Exploring Biotechnology in the

Perspective of Intellectual Property

Rights.

KIIT SCHOOL OF LAW

KIIT UNIVERSITY
BY:

SHRADDHA SUMAN CHANDEL

BALLB

ROLL NO. : 1283087

SEM: 10th (IPR Hons.)

 ABSTRACT
Biotechnology is a field of technology of growing importance in which inventions may have a
significant effect on our future, particularly in medicine, food, agriculture, energy and protection
of the environment. The has been dramatic expansion of intellectual property law to
accommodate various forms of biotechnology from micro-organisms, plants, and animals to
human genes and stem cells and hence as in other fields of technology, there is a need for legal
protection in respect of biotechnological inventions.

This article focuses on the interface between law and biotechnology by examining how
innovations in biotechnology accelerate the role of science as well as the need for legal
protection of the innovations in the form of intellectual property rights. The main aim and object
of this research project is to highlight and explore the inter-relationship and the functioning in
field of biotech by granting of an intellectual property right in the biotechnology industry

This article will aim to explore, discover, define and detail the causes, inter-relationship between
IPR Protection and need and importance of biotechnology. The article will open with an
introduction and will briefly study the need and importance of Biotech sector. The third part will
throw light on the scope and Criteria of IPR protection to the biotech sector. The fourth section
of the article will briefly study the IPRs available for the various innovation of biotechnology
industry and the legal regime therein. The fifth part will explore the importance of IP Protection
which will followed by the 7th part dealing with various IP regulations .Further the article will
seek to identify the keys IP regulations in India and the scenario prevailing in India wrt IP and
the last part is conclusion.

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.

KEYWORDS: Biotechnology, IPR Protection, Research and Development(R&D), TRIPS,

WIPO
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CONTENTS

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 I. INTRODUCTION

II. BIOTECHNOLOGY & AND ITS GROWING IMPORTANCE

Need to Protect Biotechnological Inventions

III. SCOPE AND CRITERIA FOR IPRs PROTECTION

IV. INTELLECTUAL PROPERTY RIGHTS FOR BIOTECHNOLOGY

IPR and Intellectual Property Rights
Rights in plant varieties
Patents for biotechnology
Copyrights, Trademarks etc and IPR

V. IMPORTANCE OF IP PROTECTION

VI. GLOBAL IP REGULATIONS

VII. IP SCENARIO IN INDIA

Regulatory Framework

VIII. CONCLUSION

I. Introduction

The Indian Biotechnology sector is poised for a tremendous growth and IP protection is necesary
for India to make it to the top as a global competitor. An international group of scholars from a
range of disciplines economic geography, health law, business, philosophy, history, public
health, management examine how IPRs actually operate in innovation systems, not just from
the perspective of theory but grounded in their global, regional, national, current and historical
contexts.1 In so doing, the contributors seek to uncover and move beyond deeply held
assumptions about the role of IPRs in innovation systems.

1
IPRthe backbone of the Biotech industry.
http://www.amityedumedia.com/industry/biotec-Issue17-3.htm (last visited on 18 Feb 2017)
4
Recent advances in biotechnology are expected by many to improve crop yield, reduce reliance
on agricultural inputs like pesticides and herbicides, alleviate world hunger, improve the safety
and effectiveness of pharmaceuticals, assist in the discovery of genes that trigger diseases like
cancer, and make more efficient our legal institutions through DNA testing. Clearly, innovations
in biotechnology are a powerful force for social change, and they pose unique challenges and
opportunities for legal scholars and institutions. Intellectual property (IP) is the creation of the
human mindthe intangible intellect that can translate into tangible products. Intellectual
property rights (IPR) protect the use of these human creations. The major elements or forms of
intellectual property rights today include patents, utility models, industrial designs, trademarks
and service marks, geographical indications and layout of integrated circuits, copyright, and
plant breeder rights. Recent advances in biotechnology are expected by many to improve crop
yield, reduces. However, evidence on the response of R&D investments in developing countries
to changes in IPR protection remains scarce. It has also been found that the contribution of IPR
to economic growth increases with the openness of the economy. Agricultural research in
developing countries has traditionally been carried out by the public sector. The introduction of
protection for plant varieties is expected to foster the privatization of agricultural research. The
reaction of national or international research centers to this trend is likely to have important
economic implications. With increasing investment of resources in research and development
(R&D) in national research systems, policy makers and research managers have an opportunity
to become more sophisticated in their approaches. As in other fields of technology, there is a
need for legal protection in respect of biotechnological inventions. Such inventions are creations
of the human mind just as much as other inventions, and are generally the result of substantial
research, inventive effort and investment in sophisticated laboratories. Typically, enterprises
engaged in research only make investments if legal protection is available for the results of their
research. As with other inventions and industries, the need for investment in research and
development efforts creates an obvious need for the protection of biotechnological inventions.
This need is not only in the interest of inventors and their employers, but also in the public
interest of promoting technological progress. Modern, flexible intellectual property systems and
policies have contributed to fostering investment needed to establish biotechnology industries
creating tangible products. Flexible intellectual property policies can play a role in favoring

5
stable legal environments conducive to public/private partnerships, investment and other
economic activity needed to spread biotechnological innovations to more countries.2

II. Biotechnology & and its growing importance

Blacks Law Dictionary, defines biotechnology as, A branch of molecular biology dealing
with the use of biological process to produce useful medical and industrial materials.1
Biotechnology is a field of applied biology that involves the use of living things in engineering,
technology, medicine, and other useful applications. Modern use of the term includes genetic
engineering as well as cell- and tissue culture technologies. The concept encompasses a wide
range of procedures (and history) for modifying living organisms according to human purposes -
going back to domestication of animals, cultivation of plants, and "improvements" to these
through breeding programs that employ artificial selection and hybridization.

The biotechnology industry has growing concerns over decisions to be taken this year by the
United States Supreme Court in two cases involving the patenting of human genes and the
exhaustion of patent rights in the context of easily reproducible products. 3 Presently, the need for
biotechnological techniques, processes and procedures has arisen to such an extent because of
the advance in technologies and the scientific discoveries and inventions. Hence Bio-technology
has become one of the emerging spheres and technologies in India as well on a global level.

Need to Protect Biotechnological Inventions

As in other fields of technology, there is a need for legal protection in respect of biotechnological
inventions. Such inventions are creations of the human mind just as much as other inventions,
and are generally the result of substantial research, inventive effort and investment in
sophisticated laboratories. This need is not only in the interest of inventors and their employers,
but also in the public interest of promoting technological progress. Modern, flexible intellectual
property systems and policies have contributed to fostering investment needed to establish

2
Biotechnology & Intellectual Property Rights,
http://www.ciesin.org/docs/008-265/008-265i.html (last visited on 22 Feb 2017).
3
Bowman v. Monsanto Co & Association for Molecular Pathology v. Myriad Genetics (IPW, US Policy, 11 January
2013).
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biotechnology industries creating tangible products. Flexible intellectual property policies can
play a role in favoring stable legal environments conducive to public/private partnerships,
investment and other economic activity needed to spread biotechnological innovations to more
countries. The patenting of biotechnology innovations has been accompanied by controversy, as
has the use of some of these new innovations. Policy makers of all countries, however, have been
careful to avoid extending patent rights to things, as they exist in nature or to natural phenomena.
A new plant species discovered in the wild, for instance, cannot be patented and neither can laws
of nature. In each country, the laws on patentability of biotechnological inventions need to be
consulted to learn the availability of patent protection and its scope. When considering these
issues, one also needs to recognize that legal regimes other than patent systems are typically
relied upon to address other public interests, such as the environmental or medical safety of
products, efficacy of products, and unfair competition that may occur in the assertion of patent
rights. The confluence of this new technology with legal and regulatory systems makes
biotechnology an evolving and dynamic component of intellectual property law.4

III. SCOPE AND CRITERIA FOR IPRs PROTECTION

The main elements of protection of each IPR are generally defined in terms of the subject matter
that is to be protected or that can be excluded such as the preconditions for such protection; the
rights accruing on protection and the permissible exceptions to these rights and the minimum
duration of protection.52 Generally, IPRs give creators exclusive rights over the use of their
creations for a fixed duration of time. In some cases, however, IPRs are valid indefinitely, as long
as the conditions for their protection continue to be met, as in the cases of trademarks,
geographical indications, and trade secrets.

Biotechnology and Intellectual Property Rights

Intellectual Property (IP) is central to the biotechnology industry, and brings with it a dimension,
facilitating collaborative activity, whether it is a drug discovery or clinical or market-related
4
Supranote2
5
Intellectual Property Protection and Biotechnology: Issues and Processes for African Consensus,
http://www.ictsd.org/intellectual-property-protection-and-biotechnology-issues-and-processes-for-african-
consensus-0 (Last visited on 18 Feb 2017)
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trials. Essentially, collaborative activity is the synergy between India's ability to provide
conditions for research, clinical trials and development, technological lead and capital
availability in developed nations. The successful translation of these synergies into commercially
viable applications and marketable products critically depends on the compatibility of
regulations that deal with the registration and protection of intellectual property, originating from
the collaborative process. Affordability and accessibility to the products of biotechnology are
also the two key factors central to the advancement of this sector. Policies that foster a balance
between sustaining innovation and facilitating technology diffusion has been addressed with
substantial progress in terms of support for R&D, human resource generation and infrastructure
development.63 Over the past decade, India has shown excellence in scientific performance as
evidenced by number and quality of publications made each year in international journals.
However, its technological and commercial performance is low as indexed by the number of
patents issued per unit of investment made in R&D. Realizing the potential and relevance to the
needs of society, the Department of Biotechnology (DBT) has emphasized the development of all
facets of IPR with relation to biotechnology.7

Rights in Plant Varieties

Prior to the mid-1960s only a few countries (e.g., Germany, USA) gave any intellectual property
protection to plant varieties. Because of pressure from their plant breeding industries, 10 western
European countries entered into a diplomatic process in the early-1960s which eventually
culminated in the formation of an International Union for the Protection of New Varieties of
plants (UPOV) and the signing of a Convention (the UPOV Convention 1961). Since that time a
number of other countries have become parties to the UPOV Convention Duration of protection
depends on national legislation and on the plant species to which the variety belongs, but is
generally for 20-30 years.8 Grant of plant variety rights confers certain exclusive rights on the
holder, including the exclusive right to sell the reproductive material (e.g. seed, cuttings, whole

6
Patel Neesha, IPRthe backbone of the Biotech industry.
http://thebiotechnology.blogspot.in/2006/03/iprthe-backbone-of-biotech-industry.html (Last visited on 19 Feb
2017)
7
Catherine Saez. , Myriad: Two US Legal Cases Shaking Biotechnology Industries, Intellectual Property Watch.
http://www.isb.vt.edu/news/2013/Mar/Saez.pdf
8
J.E.M. Ag Supply Inc v. Pioneer Hi-Bred, Inc., 534 U.S. 124 (2001).
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plants) of the protected variety. However the rights do not extend to consumption material (e.g.
fruit, wheat seed grown for milling flour). Essentially the exclusive rights define what others
may or may not do in relation to the protected varieties. Plant breeders were for some time
dissatisfied with the protection provided by the UPOV system. This eventually resulted in a
major diplomatic conference in March 1991, at which the UPOV Convention was substantially
revised. The new 1991 text will provide far greater protection than is afforded at present, most
notably by requiring that all member countries apply the convention to all genera and species, by
extending the exclusive rights to include harvested material (e.g., fruit, wheat grown for milling
into flour) and, most controversially, by allowing enforcement against farm-saved seed (where a
farmer produces further seed of the protected variety from the previous year's crop). However,
until the national governments ratify the new convention the system will continue to be based on
the 1978 text. There will be considerable national opposition to the strengthening of plant variety
rights and thus these changes may take years before they are implemented and may even be
superseded by greater availability of patent protection in the meantime.

Patents for Biotechnology

A patent is a grant of exclusive rights for a limited time in respect of a new and useful invention.
The exact requirements for grant of a patent, the scope of protection it provides and its duration
differs depending on national legislation. However, generally the invention must be of patentable
subject matter, novel (new), non-obvious (inventive), of industrial application and sufficiently
disclosed. A patent will provide a wide range of legal rights, including the right to possess, use,
transfer by sale or gift, and to exclude others from similar rights. Duration will be for around 20
years (although for only 17 years in the USA). Life science companies quickly realized that
many of their novel inventions, such as genetically engineered seeds, could qualify for utility
patents. This provided an additional layer of intellectual property protection beyond trade secrets
or plant variety protection certificates. These rights are generally restricted to the territorial
jurisdiction of the country granting the patent and thus an inventor wishing to protect his/her
invention in a number of countries will need to seek separate patents in each of those countries.
Whilst the majority of countries provide some form of patent protection, only a few provide
patent protection for biotechnology (these include: Australia, Bulgaria, Canada, Czechoslovakia,

9
Hungary, Romania, Japan, the Soviet Union and the parties to the European Patent Convention).
The reasons for this may differ, but generally it has been because biotechnology has been thought
inappropriate for patent protection, either because the system was originally designed for
mechanical inventions, or for technical or practical reasons, or for one or more ethical, religious
or social concerns.

Copyrights, Trademarks etc and Biotechnology

Keeping biotechnology 'secret' can also is a valuable form of protection. National treatment of
trade secrets is diverse, and all attempts to harmonize trade secret laws in Europe, have failed.
Most jurisdictions do provide some form of protection against those who steal or use others'
trade secrets unfairly. 9However, the problem with this form of protection is that the secret
generally becomes public once the biotechnology is used commercially and thus the protection is
lost. It is conceivable that the law of copyright could afford some protection for biotechnology.
Lines of genetic code are analogous to some extent with computer program code, which has now
been incorporated into the copyright systems of most industrialised countries. However, this
route to protection is fraught with practical and conceptual difficulties and is generally thought to
be unsuitable. There is as yet no recorded case of biotechnologists claiming copyright in their
inventions. Trademarks are also unlikely to be of much use in protecting biotechnology, though
they may of course prove important later in regard to marketing products, processes or services.
An attempt to register the name of a plant or an animal as a trade mark is unlikely to be
successful as public policy would prevent it (in England, registrations for names of varieties of
roses have been removed from the Trade Mark Register for lack of distinctiveness and because
of the likelihood of confusion).

IV. Importance of IP protection

In contrast, most developing countries do not have strong IPR regimes and suffer negative
effects of "brain drain". The reason being, lack of effective copyright laws, which force
scientists and technicians to immigrate to countries, where their research is protected from unfair
9
Hansen, S .Brewster, A. &Asher .J. Intellectual Property in the AAAS Scientific Community (American
Association for the Advancement of Science.
10
exploitation by competitors. Both Japan and Mexico saw a tripling of US pharmaceutical
investments and R&D after they improved patent laws. In fact, over the past years, the stumbling
block for global investors, looking for tie-ups with Indian firms has been the perception that
India's IPR norms are too lenient. "The prime reason Singapore is chosen over India is because
they protect Intellectual Property Rights. Companies take their R&D and clinical trial operations
to Singapore because they see clarity in regulation, besides other financial benefits," notes the
CEO of a prominent pharmaceutical company, based in Singapore.

V. Global IP regulations

Even though, the WTO TRIPS agreement provides a foundation for IPR protection, enforcement
is lacking in many parts of the world. The basic obligation in the area of patents is that inventions
in all fields of technology, whether products or processes, shall be patentable if they meet three
criteria - being novel, involving an inventive step and being capable of industrial application.

Additionally, a patent can be granted for any invention that meets the patentability conditions in
all fields of technology, irrespective of the place of invention. Over and above, in the general
security exception, which applies to the entire TRIPS Agreement, only specific exclusions are
permissible from the scope of patentability. Such exclusions span research areas, whose
commercial exploitation should be prevented to protect public order, human, animal and plant
welfare, and to avoid environmental damage. Biotechnology patent applications experience
numerous restrictions, primarily, due to the undefined scope and complex nature of the
technology. Deciding the scope of patent protection for inventions is a difficult task, as it raises a
number of technical and ethical issues. To begin with, biotechnology is an intimidating
amalgamation of biology and chemistry and claim interpretations. They force a judge or patent
examiner to grapple with rather fundamental issues, such as the significance of the term 'human'
when describing a protein. Next, it raises important policy questions, such as, the degree to
which a legal monopoly should be granted to an innovator, whose significant contribution could
be diminished by the consequent development of a competitor product or technique.

Article 27 of TRIPS agreement concerns the availability, scope and use of IPR in making
distinctions between material produced by biological processes and by non-biological routes;
11
only the latter is considered patentable. Natural material of any kind is not patentable and article
27(3) (b) makes it clear that member states are entitled to exclude plants and animals but not
micro-organisms from the scope of patentability. However, it is unclear whether TRIPS permits
member states to exclude biological substances like genes and cells. Currently, two schools of
thought exist. The first school states that there is no scientific basis to support the patenting of
genes and genomes, which are discoveries at best, while the second school states that
characterization of genes is not straightforward, so it does constitute an inventive step and
therefore should be patentable. Few companies can devote such funds to a single technology.
Small companies and start-ups, in particular, cannot afford the number of applications necessary
to obtain complete coverage for their inventions. As investors and industrial collaborators refuse
to invest in unprotected concepts, intermittent patent protection can delay or halt the
development of a promising therapeutic or diagnostic product. Along with this, multiple patent
applications often create uncertainty in the market, as aspects of a single discovery, obtain
protection over a period of years, rather than simultaneously.

VI. IP and Biotech scenario in India

India needs to implement strong patent legislation, data exclusivity, and improve IPR
infrastructure and enforcement in order to achieve its potential as an R&D powerhouse. The
much-delayed second amendment to India's 1970 patent law was passed in May 2002,
welcoming the extension of pharmaceutical patent protection from seven to twenty years. With
this change, India fulfilled part of its commitment to the international community by protecting
intellectual property. The Bill, however, makes broad ambiguous allowance for compulsory
licensing, and is unclear about patent protection for imports.

Judges might not be well-versed with the technical know-how of IPR related issues, thus fuelling
a need for an arbitration council to redress IPR disputes and showcase India as the next hub for
contract research, clinical trials and contract manufacturing.

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In 2005, India's Minister for Commerce and Industry, formed a Technical Expert Committee to
investigate the patentability of new chemical entities and micro-organisms, which the Parliament
did not consider when it passed the Patents (Amendment) Act.

Several ambiguous provisions in the patent laws have widened the scope of opposition in India
and one such nebulous provision is Section 3(d). This states that new forms, properties or use of
a known substance or discovery renders it un-patentable. Furthermore, salts, esters, ethers,
polymorphs, metabolites, isomers, mixtures of isomers, complexes, combinations and other
derivatives are considered the same substance unless their properties and efficacy differ
significantly. Although India has many of the core ingredients for a successful innovation
system, to maintain development of the biotechnology sector, progress is warranted in the areas
mentioned.10 Early implementation of a strong pharmaceutical patent regime would strengthen
India's R&D sector, attract more foreign investment, and provide a basis for Indian firms to begin
tackling diseases that have a serious effect on the country.

Regulatory Framework :

Since R & D in biotechnology is extremely time consuming and requires huge investment,
granting Intellectual Property Rights (IPR) is an effective tool to protect biotechnology
inventions. There are however, no internationally accepted guidelines for the management of
IPR, and a wide range of opinions exists regarding the utility of IPR in the area of
biotechnology.11 The Legal Framework remains very sensitive and complex in case of
biotechnology in general and agricultural biotechnology in particular because of technical and
ethical issues involved. Indian biotech industry at present is facing great challenges of the
emerging Trade Related Aspects of Intellectual Property Rights (TRIPS) compliant patent system
in India from January 1, 2005. Article 27.3 (b) of TRIPS excludes biological processes for the
production of plants or animals as a patentable subject matter, but patents can be granted to the
microorganisms, non-biological, and microbiological processes used in the production of plants
and animals. This covers even the gene sequences, which may be for a particular character, or a
10
Richard Y. Boadi, The Role of Intellectual Property Rights in Biotechnology Innovation: National and
International Comparisons.
11
Sharma Bindu, IPR Issues in Biotechnology,
http://fbae.org/2009/FBAE/website/our-position-ipr.html ( last visited on 25th Feb 2017)
13
promoter or genetic markers or similar ones. With the increase of transgenic research both in
public and private research organizations, the issues of royalty payments, material transfer
agreements (MTA), and legal obligations and bindings are to be clearly understood. IPR
protection of new life forms raises a number of difficult technical and ethical issues because of
which the patentability of new biological forms and processes is still not accepted in many
countries.

Indian Patent Act 1970, defines patentable invention as: a new product or process involving an
inventive step and capable of industrial application. Since IPR protection is granted only for
invention and not for discoveries, in case of biotechnology innovations, it is difficult to say
whether the new life form in the form of gene, DNA, cell etc is a scientific discovery or a
technological invention. Discovery is merely making available what already exists in nature. A
substance freely occurring in nature, if merely found or discovered, is not patentable. However,
if the substance found in nature has first to be isolated from its surroundings, and a process for
obtaining it is developed, that process is considered invention and hence patentable. The
consideration of industrial application is yet another obstacle for securing patents for inventions
in biotechnology.12 However, in India there are several ethical issues too related to patenting of
life forms, the most important being extent of private ownership that could be extended to life
forms. One of the major causes of uncertainties and controversies related with IPR protection of
life forms is lack of an established practice in protecting not only such living materials, but any
form of intellectual property. But, it is not so with regard to ownership of physical property that
has a tangible market value.13 In the traditional cultural context, Indians have considerable
problems fixing monetary value to anything that is not a tangible physical pretty that has market
value. Hence, there is an urgent need for developing countries like India to define clear policies
for IPR in case of scientific and technological innovations.

Article 27 (3)(b) of TRIPs agreement allows members to exclude from patent protection, plants
and animals other than micro-organisms; and biological processes for the production of plants or
animals other than microbiological processes. TRIPs provide option to member states protecting
12
Prof. Sullia S.B. , Biotechnology and Bioethics
http://www.fbae.org/2009/FBAE/website/our-position-biotechnology-and-bioethics-fbae-osition-paper.html(last
visited on 25th Feb 2017)
13
Matthew Rimmer,, Intellectual Property and Biotechnology: Biological Inventions.

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new plant variety by means of patent or sui generis system or both. India opted for sui generis
protection and legislated Plant Varieties Protection and Farmers Right Act-2000 that enables
the farmer to save, use, sow, re-sow, exchange, or share the seeds of protected variety, besides
offering protection on farmers' variety, extant variety and essentially derived variety.

Whereas plant variety protection could boost research in the area of plant biotechnology by both
public and private bodies, it could also result in higher prices for seeds, thus naturally excluding
the small and marginal farmers from accessing such new technologies. Farmers and indigenous
peoples in developing countries such as India are facing serious problems as plants that they
developed and conserved are being 'appropriated by private entities leading to biopiracy and
exploitation of traditional knowledge claiming the exclusive right to produce and sell many
'modified' plants and animals. 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. Increasing activity is taking place internationally where intellectual property
is being defined in various fora for the utilization and protection of biodiversity and
biotechnological inventions. Intellectual property obtained by multinational corporations and
other institutions may erode communities rights and their traditional practices.

The relevant international fora and processes are:

The Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement, 1994

The Convention on Biological Diversity (CBD), 1992.

The World Intellectual Property Organization (WIPO)

The International Treaty on Plant Genetic Resources for Food and Agriculture, FAO, 2001.

The International Union for the Protection of New Varieties of Plants (UPOV), 1978 and

1991 Acts. This is a great matter of concern today that knowledge, innovation and efforts of
these communities are not acknowledged when the legal 'intellectual property rights' systems
grant patents on genetic and biological materials and on living organisms to private corporations.
Hence such system of IPR only benefits the private industries or multi-national corporations of

15
industrially developed countries at the expense of the developing countries. There is need to
define guidelines and policies for the implementation of IPR in India so that the people like
farmers get recognition for their efforts and contributions prevent bio-piracy. World Intellectual
Property Organization (WIPO) is now developing guidelines to protect traditional and
indigenous knowledge systems.

The current system in India allows patent protection on methods and processes of substances
intended for use or capable of being used as food, medicine or drug and not on the end
result/product itself. Companies are therefore able to study the end product and produce it using
an unpatented processing method. However, in keeping with the TRIPS provision, it is now
possible to file application for patent in India on product claims relating to drug/medicinal
product and obtaining of priority date for such invention with effect from January 1, 1995 as
amended by Patents (Amendment) Act, 1999. These applications are categorized as Mail Box
applications and shall not be processed until the end of 2004 due to transition period of 10 years.
However, Exclusive Marketing Rights (EMR) can be obtained based on such applications.14

14
ibid
16
 VII. CONCLUSION

Biotechnology is a field of technology of growing importance in which inventions may have a

significant effect on our future, particularly in medicine, food, agriculture, energy and protection
of the environment. In closing, biotechnology is a promising technology with the potential to
provide tremendous benefits to society. It is hoped that article will provide some insights into
how biotechnology is transforming our society, and on how some kinds of technological
innovations require profound changes in the relationships between science and technology, and
new relationships between government, industry and universities, and the law. As in other fields
of technology, there is a need for legal protection in respect of biotechnological inventions. Such
inventions are creations of the human mind just as much as other inventions, and are generally
the result of substantial research, inventive effort and investment in sophisticated laboratories.
Typically, enterprises engaged in research only make investments if legal protection is available
for the results of their research. The changes in biotechnology and intellectual property
protection that have occurred since 1980 make private enterprise possible for the first time in
many broad research areas in agriculture and the health sciences. Furthermore, universities,
cooperatives and other public and non-profit institutions now have the option of licensing or
selling research outputs in this area, rather than giving their results away for free. As the scope
and power of IPRs in biotechnology has grown, their international reach has expanded. These
developments raise many fascinating and important issues: optimal patent design and licensing;
the implications of IPRs under cumulative innovation, typical of agriculture and biotechnology;
the effects of the TRIPS agreement on developing countries; the effects of IPRs on
monopolization of key sectors; and the optimal way to ensure that the poor of the world have
access to pharmaceutical products including AIDS drugs.
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