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LEGAL FRAMEWORK FOR BIOTECHNOLOGY PATENTS IN INDIA

INTRODUCTION
The term “biotechnology” was first coined by Hungarian engineer named karl Ereky.
Biotechnology is the use of biological methods and processes for commercial or industrial and
scientific purposes. Biotechnology exploits biological materials both living and non living and is
widely classified as classical and modern biotechnology. Modern biotechnology stated as a
species of classical biotechnology which developed in the late 70’s .

Biotechnology patents means the power given to the creators or innovators to protect the other or
third parties from producing, using ,selling or importing his biotechnological inventions.
Biotechnology plays an important role in the field of food, medicines, fertiliser’s, energy and
protection of environment .Biotechnology concerns living organisms as well as non living
biological materials such as seeds, enzymes and plasmas.

Biotechnology has become a crucial part of our economy now and with new discoveries in
areas like medicine, energy, and research, the role of patents has become more important than
ever in India . The nation’s ability to innovate or create new technologies that compete the edge
of the global market is crucial for its economic development. It is commonly known that patents
plays pivotal role in the development of biotechnology industry in India.
However , there are some emerging issues related to patenting of biotechnology inventions that
are serious concern to the Patent System such as novelty , inventive step , obviousness and
clarity in claims but in addition issues related to moral and ethical concerns and environmental
safety or issued related to patenting of ESTs , etc.
PATENT FOR BIOTECHNOLOGY IN INDIA
The Patents Act,1970 deals and governs the patent laws in India. At the beginning
biotechnology patents were not included in the Patents Acts of 1970 but after the amendment
of 2002, biotechnology patents came . Patenting biotechnological inventions requires unique
criteria due to its complex nature .
The term patent is given under Section 2(1)(m) of Patents Act 1970,means a
patent for any invention granted under this Act.
Section 2(1)(j) talks about “invention” means a new product or process involving an
inventive step involving an inventive step and 2(1)(ja) talks about “inventive step”
means a feature of an invention that involves technical advance as compared to the
existing knowledge or having economic significance or both and that makes the
invention not obvious to a person skilled in the art.
So according to these definitions there are 3 essential conditions in order to obtain a patent in
India:

1. An invention must be unique involve an inventive step.

Section 3 and 4 of The Patents Acts, 1970 defines the inventions which are non-patentable
in India. Some of the sub-sections of section 3 talks about the inventions that are not-
patentable under biotechnology patent law in India which are:

 Section 3(b) which talks about inventions which is primarily related to the commercial
exploitation related to the serious prejudice to human, animal or plant life or health or to
the environment.
 Section 3(c) which talks about inventions related to discovery of new living things or
substances in nature
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The Patents Act ,1970
  Section 3(h) talks about the methods of agriculture and horticulture.
 Section 3(i) talks about the process of treatment, therapy and diagnosis.
 Section 3(j) talks about patents related to plants and animals other than microorganisms. 2
India became the member nation of TRIPS Agreement in [Link] agreement makes it
obligatory for the nation state to protect biotechnological patent or inventions and obligates by
Article 27 of TRIPS agreement. The agreement makes a room for interpretation when it comes to
microorganisms and their functions as it fails to specify for patenting protection of
microorganisms.
BACKGROUND OF BIOTECHNOLOGY PATENT LAW
In the case of Diamond Vs Chakrabarty (1980) which is the landmark case in the field of
biotechnology patents. In this case Mr. Chakrabarty created a genetically engineered bacteria
capsule of breaking down multiple components of crude oil and applied for patents on the
ground that this bacteria poses a threat which is not natural founded . And the court
acknowledged that the human invention of living organisms per se could be patented.
Till 2002 , patents were not granted for the invention related to:
a) Living organisms
b) Biological materials
c) Substance derives from biological or living materials
d) Any processes for the production of living substances including nucleic acids.
However, patents could be generated for non living substance’s production by chemical
processes ,bioconversion and microbiological processes using microorganisms or biological
materials. In India after 2002, amendments made under the Patents Act in 2002 which included
microorganisms patentable . This amendment was made to fulfill India’s obligation under TRIPS
Agreement.
In the case of Dimminaco AG [Link] of Patents and Designs, the Calcutta HIGH
COURT held that the manner of manufacturing a product which contains living organisms can
be patented in India and ruled that the Act did not preclude a living end product from being
patented .

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The Patents Act,1970
This further opened the door for biological patents in 2002 when the Patents Act of 1970 was
amended . After this a large number of microorganisms patent id granted in [Link] which the
definition of “Invention” was changed .
India joined the Budapest Treaty on International Recognition of the Deposit of Microorganisms
for the Purpose of Patent Procedures on 17 th December 2001 and section 10 of the Act was
amended in 2002, which provides for the deposition of the biological material and its references
in the patent application in case where it is not possible to describe the biological material in a
sufficient manner and not available to public.
ETHICS IN PATENTING BIOTECHNOLOGICAL INVENTION
In India morality and ethics plays a crucial role as it is adhered to at the same level as the law.
Many people considers the patenting concept as an unethical practice as Indian culture is well
known for worshipping plants and animals as they consider them as God, so they believe it’s
unethical to “own” a living thing. As they concern that the patenting in biotechnology can lead to
big organization controlling important part of agriculture.
Traditionally, India has prohibited the giving private ownership over natural, living things but
since India has became an member of the TRIPS Agreement which makes it obligatory to allow
patents in some area like, microorganisms and inventions invented using biological materials.
In India , according the the amendment , inventions which goes against the public morality or
order , or harm animals or environment cannot be patented . As India has cleared that plants and
animals and essentially biological processes for producing plants and animals are not patentable
on the basis of ethics.
The Indian Patent Office follows specific guidelines for examining biotechnology inventions
(revised in 2013). These provide clarity on:
 Patentability of gene sequences and microorganisms,
 Sufficiency of disclosure and industrial application ,
 Exclusions from traditional knowledge and natural materials.
CONCLUSION
Biotechnology field has seen a remarkable growth in recent years by making its legal recognition
and protection under Patents Act of 1970 in India. India has shaped the biotechnological patents
with the blend of global obligations as well as deep rooted ethical values and morality . As the
Indian Patents Act of 1970, especially after the 2002 amendment, opened the doors for patenting
biotechnological inventions—particularly microorganisms but it still maintains clear boundaries
when it comes to protecting life ethics , traditional knowledge, and the environment and
morality.
India’s commitment with the TRIPS Agreement ensures that its patent laws are aligned and
obligates with international standards, while allowing space for interpretation in the country’s
best interests and morality. Sections 3 and 4 of the Patents Act demonstrate a key role in keeping
a check on what can and cannot be patented in India, especially in sensitive areas like
agriculture, medicine, and living organisms.
The judiciary has also played an important role in interpreting the biotechnology patent laws in a
way that supports innovation without compromising on the ethics or public interests or morals.
The judgements has widened the scope of biotechnology patents by reforming some of the key
areas and concerns.
It is crucial to provide and enhance the clarity and consistency of examination of biotechnology
patents application in India. There is a need for strengthening the laws on it. As biotechnological
industries continues to evolve , there will be need to balance the benefits of patents with the need
for innovation or to balance between Private Rights with Public Interests.
~RAKHI DUGAR
AMITY UNIVERSITY RAJASTHAN