Documente Academic
Documente Profesional
Documente Cultură
JANUARY 12th-13th
TABLE OF CONTENTS
1. List of Abbreviations………….…………………………………………………...3-4
2. Index of Authorities…………….………………………………………….………5-7
Table of Cases
Books
Websites
Statutes
5. Statement of Issues…………………….…………………………………….…….11
6. Summary of Arguments……………….……………………………………….….12
7. Arguments Advanced………………….…………………………………………..13-34
Issue-2: Whether the granted patent for ‘Rausilux’ can be revoked on the basis of
8. Conclusion………………………………………………………...…………….….36-37
9. Prayer …………………………………………………………..…………...……...38
ABBREVIATIONS
Ibid Ibidem
Id., Ibid
Inc. Incorporation
S. Section
TK Traditional Knowledge
TM Traditional Medicine
UN United Nations
US United Sates
INDEX OF AUTHORITIES
TABLE OF CASES
511
No.493
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)
13. United States v. Adams, 383 U.S. 39, 148 U.S.P.Q. (BNA) 479 (1966)
BOOKS
5. Emily Marden, The Neem Tree Patent: International Conflict over the
6. Bennett, Bradley C. Hallucinogenic plants of the Shuar and related indigenous groups
WEBSITES
1. en.oxforddictionaries.com – ‘Biopiracy
3. http://ipindia.nic.in/ipr/patent/Patent_Manual_Feedback/ FICCI%27s_comments.pdf
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_
STATUTES
8. WIPO
9. TRIPS Agreement
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.
(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.
claims of a patent on any ground that could be raised under paragraph (2) or (3) of section 282(b)
(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
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
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
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
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
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
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
STATEMENT OF ISSUES
B. Whether the respondent has committed bio piracy under National Biodiversity Act
Issue-2: Whether the granted patent for ‘Rausilux’ can be revoked on the basis of
SUMMARY OF ARGUMENTS
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
ISSUE 2: Whether the granted patent for ‘Rausilux’ can be revoked on the basis of
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
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.
MEMORIAL FOR THE STATE OF TOQOI 12
CLEA (ASIA-INDIA) MOOTING COMPETITION -2019
ARGUMENTS ADVANCED
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
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.
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
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.
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
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
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
Each Contracting Party “shall protect and encourage customary use of biological
resources in accordance with traditional cultural practices that are compatible with
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
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
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
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
b) Adopt measures relating to the use of biological resources to avoid or minimize adverse
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
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.
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
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
obtained from India without obtaining the previous approval of the National Biodiversity
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
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
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)
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
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.
genetic material, especially by obtaining patents that restrict its future use, while failing to pay
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
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
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
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
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
traditional knowledge underpinning the invention, were entitled to receive a fair share of any
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
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
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
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
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
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
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
traditional knowledge of indigenous communities for the purpose of seeking exclusive patent
II. The granted patent for ‘Rausilux’ can be revoked on the basis of
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
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.
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
Act24 and when there are materials on record to show that there was prior publication of the
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;
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
1) Novelty (i.e. the invention should be new and should not be anticipated by any prior
2) Inventiveness (i.e. the invention should be non-obvious to a person skilled in the art).
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
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
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
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
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
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
practice, not all categories offer the same level of protection. For instance, a drug may not be
‘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
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
Increasingly, evidence of TM can be used to destroy novelty in some jurisdictions, but in the US
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
conditions when applying for a patent: (1) novelty, (2) non-obviousness, and (3) utility. 41 Each of
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
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).
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
In order for an invention to be patentable it must be new as defined in the patent law, which
“(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
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
meeting, a demonstration at a trade show, a lecture or speech, a statement made on a radio talk
“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
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
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
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).
with such procedures, it is extremely difficult and costly for developing countries to monitor and
Prior art is any evidence that your invention is already known. Prior art does not need to exist
previously has described or shown or made something that contains a use of technology that is
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
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.”
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
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
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
One of the most known activists against Biopiracy is the Indian scientist Vandana Shiva. She
“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
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.
being re-examined, and the patents granted to Pure World Botanicals for extracts of the Maca
In any suit for infringement of a patent every ground on which it may be revoked shall be
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”
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
The Marrakesh Agreement Establishing WTO between State of Parsinia and Toqoi also provides
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
CONCLUSION
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
70
Article 52(1) of the Munich Convention.
The major criticism of American patent law on this point is its state-centric nature. The United
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
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
71
Section 32 of The Marrakesh Agreement Establishing WTO
DeGeer 2003 New Eng J Int'l & Comp L 364.
72
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 :-
2. The respondent has committed bio piracy under National Biodiversity Act and
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