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As the Indian market harbors some of the top biotech firms and
companies functioning in India, it becomes clear as to why the
biotech industry is one of the most upcoming, revolutionary and
mushrooming domains in the Indian perspective. The figures
estimating the presence and the existence of the biotechnology
sector in India and its control and dominance over the market. It can
be seen that due to it having a wide scope and rapidly developing
nature, the firms dealing in Biotechnology and its products and
services do exercise some type of control and dominance over the
market mechanisms. It can be concluded that even though India
being a developing economy it nevertheless show cases a vast arena
for the rise, cultivation and evolution for this Industry and promises a
bright future and scope for Biotechnology and its products and
services since it holds some of the key factors which are essential for
the overall development of the economy.
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The Biotechnology Sector is one of the fastest growing sectors
in India with almost all global majors and large Indian players
having established a presence in this sector in India.
International players are leveraging the competitively priced
but highly qualified and skilled human capital available in India
for undertaking Research and Development in India to develop
new technology and products both for Indian and global
markets. India further offers a well developed legal/regulatory
system enabling the creation and enforcement of intellectual
property and related technology transfer and licensing
arrangements. Agri-Biotech as a sub-sector is amongst the
fastest growing in the biotech sector and has witnessed globally
and in India, emergence of a single large dominant enterprise,
namely Monsanto, that has been alleged by competitors and
consumers alike of abusing its dominant position and engaging
in behaviors and activities that are prima-facie anti-competitive
and against the interests of consumers. In the India as well as
global context this assumes critical importance with the
growing concerns relating to food security. Agri-biotech has
accordingly been selected as the focus area of this project and
the project shall seek to explore the interface between
intellectual property protection in the biotechnology sector in
India and other jurisdictions and the interface of the same with
Competition Policy, Law and Regulation. The need for food
security and bio safety, better achieved in a competitive
market, has to be balanced with the protection of inventive
rights of the inventor through frameworks for protection of
intellectual property rights. It becomes imperative for
prevention of any kind of misuse and abuse of such an interest
of the inventor there has to be an effective protection regime.
This paper aims to focus and look at the types of protection
regimes and also what kinds of misuse can occur at the national
as well as the international levels mainly focusing on the Agri-
Biotech Sector perspective. The next segment deals with the
detailed discussion on the Agri-Biotech Sector concentrating
largely on the nature and scope of this sector in the Indian as
well as in the global context. It also attempts to lay down the
various regulatory policies and frameworks for controlling any
type of abuse and protect the rights of the Breeders and
Farmers and other entities who develop the concept of hybrids
and GM crops. Further in this paper, the issue of the interface
between Intellectual property rights arising in the Agri-Biotech
sector and Plant-biotechnology Industry and competition laws
will be dealt with and the anti-competitive practices which may
arise in this sector will also be looked at. Plant biotechnology or
Agriculture-biotechnology is one of the coming-of-age sciences
which are proving to be a boon to the society hence it is
essential to examine and explore this arena with its legal
implications and protection opportunities. The above section
dealt with a brief overview of the presence and the existence of
the Biotech Industry in India. This would help us understand
the nature and scope of this sector while dealing specifically
with Agri-Biotech Sector.
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Agriculture-Biotechnology or Plant-Biotechnology (herein after
referred to as the Agri-biotech sector), is the application of the
science of biotechnology in agriculture and its related
processes and products. Agri-Biotech focuses on one or all of
the following:
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Using the techniques of conventional plant breeding or
modern biotechnology, one or two genes may be transferred
to a highly developed crop variety to impart a new character
that would increase its yield. However, while increases in
crop yield are the most obvious applications of modern
biotechnology in agriculture, it is also the most difficult one.
Current genetic engineering techniques work best for effects
that are controlled by a single gene. Many of the genetic
characteristics associated with yield (e.g., enhanced growth)
are controlled by a large number of genes, each of which has
a minimal effect on the overall yield.8 There is, therefore,
much scientific work to be done in this area.
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-odern biotechnology can be used to slow down the process
of spoilage so that fruit can ripen longer on the plant and then
be transported to the consumer with a still reasonable shelf
life. This alters the taste, texture and appearance of the fruit.
-ore importantly, it could expand the marketfor farmers in
developing countries due to the reduction in spoilage with
resultant avoidance of food wastage.
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The need for an extensive and comprehensive intellectual property
rights protection regime was identified since various inventions and
subject-matters, as discussed above, faced misuse and the inventor
without exclusive rights or adequate protection in respect of the
inventions, wasdiscouraged from investing time, effort and money in
future developments and this led to a slowdown in the rate of
inventions and innovations. India is a part of the global community
that seeks to establish an equitable and extensive framework of
intellectual property rights protection. Intellectual property right
protection applies to those ʊproperties which are intangible in
nature and this protection is applicable in the form of patents,
trademarks, copyrights and trade secrets etc. This intellectual property
right protection granted to a biotechnological invention, being the
subject matter of the intellectual property may be in the form of patent
protection having great importance and value commercially. There
has been a sharp division of opinion and extensive debate regarding
whether living material created through biotechnological efforts
should be allowed to be patented and Indian patent law at present
does not allow patenting of living material. Plant varieties are
however, eligible for protection under the Protection of Plant
Varieties and Farmers Rights Act. Grant of intellectual property
protection to living organisms and plant varieties is contentious and
faces stiff opposition from environmentalist and other groups opposed
to genetic modification/engineering ostensibly on account of bio-
safety and public health issues as well as on the core issue of grant of
IP protection on living organisms being unsuitable and against the
laws of nature. There is considerable concern that the intellectual
rights protection might adversely affect food sovereignty and security
as well as result in abuse of competition by creation and perpetuation
of a small number of ever-growing very large players controlling
technology and production rights over agricultural produce.
The protection of different seeds, crop and food varieties has also
become one of the upcoming fields of intellectual property right
protection. These are protected through ʊPlant Breederµs Rights
(PBR) or the Farmerµs rights (mostly in developing countries). This
type of protection accorded to the living organisms such as to plants
and animals, may affect adversely or favourably the conservation,
availability and the use of plant and animal genetic resources.12 It is
believed that the granting of patent protection or any type of other
intellectual property rights may be beneficial as well as having a
detrimental effect on the prospects of further developments. In the
case of Breederµs rights, he enjoys exclusive rights of marketing over
the biotechnological invention and as far the Farmers are concerned,
they also are exempted from the protection and are permitted to use
the variety for further breeding, replantation of seed etc.
As seen above, till now, we have tried to explore and lay down one
type of intellectual property right protection, namely being the
Patenting regime for protecting biotechnological inventions.
But these can also be protected by alternate routes of recognition i.e.
trademarks, trade secrets, copyright protection, geographical
indications. Biotechnological inventions are not limited and restricted
to only patenting and can also be sought protection under these
alternative platforms. These being the subject-matter for intellectual
property rights, hence the properties can be bought, sold, transferred
or licensed. Express provisions have been laid down in legal
frameworks of many countries protecting and recognizing the
exclusive interest held by the inventor in the subject-matter. The
nature of intellectual property rights which should be accorded to any
biotechnological inventions will depend on certain factors and
circumstances and may differ from case to case and hence it cannot be
said that such inventions will only be protected under the patenting
regime or trademark or copyright etc. Further, the type of regulatory
and policy framework which exists in India and also at a global level
mainly being the EU and the USA will be discussed. These policies
and regulations help lay down the modes, grounds and conditions for
protecting mainly the crop and plant varieties and also promote
biological and ecological diversity.
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The Agreement on Trade-Related Intellectual Property Rights
(TRIPS), is an instrument of the World trade Organization (WTO)
pertaining to the protection and recognition of invented subject-matter
and laying down a standardized intellectual property rights
framework. In India, the Patents Act, 1970, has also been drafted and
enacted in consonance of the provisions of TRIPS with respect to the
Indian context.
TRIPS, also includes and lays down certain patenting provisions for
the application of effective patenting regimes in different member
states of the WTO. Article 27-34, TRIPS enumerate strong patenting
directives as guiding principles18 such as;
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lPatents to be available under essentially the same criteria of
patentability as in the European Patent Convention (EPC) for all
fields of technology, including product patents for pharmaceuticals
(Article 27).
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?The European Patent Convention (EPC), 1973, lays down an express
prohibition against the patenting of living organisms such as plants
and animal varieties under Article 53(b)34, but the concept of
patenting of plants and animals needs more focused study and
discussion. The intellectual property regime in the EU context
provides some options on the issue of Plant variety35 protection. But
even in the EPC ʊ
M have been excluded from the intellectual property
protection similarly as laid down under the TRIPS Agreement.36
In the United Kingdom, one of the major developments to catalyze
the emergence of plant variety rights was the enactment of the Plant
Varieties and Seeds Act, 1964.37 Other European nations also
adopted similar legislations after signing the UPOV38 Convention,
1961.39 Under this protection regime, protection of plant varieties
from Bio-piracy and violation of licensing bygiving rights to plant
breeders was ensured. Although this type of protection given to Plant
varieties were not the same as a patent protection since it was
restricted only to till the sale of the variety and not to the use of such a
variety. Hence this made this system weaker. The production of plant
varieties was not considered to be an ʊ under the
European patenting system and therefore made it ineligible for patent
protection but it could still be protected under the Plant Breederµs
Rights (PBRs). The conditions laid down for qualifying the eligibility
criteria for acquiring such protection were the criteria for
Distinctness, Uniformity and Stability popularly known as the DUS
Test.40 Subsequently as per further developments, Novelty was also
added to the DUS Test criteria under UPOV 1991.41 The UPOV
1991 however tries to eliminate the arbitrage between plant varieties
protection and patent regimes.
In a leading case42 decided by the EPO in the year 1984, the
exclusion of plant varieties from patent protection was construed in a
very restricted manner.43 The case dealt with the issue of chemically
treated seeds apart from the issue of the transgenic plants. It was held
that,
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Whereas this position was later reviewed in a subsequent judgment44,
the issue of claim regarding transgenic plants had arisen and the
decision related specifically to a plant variety and it was held that
transformed plants could also be known as ʊplant varieties as they
having a stably transmitted characteristic phenotype, and the
prohibition given under Article 53(b) could not merely be avoided45.
Under this scenario plant cell claims were being granted and claims
regarding plants and seeds were being denied. Further, the issue
whether the final outcome of the process of transformation of the
plant cell could be termed as a ʊmicrobiological product was being
questioned since the transformation of the plant cell involved
microbiological processes. This decision faced widespread criticism
from the seed industry and the matter was referred to the Enlarged
Board of Appeal (EBA), and there already existed conflicting
previous decisions46 on this point of law. Subsequently, the decision
went into appeal and the Technical Board of Appeal (that had decided
the () case previously) extended some of the
concerns to the Enlarged Board of Appeal over the interpretation of
Article 53(b) of the EPC. Therefore the EBA ruled48 that transgenic
plants could be considered as patentable subject-matter and this
decision was reached at by the EBA after reasoning that ʊ
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The main aim and object of this research project is to highlight and
explore the inter-relationship and the functioning of the competition
policies and laws by granting of an intellectual property right in the
biotechnology industry with special focus on the Agri-Biotechnology
Industry. The rising tide of patent applications can be witnessed
globally in this industry as the need for such protection and licensing
has become imperative so as to safeguard the rights of the inventor
and also to encourage and promote new talents, inventions and
innovations which can be a boon for the economy. The field of
biotechnology is an upcoming science which is still at the initial stage
of establishing a foundation but it promises a revolution in the fields
of medicine, agriculture, pharmaceuticals and industrial sector
amongst other sectors of the economy along with contribution to the
GDP growth. With adequate IPR protection (and that is a key issue in
regulation) given to such eligible participants, it should be anticipated
that an abuse or misuse of such a protection should not be intended by
the protected person/entity. In certain circumstances the granting of
IPR protection too freely may be criticized on the basis that this
protection may stifle the growth and may also lead to the unnecessary
creation of power and regression in the process of inventions. This
situation may result in the abuse of the power by the participant
bearing the protection. Hence it is necessary to have regulatory and
policy controls by the application of law to enable a competitive
market and prevent abuse of domination.
lThis research project will aim to explore, discover, define and
detail the causes, inter-relationship between IPR Protection and
Competition in the biotechnology sector with special focus on the
Agri-Biotech Sector at a national as well as at a global level.
lThe project will briefly study the Biotechnology Sector in India
including sub-sectors such as Pharma (vaccines and therapeutics),
Agri-Biotech (seeds and traits), Bio-Fuels, Industrial Biotech
(Industrial Enzymes etc.), Bio-Informatics, Research Services
(Clinical Research) and other Biotech Suppliers.
lFurther the project will seek to identify key areas of interest and
concern in the existing biotechnology policy, regulatory regime, IPR
protection regime and the inter-relationship of the same with the
Competition Policy and Regulation. The project will be based on the
understanding that the Competition Act has as its objects the (a)
identification and prevention of practices that have an adverse effect
on competition, (b) promotion of competition in the relevant markets
in a sustainable manner, and (c) protection and promotion of
consumer interests.
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In an evolving intellectual property as well as competition policy
context of India the issues that have emerged in the Biotechnology
sector in United States of America as well as other jurisdictions merit
careful attention and a calibrated application to inform and enforce
the competition policy regulation. The biotech sector in India is
emerging as a high growth sector though witnessing similar issues as
are prevalent in the other global economies such as the USA.
Safeguarding of proprietary technologies through a robust intellectual
property regime needs to be balanced against the merits of healthy
competition and the public welfare especially as the Indian farm
sector is comprised largely of unorganized small holders. The order of
the Honorable -RTP Commission in the case of -onsanto, indicates
the adoption of this balanced approach and as India further integrates
into the WTO framework, the Honorable Competition Commission of
India may consider to keep a close watch on the biotechnology sector
and resolve the issue tensions arising from the interface and
interactions between the intellectual property and competition policy
domains. While there is a case for effective protection, there is a need
for a reasonable and balanced approach that is relevant to the Indian
context and takes a fine look at some key issues such as:
lUnlimited v. Limited Period of protection-
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(i) Continental Paper Bag Co. v Eastern Paper Bag Co. (210 U.S. 405, 429
(1908))
(vii) Enzo Biochem Inc. v Calgene Inc. (29 USPQ 2d 1679 (E. Cal. 1994))
(xvii) Quanta Computer Inc. v L.G. Electronics (128 S. Ct. 2109 (2008))
(xviii) Texas Grain Inc. v -onsanto Co. (2008 WL 2570530 (W.D. Tex. 2008))
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V? Towards A Functional Competition Policy For India
Edited by Pradeep S. Mehta, 2006
V? http://www.cci.gov.in/images/media/ResearchReports/NaveenDahiyaRO
UGHDRAFT.pdf
V? http://www.ris.org.in/abdr_mar043.pdf
V? http://www.competition-commission-
india.nic.in/competition_forum/IPRs_by_Dr.Chakravarthy_22July2005.p
df
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