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IPR-II Project - 059

The document discusses the international framework for protection of plant varieties and traditional knowledge. It provides context on the development of intellectual property rights for plants and analyzes options for sui generis protection systems. It also examines examples of national approaches such as in India.
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0% found this document useful (0 votes)
49 views26 pages

IPR-II Project - 059

The document discusses the international framework for protection of plant varieties and traditional knowledge. It provides context on the development of intellectual property rights for plants and analyzes options for sui generis protection systems. It also examines examples of national approaches such as in India.
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

LAW AND AGRICULTURE

Dr. Ram Manohar Lohiya National Law University

Lucknow, U.P.

SUBJECT: Intellectual Property Rights-II

TITLE: SUI GENERIS PROTECTION FOR PLANT


VARIETIES AND TRADITIONAL KNOWLEDGE

Submitted to: Submitted By:


Dr. Vikas Bhati Irul Srivastava
Assistant Professor (Law) Section – ‘A’
RMLNLU Enroll. No. – 180101059

1
ACKOWLEDGEMENT

I owe a great many thanks to a great many people who helped and supported me during the
writing of this research project. I wish to express my deep appreciation to my teacher Dr
Vikas Bhati, for his guidance and persistent help without which completing this research
would not be possible. He continuously and convincingly conveyed his knowledge on the
subject and the right spirit and excitement for teaching. He has taken pain to go through the
project and make necessary correction as and when needed.

I would also thank my Institution and my faculty members without whom this project would
have been a distant reality.

I also extend my heartfelt thanks to my family, seniors and friends for their continuous
support and advice helping me to complete my project.

INTRODUCTION

The legal protection of plant breeders in developed countries goes back to the 1920s and
1930s.1 More recently, it has expanded dramatically with the various amendments of the
UPOV Convention2, and also following the ‘biotechnology revolution’, which in turn led to a
more liberal use of the principles of patent law for subject matter of a biological nature. 3

However, while the debate has advanced rapidly in the industrialised world, it is still
relatively new to developing countries, whose intellectual property systems are still focused
on the more conventional and established forms of intellectual property rights such as
trademarks and copyright. As in so many other fields of intellectual property, the WTO-
TRIPS Agreement accelerated the process of introducing intellectual property rights for plant
material to developing countries. The so-called ‘biotechnology clause’ of Article 27.3(b)
allows WTO member states to exclude plants and animals and essentially biological

1 See, e.g., the Plant Patent Act, 35 U.S.C. §§ 161-164 (1930).


2 International Union for the Protection of New Varieties of Plants.
3 LIONEL BENTLY & BRAD SHERMAN, INTELLECTUAL PROPERTY LAW (2003)

2
processes for the production of plants or animals from patenting, but it requires the
availability of patents for micro-organisms and non-biological and microbiological processes.
In addition, it requires protection for plant varieties, which member states may provide either
via the patent system or via an ‘effective sui generis’ system or by using a combination of the
two systems.4

Because of its potential impact on food security, traditional farming methods and the
livelihood of small-scale farmers in developing countries, the provision has been among the
most controversial aspects of the TRIPS Agreement. As a consequence, a provision was
made for a review of Article 27.3(b) four years after the WTO Agreement came into force.
However, this review process, which should have taken place in 1999, has been marred by
difficulties and even by disagreement over the meaning of the term ‘review.’ Some
developing countries have brought forward far-reaching proposals to amend Article 27.3(b).
The thrust of such proposals is to prohibit patenting of life forms and to strengthen the
traditional rights of farmers to the use of saved seeds (farmers’ rights), traditional knowledge
about plants and farming methods and the preservation of biological diversity. 5 Developed
country members of the WTO, on the other hand, have argued that any review of Article
27.3(b) should only concern the implementation of the provision. For developed country
members with advanced biotechnology industries such as the US, the aim is rather to
eliminate the exclusion from patentability of plants and animals and to restrict the freedom
for developing countries to develop their own sui generis systems for plant variety protection
by relying as far as possible on the UPOV Convention in its 1991 version.

Possible elements of such sui generis protection systems and their relationship to forms of
traditional knowledge are the subject of this article. In view of the concerns of developing
countries regarding patents in this field, many countries so far show a preference for sui
generis protection for plant varieties to the patenting option or a blending of the two systems.

The paper will begin with an explanation and an update of the international framework of the
debate and of the terminology used for various forms of traditional knowledge, which is
essential for an understanding of the national efforts that are undertaken in this field. It will
4 Margaret Llewelyn, Which Rules in World Trade Law – Patents or Plant Variety Protection, in
INTELLECTUAL PROPERTY: TRADE, COMPETITION AND SUSTAINABLE DEVELOPMENT 303-339
(Thomas Cottier & Petros C. Mavroidis eds., 2003).
5 UNITED NATIONS CONFERENCE ON TRADE AND DEVELOPMENT (UNCTAD) &
INTERNATIONAL CENTRE FOR TRADE AND SUSTAINABLE DEVELOPMENT (ICTSD), RESOURCE
BOOK ON TRIPS AND DEVELOPMENT 396-397 (2005) (submission to the WTO Council by the African
Group of Countries in 2003).

3
then analyse UPOV as the “ready-made” solution to implement plant variety protection and
discuss alternative models and additional provisions that provide practical solutions. Finally,
it will provide case studies of national approaches, that of the India. The example show quite
a more centralised approach to the administration of farmers’ rights and access to biodiversity
in India. Some of these differences are less accentuated if one examines the actual
implementation of the policies. In addition, with the recently released Protection,
Conservation and Effective Management of Traditional Knowledge Relating to Biological
Diversity Rules of 2009, India also attempts to move to more decentralised mechanisms for
access to traditional knowledge and benefit sharing.

THE INTERNATIONAL FRAMEWORK FOR TRADITIONAL KNOWLEDGE


ACCESS TO GENETIC RESOURCES AND PLANT VARIETY PROTECTION

While the use of intellectual property law related to life forms expanded, particularly in
industrially advanced countries, there has been a tightening of access to the biological
resources necessary for biotechnological research in the most bio diverse countries of the
world, which are predominantly developing countries. Thus, while the non-binding
International Undertaking on Plant Genetic Resources of 1984 still regarded plant genetic
resources as “heritage of mankind” and as freely accessible and exchangeable, 6 the 1992
6 Michael Blakeney, Intellectual Property Aspects of Traditional Agricultural Knowledge, in IP IN
BIODIVERSITY AND AGRICULTURE 44 (Peter Drahos & Michael Blakeney eds., 2001); Carlos Correa,
Access to Plant Genetic Resources and Intellectual Property Rights, in IP IN BIODIVERSITY AND
AGRICULTURE 105 (Peter Drahos & Michael Blakeney eds., 2001).

4
Convention on Biological Diversity (CBD) gave nation states “the sovereign right to exploit
their own resources pursuant to their own environmental policies” (Article 3, CBD) and
provided that “the authority to determine access to genetic resources rests with the national
governments and is subject to national legislation” (Article 15(1), CBD).7 The CBD
discourages neither biotechnological research (Article 19, CBD) nor intellectual property
rights (Article 16(2), CBD). However, intellectual property rights should be “supportive of
and not run counter to” the objectives of the CBD (Article 16(5)). Resource-rich parties are
required to “endeavour to create conditions to facilitate access to genetic resources for
environmentally sound uses” (Article 15(2), CBD), while technologically advanced users
shall provide access to and transfer of technology relevant for or resulting from the
sustainable use of genetic resources (Article 16, CBD) as well as participation in relevant
research projects (Article 15(6), CBD). Access to such resources shall be on “mutually
agreed terms” (Article 15(4), CBD) and with “prior informed consent” (Article 15(5), CBD)
and shall lead to fair and equitable sharing of “the results of research and development and
the benefits arising from the commercial and other utilization of genetic resources” (Article
15(6), CBD). Importantly, while the International Undertaking on Plant Genetic Resources
and the subsequent Plant Genetic Resources Treaty are confined to plants for food and
agriculture, the CBD extends also to plants for medicinal and pharmaceutical purposes.
Indeed, desire by providing countries of genetic resources to share in the profits made from
pharmaceutical research was a substantial reason for the negotiation of Article 15.8

While the parties to the convention are of course nation states, the CBD foresees an important
role for indigenous and local communities. According to Article 8(j) of the CBD, each party,
subject to its national legislation, is required to “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.” In other words,
parties to the Convention are required to pass on the benefits of the Convention and to
replicate benefit-sharing mechanisms at the local level.

7 The shift in the CBD was preceded by similar resolutions at the FAO conferences in 1989 and 1991 that added
Annexes to the International Undertaking on Plant Genetic Resources. See Gregory Rose, International Law of
Sustainable Agriculture in the 21st Century: Resources for Food and Agriculture, 15 GEO. INT’L ENVTL. L.
REV. 583, 602 (2003).
8 Id at

5
The shift to national sovereignty over biological resources has been further reaffirmed in the
International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA),
negotiated under the auspices of the United Nations Food and Agriculture Organization
(FAO). In creating a multilateral system of access and benefit sharing, the parties “recognize
the sovereign rights of States over their own plant genetic resources for food and agriculture,
including that the authority to determine access to those resources rests with national
governments and is subject to national legislation” (Article 10, ITPGRFA). However, in
contrast to the CBD, the ITPGRFA relates only to plant genetic resources for food and
agriculture and the multilateral system covers essential food crops listed in Annex I of the
Treaty. The Treaty promotes a standard material transfer agreement (MTA) with certain
mandatory provisions,9 including the limitation of access to food and agriculture related
purposes of utilisation and conservation for research, breeding and training (Article 12.3(a),
ITPGRFA), a prohibition for the recipients to claim intellectual property rights or other rights
limiting facilitated access (Article 12.3(d), ITPGRFA), the continuous process of making
available conserved resources by the recipients (Article 12.3(g), ITPGRFA) and the payment
of an equitable share of the benefits arising from the commercialisation of products
incorporating accessed materials to a Trust Account established by the Governing Body of
the Treaty (Article 13.2(d)(ii), ITPGRFA). The last mentioned article also provides that the
Governing Body may decide to establish different levels of payment for various categories of
recipients and may decide to exempt small farmers from developing countries or countries
with economies in transition from such payments.

In contrast to the bilateral mechanisms thus far available under the CBD, the access and
benefit sharing mechanism promoted by the ITPGRFA is a multilateral system. Since
payments to the envisaged trust fund are not mandatory for material “available without
restriction”, payments are mandatory mainly for plant patent holders, but not necessarily for
holders of plant breeders’ rights.10 Under the circumstances and given the absence of the main
patenting nations US and Japan from the ITPGRFA11, the available funds under the system

9 The predecessors of these MTAs are to be found in the agreements between the FAO and the International
Agricultural Research Centres (IARCs) within the Consultative Group on International Agricultural Research
(CGIAR). See supra note 7, at 595.
10 Charles R. McManis & Eul Soo Seo, The Interface of Open Source and Proprietary Agricultural Innovation:
Facilitated Access and Benefit-Sharing under the New FAO Treaty, 30 WASH. U. J.L. & POL’Y 405, 452-453
(2009) (it is argued that UPOV-compliant plant variety protection as well as intellectual property rights with
sufficiently broad ‘experimental use’ privileges will not ‘limit facilitated access’ under Article 12.3(d)).
11 The United States signed the treaty in 2002, but did not move further to accession, approval, acceptance and
ratification. See List of Contracting Parties, [Link] (last visited 20th
October 2018)

6
will remain very small and are unlikely to even cover the administrative costs of the treaty. 12
And while the ITPGRFA still covers in its Annex approximately 80-90 per cent of the most
vital crops, a number of vital crops were not included, because specific developing countries
were not willing to add them to the list.13

Similar to the CBD and the earlier International Undertaking on Plant Genetic Resources, the
ITPGRFA recognises the traditional knowledge of local and indigenous communities and of
farmers in Article 9 on ‘Farmers’ Rights. ’ In particular, it encourages national governments
to realise farmers’ rights by protecting and promoting traditional knowledge relevant to plant
genetic resources for food and agriculture, the right to equitably participate in sharing
benefits from the utilisation of plant genetic resources and the right to participate in decision
making at the national level on the conservation and sustainable use of food and agriculture
related plant genetic resources (Article 9.2, ITPGRFA). However, the treaty language is
couched in the most qualified terms. Parties have to protect and promote farmers’ rights “in
accordance with their needs and priorities” and “as appropriate, and subject to national
legislation.” Article 9.3 of the treaty reserves the traditional farmers’ privilege to “save, use,
exchange and sell farm-saved seed/propagating material, subject to national law and as
appropriate.”

Of the various provisions of the treaty, the obligation not to claim “intellectual property or
other rights that limit the facilitated access to the plant genetic resources for food and
agriculture, or their genetic parts or components, in the form received from the Multilateral
System” has been controversial. While the provision has been interpreted as not covering
intellectual property rights to germplasm modified by the recipient, 14 the provision is
regarded as one of the reasons for the absence from the treaty of both the US and Japan, the
two main countries active in the patenting of life forms.

Since the Johannesburg World Summit on Sustainable Development in 2002, an international


regime for access and benefit sharing is further being negotiated in the Ad Hoc Open-Ended
Working Group on Access and Benefit-Sharing of the Convention on Biological Diversity.

12 See supra note 10, at 460 (quoting a calculation by the NGO Berne Declaration that on the basis of an
estimated seed market of $30 billion in 2019, income from benefit-sharing will be as little as $2.31 million per
year
13 As for example with the inclusion of soybeans that was objected to by China. For this aspect of the debate
and for further examples, see supra note 7, at 616. See also supra note 10, at 460 (provides further examples).
14 Michael Blakeney, Bioprospecting and Biopiracy, in INTELLECTUAL PROPERTY AND BIOLOGICAL
RESOURCES 393, 417 (Burton Ong ed., 2004). The interpretation hinges on the term ‘in the form received’
which was one of the most contentious issues during the treaty negotiations, see supra note 10, at 453.

7
The latest meeting of the Working Group in Cali, Colombia, in March 2010 produced a
revised Draft Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of
Benefits Arising from their Utilization. The Working Group hopes to finalise negotiations on
the Draft Protocol in time for the next Conference of the Parties of the CBD in Nagoya,
Japan, in October 2010.15

THE CONCEPT OF FARMERS’ RIGHTS

It has often been said that the concept of Farmers’ Rights is based on equity considerations to
compensate traditional farmers for their past contributions in improving and making available
Plant Genetic Resources for Food and Agriculture (PGRFA). While the concept had already
been introduced in FAO discussions in the early 1980s and is now well established, the
debate has recently turned to the question of how to best implement farmers’ rights. Here, a
market based solution, that is treating Traditional Plant Genetic Resources for Food and
Agriculture (TPGRFA) as private goods is often contrasted with a compensation solution, in
which TPGRFA remain in the public domain, but the nation states where they occur are
empowered to negotiate compensation for their traditional farming sectors. Because of the
difficulties in assessing the value of landraces and other forms of TPGRFA, the focus in this
field has been on compensation approaches based on equity considerations, so that the use of
15 Conference of the Parties to the CBD, Ad Hoc Open-ended Working Group on Access and Benefit-Sharing,
Report of the First Part of the Ninth Meeting of the Ad Hoc Open-ended Working Group on Access and
Benefit-Sharing, U.N. Doc. UNEP/CBD/WG-ABS/9/3 (Apr. 26, 2010), available at
[Link]

8
‘rights’ in this context has been largely symbolic. This means also that the paradigm shift
from ‘heritage of mankind’ to proprietary concepts has been incomplete. While resources are
now under national control, this control has not yet been further devolved to local
communities, cooperatives or individuals. Further, the Multilateral System of the ITPGRFA,
designed to counter the emerging proprietary concepts in this field, has been described as “a
hybrid approach to agricultural innovation, combining open source and proprietary
elements.”16

16 Daniel Alker & Franz Heidhues, Farmers’ Rights and Intellectual Property Rights – Reconciling Conflicting
Concepts 14-15, available at
[Link]

9
ESSENTIAL AND FACULTATIVE ELEMENTS OF A SUI GENERIS SYSTEM FOR
PLANT VARIETIES

As the WTO-TRIPS Agreement does not make reference to the UPOV Convention, the
UPOV Acts of both 1978 and 1991 are suitable models for a national sui generis system.
However, if a country wants to join UPOV as such, it must adopt the 1991 version, as the
deadline for UPOV members to join the 1978 Act was 24 April 1999. 17 Whether a country
wants to join UPOV or adopt any of its Acts ultimately depends on its capacity and national
ambition in the field of plant breeding. Both Acts promote commercial plant breeding.
Because of the protection criteria of distinctness, uniformity and stability (commonly referred
to as the DUS criteria) they have been criticized for furthering the genetic uniformity of crops
and, thereby, being ultimately harmful to biodiversity. Both Acts are adequate for a country
that has ambitions and realistic hopes for its plant breeding industry in the near future. The
more ambitious and better positioned countries may want to join UPOV directly and thus
have to adopt the 1991 version of the Act. The 1991 version extends the rights of breeders in
comparison to the 1978 version. The acts which require authorization under UPOV 1991
include according to Article 14: production or reproduction, conditioning for the purposes of
propagation, offering for sale, selling or other marketing, exporting, importing and stocking
for the aforementioned purposes. This compares to the still relatively simple list of rights in
Article 5 of UPOV 1978, which is to authorise the production for purposes of commercial
marketing, the offering for sale and the marketing of the reproductive or vegetative
propagating material, as such, of the variety.18

More importantly, under UPOV 1991, the rights of the breeder also extend to the harvested
material obtained through the use of propagating material and of “essentially derived”
varieties. This means, first of all, that the so-called ‘farmers’ privilege’ of re-using harvested
seed from protected varieties no longer applies automatically, but it must now be specifically
implemented by a government concerned about traditional farming practices. It is, therefore,
now regulated as an exemption to breeders’ rights in Article 15 of the 1991 version.
Secondly, commentators from developing countries19 have expressed concern about the vague

17 Tshimanga Kongolo , Unsettled International Intellectual Property Issues 64 (2008).


18 Graham Dutfield , Intellectual Property Rights , Trade And Biodiversity 26-29 (2000).
19 Biswajit Dhar & Sachin Chaturvedi, Introducing Plant Breeders’ Rights in India – A Critical Evaluation of
the Proposed Legislation , 1 J. WORLD INTELL . PROP . 245 (2005).

10
criterion of the “essentially derived variety”, which they expect to be settled more often than
not through agreement or litigation rather than examination, thereby favouring the stronger
party.20 Even among those countries with ambitions to establish a commercial plant breeding
sector, the choice between the two UPOV versions is, therefore, one of graduation and
levelling out of the advantages and disadvantages. Countries with strong prospects for a
commercial plant breeding sector may opt for direct accession to UPOV and adoption of the
1991 version.21 The majority of the developing countries in Asia will probably be fairly
advanced in classical scientific breeding with a strong involvement of the public sector.
Adoption of one of the UPOV versions seems a possibility here, perhaps in some cases
modified along the lines of the various options outlined below.

For countries below that threshold, especially those with a mainly traditional farming sector
and without any immediate prospects for a successful commercial plant breeding sector,
modifications to the UPOV framework may be advisable. Leskien and Flitner have
summarised options for such modifications in a report for the International Plant Genetic
Resource Institute (IPGRI) of 1997.22 First, countries may define the subject matter of
protection more widely in their own interest. A wider definition of ‘plant varieties’, for
example, would create space for the recognition of ‘traditional’ or ‘local varieties’, which are
not as uniform as varieties under the UPOV definition and could be distinguished from these
commercial varieties. Moreover, there is nothing in the TRIPS Agreement preventing
countries from extending the protection of a sui generis legislation to traditional knowledge
and farmers’ rights.23 Second, TRIPS allows for variation of the so-called DUS requirements
of UPOV (referring to the necessity for protection that a plant variety must be distinct,
uniform and stable). While distinctness is a requirement also under TRIPS, the wording used
should make it plain that more than merely ‘cosmetic breeding’ is required. But apart from
distinctness, TRIPS merely requires that the variety is sufficiently identifiable to allow for
registration and protection, so there is some scope for a re-interpretation of the uniformity
and stability requirements or for the setting up of ‘second registers’ for traditional and

20 Supra note 10
21[Link]
%20dec [Link]. Last Visited on 10/10/2018 at 6:00 P.M
22 Dan Leskien & Michael Flitner, Intellectual Property Rights and Plant Genetic Resources: Options for a Sui
Generic System (IPGRI, Issues in Genetic Resources No. 6, 1997 ), available at
[Link] Last visited on
11/10/2018 at 8:00 P.M
23 Id . at 48-49.

11
landraces.24 Third, the sui generis legislation may link the granting of rights to proof of prior
informed consent by the providers of germplasm. 25 In 2003, such a disclosure requirement
was proposed by a group of developing countries in the Council for TRIPS as an amendment
of the TRIPS Agreement to harmonise the requirements under TRIPS with those under the
CBD.26 The proposal is since strongly debated in the various forums concerned with
traditional knowledge. Industrialised countries have either opposed the proposal or adopted
disclosure requirements that leave the remedies for failure to comply outside of the patent
system and do not lead to revocation of patents. 27 Fourth, the scope of sui generis protection
may range from rights via the 1991 and 1978 UPOV models to the use of PVP seals,
depending on the needs and prospects for commercial plant breeding in a particular country. 28
Fifth, any sui generis legislation may be further supported by measures such as the
establishment of community gene funds, registers and databases for forms of traditional
knowledge and the creation of an office of public defender to mediate and intervene in
conflicts between communities and national governments or between states and multinational
corporations.29 With a view to some of these options outside of UPOV, analysts have
critically noted, however, that they will have to be assessed against the TRIPS requirement of
Article 27.3(b) that an ‘effective’ sui generis system must be provided.30

24 Supra note 42
25 Supra note 42
26 Disclosure Requirements : Ensuring Mutual Supportiveness Between The Wto Trips Agreement And The
Cbd (Martha Chouchena-Rojas Et Al. Eds., 2005).
27 Brendan Tobin, The Role of Customary Law and Practice in the Protection of Traditional Knowledge
Related to Biological Diversity , in TRADITIONAL KNOWLEDGE , TRADITIONAL CULTURAL
EXPRESSIONS AND INTELLECTUAL PROPERTY LAW IN THE ASIA -PACIFIC REGION 127, 140
(Christoph Antons ed., 2009).
28 Supra note 42
29 Supra note 42
30 Supra note 10

12
SUI GENERIS :LAWS IN INDIA

Indian policy makers seem torn between high technology ambitions in areas such as
biotechnology and the need to account for a large rural sector.31 The move from traditional to
commercial farming is still a matter of hefty debate in India. Many Indian farmers have
become heavily indebted. Press reports indicate that32 percent of cotton farmers are struggling
with heavy debt and that an unusual large number have committed suicide over the past few
years.33 At the same time, commercial farming in India has been boosted by a number of new
laws and amendments, which India had to enact as a result of the country’s accession to the
WTO-TRIPS Agreement. The Indian Government has also taken steps to accede to the
UPOV Convention, but these accession plans have remained controversial and their current
status is unclear.34 The following part of this paper will discuss changes to laws as well as
newer laws and draft laws related to plant varieties and to associated traditional knowledge.
These include amendments to the Indian Patents Act, the Protection of Plant Varieties and
Farmers’ Rights Act, the Biological Diversity Act, the Seeds Bill introduced in 2004 and the
most recent Protection, Conservation and Effective Management of Traditional Knowledge
Relating to Biological Diversity Rules, 2009.

1. Indian Patents Act

The Patents Act of 1970 originally excluded methods of agriculture or horticulture from
patentability (section 3(h)). Equally excluded were “any processes for the medicinal, surgical,
curative, prophylactic or other treatment of human beings or any process for a similar
treatment of animals or plants to render them free of disease or to increase their economic
value or that of their products” (section 3(i)). The Indian courts further interpreted the term
“manner of manufacture” in a restrictive way as exclusively related to processes resulting in
non-living tangible products. This approach was only overturned in 2002 in Dimminaco AG

31 Draft Bill – Community Intellectual Rights Protection Act (July 24, 2008), [Link]
docid=767&lawid=1469 (last visited Oct 9, 2010 at 10:00 P.M)
32 at [Link] Last Visited on
15.10.2018 at 10:00 P.M
33 Amelia Gentleman, Despair takes toll on Indian farmers, N.Y. TIMES, May 31, 2006, available at
[Link] Last Visited on 15.10.2018 at
10:00 P.M
34 Ranjan, supra note 50, at 30-34

13
v. Controller of Patents.35 For inventions related to substances intended for use or capable of
being used as food or medicine or drug and to substances prepared or produced by chemical
processes, only process patent protection was given; no product patent was available (section
5).36

With India’s entry into the WTO, transitional measures such as mailbox applications and
exclusive marketing rights were introduced at first via an ordinance and then via amendments
to the Patents Act in 1999.37 In 2002, the Indian Patents Act was substantially amended.
Section 3(c) referring to discoveries of scientific theory was extended to the “discovery of
any living thing or non-living substance occurring in nature.” The phrase has been interpreted
restrictively as not including the isolation and purification of living substances or non-living
substances involving human intervention.38 The reference to plants in section 3(i) was
omitted, and a new exclusion clause 3(j) was added covering “plants and animals in whole or
any part thereof other than microorganisms but including seeds, varieties and species and
essentially biological processes for production or propagation of plants and animals.”
Commentators have pointed out that the section, in spite of the negative terms in which it is
couched, in fact would allow the patenting of not only micro-organisms, but also of
biotechnological process inventions requiring substantial human intervention. 39 Importantly,
section 3(p) added a further exemption from patentability for “an invention which, in effect,
is traditional knowledge or which is an aggregate or duplication of known properties of
traditionally known component or components.” Section 25(j) provides ground for opposition
and section 64(p) the new revocation ground “that the complete specification does not
disclose or wrongly mentions the source or geographical origin of biological material used
for the invention.” Under sections 25(k) and 64 (q), the ground for opposition and revocation
is “that the invention so far as claimed in any claim of the complete specification was
anticipated having regard to the knowledge, oral or otherwise, available within any local or
indigenous community in India or elsewhere.” 40 Also newly worded is section 3(b), which
35 Shanti Kumar et al., India: Patent regime comes of age, MANAGING INTELL. PROP., October 2006:
Supplement – AsiaPacific IP Focus 2006, available at [Link]
ArticleID=1321297. Last Visited on 15.10.2018 at 7:00 P.M
36 Philippe Cullet, Property Rights over Biological Resources: India’s Proposed Legislative Framework, 4 J.
WORLD INTELL. PROP. 211 (2001).
37 Shanti Kumar & Neeti Wilson, Biotechnology in the limelight, MANAGING INTELL. PROP., April 2006:
Supplement – Life Sciences 2006, available at [Link]
38 Supra note 57.
39 Supra note 59.
40 On the 2002 amendments, see S. K. Verma, Plant Genetic Resources, Biological Inventions and Intellectual
Property Rights: The Case of India, in INTELLECTUAL PROPERTY AND BIOLOGICAL RESOURCES 128,
147-148 (Burton Ong ed., 2004).

14
henceforth holds non-patentable “an invention the primary or intended use or commercial
exploitation of which would be contrary to public order or morality or which causes serious
prejudice to human, animal or plant life or health or to the environment.” The Indian Patent
Office has interpreted this as including “method(s) of adulteration of food.”41

Another amendment followed in 2005, which abolished with section 5 the restriction to
process patents for substances and made product patents available. Because of the looming
deadline of 1 January, 2005 for TRIPS compliance, this latest amendment was initially
introduced via an ordinance and then signed into law in March 2005. 42 Currently still
controversial is in particular section 3(d) of the amended Patents Act declaring as not
patentable “the mere discovery of a new form of a known substance which does not result in
the enhancement of the known efficacy of that substance or the mere discovery of any new
property or new use of a known substance or of the mere use of a known process, machine or
apparatus unless such known process results in a new product or employs at least one new
reactant.” The subsequent debate about “second medical uses” led to a court challenge to the
constitutionality and TRIPS compatibility of section 3(d) by Swiss pharmaceutical
manufacturer Novartis, which was dismissed in 2007. 43 The remainder of the challenge
regarding the rejection of the patent application was recently rejected by the Intellectual
Property Appellate Board (IPAB), which hears appeals from decisions of the Registrar of
Trademarks and Geographical Indications as well as from the Controller of Patents. 44
Controversially also mentioning the cost factor of the drug as being detrimental to patent
protection,45 the IPAB based its decision mainly on section 3(d) holding that the free form of
the drug was known and that “enhanced efficacy” of the new drug over the know substance
had not been demonstrated.46

The controversial section 3(d) was also one of the subjects of the report of the Mashelkar
Committee, an expert committee appointed to examine whether it would be TRIPS

41 Robyn Ott, Patentability of Plants, Animals and Microorganisms in India, 2 OKLA. J.L. & TECH. 17
(2004).
42 The Patents (Amendment) Act, 2005, No. 15 of 2005
43 Novartis refuses to back down in Indian patent dispute (Jan. 8, 2007),
[Link]
(last visited Oct 8, 2018);
44 Id
45 Rahul Chaudhry & Aditi Sharma, India: How IP protection has improved this year, MANAGING INTELL.
PROP., October 2009: Supplement – Asia-Pacific & Middle East IP Focus 2009 (7th ed.), available at
[Link] Last Visited on Oct 17, 2018 at 10:00 P.M
46 Lex Orbis Intellectual Property Resource Centre – Lack of “enhanced efficacy” and High Price deprives
Glivec of a Patent, [Link] (last visited Oct 8, 2018)

15
compatible to: a) limit the grant of a patent for pharmaceutical substances to new chemical
entities or to new entities involving one or more inventive steps; and b) to exclude micro-
organisms from patenting. The Committee concluded in its report that such a limitation of the
patent would exclude an entire class of incremental innovations from patenting and would not
be TRIPS compliant. It would equally not be TRIPS compliant to exclude micro-organisms
from patenting.47

2. The Protection of Plant Varieties and Farmers’ Rights Act

India’s reaction to the requirements of Article 27.3(b), TRIPS is the Protection of Plant
Varieties and Farmers’ Rights Act (PPVFRA) of 2001. The Act follows largely the 1978
UPOV model, but commentators have pointed out that it also includes elements of the 1991
UPOV version, such as the possibility to register essentially derived varieties. 48 On the other
hand, the legislation attempts to balance in a rather unique manner the rights of commercial
breeders and those of traditional small-scale and subsistence farmers. The conflicting goals
come to expression in the preamble of the Act. On one hand, it speaks of the necessity “to
recognize and protect the rights of farmers in respect of their contribution made at any time in
conserving, improving and making available plant genetic resources for the development of
new plant varieties”, while on the other hand it regards plant breeders’ rights protection as a
necessary precondition “for accelerated agricultural development” and “to stimulate
investment for research and development” as well as to “facilitate the growth of the seed
industry.”

Farmers’ rights are regulated in Chapter VI of the legislation. Interestingly, and going beyond
schemes for mere compensation of traditional contributions, the PPVFRA allows for the
registration not only of new and essentially derived varieties, but also of “farmers’ varieties”
as well as of so-called “extant varieties.” The definitions of these varieties can be collected
from section 2. A “farmers’ variety” is defined in section 2(l) of the PPVFRA as “a variety
which: (i) has been traditionally cultivated and evolved by the farmers in their fields; or (ii) is
a wild relative or land race of a variety about which the farmers possess the common
knowledge”. Farmers’ rights are once again mentioned as a sub-category of “extant variety”,
which according to section 2(j) is a variety notified under section 5 of the Seeds Act, a

47 Lex Orbis Intellectual Property Resource Centre – Mashelkar Committee Report accepted by the
Government, [Link] (last
visited Oct 8, 2018).
48 See § 23, Protection of Plant Varieties and Farmers’ Rights Act, 2001, No. 53 of 2001 (PPVFRA)

16
farmers’ variety, a variety about which there is common knowledge, or any other variety
which is in the public domain. “Extant varieties” are, therefore, varieties recognised or in
existence at the time of the coming into force. The PPVFRA allows for registration of extant
varieties and of farmers’ varieties (section 14 (b) and (c), PPVFRA), which, in the case of
farmers’ varieties, can be effected by “any farmer or group of farmers or community of
farmers claiming to be the breeder of the variety” (section 16 (d), PPVFRA). While the
registration requirements for new varieties are novelty, distinctiveness, uniformity and
stability (section 15(1)), novelty has been dispensed with in the case of extant varieties,
which need to conform only to “such criteria of distinctiveness, uniformity and stability as
shall be specified under regulations made by the Authority” (section 15(2)). Of course, “a
famer who has bred or developed a new variety shall be entitled for registration and other
protection in like manner as a breeder of a variety under this Act.” However, farmers’
varieties are of course not new, but as a sub-group of extant varieties they still have to
conform to the distinctiveness, uniformity and stability (DUS) criteria. Critics have,
therefore, concluded that the extent to which farmers will be able to make use of the
registration option may remain quite limited.49 First statistical figures discussed below seem
to confirm that this is a justified concern.

Different from established forms of intellectual property rights, the legislation does not
provide some form of royalties enforceable by the farmers against other private parties.
Instead, farmers “shall be entitled in the prescribed manner for recognition and reward from
the National Gene Fund” (section 39(1)(iii), PPVFRA).50 The National Gene Fund is
constituted by the Central Government. Credited to this National Gene Fund are benefit-
sharing payments, annual fees paid to the authorities, money received from compensation
claims and contributions to the fund from national and international organisations and other
sources (section 45(1)(a)-(d), PPVFRA). Rather than benefit sharing agreements freely
negotiated between the users and the breeders of the farmers’ varieties, the legislation
foresees a determination of the benefit sharing by a government authority, the Protection of
Plant Varieties and Farmers’ Rights Authority (hereinafter ‘Authority’).

The Authority is regulated in Chapter II of the PPVFRA. It is the main government agency
responsible for plant variety protection and for the registration of the various varieties. Its
composition is prescribed in section 3 (5), PPVFRA. It was being established from the end of

49 Supra note 55
50 Verma, supra note 65

17
2005 with the appointment of the Plant Varieties Protection and Farmers’ Rights Board. 51 The
notification of the Protection of Plant Varieties and Farmers’ Rights Regulations followed in
December 2006. In 2007, the Authority began to publish the Plant Variety Journal of India as
well as guidelines for the conduct of the Distinctness, Uniformity and Stability (DUS) testing.
Initially, guidelines for twelve crops were published. According to the website of the
Authority,52 registration is now open for 31 crop species.

Statistics on the website of the Authority also indicate that extant varieties other than farmers’
varieties thus far account for the bulk of the Authority’s work. This was anticipated in the
Protection of Plant Varieties and Farmers’ Rights Regulations of 2006, which in Rule 6
prescribed the constitution of an Extant Variety Recommendation Committee (EVRC). About
40 extant varieties covering nine crop species have been registered in 2008-2009. 53 Section
28(1) PPVFRA confirms the essentially public character of many of the “extant varieties”
notified under the Seeds Act of 1966 when seed production was still largely seen as a task for
the public sector. In the case of an extant variety, “unless a breeder or his successor
establishes his right”, the Central Government or the State Government, where notification
occurred for a state, shall be deemed to be the owner of such right. The 1003 applications for
registrations of extant varieties contrast with 353 applications for new varieties, which are
now under examination or DUS testing. Eighteen applications for farmers’ varieties are
equally under examination. Where there is an entitlement for recognition and reward from
the National Gene Fund, the Authority fixes the amount of benefit sharing after giving the
parties the opportunity to be heard by taking into consideration the extent and nature of the
use of genetic material of the claimant in the development of the variety and the commercial
utility of and market demand for the variety (section 26, PPVFRA).

Apart from such benefit sharing claims of individual or collective breeders of traditional
varieties, there is further under the heading “rights of communities” in section 41, PPVFRA a
right to lodge a compensation claim against a commercial breeder for the contributions of a
community to the evolution of a variety used in the breeding process. This claim may be
raised by any person, group of persons (whether actively engaged in farming or not) or any
51 Farmers hail PVP & FR Act notification, FIN. EXPRESS, Nov. 14, 2005, available at
[Link]
%20%20/15 9181/.
52 See Protection of Plant Varieties and Farmers’ Rights Authority, India – Registration Open For,
[Link] (last visited Oct 8, 2018).
53 PROTECTION OF PLANT VARIETIES AND FARMERS ’ RIGHTS AUTHORITY , ANNUAL REPORT
2008-2009 (2009), available at [Link] Last Visited on
10.10.2018

18
governmental or non-governmental organisation on behalf of any village or local community
in India. The decision whether or not to grant compensation and the amount of compensation
is again a discretionary decision of the Authority. Commentators have raised concerns about
the partly overlapping and partly diverging regulations on benefit sharing and compensation
in the legislation, which may give rise to confusion and disputes. Equally, the lack of real
property rights and the dependence on the Authority in the current scheme have been
criticised.54 In particular, it has been observed that the effect of the current legislation is that
breeders may have to pay more than once for using traditional knowledge, because of the
overlap between benefit sharing and compensation to the community. At the same time,
commentators have found a “reluctance of Parliament to recognize that ownership of
traditional knowledge rests with the community and to develop legislation from that
perspective”, so that “it can safely be concluded that the provisions to protect the traditional
knowledge of the farming community are not going to work to the advantage of these
communities.”55

Apart from the benefit sharing and compensation mechanism, section 39(1)(iv), PPVFRA
also provides for the traditional farmers’ right to reuse saved seed, including to exchange,
share or sell it. Here, however, the legislation follows the 1991 UPOV model in that the
farmer is not allowed to sell branded seed of a protected variety.

Section 39(2), PPVFRA allows for a further compensation claim by farmers against
commercial breeders on the grounds that the performance of a commercial variety remains
below the performance projections that the commercial breeder had disclosed in advance.
Again, the Authority will make the decision about such compensation after hearing the
parties. Finally, commercial breeders need to disclose and acknowledge the contribution of
traditional breeders in their applications. Failure to do so will result in a rejection of the
application (section 40, PPVFRA).

3. The Seeds Bill

In 2004, the Indian Government introduced a new Seeds Bill to replace the Seeds Act of
1966. Since then it has generated much controversy. Government statements on the website
of the Department of Agriculture and Cooperation explained the reasons for the new law.

54 Supra note 90
55 N. S. Gopalakrishnan, Protection of Traditional Knowledge: The Need for a Sui Generis Law in India , 5 J.
WORLD INTELL . PROP . 725, 735 (2002).

19
Among the more important reasons is the creation of a facilitative climate for growth of the
seed industry, boosting of the export of seeds and encouragement of the import of useful
germplasm and the creation of a conducive atmosphere for application of frontier sciences in
varietal development and for enhanced investment in research and development. 56 The latter
reason refers especially to transgenic varieties, which are now included in the draft. The
government points out that GM seeds are generally not notified under the previous Act. As
the seeds are very costly and farmers have sometimes been cheated, there is a need for
regulation and strengthening of testing and seed testing laboratories involved. 57 The draft
seeks to achieve this by widening the circle of institutions accredited to conduct agronomic
trials and testing, which, besides public centres and universities, would also include private
organisations and private seed testing laboratories.

Whereas under the current legislation only notified varieties have to be registered, all seeds
for sale must be registered under the Seeds Bill. The Bill foresees Central and State Seed
Committees as well as a Registration Sub-Committee to keep a National Register of Seeds.
There are provisions for transgenic varieties and for fines and imprisonment for contravention
of the Act and for providing false information.58

Critics of the bill argue that traditional and small-scale farmers should be concerned in
particular that it regulates not only the selling, keeping for sale, offering to sell, import or
export of seed, but mentions in the same context also bartering, a typical manner of seed
exchange among traditional farmers.59 This, it is argued, has the potential to further limit the
avenues for exchange of seeds.60

The Bill has further been criticised for its potential contradictions to and undermining of the
provisions of the Protection of Plant Varieties and Farmers’ Rights Act. 61 For while the Seed
Bill confirms the farmers’ privilege that “nothing shall restrict the right of the farmer to save,
use, exchange, share or sell his farm seeds and planting material”, this comes with the
restriction “except that he shall not sell such seed or planting material under a brand name or
which does not conform to the minimum limit of germination, physical purity, genetic purity

56 New Policies Initiation In Seed Sector – New Seeds Bill (Apr. 1, 2005).
57 New Policies Initiation In Seed Sector – Use of Biotechnology in Agriculture (Apr. 1, 2005)
58 For a detailed comparison between the provisions of the Bill and the 1966 Seeds Act, see M. R.
MADHAVAN & KAUSHIKI SANYAL , LEGISLATIVE BRIEF : THE SEEDS BILL , 2004 (2006), available
at [Link]
59 §§ 22(1), 25, 28(1), 38(b), 38(c), 38(d), Seeds Bill, 2004.
60 Shiva, supra note 63.
61 Bala Ravi, Seeds of Trouble , HINDU , Mar. 8, 2005

20
prescribed…”. Critics point out that this could make farmers anxious about small local sales
in village sales and could prevent the registration of their traditional varieties, which may not
pass the required standards.62 While the Bill is concerned with compensation for farmers if
commercial seeds do not perform to expected levels, it refers potential claimants to the
Consumer Protection Act of 1986.63 However, this is a less straightforward avenue than under
similar compensation provisions in the PPVFRA, in which the Protection of Plant Varieties
and Farmers’ Rights authority assesses the case and grants the compensation. This latter
avenue would seem far preferable, particularly as the urban based consumer courts are not
very accessible for farmers in rural areas.64 Observers in the Indian media concluded,
therefore, with regards to the Seeds Bill, 2004 that “public interest demands that its legal
incongruities and farmer-unfriendly provisions are corrected before the Seeds Bill is passed
by Parliament.” The discussion may soon be back in Parliament, as the government is
expected to table in the next session a report from the Parliamentary standing committee on
agriculture on the Seeds Bill.65

4. The Protection, Conservation and Effective Management of Traditional


Knowledge Relating to Biological Diversity Rules, 2009

In early 2010, the NBA released a number of draft amendments and requested public
comments, including on the Protection, Conservation and Effective Management of
Traditional Knowledge Relating to Biological Diversity Rules (subsequently Traditional
Knowledge Rules).66 Commentators are intrigued that this sui generis legislation for
traditional knowledge protection is not introduced as a Bill and as such subjected to
parliamentary scrutiny, but as delegated legislation in the form of rules under the Biological
Diversity Act of 2002. Given the broad scope of some of the provisions, the question has
been raised whether this is constitutional.67 The Traditional Knowledge provisions go

62 GRAIN & Devinder Sharma, India’s new Seed Bill , SEEDLING , July 2005, available at
[Link]
63 See supra note 35
64 See supra note 35
65 MNCs will dominate if Seeds Bill adopted: Farmers Associations , BUS . STANDARD , June 29, 2009,
available at [Link]
associations/65912/on; Bhavdeep Kang, Why the US is so keen to sell Bt brinjal to India (Nov. 19, 2009),
[Link] (last visited
July 7, 2010).
66 Prashant Reddy, The National Biodiversity Authority invites comments on draft amendments (Feb. 2, 2010),
[Link] (last visited Oct 7, 2018).
67 Prashant Reddy, A Comment on the Vires of ‘The Protection, Conservation and Effective Management of
Traditional Knowledge relating to Biological Diversity Rules, 2009’ (Feb. 15, 2010),
[Link] (last visited Oct 17, 2018).

21
significantly beyond and frequently contradict those of the Biological Diversity Act. The
NBA has just collected public reactions to the Traditional Knowledge Rules. These reactions
were collected jointly with those related to the further debates on an international regime on
access and benefit sharing and on amendments to the Biological Diversity Act, 2002, and the
Biological Diversity Rules, 2004. Since the parent legislation for the Traditional Knowledge
Rules could also be amended, it is unclear at this stage how these various laws and rules will
ultimately relate to each other and which form the Traditional Knowledge Rules will finally
take. Nevertheless, a few preliminary comments can be offered. First, it is interesting to note
that the Rules apply a very wide definition of ‘traditional knowledge’, which includes
traditional cultural expressions. Thus, ‘traditional knowledge’ relates not only to “properties,
uses and characteristics of plant and animal genetic resources; agriculture and healthcare
practices, food preservation and processing techniques and devices developed from
traditional materials”, but also to “cultural expressions, products and practices such as
weaving patterns, colours, dyes, pottery, painting, poetry, folklore, dance and music.”
Equally wide is the definition of beneficiaries belonging to a ‘traditional community’, which
includes “families, people belonging to Scheduled Tribes as per Article 342 of the
Constitution of India, and other notified tribal groups including nomadic tribes…” The
inclusion of families shows that tradition is, quite rightly, not supposed to remain confined to
tribal groups. However, in view of the definition of ‘misuse of traditional knowledge’ as
“access to and/or use of traditional knowledge by persons not belonging to the traditional
community” without license or in breach of licensing terms, it brings back the question how
group/community membership is defined and who decides about membership. This is all the
more important, because the Traditional Knowledge Rules differ from the regulations in the
Biodiversity Act in that they provide for direct negotiations between a user (or ‘accessor’ in
the terminology of the Rules) and a traditional community and for direct payment of the
benefits to the traditional community.

While the Rules in so far strengthen the role of the communities, the national and state
authorities still have the final say in many instances, for example, if traditional knowledge is
already in the public domain, not specifically owned by any particular community or is
owned by communities spread out over more than three states. It gives the NBA decision-
making powers over access by one traditional community to the knowledge of another
community, if this is for earning their livelihood and not for commercial gain. It requires
from communities to comply with the registration requirements of the Traditional Knowledge

22
Register, if they want to receive benefits. Users, on the other hand, have to await the outcome
of fairly complicated and potentially lengthy procedures, involving national and state
authorities as well as local communities, to finally get access. These procedures include a
potential waiting period of up to one year to allow states to set up State Biodiversity Boards
and/or Biodiversity Management Committees, where they do not yet exist. Assessment
further involves a report by such committees on such complicated matters as sustainability of
resources, social and environmental implications and potential value of the knowledge as
well as a resource management plan.

23
CONCLUSION

The last few decades have seen a shift from an understanding of agricultural and biological
resources as the “common heritage of mankind” to an understanding where such resources
are under the sovereign control of nation states. This has been accompanied by a
strengthening of the intellectual property rights system for biological material in the wake of
the WTO-TRIPS Agreement and more recently on the basis of bilateral Free Trade
Agreements between developed and developing nations. The result has been a further shift in
the agricultural sector of developing countries from public research institutions to private
R&D. Under the circumstances, traditional knowledge and farmers’ rights are defended as a
crucial counterweight in societies that are still dependent on the farming sector.

The debate about traditional knowledge protection links up to a larger debate about
approaches to the environment and to sustainable development in developing countries. Here,
the failure of statist planning has led to a move away from top-down solutions to
development and to environmental management and to a search for bottom-up approaches. At
first, these were mainly seen in the form of privatisation and private monopoly rights, but
more recently there is also a renewed interest in limited common property rights of
communities and in a revitalisation of customary law systems.

This paper has examined example of India for attempts to implement a system for traditional
knowledge protection using a variety of intellectual property and sui generis mechanisms.
India has from the outset taken a centralist approach to traditional knowledge. India belongs
to a group of countries that have resisted attempts by international organisations to focus on
‘indigenous people’ and prefers to speak of ‘local and indigenous communities.’ The focus of
the debate in India is on agricultural biodiversity and on farming, with farmers’ rights
featuring particularly prominently in the Protection of Plant Varieties and Farmers’ Rights
Act. While this Act allows for the registration of farmers’ varieties, it falls short of
establishing a real property right of farmers to their knowledge and instead makes them
dependent on the national authority for most benefit sharing and compensation claims.
Confirming the nationalist and centralist approach further, the Biological Diversity Act
distinguishes sharply between foreign and Indian national access to biological resources and
leaves local communities with little protection against the latter group of users and with little
immediate influence in negotiations about benefit-sharing. This would change to some extent,
if the Traditional Knowledge Rules drafted under the Biodiversity Act in 2009 and currently

24
presented for public discussion would find approval. The Rules decentralise the negotiation
process over access and benefit sharing and strengthen in so far the role of communities.
Otherwise, however, national and state authorities retain a central role and the procedures are
overall quite complicated and bureaucratic, which in the end could put off potential users and
traditional communities alike from using the system.

Developing countries seem torn between a desire to develop high tech and biotechnology
industries and a need to look after the interests of a large traditional farming sector. It is in
this latter context that traditional knowledge has received great significance and raised hopes
that so far have rarely been justified by the relatively meagre benefits. In fact, traditional
knowledge may only assist in safeguarding the traditional farming sector or biodiversity, if it
is accompanied by policy decisions that go far beyond the relatively narrow field of
intellectual property. It seems further important that the focus is redirected towards the
original conservationist goals of the CBD. Thus, if royalties for the use of traditional
knowledge are collected at the national or state level, then it is important that such benefits
are passed on to those communities at the grassroots level that are regarded as the most
important stakeholders in the new ‘bottom up’ environmental protection models. It is further
important to gain a realistic understanding of the expectations of users and those who are
seeking access, so that access regulations do not become overly complicated and unwieldy
for users and knowledge holders alike. The traditional knowledge discussion has certainly
sensitised IP academics and practitioners to imbalances in the system that require correction.
The successful prevention of a traditional knowledge based patent with prior art information
from the Indian TKDL shows that this adjustment process is making progress.

Beyond this, the traditional knowledge debate has put intellectual property into an unfamiliar
environment where it is no longer concerned with clearly delineated territorial rights in the
modern sector of nation states. The debate takes place at the grassroots level, it involves local
development plans as well as communities and their customary laws and it is messy and
intensely political. Here, in discussions about decentralisation, environmental problems and
new development paradigms, new rights discourses emerge that use elements from customary
law and from different traditions. In how far all of this will affect intellectual property law
remains to be seen, but as increasingly influential developing countries decentralise,
intellectual property will to some extent have to adjust or risk to become marginalised outside
of the commercial enclaves of big cities.

25
BIBLIOGRAPHY

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26

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