DR.

RAM MANOHAR LOHIYA NATIONAL LAW UNIVERSITY

LUCKNOW

INTELLECTUAL PROPERTY RIGHTS LAW-II

PATENT ON GM CROPS IN INDIA

UNDER THE GUIDANCE OF-

Mr. Vikas Bhati

ASSISTANT PROFESSOR (Law)

Dr. Ram ManoharLohiya National Law University

SUBMITTED BY:

Pushpendra Pratap Singh

Enroll no:150101102
 ACKNOWLEDGEMENT

I express my gratitude and deep regards to my teacher for the subject Mr. Vikas Bhati giving me
such a wonderful opportunity to write a case study which involves such a relevant question of
law. It will indeed enhance my knowledge and also widen the scope of my study. I would like to
thank him for his exemplary guidance, monitoring and constant encouragement throughout the
course of this study.

I also take this opportunity to express a deep sense of gratitude to my seniors in the college for
their cordial support, valuable information and guidance, which helped me in completing this
task through various stages.

I am obliged to the staff members of the MadhuLimaye Library, for the timely and valuable
information provided by them in their respective fields. I am grateful for their cooperation during
the period of my assignment.

Lastly, I thank my family and friends for their constant encouragement without which this
assignment would not have been possible.

Pushpendra Pratap Singh

TABLE OF CONTENTS

 PATENT ON GENETICALLY MODIFIED CROPS

 TRIPS AGREEMENT
 PPVFR ACT
 CONCLUSION
 BIBLIOGRAPHY
PATENT ON GENETICALLY MODIFIED CROPS

For thousands of years farmers and plant breeders have been changing crop plants to improve
characteristics such as size, resistance to disease and taste. Plants which grow well, have a higher
yield or taste better are selected and bred from. This is still the most widely used technique for
developing new varieties of a crop, and is limited by natural barriers which stop different species
of organisms from breeding with each other. Genetic modification is very different to these
traditional plant breeding techniques. Genetic Modification is a technology that involves
inserting DNA into the genome of an organism. To produce a Genetically Modified plant, new
DNA is transferred into plant cells. Usually, the cells are then grown in tissue culture where they
develop into plants. The seeds produced by these plants will inherit the new DNA. Genetic
modification of plants involves adding a specific stretch of DNA into the plant’s genome, giving
it new or different characteristics. This could include changing the way the plant grows, or
making it resistant to a particular disease. The new DNA becomes part of the GM plant’s
genome which the seeds produced by these plants will contain.1 With the radical change in the
agriculture technique intellectual property related to fertilizers, herbicides, pesticides, genes,
genetic transformations, etc. also have changed.

In India the law of patents is in the Indian Patents Act, 1970 which has been amended three times
as per the need of the situation. The act prohibits any patents on plants, plant varieties or seeds, it
does not specifically exclude man-made gene sequences that are present in GM seeds. As a
1
result, biotech companies that may have patent rights on man-made gene sequences use patent
law to claim indirect patent rights on the seed itself. The Patents Act offers patent protection for
inventions. An invention is defined as a new product or process involving an inventive step and
capable of industrial application. Section 3 of the Patents Act lists what are not inventions in
India. Thus, in order to be eligible for a patent in India, not only must the claimed invention meet
the criteria for eligibility, it must also not fall under the exclusion listed under Section 3.

Section 3(c) –Discoveries of living things or non-living substances occurring in nature are not
patentable subject matter. Thus, micro-organisms isolated from nature and DNA, RNA or
proteins isolated from living organisms are unpatentable. Although naturally occurring micro-

1
VenkiRamakrishnan, “GM Plants Questions and Answers”, The Royal Society
organisms are unpatentable, genetically modified micro-organisms and vaccines are patentable,
subject to other requirements. Synergistic compositions of new or known micro-organisms can
also be patentable, as can processes for isolating such substances. To remove any ambiguity, the
act was amended in 2002 to include “biochemical, biotechnological and microbiological
processes” within the definition of potentially patentable chemical processes. Therefore the
distinction to understand discovery and invention is necessary.

The Patents (Amendment) Act 2002 introduced Section 3(j) which prohibits patenting of “plants
and animals in whole or any part thereof other than microorganisms but including seeds,
varieties and species and essentially biological processes for production and propagation of
plants and animals.” The expression “essentially biological process” has not been specifically
defined either in the statute or through judicial decisions or the manual of the patent office. 2
Although the act does not define an ‘essentially biological process’, in Monsanto (2013)3 the
Intellectual Property Appellate Board (IPAB) provided some guidelines on what constitutes one.
The patent application under consideration claimed a method of producing a transgenic plant.
Although the patent application was rejected on other grounds, the IPAB overturned the IPO’s
objection that it was an essentially biological process. The IPAB agreed with Monsanto’s
submission that the plant cell in the claimed process was transformed as a result of human
intervention in the manner claimed in the application, and was therefore patentable. Thus,
although genetically modified plants or seeds are not patentable in India, processes for the
genetic modification of plants are patentable.4 The introduction of the words ‘seeds’ and
‘varieties’ in Section 3(j) are also significant as they exclude from patentability all types of seeds
and varieties without any qualification. Thus, both naturally-occurring and genetically modified
seeds and varieties are excluded from patent protection in India. The words “any part thereof” in
Section 3(j) would logically include all parts of plants and animals such as genes, enzymes,
proteins, cells, cell lines, tissues, organs, which in turn would not be patentable. Thus, naturally-
occurring genes or nucleic acid sequences and proteins are not patentable. However, synthetic or
artificial nucleic acid sequences and proteins may be patented if they satisfy other criteria of
patentability. Such nucleic acid sequences or proteins are treated as chemical compositions.

2
Swarup Kumar and Shivaarti Bajaj, Challenges to the patenting of “essentially biological processes” in India
3
IPAB Decision dated July 05, 2013 in the matter 2 407/DELNP/2006
4
Swarup Kumar and Shivaarti Bajaj, Challenges to the patenting of “essentially biological processes” in India
TRIPS AGREEMENT

India being a member had obligations under Article 27 of the Agreement on Trade-Related
Intellectual Property Rights (TRIPS). Article 27.3(b) of TRIPS allows members to exclude from
patentability plants, animals, varieties and “essentially” biological processes, but mandates that
micro-organisms, nonbiological and microbiological processes have to be eligible for patents.
Article 27.3(b) also states that plant varieties have to be eligible for protection either through
patent protection or a system created specifically for the purpose (“sui generis”), or a
combination of the two.

PPVFR ACT

To adhere to the obligations India established a sui generis system, The Protection of Plant
Varieties and Farmers Rights Act, 2001 (PPV&FRA) was enacted. The main aim of this Act is to
establish an effective system for the protection of plant varieties and, the rights of the breeders
and to encourage the development of new varieties of plants. Any variety that fulfills the DUS
criteria and that is "new" (in the market) is eligible for this kind of protection, and there is no
need to demonstrate an inventive step or industrial application, as required under a patent regime.
A DUS examination involves growing the candidate variety together with the most similar
varieties of common knowledge, usually for at least two seasons, and recording a comprehensive
set of morphological (and in some cases agronomic) descriptors. Plant varieties present in
wilderness cannot be registered, under PPV&FR Authority. However, any traditionally
cultivated plant variety which has undergone the process of domestication / improvement
through human interventions can be registered and protected subjected to fulfillment of the
eligible criteria.5

The PPVFR Act also provides for “researchers’ rights” that permit any person to use a plant
variety as an initial source for creating other varieties without requiring any authorization. This is
particularly relevant for breeders who typically use transgenic varieties as an initial variety to
create new transgenic varieties by natural biological processes. In return, the creator of the

5
http://www.mondaq.com/india/x/519652/Patent/Plant+Variety+Protection
transgenic variety is eligible to claim a share in the benefit accruing to the breeder (Section 26
read with Rule 43). The benefit sharing amount must be determined by the Plant Variety
Protection Authority (“the Authority”), and must be fair and reasonable. It must also address the
interests of all the parties i.e., breeders, the trait provider and farmers. Further, the amount must
not be high or arbitrarily fixed. For example, in the case of Bt cotton, Monsanto ought to have
sought benefit sharing rights for its Bt cotton variety by applying to the Authority. In turn, the
Authority would determine the amount that Monsanto could claim from the Indian seed
companies. Two factors are relevant while determining the amount for benefit sharing: firstly,
the extent and nature of the use of genetic material of the claimant of benefit sharing in the
development of the variety relating to which the benefit sharing has been claimed; and secondly,
the commercial utility and demand in the market of the variety relating to which the benefit
sharing has been claimed.

CONCLUSION

To conclude the patent on Genetically Modified crops in India it is balanced as it balances the
rights of farmers, breeders and biotech companies. The Patents Act permits biotech companies to
patent their artificially engineered genes and use them to create transgenic seeds in a laboratory.
Biotech companies have the corresponding right to prevent anyone else from producing such
transgenic seeds in a laboratory and selling the same. In fact, in the case of Bt cotton, Monsanto
did precisely this, when it sold transgenic seeds to Indian seed companies for use as initial
varieties for creating new varieties. However, once the transgenic seed is sold by a biotech
research company, it cannot claim patent rights on subsequent seeds produced by farmers and
breeders using essentially biological processes. For that, arguably, it must rely on the provisions
of benefit sharing under the PPVFR Act.
BIBLIOGRAPHY

 PankhuriAgarwal, “The Plant Variety Authority and Bt Cotton: A Case of Regulatory

Capture?”
 S. Bala Ravi, Effectiveness of Indian Sui Generis Law on Plant Variety Protection and its
Potential to Attract Private Investment in Crop Improvement
 VenkiRamakrishnan, “GM Plants Questions and Answers”, The Royal Society
 Swarup Kumar and Shivaarti Bajaj, Challenges to the patenting of “essentially biological
processes” in India