legal perspective, it is possible to recognize orally disclosed

material as being relevant prior art, and this recognition may be universal, in the sense that

knowledge disclosed by any means, in any geographical location, may be considered as prior art

relevant to the novelty of a claimed invention. 63

Under Patent laws, to be eligible for patent, the invention must involve any innovation or

technology the knowledge of which is not previously acquired, i.e. not anticipated by publication

in any document or used in the country or elsewhere in the world before the date of filing of

patent application with complete specification. Here we can clearly state that these knowledge

are previously known to the people and it is a case of Bio-piracy. Biopiracy refers to the

appropriation of the knowledge and genetic resources of farming of indigenous communities by

individuals or institutions who seek exclusive monopoly control (patents or intellectual property)

over these resources and knowledge64 Biopiracy has emerged as a term to describe the ways by

which the corporations from the developed world claim ownership of or otherwise take unfair

advantage of or free ride on the genetic resources and traditional knowledge and technologies of

developing countries.

62
See 35 U.S.C. S. 103 (2000).
63
See, for example, the proposal under consideration by the Standing Committee on the Law of Patents, document
SCP/9/2, p. 21.
64
ETC Group on Biopiracy, available at: http://www.etcgroup.org/issues/biopiracy

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One of the most known activists against Biopiracy is the Indian scientist Vandana Shiva. She

interprets the term in the following way:

“Biopiracy refers to the use of intellectual property systems to legitimize the exclusive

ownership and control over biological resources and biological products and processes that have

been used over centuries in non-industrialized cultures.” 65

Perhaps the most contentious issue of Biopiracy is related to patenting. For the ETC Group

(before RAFI) biopiracy is “the privatization of genetic resources (including those derived from

plants, animals, microorganisms and humans) from those people who hold, maintain, embody,

develop, breed or otherwise create, foster or nurture those resources” and “the biopirates’ most

frequent modus operandi is intellectual property”. The organization, which claim to have coined

the term biopiracy at the beginning of the 90s, states that “if a resource is privatized through the

patent system, it is likely that a community that once had access to the resource will no longer

have the legal right to use it or may no longer afford to buy it” (ETC Group, 2004). Exploring

how frequent and damaging the patenting of genetic resources is, we have found different

situations. In a number of cases, patents were granted before the CBD was in force, like the

patent granted to Terumo Corp. for extracts of the Neem Tree bark in 1983. In others, the patents

have expired by lack of payment, such as the patents US 5688772 and US 5597807 granted to

the University of Saskatchewan for the Bolivian Quinoa plant extract. Some patents have been

revoked after challenge. This is the case of the patent EP 0436257 over extracts with fungicide

action derived from the Neem Tree and granted to W.R. Grace; and the patent US 5401504

protecting the use of Turmeric as wound healer. Currently, the patent protecting Ayahuasca is

65
V. SHIVA, Protect or Plunder? Understanding Intellectual Property Rights, London, Zed Books, 2001, 49.

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being re-examined, and the patents granted to Pure World Botanicals for extracts of the Maca

plant are to be challenged by the Peruvian government (Singh, 2004).

 Revocation, Pre-Grant Opposition & Post Grant Opposition

In any suit for infringement of a patent every ground on which it may be revoked shall be

available as a ground of defence. 66


A division bench of the Honorable Delhi High Court67 held

that it is not sufficient merely to have registration of the patent and that the court must look at the

whole case of the patentee and the strength of the defence such as those falling under section 107

of the Act conjointly read with section 64 of the Act. A granted patent may be revoked by any

person interested in a counter claim in a suit for infringement of the patent by the High Court on

the ground that the invention so far as claimed in any claim of the complete specification is not

new, having regard to what was publicly known or publicly used in India before the priority date

of the claim or to what was published in India or elsewhere in any of the documents referred to

in section 13 of the Act.68 Similarly, a published pending patent application may be opposed by

any person against the grant of a patent under section 25 (1)(b), (c) and (d) and a granted patent

may be opposed by any person interested within a period of one year of grant from the

publication of grant under section 25 (2) (b), (c) and (d). In such circumstances the onus is on the

opponent to prove the ground for prior publication and to submit any evidence to the fact that the

invention is obvious. 69

66
Section 107 of the US PatentAct
67
Franz Xaver Huemer v. New Yash Engineers, AIR 1997 Del 79
Section 64 (e) of the US PatentAct
6868
69
Patent No. 151977 of M/s. Jaya Hind Industries Limited (Applicants) for “External Rotor Assembly for a
Magneto”

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 The Neem Patent at the EPO

The European Patent Office (EPO) did not uphold the granting of the patent; it rejected it for

lack of inventive step. Patents are granted on the basis of novelty, inventive step, and suitability

of indus-trial application70. Novelty is determined in relation to the state of the art, which

according to Article 54(2) of the Munich convention means: “... everything made available to the

public by means of a written or oral description, by use, or in any other way, before the date of

filing of the European patent application.” Unlike the case for the US system, where there is a

clear division between information originating inside and outside the state, there is no such

distinction here. The EPO can consider prior art that could be embodied orally or in practice, and

not simply according to printed sources. These provisions clearly protect TK, the bulk of which

is not written. In the Neem case, however, the EPO did not consider TK rights per se. Likewise

in this case, there is no novel invention for the drug Rausilux.

The Marrakesh Agreement Establishing WTO between State of Parsinia and Toqoi also provides

an opportunity for judicial review of any decision to revoke or forfeit a patent. 71

Thus from the Indian perspective and US perspective ; the Patent Act sets out the necessity of

novelty for granting patent to an invention. The various provisions make it mandatory to include

an inventive step in order to be eligible for patent. However the facts in question never provided

for an element of novelty in the said invention. In fact the components used for the manufacture

of the medicine was already being known and used by the traditional community of kehuar. It

was proved to be the indigenous knowledge of their community by their persistent use. Hence

the novelty is challenged by the anticipation and prior art

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CONCLUSION

Traditional knowledge, as we have observed, is communal property, passed on from one

generation to the next. If it is protected under intellectual property law it would be privatized,

and this may deny future generations and industry access to such knowledge. It is crucial to

remember that the underlying purpose of IPR is to turn knowledge into a marketable commodity,

not to conserve such knowledge in its most fitting cultural context. This goal necessarily

translates into a focus on segregating and isolating information into identifiable and manageable

pieces that can be protected by law as intellectual property. In contrast, ethno botanical

knowledge by its very nature is integrative, holistic, and synergistic. It is most meaningful in situ

where plants are understood in relation to the ecological and cultural environments in which they

have been grown, managed, and used by local residents. IPR departs from such traditions by

valuing the discrete properties of plants that can most easily be taken out of their natural and

cultural context and replicated through artificial selection in a laboratory or greenhouse. Given

the legal premises upon which IPR are based, it is unlikely that IPR will ever be a useful model

for protecting ethnobotanical knowledge.” The “inventive step” and “capable of industrial

application” requirements are deemed “to be synonymous with the terms ‘non-obvious’ and

‘useful’ respectively.” Traditional knowledge products fail the test for patenting on one, or all, of

the “new”, “inventive step” and “industrial application” standards. On the “new” standard they

will probably fail because by its very nature traditional knowledge has been known for some

length of time. One could try and argue that traditional knowledge is new to the world outside of

the community from which it came but this is unlikely to succeed.

70
Article 52(1) of the Munich Convention.

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The major criticism of American patent law on this point is its state-centric nature. The United

States operates under a system of geographically specific notions of printed publications to

determine prior art. Scholars argue that American patent law thus "waters down the novelty

requirement by patenting inventions known or used in foreign countries as long as they have not

been patented in a printed publication." 72


Developing countries which do not have strong

systems of patent protection could therefore suffer, and traditional knowledge could be exploited

in the United States. Indeed, the cultural and economic damage that this regime could cause to

indigenous people is mammoth.

71
Section 32 of The Marrakesh Agreement Establishing WTO
DeGeer 2003 New Eng J Int'l & Comp L 364.
72

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PRAYER

In the light of the issues raised, arguments advanced and authorities cited, the counsel for

the Petitioner humbly prays and implore before this Hon’ble Applellate Court to kindly

adjudge :-

1. The application of patent is barred by the TK under National Biological

Diversity Act and Convention on Biological Diversity.

2. The respondent has committed bio piracy under National Biodiversity Act and

convention on biological diversity

3. The element of novelty is challenged by anticipation and prior art.

4. The granted patent can be revoked on the basis of anticipation and prior art.

And pass any order as the Court may deem fit. And for this act of kindness the Petitioner

as in duty bound forever shall pray.

COUNSEL FOR PETITIONER

MEMORIAL FOR THE STATE OF TOQOI 38

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