ANALYSIS OF CURRENT INDIAN LEGISLATION ON BIOTECHNOLOGY BY - SMITA R. NAIK & PRAJAKTA PIMPALSHENDE
AUTHORED BY - SMITA R. NAIK & PRAJAKTA PIMPALSHENDE
Semester-III, Seconder year LLM, PES’ Modern Law College,
Pune
ABSTRACT
The present
study evaluates concern
prevailing legislative provisions pertaining to biotechnology in India. Legislation
related Environment Protection Act of (1986), Biosafety Rules (1989), Biotechnology Safety Guidelines (1990), Regulatory
Committees, Patent-laws, and bill of
Biotechnology Regulatory Authority
of India (BRAI)
have been discussed.
Key words: Indian legislation, biotechnology, patent-laws, regulatory committees
1.
INTRODUCTION
The
term biotechnology was first introduced
by Hungarian scientist, Earl Carley
in 1919 which comprises two words bio
and technology; bio means life and technology mean to use scientific research in getting desired result. Biotechnology
means using living organisms (plant
and/or animal) with technology for getting desired result. Development of the
genetic resources of biodiversity is
known as biotechnology. By using genetic engineering modifies basic DNA prevailing in plant or animal to enhance its functions to solve desired
problem and to make useful
products out of it. DNA (Deoxyribo-nucleic Acid) is a molecule which is made up of biological instructions that
result in the uniqueness of each species; it is passed from adult organisms
to their offspring at the time of
reproduction.
Biotechnology may be broadly
categorized into two groups viz., Gene and Non-gene, the latter being more popular practice.
Gene biotechnology deals with genes wherein genes are transferred from one to another organism. Non-gene
biotechnology deals with the entire cells,
tissues or even individual organisms. Using biotechnology,
scientist have developed vaccines for certain infectious diseases and some medicines beneficial to human health; developed good quality of seeds for higher crop productivity. In
couple of years, modern biotechnology is revealing many advances in healthcare, food and energy security, and environmental
conservation.
Biotechnology
is utilized in four major sectors mostly depending upon its use like medical, agriculture, industry and marine.
In medical sector it is used in pharmaceutical
(drugs) and in employing stem cells to replace or regenerate tissues. In
agriculture sector it is used to
evolve pest and disease resistant seeds. In industrial sector it is used in
process of developing novel chemicals
or vehicle-fuel. In marine aquatic sector it is used to control harmful
water borne organism.
In India, biotechnology is at threshold of fantastic growth; around 60, 10 and 30 per cent industry is devoted to human health applications, agri-biotechnology and bioinformatics
and genomics, respectively.[1] Recombinant DNA
(rDNA) technology is being successfully used in agriculture, health
care, process industry
and environment management. Current focus is on genomics, proteomics, transgenics, stem
cell research and product development. In
these sectors, adequate balance between benefit, safety, access and consumer
interest is required. Scientifically
rigorous, transparent, efficient and consistent regulation for biosafety evaluation and product-release are essential to achieve the goal.[2] India has now started attracting global attention in the field
of clinical trials, contract-research and manufacturing and other services of Bio-pharma segment.[3] Biotechnology
in its true sense was escorted into India
in the year 1997 by the launch of an indigenously developed rDNA
technology-based product, hepatitis-B
vaccine, by Shantha Biotechnics. Approval for cultivation of the first genetically manipulated (GM) crop in India
was given for Bt cotton in 2002 and
about 135 GM cotton varieties from 16
companies have been approved by now. Presently there are 7- recombinant crop-products indigenously developed and manufactured in India.[4]
2.
BIOTECHNOLOGY REGULATIONS
India’s
journey with biotechnology began in the 1980s with the establishment of the Department of Biotechnology (DBT) under Ministry
of Science and Technology. This marked
the beginning of institutional support for biotechnology research and
development in India. DBT played
crucial role in framing policies and creating encouraging environment for biotechnology to flourish in India.
In
order to understand today’s regulatory
system of biotechnology in India, one should
look back at the prevailing system in 1997. All regulatory requirements
were based on the provisions under India’s Environment
Protection Act (1986) wherein, three provisions formed basis for biosafety regulations; these were formulated and
formalized as Biosafety Rules (1989),
which applied to research, manufacture, use, import and storage of
microorganisms, gene-technology
products and products made out of genetically engineered microorganisms. The ‘Rules’ were supplemented by
Biotechnology Safety Guidelines (1990) issued by central governments’ Department of Bio-technology (DBT) which
subsequently revised in 1998 and 1999. Several
committees were then institutionalized in India through the DBT policies.
3.
REGULATORY COMMITTEES
Recombinant
DNA Advisory Committee (RDAC) reviews biotechnology developments at both national and international
level. It recommends suitable and appropriate regulations in for recombinant research, its use and applications. Review
Committee on Genetic Manipulation (RCGM)
monitors safety-related aspects
of ongoing research
and activities involving
genetically engineered organisms. To navigate this complex policy
landscape, India needs to craft a
more streamlined regulatory system and take other concrete steps to support
growth in its domestic biotech
sector.[5]
Apart from pharmaceutical sector,
biotechnology innovations and research are instrumental
in health care systems, agricultural industry, and polymers and materials
sectors. Research and development
in these areas is relatively time consuming and involves huge investment with risk involved with
outcome. To promote such results much more importance is affixed with respect to patenting the inventions in said
field and enabling growing research sector
to monetarily sustain itself. In order to help the patent seekers,
Biotechnology Patent Facilitation
Cell (BPFC) was established by DBT in 1999. Another government authority working for the same cause is Council of
Scientific and Industrial Research (CSIR) which formulated Science and Technology Policy (2003).[6]
DBT is parent body of
Recombinant DNA Advisory Committee (RDAC). Committee bears the responsibility of studying and reviewing the changes
and developments made in the field of biotechnology at the national
and international arenas.
Consequently, it renders
apposite suggestions to enhance safety regulations in the area of
recombinant research and their applied utilities.
DBT is parent body of Review Committee on Genetic Manipulation (RCGM). However, this committee concerns itself with the
safety and precautionary aspects of research in genetic engineering. In order to ensure the same, the committee
has to stipulate the specific
guidelines regarding the activities involving
genetic engineering of organisms and their consequent use or release. The utmost
importance is given to its prime objective which is to ensure environmental safety. It also bears the responsibility of
monitoring the products, field experiments, production, sale and shipment
involving even a fraction of genetically engineered organisms and cells which
are classified as so in the schedule.
DBT is the parent body of Institutional Biosafety Committee (IBSC).
Duty lies with institution which is conducting research that includes
usage of even the smallest
proportion of genetically
modified organisms and even microorganisms that are not natural to the local conditions. This committee needs to be
comprised of head of the parent institution directly invested in the research, the scientists hired by the institution
for the genetic engineering of organisms,
at least one medical expert and one nominee of the Department of Biotechnology. The parent institution is required to
prepare an up-to-date emergency
procedure(s) with the aid of the IBSC
which conforms to the guidelines of the RCGM. It is also imbibed with the duty of providing the copies of such a
contingency plan and procedure to the District Level Committee and the
Genetic Engineering Appraisal Committee.
Genetic Engineering Appraisal
Committee (GEAC) is constituted by the Ministry for Environment and Forests and grants requisite approvals for
activities or procedures involving large-scale commercial use and discharge
of potentially hazardous
microorganisms not excluding any such import comprising of
GMOS and recombinant DNA. Committee has the authority to prohibit production, sale, shipment,
GMOs use if deems it threat to environment.
State Biotechnology
Co-ordination Committee (SBCC) is constituted by the respective State and acts as State nodal agency
monitoring and assessing damages caused by the release of genetically modified organisms. The Committee yields power to
enforce punitive action against
violations after it has conducted an appropriate investigation. Committee bears
the additional responsibility of
periodically reviewing the safety and control measures employed by the industries or institutions invested
in the occupation of handling genetically modified organisms and hazardous microorganisms.
District Level Committees (DLC)
is constituted at the districts where biotechnology projects are to be undertaken. Its authority is subject to that
of the SBCC. The head of DLC is the
District Collector and it is him who reviews and assesses the safety regulations
employed by the industries or institutions engaged
in the use of GMOs or hazardous microorganism. The
committee’s responsibilities include the checking of the institution’s
compliance with recombinant DNA
guidelines and reporting the violations, if any, to the SBCC or the GEAC. It needs to coordinate activities of
concerned institution or industry to effect that it becomes easier to
contain emergency situations caused from accidental or even intentional discharges.
Monitoring and Evaluation
Committee which has the duty of undertaking regular visits to sites of experiment and recommends procedures
in case any remedial measure
is required to adjust any potential threat from
discharges. Committee also aids the RCGM in tabulating and analyzing primary data from the field so as to ascertain the
comparative agronomic advantages of genetically engineered crops or plants.
4.
KEY LEGISLATIVE FRAMEWORK
I)
Environment Protection Act (1986)
This is one of the key
legislations that regulate biotechnology in genetically modified organisms (GMOs). Act provides framework
for addressing environmental issues and its provisions
are applied to regulate the use, release and containment of GMOs. Under this
Act, the Genetic Engineering
Appraisal Committee (GEAC) was established to oversee the use of GMOs and
ensure that they do not pose threat to the environment
or human health.
Regulations pertaining to
biosafety constitutes primarily of rules and guidelines that are based on this Act. Sections-6, -8 and -25
jointly form preamble of currently existing biosafety regulations. Section-6 gives authority to central Govt. to
form essential rules on standard procedures,
implement safeguards and place necessary restrictions for handling of hazardous substances and outright prohibit the
others. Section-8 imposes prohibition on person from handling any substances considered to be hazardous except when
procedures and safeguards have been
complied to. Section-25 places responsibility of stipulating the rules
regarding procedures and safeguards
for handling hazardous substances. As general consensus in our judicial
system is that biosafety rules are of statutory nature as
their genesis lies in this Act.
A)
Biosafety Rules
(1989)
Aforesaid provisions have also
leaded to announcement of the Biosafety Rules (1989). These rules apply to the products made from genetically
engineered micro-organisms and other
gene-technology produce and regulate their manufacture, storage and import.
These rules also cover the
pre-release facet of genetically modified organisms, viz., their research and
development besides the large scale applications and trials. Hazardous
organisms which are not genetically
modified are also regulated by these rules. Rule no. -8 of this statute mandates requirement of an approval by the
regulatory bodies prior to the discharge or even production of genetically modified organisms and cells. Rules
nos. -10 and -11 necessitates requirement of approval for any such substances that contain genetically engineered organisms
or even cells. Rule-9 of this statute is foremost in significance as it
expressly prohibits deliberate and/or
unintentional discharge of genetically modified organisms (for experimental purposes) covered under its schedule,
barring situation where it has been approved as ‘special case’ by the
appropriate authority. The said schedule is feature of these ‘Rules’
which classifies human and animal pathogens in terms of
their risk profiles.
B)
Biotechnology Safety
Guidelines (1998)
Biosafety rules have been
augmented appropriately by Biotechnology Safety Guidelines which
have been put into effect by DBT. These guidelines
are the consequence of Rule 4(2)
of the ‘Biosafety Rules’, which mandates the requirement of guidelines manuals
which are to be stipulated by ‘Review
Committee on Genetic Manipulation’, which is serviced by DBT. These guidelines are concerned with the
assessment of biosafety levels of which it carries a detailed analysis. Detailed
reproach on recombinant DNA or rDNA related activities, experiments, shipments and quality control produced by genetic
engineering is also provided by DBT.
The safety guidelines, before reaching its current form and after being issued
by DBT in 1990 were revised and amended two times and finally amended
in 1998 in accordance with progressive strides made in the
field of rDNA research.
II)
Patent (Amendment) Act (2005)
Intellectual property rights
(IPR) play crucial role in biotechnology sector. This Act aligned India's patent laws with
trade-related aspects of Intellectual Property Rights (TRIPS) agreement. Amendments were made earlier in
1999, 2002 and 2004. Amendment allows patenting
of biotechnological inventions, including microorganisms and provided
protection for biotechnological
processes and products. Under current
patent law, provisions made are as under.[7]
A.
Compulsory licensing: Necessary u/s 92(1) for public,
non-commercial and governmental use
or in situations of national emergency or extreme urgency or for local
production of generics under many
conditions. It concerns about public health and access to medicines significantly restricts pharmaceutical
patent rights in the new Indian law. It
is important because in India more
than 70 per cent of medicines are sold through the private retailers. There are no restrictions on the kinds of
diseases for which this provision can be applied. The compulsory licensing provisions can be used for all classes of
drugs. Article 31 (f ) of TRIPS restricts
the export of compulsorily licensed medicines in member countries to an amount inferior than that destined for the
domestic market; however, as the domestic market in India is relatively large, the country could still supply most export markets.
B.
Restrictions and opposition to the concession of patents: Major concern
associated with the patenting of drugs and food products
refers to granting extension of term of the patent (20 years old) or patenting
of molecules that are similar to pre-existing ones and that represent relatively little innovation. Section 3
(d) says that the mere discovery of a new form of a known substance which does not result in enhancement of the known efficacy is not patentable; further says that salts,
esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures
of isomers, complexes, combinations and other derivatives of known
substances shall be considered to be the same substance, unless they differ
significantly in properties with
regard to efficacy. The Section is most controversial and powerful instrument to prevent patents, banning patenting
activity in absence of an innovative or inventive step. Indian law allows opposition to patents before and after their
concession. Section 25 (1) requires
that the Controller publish the patent application and enables any entity or
individual to challenge such patent
before it is granted. Section 25 (2) allows any entity or individual to submit an opposition to the patent after
it is granted, but before the expiration of the one year deadline from the date of its publication. One of the main
grounds for patent pre or post-grant opposition
is the lack of an inventive or innovative step. The object of the patent can’t
be commercially exploited by any
entity other than its holder or third party licensed by it. TRIPS allows
for exceptions in cases wherein this object is used for non-commercial purposes; this is known as ‘Bolar exception’ and allows
for use of patented innovations without permission from the patent holder and is embodied in Section 107 (a) of the
Indian patent law. It is an important provision, because it allows generic drug companies to conduct research
on patented drugs and
biological resources in order to obtain the approval of and to market equivalent or similar drugs or biological resources immediately after
the patent expires.
C.
Patenting of biological resources: Within the constraints imposed by TRIPS,
Indian law seeks to limit patent protection of living beings and biological materials. Amendment (2002)
of patent law restricts patenting
of genetically modified
organisms (GMOs) to their processes
or preparation methods.
Living entities of artificial origin e.g. microorganisms or vaccines may be proprietary as well as biological
material that has been subjected to substantial human intervention such as recombinant DNA and plasmids. Other manufacturing processes of biological materials
that are also produced by substantive human intervention, relating
to microorganisms or
chemicals using microorganisms, may also be protected by patent rights. However, the technology of genetic seed sterilization,
procedures for cloning or modifying germ line or genetic identity
of either humans or animals,
because they are contrary to public order or morality,
can’t be patented in India. Similarly, the use of human embryos
or animals for any purpose
is also excluded
from the patent protection. Since it does not meet the invention requirement, mere discovery
of a scientific principle, the formulation of an abstract
theory or the discovery of any living matter or nonliving substances
occurring in nature are also disqualified for patents in the
country. Biological materials, such as organs, tissues, cells, viruses, or substances obtained
merely by mixture,
resulting only in the aggregation of the properties of its components or in a process for producing such substances, where there is no increase in efficacy, also do not meet the invention requirement and can’t be patented. In addition, agriculture and horticulture methods and any procedures for medical, surgical
dressings, prophylactic, diagnostic, therapeutic or other treatments of
humans or any process for similar
treatment of animals to prevent them from acquiring diseases or to increase
their economic value or that of their
products including prophylactic treatments e.g.
vaccination and inoculation are not patentable. Whole or part of plants and animals
other than microorganisms, including seeds, variety,
species and clones or essentially biological processes
for the production of plants and animals as well as any source of artificial
living entities, e.g. entirety or part of transgenic plants or animals, cannot be
patented. The matter which has no determined function nor industrial application or inventive
activity e.g. sequences or inventions which in effect are traditional knowledge or which are an aggregation or duplication of known properties of traditionally known components are likewise not eligible for patenting.
In 2001, India became member of the Budapest
Treaty on International Recognition of Deposit of Microorganisms for purposes of patent procedure. Treaty allows that the deposit
of micro-organisms in an international depositary authority be recognized for the purposes
of patent applications. Its relevance stems from the fact that the reproduction of micro- organisms based solely on their description in patent applications is not feasible
in practice, making
it necessary to deposit their lines to allow for their testing and examination by others. The authorized
depositary is Institute of Microbial Technology, Chandigarh.
III)
Protection of plant-varieties and Farmer’s rights
(PPVFR) Act (2001)
Article 27.3 (b) of TRIPS states
that members shall provide protection of plant varieties either by patents or by an effective
sui generis system or by combination of both. Indian sui generis law was created to comply with TRIPS is the PPVFR Act (2001). India was the first country to include farmer’s rights in
its legislation in order to counter balance breeders rights. Farmers’ rights in Indian law are protected by provisions that determine the following:
A.
Farmers have right to keep and sell seeds, even those
of protected varieties, provided they have
not been imported and branded with the breeder’s registered name so as to
indicate that they are seeds
protected by law.
B.
Farmers who breed or develop new plant varieties also
have privilege to register them and to
benefit from other forms of protection. The law recognize farmer not only as
cultivator but also as conserver of agricultural gene pool
and an informal breeder.
C.
Creation of National Gene Fund through which breeders
have to pay for use of farmers’ plant
varieties in the generation of essentially derived varieties. Any individual is
entitled to register claim for protection
of plant variety at a notified center that, if deemed genuine,
will lead to initiation of a procedure for benefit sharing and
the deposit of share of the resulting profits
in the Fund. This procedure allows for the registration of plant varieties on
behalf of farmers even when farmers
themselves are handicapped by illiteracy or
ignorance.
D.
Full disclosure of the sources and origins of plant
varieties and of passport data on the part
of breeders. Failure
to meet this prior requirement is punishable with heavy fines and imprisonment. The law adopts the
principles of prior informed consent and benefit-sharing endorsed by the Convention on Biological Diversity (CBD).
E.
Use of
reproductive technology for genetic seed sterilization i.e. terminator, is prohibited.
F.
Farmers can’t be prosecuted for violating rights of
breeders if they can prove that they were not aware of the rights.
G.
Farmers who wish to examine documents and papers or
receive copies of the rules or decisions taken by
the various authorities may do so with exemption of all fees.
The law effectively exploits
flexibilities of TRIPS, meets requirements of CBD and protects farmers’ rights. The law also allows use of registered
and protected varieties for research
purposes, even when creating new varieties, provided that they are not
essentially derived varieties so as
to include natural selection, mutant selection, soma-clonal variants, backcrosses and transformation by genetic
engineering. The law aimed at preserving public interest allowing exclusion of certain varieties from protection
when the ban on commercial exploitation
of these varieties is necessary to protect the order or public morality or
human, animal and plant life and
health or to avoid serious prejudice to environment. Compulsory licenses shall be issued if the protected
varieties are not available at reasonable prices without justification from
the breeders.
Breeders’ rights include
not only marketing exclusivity
for registered plant varieties, but also exclusivity for the production,
sale, distribution, import or export of such varieties or for appointing another party to do so.
Moreover, such rights are not applied only to the varieties, but also to their packaging and trademarks and when there are suspicions of violation or
infringement of these rights the burden of proof of innocence is placed on the accused. Use of trademarks or packages
similar to those registered by breeders without their permission constitutes violation
of those rights.
In cases of conviction, the punishment includes
heavy fines and imprisonment for up to two years.
IV)
Drugs and Cosmetics Act (Amended in 2008)
Act governs manufacture,
distribution and sale of drugs. With growth of biotechnology particularly in the field of
biopharmaceuticals, the Act of 1940 was amended twice in 1998 and 2008 to include provisions for the regulation of biotechnological drugs, including
recombinant DNA products, bio-similars and other biologics. The Central Drugs
Standard Control Organization (CDSCO) is the regulatory body responsible for overseeing the approval and monitoring of biotechnological drugs in India.
V)
Biological Diversity Act (2002)
Act was enacted to provide for conservation of biological diversity,
sustainable use of its
components and fair-equitable sharing of benefits from use of biological
resources. It addresses issue of
biopiracy and ensures that indigenous communities receive their due share of benefits
from use of their traditional
knowledge in biotechnological inventions.
VI)
Establishment of Biotechnology Regulatory Authority of India (BRAI)
The bill was introduced in
parliament on 22-4-2013 by the Ministry of Science and Technology which was referred to the Standing Committee on
17-5-2013 and the Committee was
supposed to submit its report in June 2014. Its current status however is still
not clear. It will provide
single-window platform for scientific risk assessment of all biotechnological products viz., agriculture, health, environment and industrial sectors. It
will help to keep pace in regulatory
measures with rapid technology advancement in biotechnology and to ensure safety to human and animal health and the
environment. It will supervise and regulate field trials of genetically modified crops and research,
transport, import, manufacture, use of organisms and products of biotechnology.
It will provide necessary certification and approval whether it is safe for use. It will only grant regulatory
approval after a multi-level process of assessments
is undertaken by scientific experts
in the field. It will impose penalties for conducting field trials without its
approval. Regulatory Appellate Tribunal will be formed to hear civil
cases that involve substantial question relating
to biotechnology and hear appeals on the decisions and orders of BRAI. Certain
criticisms expressed on this bill are the proposed
new institute doesn’t clearly defining boundaries of responsibilities and
powers; the bill was introduced
without consulting stakeholders; bill is considered to be unconstitutional as agriculture comes under the domain of
State; term ‘confidential commercial
information’ has been kept out of the
Right to Information (RTI) Act; the uses vague wordings which would criminalize sequencing or isolation
of DNA and PCR techniques, requiring approval
for each usage which may hinder the field of education and research;
there is no provision for mandatory
labeling of Genetically Modified (GM) foods; Regulatory Appellate Tribunal will consist of just one judicial member and five technical
members that is against the directives of Supreme Court that bench of tribunal
can’t have more technical members than judicial members; Tribunal has jurisdiction over substantial question
relating to modern biotechnology however,
Bill does not define this term, leaving
term undefined increases ambiguity; it does not specify any liability for damage caused by
biotech-product etc.[8]
5.
CASE LAWS IN INDIA
1)
Indian subsidiary of Swiss pharmaceutical
multinational Novartis has filed lawsuit against the rejection of its patent application for the leukemia drug
Gleevec. This drug was originally patented
abroad in 1993 and TRIPS allows countries such as India that did not recognize patents on pharmaceutical products before
complying with the Agreement to render drugs
patented before 1995 forever ineligible for patenting. However, Novartis
applied for patent in India for the beta crystalline form of Gleevec
arguing that such drug represented improvement over its previous form, because it is less
hygroscopic and therefore more stable. Nevertheless,
Indian patent office rejected such application arguing that in its new version, Gleevec did not meet the requirements of inventive
step and non-obviousness. This version did
not constitute a new molecule; moreover researchers versed in chemistry of the
molecule could see that its patented beta crystalline form would already
have useful properties indicated by Novartis.
In other words, the new version of Gleevec would represent structurally distinct form of previously
known substance, the patenting of which would be specifically vetoed by Section 3 (d) of the Indian patent law. Novartis filed the
lawsuit in 2006 in Chennai High
Court, which upheld the patent office’s denial to grant a patent for Gleevec.
2)
Novartis has filed lawsuit challenging the
constitutional validity of Section 3 (d) and
claiming that it violates TRIPS. Chennai High Court considered
itself without jurisdiction and unfits to judge the conformity
of national legislation with TRIPS, something
which can be done by WTO in response to member
country complaint and denied unconstitutionality of Section 3 (d). For these reasons, lawsuit was dismissed in 2007.
Subsequently, Switzerland informed it
would not take complaint to Dispute Settlement Body of WTO. Novartis has however decided to continue to pursue the
case in the ambit of Intellectual Property Appellate Board and Supreme Court of India. Patent applications filed by
other multinationals such as Roche
were also denied. Novartis court cases should create jurisprudence with
significant effects for our patent
regime and production-pricing of medicines in country and abroad.
3)
Indian companies asked Monsanto, the licensor to reduce their
license fees as new price control policies
were pursued by the State government. Indian companies the licensees stooped payment of royalties when Monsanto
denied their request. In 2015 Monsanto
filed an application for an injunction for trademark infringement and violation of registered patent
with a view of the termination of the agreement.
Monsanto started the arbitrary procedure
of recovering 400 corers from the licensees.
Defendants alleged that the patent is in violation of section 3(j) of Indian Patent Act (1970) and claimed revocation
of a patent u/s 64 of
the same Act. Section 3(j) states that plant and animal in whole or any part thereof other than micro-
organisms but including
seeds, varieties and species and essentially biological
processes for production or propagation of plant and animal; the said Section
points out that biological processes for production or breeding by natural process unless it is microorganisms. Process is considered to be essentially biological if it is entirely
natural phenomenon. However,
Indian Patent Act (1970) doesn’t define essentially biological process; Section-64
of the Act states grounds
for revocation of the patent.
High Court stated
that license terminated by Monsanto was
reinstated; Indian companies were allowed to use the patented technology; the patent
protection can’t be enforced until the suit was disposed of and rejected all the claims.
4)
Appeal in Supreme
Court of India, the
interpretation of the judgment
was as under.
a) Defendants
(Naziveedu Seeds & Ors) claimed that there is no inventive step in
plaintiff’s (Monsanto) patent until
artificial NAS is inserted into plant so that plant starts producing the delta-endotoxin which is toxic to the Bollworms.
b) Defendants
claim that there is no capability of industrial application of NAS except to become
part of plant and to develop transgenic plant.
c) Supreme
Court states that will not define essentially biological product for now, we do
not consider it necessary to deal
with the same at this stage and leave open all questions of facts and law to be urged for consideration in appropriate proceedings.
d) Section
64 of Indian Patent Act 1970 provides for revocation of the patent based on the counter-claim in suit. It presumes valid consideration of claims in the suit and counterclaim in accordance with the law and not summary adjudication. This
section is available as a defense
against an infringement action.
e) Civil
Procedure Code provides detailed procedure with regard to manner in which a
suit instituted under
Section-9, including counterclaim
has to be considered and
adjudicated.
f) Supreme
Court was satisfied in facts and circumstances of the case that nature of the injunctive relief granted by the Single
Judge of Delhi High Court was in order and merits, no interference during the pendency of the suit.
g) Supreme
Court expresses that Division Bench should have confined itself to examination of the
validity of the order of
injunction granted by the
learned Single Judge.
h) The
order of Division Bench was set aside and the order of single Judge was
restored and the suit was
remanded to the Single Judge
for disposal in accordance with the
law.
6.
CHALLENGES IN BIOTECHNOLOGY LEGISLATION
Despite the comprehensive legislative framework, several challenges remain in the regulation of biotechnology in India are given below.[9]
a) Coordination
among regulatory bodies: Regulation of biotechnology involves multiple regulatory bodies, which can lead to overlap, confusion and delays in
decision-making.
b) Public
perception and acceptance: GMOs often faces public opposition due to concerns about safety and environmental impact
which requires clear and transparent communication from the government and regulatory bodies.
c) Capacity building:
There is need for continuous capacity building among regulatory bodies,
researchers and industry stakeholders
to keep up with rapid advancements.
d) Ethical and safety concerns:
Use of biotechnology in human health and genetic modification raises ethical questions;
there is need for robust ethical framework to guide research and application in these areas.
7.
CONCLUSION
Indian legislation on
biotechnology has evolved significantly over the past few decades, providing widespread framework to
regulate this sector. Since this sector will continues to advance,
it is essential for legislation to adapt and address new challenges. Ensuring
coordination among regulatory bodies, addressing public concerns,
building capacity and establishing strong
ethical framework to be key to continued growth and safe application.
[1]
Available at:
file:///C:/Users/NAIK/Desktop/Laws%20of%20biotechnology%20in%20India/Biotechnology
% 20 Laws%20in%20India%20-%20Mondaq%20India%20-%20Blogs%20-%20VLEX%2029357790.html
[3] Dubey,
R. Biotechnology-destination India (2004). JIBL: 1(I), Pp. 205-210.
[4]
Ibid 2.
[5] Supra
2.
[6]
Rastogi, (2026) Protection
of biotechnology under Indian laws. Available at: file:///C:/Users/NAIK/
Desktop/ Laws%20of%20biotechnology%20in%20India/Protection%20Of%20Biotechnology%20Under%20Indian%
20Laws%20-%20Patent%20-%20Intellectual%20Property%20-%20India.html
[7]
Available at: André de
Mello Souza. https://repositorio.ipea.gov.br/bitstream/11058/4551/1/BEPI_n10_indian
Last seen on 3-8-2024
[8]
Available at: https://byjus.com/free-ias-prep/biotechnology-regulatory-authority-india/
Last seen on 3-8-2024.
[9]
Supra 7