BIOTECHNOLOGICAL INNOVATIONS: LEGAL ISSUES AND PERSPECTIVES BY - RADHIKA DATAR
“BIOTECHNOLOGICAL INNOVATIONS:
LEGAL ISSUES AND PERSPECTIVES”
AUTHORED BY - RADHIKA DATAR
Abstract:
The purpose of the research
article is to study and analyse the various legal issues in the field of
biotechnology and specifically in biotechnological innovations. Biotechnological innovations refer to techniques that use living organisms, or parts of them, in
order to make or modify products, or to improve or modify certain or all the
characteristics of plants, or animals, in order to develop micro-organisms, and
organisms intended for specific uses in healthcare,
agriculture, pharmaceuticals, and environmental science. The analysis describes
the concept and evolution of biotechnology as well as biotechnological innovations in
India. It stipulates in short; the various issues in biotechnological innovations which includes environmental,
socio-economic, religious and cultural, ethical and legal issues. The study
further describes; imbalance between incentivizing of biotechnological
innovations and access to its benefits, issue of patentability
data ownership and sharing issue, liability of product safety issue as the
major legal issues in biotechnological
innovations with supporting judicial pronouncements which describes
the cause of evolution and amendments in various science and technology laws in
India. The study finally suggests some recommendations to combat the ill-effect
of legal issues and to enhance the further developments in biotechnological innovations in
India.
Keywords: biotechnology,
biotechnological innovations, legal issues, healthcare,
agriculture, pharmaceuticals, environmental science.
INTRODUCTION:
Biotechnology is a rapidly evolving and multifaceted field that
encompasses various applications in healthcare, agriculture, pharmaceuticals,
and environmental science. The biotechnology sector in India as well as in
various other countries has grown significantly over the years and plays a
crucial role in driving innovation, research, and economic development. Biotechnology exists since ancient
times and its progress has been witnessed through many centuries. It is the
field that exploits living organisms to make technological advances in various
fields for the sustainable development of mankind. The term “biotechnology”
broadly includes not only the old biotechnology such as the traditional method
of manufacturing fermented products but also the new biotechnology represented
by genetic engineering and recombinant technology. The biotechnological
research, application and innovations can be traced back decades ago with the
agricultural revolution. The biological processes of living organisms have also
been used for more than 6000 years to make essential products such as bread,
cheese, alcohol, etc. In 19th century after the establishment of
Department of Biotechnology (DBT) in 1986[1];
India saw the rapid emergence and development of the biotechnology industry in
agriculture, healthcare, and pharmaceuticals attracting investments from both
domestic and international sources. India became a hub for clinical trials,
biopharmaceutical manufacturing, and research and development.
A biotechnological
innovation has been one of the greatest scientific achievements in the
history of mankind. Biotechnological
inventions refer to techniques that use living organisms, or parts
of them, in order to make or modify products, or to improve or modify certain
or all the characteristics of plants, or animals, in order to develop
micro-organisms, and organisms intended for specific uses. However beside
all its applications some social, environmental, legal, ethical, moral and
religious issues are also coexist within the fields of Biotechnology. These
issues includes many defects and side effects of products, tools and techniques
along with economic, environmental loss and other negative impacts. Legal
and policy issue is one of such key issue in biotech innovations. This may
involve issues like intellectual property rights and patentability issues,
biosafety regulations, clinical trial and drug approvals issues and data
ownership and sharing relating to the innovation issues.[2]
Earlier nobody thought
that biotechnology could manipulate either plants, animals or human beings and
therefore no one thought about the need for evolving a comprehensive law on
biotechnology for regulation. However, as biotechnology has progressed in
various generations at different times and and due to the plenty of legal
concerns and issues which emerged in biotech innovations; this field mandated a
comprehensive legal framework for proper regulation, TRIPS agreement provided
protection and regulation of various biotechnology inventions. Indian
government have also developed comprehensive laws such as The Patents act,
1970, New drugs and clinical trial rules 2019 etc. to ensure safety and
protection of biotech innovations.
CONCEPT OF
BIOTECHNOLOGY:
Biotechnology is a rapidly evolving and
multifaceted field that encompasses various applications in healthcare,
agriculture, pharmaceuticals, and environmental science. The term biotechnology was used
for the first time by Karl Erkey, a Hungarian Engineer, in 1919. The term biotechnology is derived from the Greek
root i.e. ‘bios’, which means life, and ‘techne’ meaning craft or skill. Biotechnology is a culmination of human
intervention and natural processes. It is the field that exploits living
organisms to make technological advances in various fields for the sustainable
development of mankind. It is the use of biology
to develop new products, methods and organisms intended to improve human health
and society. The term “biotechnology” broadly includes not only the old
biotechnology such as the traditional method of manufacturing fermented
products but also the new biotechnology represented by genetic engineering and
recombinant technology.
Definition:
Biotechnology consists of "the application of scientific and engineering
principles to the processing of materials by biological agents to provide goods
and services.
Karl Erkey:
Biotechnology is “The process of using technology to convert raw, biological
material into a useful product”.[3]
EVOLUTION AND DEVELOPMNT OF BITECHNOLOGY:
Biotechnology began nearly 6,000 years ago with the agricultural revolution. During this era; agricultural
productivity increased dramatically through the development of new technologies
and land management practices. This early era was also characterized by
exploiting living organisms in their natural forms or modifying their genetic
makeup through selective breeding. Around the same time, humans learned to
harness the biological process of fermentation to produce bread, alcohol and
cheese. Biotechnology
remained limited to these selective breeding, agricultural methods until the 19th
century when biologist Gregor Mendel discovered the basic principles of
heredity and genetics. During that era, scientists Louis Pasteur and Joseph Lister
discovered the microbiological processes of fermentation. This laid the
foundation for biotechnology industries where scientists can interact directly
with the genetic and molecular processes of organisms. Based on the work of
these various scientists, genetic engineering developed in 1973. This method of genetic engineering
is the foundation of modern biotechnology and recent advancements. It enabled
the first direct manipulation of genomes of various plants and animals.
The history of biotechnology in India can be traced back several
decades, and it has evolved significantly over the years. India has a rich
history of using biotechnology in the form of traditional medicine systems like
Ayurveda, which date back thousands of years. In the 1960s and 1970s, India
underwent a Green Revolution, which involved the development and adoption of
high-yielding crop varieties and modern agricultural practices. This marked an
important application of biotechnology in Indian agriculture. Then in 19th
century, The National Biotechnology Board was established in 1982, which later
evolved into the Department of Biotechnology (DBT) in 1986 under the Ministry
of Science and Technology. [4]Therefore, 1990s
saw the emergence of the biotechnology industry in India, with the formation of
biotech companies engaged in agriculture, healthcare, and pharmaceuticals. Then
after the 2000 till present India's biotechnology sector continued to grow,
attracting investments from both domestic and international sources. India
became a hub for clinical trials, biopharmaceutical manufacturing, and research
and development.[5]
CONCEPT OF BIOTECHNOLOGICAL INNOVATIONS:
A biotechnological innovation has been one of the greatest
scientific achievements in the history of mankind. Biotechnological inventions are
nothing but the techniques that use living organisms, parts of living organisms
in order to make or modify various products, or to improve or modify specific
or all the characteristics of that plants, or animals, in order to develop
micro-organisms. Biotechnological inventions are applied in a wide range
of fields including agriculture, agro-industry, fertilizers, the food industry,
diagnostics, zoo-techniques, semi-conductors, pharmaceuticals, the refuse
industry, fuels, chemistry, etc.
Biotechnology innovation is “The
technology that utilises biological systems, and living organisms to develop or
create different products”.
DEVELOPMENT OF BIOTECHNOLOGICAL
INNOVATIONS IN INDIA:
India has made significant progress in the development of
biotechnological innovations over the years. The growth of the biotechnology
sector in India can be attributed to several factors, including a strong
research and development ecosystem, government support, a skilled workforce,
and a growing market for biotech products. The roots of biotechnological
innovations in India can be traced back to ancient practices like fermentation
and the use of traditional medicines. India has a rich tradition of herbal and
medicinal knowledge, which has contributed to biotechnological advancements.
During early 1950s to 1970s period, India laid the foundation for
biotechnological research. Research institutions and universities initiated
studies in microbiology, biochemistry, and genetic engineering. This era saw
the establishment of organizations such as the Indian Council of Agricultural
Research (ICAR) and the Indian Council of Medical Research (ICMR).[6] The
Department of Biotechnology (DBT) was established within the Ministry of
Science and Technology in 1986. [7] The
DBT's mandate was to promote, coordinate, and fund biotechnology research and
development. 19th century witnessed significant progress in
agricultural biotechnology. India developed and adopted genetically modified
(GM) crops and also emerged as a key player in the global biopharmaceutical industry,
producing affordable generic medicines and vaccines. Ever since a GMO was granted patent,
the field of biotechnology gained enormous significance and patents have been
granted to genetically engineered plant and human genetic material.
The India launched the NBDS in 2002 [8]to
provide a strategic framework for the development of biotechnology in India. It
aimed to strengthen research and innovation, promote entrepreneurship, and
address societal and environmental challenges. During this period, biotechnology
parks and incubators were established in various regions of India to provide
infrastructure and support to biotech start-ups and innovators. These
facilities fostered innovation and entrepreneurship. India developed a
regulatory framework for biotechnology to ensure biosafety and ethical
practices in research and development. This included guidelines for genetically
modified organisms (GMOs) and clinical trials. In late 20th century Indian
biotech institutions and companies entered into international collaborations
and partnerships, enhancing their global footprint and contributing to
collaborative research projects. The government introduced various policies and
initiatives to boost the biotech sector. These included grants, subsidies, and
support for research and development. India experienced a surge in biotech
start-ups, particularly in the fields of health-tech, agribusiness,
diagnostics, and bioinformatics. These start-ups played a significant role in
driving innovation and attracting investment. India became a global leader in
the production of affordable healthcare solutions, including generic drugs and
biopharmaceuticals. It contributed to addressing global health challenges
through the export of quality medicines and vaccines.
ISSUES IN BIOTECNOLOGICAL INNOVATIONS:
Biotechnological
innovations have the potential to bring about significant advancements in
various fields including healthcare, pharmaceutical, agriculture and
environmental conservation. Biotechnology had improved the way of living in
many aspects including the industrial, agricultural production, Fight
against diseases etc. and it can ensure sustainable development by improving
agricultural productivity. [9]However
beside all these applications some issues also coexist within the fields of
Biotechnology. These issues includes many defects and side effects of products,
tools and techniques along with economic, environmental loss and other negative
impacts.
Following are the key
issues in biotech innovations: -
1)
Environmental issues: Biotech innovations such as genetically
modified organisms etc. may result into some unintended environmental
consequences. These innovations may result into biodiversity loss,
contamination of non-target organisms, west generation and also can sometimes
lead to the harm to aquaculture.
2)
Legal issues: Intellectual property plays vital role in
biotech innovations. Researchers generally seek for the patents to protect
their innovations but this can create imbalance between incentivizing biotech
innovation and ensuring access to innovation. Biotech innovations also leads to
the pivotal problems such as patentability of innovations. [10]
3)
Socio-economic issues: Biotech innovations such as genetically
modified organisms etc. can have great impact on traditional farming industries
and rural livelihood. It can also create disparities in access to its benefits
since many innovations bears high costs which is only affordable to rich people
and wealthier nation.
4)
Religious and cultural issues: Reproductive technological innovations
such as IVF, surrogate mother can clash with religious and cultural beliefs
about sanctity of family, status of children born out of this issue.
5)
Ethical Issues: Biotech innovations such as gene editing,
germ line modification can have some consequences such as permanent genetic
change, creation of designer babies which can create ethical issues. [11]
LEGAL ISSUS
AND PERSPECTIVES IN BIOTECHNOLOGICAL INNOVATIONS:
Earlier nobody thought
that biotechnology could manipulate either plants, animals or human beings and
therefore no one thought about the need for evolving a comprehensive law on
biotechnology for regulation. However, due to various developments and
advancements; this field mandated a comprehensive legal framework for proper
regulation
Following are the key
legal issues in biotechnological innovations:-
1)
Imbalance between incentivizing of
biotechnological innovations and access to its benefits:
The imbalance between incentivizing biotechnological innovations and
ensuring access to their benefits is a complex challenge in India, as it is in
many countries. While incentivizing innovation in biotechnology is crucial for
scientific progress and economic growth, it must be balanced with the need to
make biotech products, especially in the healthcare sector, accessible and
affordable to the broader population. Here are some factors contributing to
this imbalance:
Intellectual Property Rights (IPR): Strong
IPR protection, including patents, can incentivize innovation by granting
exclusivity to developers. However, it can also lead to high prices and limited
access to biotech products. Balancing IPR with provisions for compulsory
licensing or limitations on patents for essential medicines can ensure that
access is not hindered.[12]
High development costs:
Biotechnological innovations often involve substantial research and development
costs. These costs are often recovered through high prices for new biotech
products. Governments and organizations can provide funding or incentives for
research in critical areas, like neglected diseases, to reduce the burden of
high development costs.
Regulatory Hurdles:
Stringent regulatory processes can delay market entry for biotech products,
increasing costs and affecting accessibility. Streamlining and expediting
regulatory processes while maintaining safety standards can make biotech
products available sooner and at a lower cost.
Public private collaboration: Private
companies or private companies in collaboration with public companies often
drive biotech innovation, and their profit motives may hinder affordable
access. Encouraging public-private partnerships and ensuring that collaboration
agreements prioritize affordable access can help address this challenge.
Balancing incentives for biotechnological innovations with access to
their benefits is an ongoing policy challenge that requires careful calibration
to address the specific needs of the population. Collaboration between
government, industry, civil society, and healthcare providers is essential to
strike the right balance between innovation and accessibility in the biotech
sector in India.
In the case of Novartis AG v. Union of India (2013)
[13]often
referred to as “Gleevec Case” the
Indian Supreme Court issued a landmark judgment in 2013 that had significant
implications for access to biotech innovations. Novartis, a multinational
pharmaceutical company, developed the drug Gleevec (generic name: Imatinib
Mesylate), which is used in the treatment of chronic myeloid leukemia (CML) and
other cancers. The drug was considered a significant medical breakthrough.
Novartis sought to patent an improved crystalline form of Imatinib Mesylate in
India. The patent application was filed in 1998 under the Indian Patents Act,
1970. In 2005, the Indian government amended the Indian Patents Act to
strengthen provisions related to intellectual property and patents. One crucial
amendment was the introduction of Section 3(d), which aimed to prevent the
grant of patents for minor modifications of known substances. The Indian Patent
Office rejected Novartis's patent application for the newer form of Gleevec.
The rejection was based on the interpretation of Section 3(d)[14], which
prohibited the grant of patents for incremental or minor modifications of known
substances unless they demonstrated significantly enhanced therapeutic
efficacy. Novartis challenged the rejection of its patent application in
various legal forums, arguing that the rejection violated international trade
agreements and intellectual property rights. The case garnered widespread
attention due to concerns about access to affordable medicines in India. India
has a large population with a significant burden of diseases like CML, and
access to affordable treatment was a public health concern. The Indian Supreme
Court ruled against Novartis in a historic judgment in April 2013. The Court
held that the amended Indian Patents Act, particularly Section 3(d), was
consistent with India's obligations under the Trade-Related Aspects of
Intellectual Property Rights (TRIPS) Agreement. The Court emphasized that the
patent application did not meet the requirement of significantly enhanced
therapeutic efficacy.
The key outcome of the Novartis AG v. Union of India case was the refusal
to grant a patent for the improved crystalline form of Gleevec. This judgment
reaffirmed India's commitment to balancing the need to protect intellectual
property rights with the imperative of ensuring access to essential medicines.
It had a significant impact on pharmaceutical and patent law in India, as well
as international discussions about access to medicines and intellectual
property. The case emphasized that in certain situations, public health
considerations and affordable access to medicines could override the exclusive
rights of patent holders, especially when it came to life-saving drugs. It set
a precedent for the use of flexibilities within the TRIPS Agreement to address
health and access concerns in the context of patents on pharmaceuticals.[15]
2)
Patentability of biotechnological innovations:
Intellectual property
rights plays vital role in biotechnological
innovations. Companies and researchers who has invented particular innovation
generally seek for the patents to protect their innovations. A patent is an
exclusive right granted to the person who has invented an innovation. It is a government grant to an inventor assuring him or her the right to stop others making, using, and selling the invention for a limited period. In India, all the patents are governed by the Patents Act, 1970. [16]However, the law has been subject to various amendments
and interpretations, particularly concerning what is eligible for patent
protection.
During the pre-independence era India had a patent system under British
colonial rule, primarily governed by the Indian Patents and Designs Act, 1911. [17]This
system allowed for the grant of patents, but it was largely influenced by
colonial interests. After gaining independence in 1947, India continued with
the existing patent law. However, concerns were raised about the impact of
patents on industrial and technological development, and the government
introduced a modified patent regime under the Indian Patents Act, 1970. This
Act aimed to balance the need for patents with the need to ensure accessibility
to essential medicines and technology. This legislation marked a significant
change in India's patent system. It limited the patenting of certain subject
matters and established criteria for patentability. Importantly, it allowed for
the pre-grant opposition and compulsory licensing, ensuring that patents did
not hinder public access to essential products, especially pharmaceuticals.
One of the most substantial changes in India's patent regime occurred in
2005, driven by India's obligations under the (TRIPS) Agreement which required
member countries to grant product patents for all fields of technology.[18] Prior to
the amendment, India had a process patent regime for pharmaceuticals, which
allowed the manufacturing process to be patented, but not the product itself.
The amendment introduced Exclusive Marketing Rights (EMRs) for pharmaceutical
and agro-chemical products that were already under patent protection in other
countries, a "mailbox" system, which allowed patent applications for
pharmaceutical and agro-chemical products filed in India but not examined until
2005; this was a transitional measure to address applications filed before the
full implementation of product patents. It also introduced post-grant
opposition proceedings, allowing third parties to oppose the grant of a patent
after it was awarded; this allowed for more extensive scrutiny of patents,
provisions to protect traditional knowledge and biological resources. It
established guidelines for the disclosure of the source and geographical origin
of biological material used in a patent application. The amendment also
introduced provisions to protect traditional knowledge and biological
resources. It established guidelines for the disclosure of the source and
geographical origin of biological material used in a patent application.[19]
Criteria for patentability in India:
Following are criteria for an invention [20]to be
eligible for a patent in India:-
1. Novelty: The
invention must be novel, meaning it must not have been disclosed to the public
in any form anywhere in the world before the date of filing the patent
application.
2. Inventive Step:
The invention must involve an inventive step, which means it must not be
obvious to a person skilled in the relevant field.
3. Industrial Applicability: The invention must be capable of industrial application. In
the case of biotechnological innovations, this typically means that the
invention should have a practical application in the field of biotechnology.
4. Non-Obviousness: The invention must not be obvious to a person skilled in the art. In the
context of biotechnology, this means that it should involve a non-obvious
solution to a problem or a significant advancement beyond the state of the art.[21]
Inventions not eligible for patenting in India:
1. Non-Novel or Previously Disclosed Inventions: Innovations that have been disclosed
to the public or are already known before the filing of the patent application
are not patentable.
2. Obvious Inventions: Inventions that are obvious to a person skilled in the field based on the
existing knowledge are not considered patentable.
3. Inventions Contrary to Public Policy or Morality: Inventions that are considered
contrary to public policy or morality may not be granted patents. This includes
inventions that are considered offensive, immoral, or harmful to public health
or the environment.
4. Discoveries of Natural Laws: Pure discoveries of scientific principles or laws of nature
are typically not patentable. However, applications that apply these principles
in a novel and non-obvious way can be patentable.
5. Methods of Medical Treatment: Methods of medical treatment of humans or animals are not
patentable in India. This includes diagnostic, therapeutic, and surgical
methods.
6.
Traditional Knowledge and Biological
Resources:
Inventions that involve the unauthorized use of traditional knowledge or biological
resources without proper disclosure or consent may be considered
non-patentable.[22]
However despite having a strong regime on patent law; India faced a lot
of issues regarding patentability of biotechnological innovations with increase
in science and technology. Key issues includes bio-piracy, misappropriation of
traditional knowledge, patentability of genetically modified organisms and life
forms.
Key issues in patentability of
biotechnological innovation:
1.
Patentability of
inventions relating to process for production of living entities:
The patent system of India, before 2002 didn’t grant patents for
inventions relating to living organisms and entities of natural and artificial
origin, biological materials, or any processes for the production of living
substances or organisms including nucleic acids. However, patents related to
processes producing non-living substances by chemical processes or
microbiological processes were granted. But a decision made in the year 2002 by
the Calcutta High Court in case Dimminaco
A.G.v. Controller of patents and designs & others played a vital role
in the evolution of biotechnological patent, wherein the end product is a
living organism with new one, then the process leading to that product can be
considered as a new invention. Dimminaco A.G.v. Controller of patents and
designs & others, [23] Dimminaco
A.G case was related to an invention relating to a process for the preparation
of bursitis vaccine responsible for contagious bursitis infection in poultry.
The vaccine was a live vaccine for protecting poultry against Bursitis
infection. Now due to the prevailing patent legislation at that time, the IPO
noted that for an invention to be patentable, it must be “new and useful”, but
preparing a vaccine containing a living virus cannot be considered as a new
invention as the process has to result either in an article or a substance and
the present invention was only a natural process devoid of any manufacturing
activity and a living organism, hence the patent office rejected Dominica’s
application. On appeal, the court applied the vendibility test and found the
invention was new. This judgment gave a new definition to biological patents in
the Indian Patent system. Further the Patents (Amendment) Act, 2002[24] opened
the arena of a grant of patents in the field of biotechnology. The Patent
Amendment Act 2005[25] paved a
way for the grant of product patents including biotechnology patents with
certain exceptions for the national policy to protect the public interest.
2.
Patentability of
inventions relating to traditional knowledge (Bio-piracy):
Bio-piracy is the unethical or unlawful appropriation or
commercial exploitation of biological materials that are native to a particular
country or territory without providing fair financial compensation to the
people or government of that country or territory or without having their prior
permission. In India, inventions that involve the unauthorized use of
traditional knowledge or biological resources without proper disclosure or
consent are considered non-patentable. Issue of patentability arises when an
individual or a group uses traditional knowledge/biological material for the inventions and claims for
their patent. Judiciary through judicial pronouncements have made clear that traditional knowledge or original biological material is not patentable.
The Basmati rice patent case [26]in India
refers to a controversial and high-profile intellectual property dispute. In
this case, RiceTec Inc. was granted a US patent (US Patent No. 5663484) in 1997
for a strain of Basmati rice. The patent covered not only the rice but also its
genetic traits and production methods. The granting of this patent led to
widespread opposition and criticism, particularly in India. Critics argued that
Basmati rice is a traditional and long-cultivated crop in the Indian
subcontinent, and the patent claimed by Rice Tec was unjustified, as it
attempted to monopolize a well-established variety of rice. India's government
and organizations like the (APEDA) challenged the patent in the US. They argued
that Basmati rice is a generic and commonly used term for a particular type of
fragrant, long-grain rice, and it should not be subject to patent protection.
As a result of the legal challenge, Rice Tec eventually narrowed its patent
claims to exclude some of the traditional Basmati characteristics, but it
maintained some claims related to Basmati-like rice varieties. This case raised
awareness about the importance of protecting geographical indications and
traditional agricultural products from bio-piracy and misappropriation of
genetic resources and traditional knowledge. It also highlighted the need for a
legal framework to protect such products and their associated traditional
knowledge.
3.
Patentability of
incremental improvement to known substances:
In India, Patentability of incremental improvement to known substances is a huge
debatable issue. But, according to the section 3(d) of patent act of 1970; [27]the
mere discovery of a new form of a known substance which does not result in the
enhancement of the known efficacy of that substance or the mere discovery of
any new property or new use for a known substance or of the mere use of a known
process, machine or apparatus unless such known process results in a new
product or employs at least one new reactant is not patentable. Therefore for
innovation o become eligible for patenting there must be enhancement of the
known efficacy of that existing substance.
The judiciary have also
given similar judgment in the landmark case of Novartis
AG v. Union of India (2013). [28]In this case, Novartis sought a patent for the
cancer drug Glivec (Imatinib Mesylate). The Supreme Court of India ruled
against Novartis, stating that the drug didn't exhibit a significant
enhancement in therapeutic efficacy and therefore couldn't be patented. The
decision reaffirmed India's commitment to preventing "ever greening"
or the granting of patents for minor modifications of known substances.
4.
Patentability of
genetically modified/engineered microorganisms:
The issue relating to patentability of genetically modified
microorganisms arose due to the rapid developments and advancements in the
field of science and technology. After these advancements; the question of
whether GMO’s are patentable or not came in front of judiciary and by
interpreting the patentability criteria in the patent act, the court declared
that genetically modified/engineered microorganisms are patentable in India.
While
genetically modified organisms are living organisms, they do not necessarily
occur naturally in nature. This fact was recognised in the famous American case
of Diamond
v. Chakrabarty, (1980) [29]the
U.S. Supreme Court declared that a genetically modified bacterium capable of
digesting multiple components of crude oil is patentable with the reason being
that the claimed bacterium was not found in nature nor was its activity
exhibited in any naturally occurring bacteria. The court also stated that the
claimed bacterium satisfied the primary essentials for patentability, as it was
a product of human ingenuity and intellect having its own distinctive name,
character and specific use. The Chakrabarty verdict greatly increased patent
activity in the field of genetic engineering.
One of the landmark cases in India
that granted a patent to a genetically engineered microorganism is the
Monsanto Company v. Nuziveedu Seeds Ltd. [30]This
is a case in Indian patent law that dealt with the patentability of genetically
modified cotton seeds. Monsanto, the developer of genetically modified cotton seeds,
had licensed the technology to Nuziveedu Seeds Ltd., a large seed company in
India. However, Nuziveedu Seeds Ltd. stopped paying royalties to Monsanto and
continued to use the technology without authorization. Monsanto sued Nuziveedu
Seeds Ltd. for patent infringement, arguing that the company’s unauthorized use
of the genetically modified cotton seeds violated Monsanto’s patent rights.
Nuziveedu Seeds Ltd. argued that Monsanto’s patent was invalid, as it claimed a
product of Nature and was therefore not eligible for a patent. The case went to
the Indian Supreme Court, which ruled in favour of Nuziveedu Seeds Ltd. The
Court found that Monsanto’s patent was invalid, as it claimed a product of
Nature and was therefore not eligible for a patent. The Court also found that
the patent needed to be sufficiently inventive and meet the standard of
non-obviousness, a requirement for patentability in India. The case has
significant implications for the patentability of genetically modified seeds in
India and has been widely discussed in legal and academic circles. It
highlights the importance of ensuring that patents are evaluated rigorously to
ensure that they meet the criteria for patentability and do not restrict access
to essential technologies.
Monsanto Company v.
Nuziveedu Seeds Ltd. was a case in the Indian patent law that dealt with the
patentability of genetically modified cotton seeds. The case was decided in
favor of Nuziveedu Seeds Ltd., finding that Monsanto’s patent was invalid as it
claimed a product of Nature and was, therefore, not eligible for a patent. The
case has significant implications for the patentability of genetically modified
seeds in India and highlights the importance of evaluating patents rigorously
to ensure that they meet the criteria for patentability.
One of the
landmark cases in India that granted a patent to a genetically engineered
microorganism is the "GE Healthcare Case."
In this case, GE Healthcare Biosciences AB applied for a patent on a
recombinant Escherichia coli (E. coli) microorganism. The genetically
engineered E. coli was designed for the expression of a protein known as
"rVEGF." This protein is used in the purification and production of
recombinant insulin. The patent application for this genetically engineered
microorganism led to a legal dispute. The primary issue at the heart of the
case was whether genetically engineered microorganisms were patentable in India
under the Patents Act, 1970. Ultimately, the Intellectual Property Appellate
Board (IPAB) upheld the patent's validity in this case. It was determined that
the genetically engineered E. coli microorganism was indeed patentable in
India, provided it met the criteria for patentability, including novelty,
non-obviousness, and industrial applicability. The case set a significant
precedent for the patenting of genetically engineered microorganisms in India.[31]
3)
Data ownership and sharing issue in
biotechnological innovations:
Data ownership in the context of biotechnological innovations in India is
a complex issue with legal, ethical, and practical considerations. This issue
primarily involves the ownership of genetic data, health-related data, and
research data generated in the field of biotechnology. Here are some key issues
and perspectives related to data ownership in India:
Genomic Data: A biotech
company in India conducts a large-scale genomic sequencing project to study
genetic variations associated with certain diseases. The company collaborates
with multiple research institutions and collects genomic data from thousands of
participants, including patients from various healthcare providers. The biotech
company claims ownership of the genomic data, arguing that they invested
substantial resources in data collection and analysis. Conflicts arise when
participants, particularly patients, question whether they fully understood the
terms of data use when they consented to participate in the research.
Research Collaborations: Conflicts
emerge between the biotech company and the research institutions regarding data
access, intellectual property rights, and the rights of the participants. In India,
individuals have the right to control access to their personal genetic
information, and the use of such data often requires informed consent. Genetic
counselling services and laboratories typically have policies to ensure data
protection and patient consent. Strict adherence to these policies of data
protection is necessary in order to deal with these issues.
Health Records and Diagnostics: A
healthcare provider in India maintains electronic health records (EHRs) of
patients. These records contain detailed health-related data, including genetic
test results and treatment histories. Patients question the healthcare
provider's data protection practices, leading to conflicts about the privacy
and security of their health records. Conflicts may arise when patients request
access to their own health records, and healthcare providers are unsure about
the extent to which patients should control their data. Conflicts emerge if the
healthcare provider wishes to monetize the health data through collaborations
with biotech companies, and patients question the terms of such data use.
Academic Research and Industry
Collaboration: An academic institution in India
collaborates with a biotech company to conduct research on a new drug. The
research generates a substantial amount of data related to the drug's efficacy,
safety, and molecular mechanisms. The academic institution and the biotech
company may have differing views on data ownership, leading to disputes
regarding control and access. Academic researchers may want to publish research
findings, while the company may seek to protect proprietary information,
leading to conflicts over data sharing and publication rights. If the research
leads to commercialization, conflicts may arise regarding the equitable sharing
of benefits between the academic institution, researchers, and the biotech
company.
Clinical Trials and Patient Data: A
multinational pharmaceutical company conducts clinical trials for a new
biopharmaceutical product in India. The trials involve thousands of patients,
generating significant clinical data. Patients participating in the trials may
question their rights to access their own clinical trial data and whether they
have a say in its use. Conflicts may arise regarding compliance with Indian
clinical trial regulations, data safety, and reporting requirements with
foreign. The pharmaceutical company may claim ownership of the clinical trial
data, while Indian authorities may seek oversight to ensure that data benefits
patients and the Indian healthcare system.
It's essential to recognize that data ownership can vary significantly
based on the specific circumstances of the research, the data type, and the
applicable legal and ethical considerations. Comprehensive legal framework,
clear documentation, informed consent, collaboration agreements, and adherence
to data protection laws are essential to address and clarify data ownership in
biotechnological research in India.
4)
Issue of liability of product safety
in biotechnological innovations:
The liability of product safety in biotechnological innovations in India
is a critical legal issue that involves ensuring the safety of biotech
products, including pharmaceuticals, genetically modified organisms (GMOs), and
other biotechnological applications. Whenever a particular biotechnological
innovation or a product used in such biotechnological innovation is not safe or
defective and when it causes harm or injury to any participant or user of that
product the in this case the issue of liability of product safety arises.
One of the key concerns related to product safety in biotechnological
innovations in India is the cultivation and consumption of (GMOs), particularly
in the agriculture sector. India has seen an increase in the adoption of GMO
crops, such as Bt cotton and Bt brinjal. [32]These
crops have been genetically modified to resist pests and diseases, potentially
increasing crop yields and reducing the need for chemical pesticides. In a
scenario involving Bt cotton, a genetically modified cotton variety that
expresses a protein toxic to bollworms, several concerns have arisen such as resistance
Development, Non-Target Effects, Human Health Concerns and Socioeconomic
Concerns which involves the high cost of genetically modified seeds, licensing
fees, and the need for new seeds each planting season have financial
implications for Indian farmers.[33]
An NGO, Swasthya Adhikar Manch, in the case Swasthya Adhikar Manch v. Union of India [34]filed
a Public Interest Litigation (PIL) in the Supreme Court of India against
various irregularities during the clinical trials such as violation of the law
governing clinical trials i.e. Drug & Cosmetics Act and ethical guidelines
provided by Indian Council for Medical Research and international guidelines
mentioned earlier, thereby alleging violation of Article 21 of the Indian Constitution. Another PIL, Kalpana Mehta v. Union
of India [35]was
filed after the death of seven tribal girls during clinical trials of Human
Papilloma Virus vaccination in Andhra Pradesh and Gujarat.
In both cases, the court applauded the efforts of various NGOs for bringing
such gross violation of fundamental and human rights to the attention of the
court. Despite this, due to the lackadaisical approach of the government and
the DCGI, the Court has not reached a final decision in both the cases yet.
However, as a result of supreme courts’ multiple orders, the government of
India introduced the ‘New Drugs and Clinical Trials Rules,
2019’ to promote a
transparent and ethical clinical research or trial process. These new
rules provide approval of clinical trials, its monitoring, decision
regarding compensation by the Ethics Committee, in case of adverse events.
The Government’s inability to curb illegal trials has been time and
again criticized by the Indian courts. In Rahul Dutta v. Union of India [36]and Swasthya Adhikar Manch, Courts have stated that the untimely death of trial participants is a
gross violation of the fundamental right to life guaranteed under Article 21 of
the Indian Constitution. The Court observed that, unrestrained clinical trials and
research are causing disaster to human life. This is a clear reflection of the
poor enforcement of ethical principles during medical experimentation in India.
The stand of the judiciary in all the aforementioned cases makes it
clear that clinical trials conducted without the ‘informed consent’ of
participants is a violation of their fundamental right to live with dignity. In
light of the fact that ‘right to live’ has been considered an essential human
right under Article 3 of the Universal Declaration of Human Rights, it is clear that an illegal clinical
trial is in violation of international principles as well. And therefore, clear
and strict legal framework is necessary while conducting new biotechnological
innovation processes. [37]
To deal with this legal concern, India has played vital role in
developing some regulatory framework:
·
India has established regulatory
authorities such as the Central Drugs Standard Control Organization (CDSCO) for
pharmaceuticals, the Genetic Engineering Appraisal Committee (GEAC) for GMOs,
and the Food Safety and Standards Authority of India (FSSAI) for food and
food-related products. These agencies are responsible for evaluating and
approving biotech products based on safety assessments.
·
India has product liability laws in
place, such as the Consumer Protection Act, 2019, which holds manufacturers,
importers, and service providers liable for any harm caused to consumers due to
defective products or deficient services. This applies to biotechnological
products and services.
·
In the case of GMOs, India has
biosafety regulations to ensure that the release and use of GMOs do not pose
risks to human health, the environment, and biodiversity. Liability issues may
arise if such risks are not adequately addressed. India has various
compensation mechanisms for patients who experience harm due to medical
treatments or clinical trials, such as the Clinical Trials Registry-India
(CTRI). These mechanisms address issues related to liability and compensation.
·
If a biotech product is found to be
unsafe or defective, there may be legal obligations for the manufacturer to recall the product from the market
and compensate affected consumers. In cases of collaborative research or
partnerships between multiple entities in the biotech sector, legal agreements
often specify responsibilities, liability, and risk-sharing in the event of
safety issues or harm. When collaborating with international
partners or exporting biotech products, India must consider international
liability and safety standards, including the implications of international
trade agreements and conventions. Compliance with Good Manufacturing Practices
(GMP) and other quality standards is essential to ensure product safety and
reduce liability risks in the pharmaceutical and biopharmaceutical sectors.
Addressing liability for product safety in biotechnological innovations
requires a combination of regulatory compliance, adherence to safety standards,
transparency in clinical trials, and robust post-market surveillance. Legal
mechanisms and compensation structures are in place to protect the rights and
safety of consumers and patients while promoting innovation in the
biotechnology sector.
RECOMMENDATIONS:
Addressing legal and patentability issues in biotechnological innovations
in India requires a multifaceted approach that balances innovation incentives
with the broader public interest, including access to healthcare, protection of
traditional knowledge, and ethical considerations. Here are some
recommendations to curb these issues[38]:
1. Clarity in Legislation: Continuously update and clarify the legal framework governing
biotechnological innovations to ensure that it remains relevant and keeps pace
with technological advancements.
2. Ethical and Regulatory Oversight: Strengthen ethical and regulatory oversight for biotech
research and development, particularly in sensitive areas like gene editing,
cloning, and synthetic biology. Develop clear ethical guidelines and principles
for biotech research and applications, and ensure that research adheres to
these guidelines.
3. Data Ownership and Privacy: Develop robust data ownership and privacy laws and
regulations to protect the personal and genetic information of individuals used
in biotechnological research. Ensure that data sharing and usage respect
individuals' consent and privacy rights.
4.
Standard Data Sharing Agreements: Encourage
the use of standard data sharing agreements that specify terms and conditions
for data access, use, and ownership. These agreements should include clauses on
data security, confidentiality, and intellectual property rights.
5. Intellectual Property Reforms: Review and reform intellectual property laws to strike a
balance between incentivizing innovation and safeguarding public interests.
Develop guidelines for the patentability of biotechnological innovations that
consider novelty, non-obviousness, and significant therapeutic efficacy.
6. Promote Research Collaboration: Encourage collaboration between biotech innovators, academic
institutions, and research organizations to facilitate knowledge sharing,
technology transfer, and innovation.
7. Public Awareness and Education: Promote public awareness and education on biotechnological
innovations, legal issues, and ethical considerations to ensure informed
decision-making and public participation in policy development.
8.
Clarify Patent Examination Guidelines: Regularly
update and clarify patent examination guidelines to ensure consistent and
transparent assessment of biotech inventions. Provide clear guidance on the
patentability of different categories of biotechnological innovations.
9. Enhance Patent Examiner Training: Invest in training patent examiners to have expertise in
biotechnology, enabling them to assess complex inventions effectively.[39]
10. Strengthen Post-Grant Opposition Mechanism: Encourage and facilitate public and
expert participation in post-grant opposition proceedings to ensure rigorous
examination of granted patents. Consider expanding the scope of post-grant
opposition to encourage stakeholders to challenge patents they believe lack
novelty, inventive step, or industrial applicability.
11. Strengthen Regulatory Capacity: Enhance the capacity of regulatory agencies to assess and
monitor the safety and efficacy of biotechnological products and applications.
12. Balanced Approach to Compulsory Licensing: Develop clear criteria and
guidelines for granting compulsory licenses in cases where patents hinder
public access to essential biotech products, while ensuring that patent rights
are protected where needed.
13. Multi-Stakeholder Dialogues: Foster
multi-stakeholder dialogues that include government agencies, industry, civil
society organizations, and academia to address biotech-related legal and
ethical issues collaboratively.
14. International Collaboration:
Collaborate with international organizations and other countries to share best
practices, harmonize standards, and develop a common approach to addressing
legal issues in biotechnological innovations.
CONCLUSION
Biotechnology is a rapidly evolving and multifaceted field that
encompasses various applications in healthcare, agriculture, pharmaceuticals,
and environmental science. The biotechnology sector in India as well as in
various other countries has grown significantly over the years and plays a
crucial role in driving innovation, research, and economic development. India
being one of the bio-diversity rich countries, it would, thus, be prudent to
protect biotechnological inventions as that would help Indian biotechnology
research to compete globally.
The legal issues surrounding biotechnological innovations in India are
multifaceted. Imbalance
between incentivizing of biotechnological innovations and access to its
benefits, issue of patentability data
ownership and sharing issue, liability of product safety issue are the key
legal issues which coexists with the application of biotechnological innovations. It require
careful consideration of patentability, ethical, and regulatory concerns. While
India has made significant strides in aligning its patent laws with
international standards and fostering innovation, there are ongoing challenges,
such as balancing incentives for research and development with ensuring
affordable access to life-saving medicines and protecting traditional
knowledge. Robust patent examination, adherence to ethical guidelines, and
transparent regulatory oversight are essential to maintain a delicate
equilibrium between progress and public welfare. Continued dialogue among
stakeholders, including policymakers, innovators, and civil society, is
necessary to navigate this evolving landscape while safeguarding India's
interests in the dynamic field of biotechnology.
[1] Department of Biotechnology (DBT),
Ministry of science and technology, Government of India https://dbtindia.gov.in/
[2] Knowledge, Technology and Law (Law, Science and Society) Hardcover;
Illustrated, 16 September 2014 by Emilie Cloatre (Editor), Martyn Pickersgill
(Editor)
[4] Department of Biotechnology (DBT),
Ministry of science and technology, Government of India https://dbtindia.gov.in/
[7] Department of Biotechnology (DBT),
Ministry of science and technology, Government of India https://dbtindia.gov.in/
[8] National Biotechnology Development Strategy (NBDS)
[11] Knowledge, Technology and Law (Law, Science and Society) Hardcover;
Illustrated, 16 September 2014 by Emilie Cloatre (Editor), Martyn Pickersgill
(Editor)
[12] Singh
R. Vol. 1. New Delhi: Universal Law Publishing Co. Pvt. Ltd; 2004. Law relating
to intellectual property (A complete comprehensive material on intellectual
property covering acts, rules, conventions, treaties, agreements, case-Law and
much more)
[13] Novartis
AG v. Union of India,1 April, 2013
[14] The Patents Act,1970, section 3(d)
[15] Knowledge, Technology and Law (Law, Science and Society) Hardcover;
Illustrated, 16 September 2014 by Emilie Cloatre (Editor), Martyn Pickersgill (Editor)
[17] THE INDIAN PATENTS AND DESXGXS
ACT, 1911 (11 OF 1911). https://www.indiacode.nic.in/repealed-act/repealed_act_documents/A1911-2.pdf
[18] World Trade Organization, TRIPS
agreement, https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm
[19] MINISTRY OF LAW AND JUSTICE
(Legislative Department), THE PATENTS (AMENDMENT) ACT, 2005 No. 15 OF 2005, https://ipindia.gov.in/writereaddata/Portal/IPOAct/1_69_1_patent_2005.pdf
[20] The Patents (Amendment) Act 2005,
section 2(1)(m)
[21] The Patents (Amendment) Act 2005,
section 2(1)(j)
[22] The Patents (Amendment) Act 2005,
section 3
[23] Dimminaco
A.G.v. Controller of patents and designs & others AID NO.1 OF 2001
[24] The
Patents (Amendment) Act, 2002 is the second of three amendments to the Patents
Act of 1970 to bring India’s patent regime into compliance with the WTO TRIPs
Agreement. This Act was introduced with the new Patent Rules, 2003, which
replaced the earlier Patents Rules, 1972.
[25] THE PATENTS (AMENDMENT) ACT, 2005
No. 15 OF 2005, https://ipindia.gov.in/writereaddata/Portal/IPOAct/1_69_1_patent_2005.pdf
[26] Basmati Rice: US Firm Withdraws
Patent Claim, The Hindustan Times (September 28, 2000) at http:// www.hindustantimes.com/nonfram/280900/fryNAT05.
[27] The Patents (Amendment) Act 2005,
section 3
[28] Novartis
AG v. Union of India,1 April, 2013
[29] Diamond v. Chakrabarty, 447 U.S.
303 (1980)
[30] Monsanto LLC & Ors. vs Naziveedu Seeds &
Ors. C.A. No.-004616-004617 / 2018 order
dated Jan 8th, 2019.
[32] Draft
regulations for Genetically Modified Organisms or Genetically Engineered
Organisms, 2021,“no person shall manufacture, store, distribute, sell or import
in India, any food or food ingredient derived from Genetically Modified
Organisms, except with the prior approval of the Food Authority.
[33] On
November 15, 2021, the Ministry of Health and Family Welfare/Food Safety and
Standards Authority of India (FSSAI) issued draft regulations for Genetically
Modified Organisms or Genetically Engineered Organisms, or Living Modified
Organisms
[34] Swasthya
Adhikar Manch v. Union of India, Writ petition (civil) No. 33 of 2012
[36] Rahul Dutta v. Union of India, W.P.C.T. 150 of 2014
[38] https://unctad.org/system/files/official-document/poitetebd10.en.pdf