Open Access Research Article
NAVIGATING THE LEGAL AND ETHICAL LANDSCAPE OF GENE PATENTS: AN ANALYTICAL RESEARCH
Article Details
AUTHORED BY - SIMRAN GAHLOT
Abstract
Patentability of human genes has been a matter of debate since a long
time as the Patents Act,1970 in India prohibits the patenting of naturally
occurring substances, altered genetic material and nucleotide sequences have
been granted patent. Moreover, from the commencement the patenting of the gene
patent was considered as unethical because it was assumed that the God is the
creator of all organisms and human can't have monopoly over it. This paper
offers comprehensive analytical research about the legal and ethical issues in
gene patenting with what is the stand of the Indian Patent Office (IPO).
Beginning with the historical context of gene patents, it will also cover the
relevant case laws. The legal aspect of gene patents will also be examined with
the help of various international treaties and national regulations. Case laws
are taken from across the world to check the status of gene patents around the
globe. Lastly, the paper discusses the emerging trends and future directions
which will give directions to the policymakers and stakeholders. This
analytical research contributes to a deeper understanding about the issues
relating to gene patenting.
Keywords- Gene patent, patent, Indian Patent
Office, altered genes and nucleotides
Introduction
The patent system is nearly over 400 years old now. The patent system is
evolving day by day as new technologies are being invented from time to time.
Over the span of 400 years many inventions have been made related to warfare,
electricity, in the field of entertainment, pharmaceutical products, computing
and information technology. But if we look back to the last 20years a new era
in the field of patent was started with the inventions in the field of genetic
materials. “Gene patent” is nowhere defined but the general meaning of gene
patent has been established over these years, the term gene patent doesn’t have
a particular definition the general meaning of gene patent is “a gene patent is
a patent issued to a unique isolated gene sequence, a natural series that has been
altered, the procedure and methods for obtaining or exploiting it, or any
combination of these. Gene patents encompass three different categories of
invention. They are diagnostics, material formulations, and practical
applications.”[1] But a bigger question that we skipped here is what is gene? What is gene
made up of? Gene is defined as “the unit of inheritance composed of a segment
of DNA situated at a specific locus that carries coded information and also has
the ability to undergo mutation and crossing over”[2]. The definition of a gene stated that it is the basic physical and
functional unit of heredity. Genes structurally are made up of nucleotides
called DNA.
Moreover, from the commencement the patenting of the gene patent was considered
as unethical because it was assumed that the God is the creator of all
organisms and human can't have monopoly over it. Further, these opponents also
argue that the patents might make the cost of genetic tests and genetic
therapies unacceptably high. Despite this opposition, patents in the field of
genetics were granted and this had given rise to many controversies. However,
the patent is granted, if the following requirements are fulfilled- novelty,
inventiveness and utility concept. Several claims were rejected on the grounds
of lack of novelty and inventiveness. As it was presumed that the gene exists
in nature and there is no invention in founding anything which already existed
in nature. Meanwhile, it was accepted that if the inventor makes some alteration
and made the invention different from the product of nature then it can be
patented.
In 1988, a new advancement in the field of gene patent was done, when the
United States Patent and Trademark Office granted the first US patent over an
entire animal, the 'Harvard Mouse'. The patent application relating to this
Harvard Mouse was not only applied in United States Patent and Trademark Office
but also in the Canada, Europe through the European Patent Office (EPO) and in
Japan. However, the United States Patent Office has granted patent on the
ground that the invention is a non-naturally occurring and human made living
matter. Thus, with the development in the field of biotechnology, new
inventions occur, and they widen the scope of patent law.
Importance of gene patents in biotechnology and
healthcare
Gene patents play an important role in creating an intention of
innovation, research and development in the field of biotechnology and
healthcare and gene patents also play a crucial role in enabling biotechnology
companies to develop healthcare products. Some of the important aspects of gene
patents in biotechnology and healthcare are-
1. Scientific and technological
advancement- Gene patents can lead to scientific
and technological as variety of new drugs can be made with the help of isolated
specific genes.
2. Ownership and access- Arguments say that gene patents can lead to the monopolization of genetic
information, limiting access to crucial diagnostic tests and treatments.
3. Legal and ethical issues- Legal and ethical issues raise various questions including whether genes
should be considered natural products or human inventions. Also, there are
concerns about the potential of gene patents to stifle innovation and impede
the advancement of science and medicine.
4. Relevant regulatory framework- Different countries have different regulatory frameworks when it comes to
gene patenting. In the United States, the U.S Supreme Court’s decision in the
case of Association for molecular pathology v/s Myriad Genetics[3], held that isolated naturally occurring DNA sequences are not
patent-eligible subject matter, but synthetic DNA sequences may be eligible for
patent protection. In contrast, European patent law allows for the patenting of
isolated DNA sequences under certain conditions.
Ethical concerns with Gene Patenting
Ethics talks about the explanations of our actions and how they will harm
society because a reason should be given for what is being done and why it is
being done. Gene patenting may bring a lot of success to the field but raises
many ethical concerns as well. Some of these concerns are-
1. Human cloning- just for the sake of utility making alteration to genetic structure is
not considered ethically correct, in this way humans are being used as a
commodity. Using humans as commodity is not ethically correct.
2. Research and Innovation- Gene patents can stifle scientific progress and innovation by restricting
access to genetic information and inhibiting collaboration among researchers
and institutions. Patent holders may use their exclusive rights to control
access to genetic sequences, hindering further research and development in the
field. This raises ethical concerns about the potential impact of gene patents
on scientific advancement, knowledge dissemination, and the pursuit of the
public good.
3. Transferring genetic material across
species boundaries and introducing foreign genes into organisms raises ethical
concerns. For instance, in the case of the “Dolly” sheep, human genes were
incorporated into the sheep’s genetic makeup, promoting ethical scrutiny.
4. Global Health Considerations-ethical concerns surrounding gene patents extend beyond national borders,
particularly in the context of global health. Patents granted in one country
may impact access to healthcare and research in other countries, raising
questions about global equity, solidarity, and the right to health as a
fundamental human right.
Addressing these ethical concerns requires a careful balance between
promoting innovation, protecting intellectual property rights, and ensuring
equitable access to healthcare and genetic information for all individuals.
Policymakers, researchers, healthcare providers, and industry stakeholders must
work together to develop ethical frameworks and policies that prioritize the
well-being of patients, promote scientific progress, and uphold principles of
justice, equity and autonomy in gene patenting.
Legal framework governing gene patents
In India, the legal framework governing gene patent is governed by
Patents Act, 1970 and the associated Patent Rules, 2003-
1. Patents Act, 1970- This is the primary legislation governing patents in India. Section 3 of
the Patents Act specifies what is not patentable subject matter. Section 3(c)
explicitly states that “the mere discovery of a scientific principle or the
formulation of an abstract theory or discovery of any living thing or
non-living substances occurring in nature” is not patentable. This provision
has significant implications for the patentability of genes, as it generally
prohibits the patenting of naturally occurring genetic sequences.
2. Patent Rules,2003- These rules provide detailed procedures for patent applications,
examination, and other patent-related matters. Rule 2(1)(ja) defines
“biological material” to include any material containing genetic information
and capable of reproducing itself or being reproduced in a biological system.
Rule 3(e) further clarifies that biological processes to produce plants and
animals are not patentable, but microorganisms and non-biological and
microbiological processes are patentable.
3. Judicial Interpretations- Indian courts have interpreted the Patents Act in several cases related
to biotechnology and gene patents. In the case of Novartis Ag v. Union of India[4] the Supreme court held that a particular drug’s patent application did
not meet the requirements of novelty and inventive step, partly because it was
a modified form of a known substance. This case highlighted the stringent
patentability criteria applied to pharmaceutical and biotechnological
inventions, including genes.
4. Guidelines- The Indian Patent Office issues guidelines to clarify the interpretation
and implementation of patent laws. The guidelines may provide specific
instructions regarding the examination of patent applications related to
biotechnological inventions, including genes.
5. Public interest- Indian patent law emphasizes public interest considerations, including
access to healthcare and food security. This can influence decisions related to
the patentability of genes and other biotechnological inventions.
Overall, the legal framework governing gene patents in India reflects a
cautious approach that prioritizes public interest considerations and limits
the patentability of naturally occurring genetic sequences. As with any legal
matter, it’s essential to consult the relevant laws, regulations, and legal
precedents for specific guidance.
History of Gene Patent
For over four centuries, the patent system has adapted to accommodate a
wide array of technological advancements. From innovations in mechanics during
the industrial revolution to breakthroughs in electricity, electronics, and
beyond, the system has evolved to encompass inventions across diverse fields.
In recent decades, there has been a notable surge in patents related to
biotechnology, especially concerning genetic materials and technologies. This
shift reflects the growing importance of biotech innovations within the patent
landscape, alongside traditional areas such as industrial, chemical, and
information technologies.
In the mid-20th century, breakthroughs in genetics laid the
groundwork for modern biotechnology. Watson and Crick’s discovery of the DNA
double helix structure in 1953 was followed by Cohen, Boyer, and Chang’s
development of recombinant DNA technology in the 1970s, leading to the creation
of the first genetically modified organisms. The commercialization of genetic
technology began with the establishment of Genentech Inc. In 1976, marking the
dawn of the biotechnology industry. Subsequent innovations such as Sanger’s DNA
sequencing method and Mullis’s PCR technique revolutionized genetic research
and paved the way for significant advancements in healthcare and agriculture.
However, the rapid pace of genetic technology also raised ethical and legal
questions, particularly regarding the patentability of genetic inventions. The
controversies surrounding gene patenting persisted through the 1980s and 1990s,
culminating in the commencement of the Human Genome Project in 1990. The
completion of the human genome sequencing in 2003 ushered in a new era of
genomics, promising further research and innovation but also posing challenges
for the future of gene patenting.
International Treaties and Agreements Relevant to Gene
Patents
1. Paris Convention for the protection
of Industrial property,1883-The Paris Convention for the
Protection of Industrial Property, established in 1883, serves as a
foundational international agreement covering various aspects of intellectual
property, including patents, trademarks, industrial designs, and utility
models.
·
National Treatment- Each contracting state must
provide the same level of protection to nationals of other contracting states
as it does to its own nationals. Additionally, nationals of non-contracting
states may receive national treatment if they have domicile or a real and
effective industrial or commercial establishment in a contracting sale.
·
Right of Priority- An applicant who files for
intellectual property protection in one contracting State may, within a
specified period, apply for protection in other contracting States, with later
applications treated as if filed on the same day as the first application. This
priority right can also be transferred to successors in title.
·
Common Rules- The Paris Convention establishes
common rules governing the grant of patents, including the independence of
patents granted in different contracting States, the availability of compulsory
licenses under certain conditions, protection of industrial designs,
trademarks, and regulations against unfair competition.
Overall, the Paris Convention aims to promote harmonisation and
cooperation in the field of industrial property, ensuring equitable treatment
of investors and creators across different jurisdictions while providing
mechanisms for protecting intellectual property rights and preventing unfair
competition.
Patent Cooperation Treaty,1970
The Patent Cooperation Treaty (PCT), established in 1970, facilitates
international cooperation in patent matters by streamlining the process for seeking
patent protection across multiple jurisdictions. Its key provisions and
procedures are mentioned below:
1) Objective- The primary goal of PCT is to simplify and improve the process of
seeking patent protection for inventions in multiple countries, benefiting both
inventors and patent office's responsible for administering the system.
2) Filling Process- investors can file a single international patent application, known as
the PCT application, with a designated Receiving Office. This application
allows them to subsequently select the jurisdictions where they wish to obtain
patent protection.
3) National Phase- the grant or refusal of a patent based on a PCT application is
determined by each national or regional patent office during the “national
phase”. This phase typically begins after the international phase of processing
the application.
4) Filling Process-
A) Filing: any national or resident of a PCT
contracting sale can file an international application at the designated
Receiving office.
B) International Search: The application undergoes an
international search by an appointed
international search authority to identify relevant prior art.
C) International Publication: The application
is published 18 months (about 1 and a half years) from the filing date, disclosing the
invention to the public and outlining the scope
of protection.
D) Optional Supplementary Search and Preliminary Examination: Additional search and
examination steps are optional for further patentability analysis.
E) National Phase: After the international phase,
typically 30months (about 2 and a half years)
from the earliest filing date, applicants pursue the grant of patents directly
before national or regional
patent offices.
Budapest Treaty, 1977
The Budapest Treaty, signed in 1977 and administered by WIPO, establishes
an international system for the deposition of microorganisms to fulfil patent
disclosure requirements.
The treaty enables patent applicants to deposit biological material with
a designated international depository authority, satisfying patent procedure requirements
for multiple countries. Depositing a microorganism strain at one recognised
institution suffices for all Budapest Treaty signatories. The deposited
material is assigned a registration number, which must be referenced in the
patent application. India, a signatory, mandated biological material deposition
before filing, with references in the patent specification. If the invention
involves Indian biological material, applicants must declare it and obtain
National Biodiversity Authority permission. To comply with Indian Patent Act
and Rules, biological material must be deposited before or shortly after patent
application filing, with reference in the specification. The depository
institution can make the material public upon patent application publication.
TRIPS Agreement,1994
The RIPS Agreement, established in 1994 as part of the Urugay Round
negotiations and administered by the WTO, sets international standards for
intellectual property rights.
TRIPS requires all WTO members to incorporate its provisions into their
domestic intellectual property laws, making it a cornerstone of global IP
protection. It sets minimum patent standards, ensuring non-discriminatory
access to patent rights regardless of the place or field of invention, or
whether products are imported or locally produced. Members must provide patent
protection for inventiions across all technological fields, with optional
exclusions for inventions deemed necessary to protect public order, morality,
or certain sectors like diagnostic and therapeutic methods. TRIPS also permits
limited exceptions to patent rights, provided they don’t unduly conflict with
normal patent exploitation or prejudice patent hoolder’s rights. Additionally,
it regulates compulsory licensing and government use of patents, mandating
adequate compensation for such use.
India, a signatory, implemented TRIPS provisions in 2005 after a
transitional period to align its intellectual property laws. Due to concerns in
sectors like pharmaceuticals, India was granted an additional five-year
transition period. This led to significant changes in existing IP legislation
and the introduction of new laws to comply with TRIPS standards.
Relevant Case Laws
Novartis Ag v/s Union of India & others:[5] This case involved Novertis’s attempt
to obtain a patent in India for the cancer drug imatinib mesylate (marketed as
Gleevec). The Indian Patent Office and subsequent courts rejected Novertis’
patent application on the grounds of lack of novelty and inventive step,
sparking a significant debate over the patentability criteria for
pharmaceutical inventions, including those related to genetic sequences.
Avesthagen Ltd. v/s Union of India & others (2007): Avesthagen Ltd., a biotechnology company, challenged the legality of
certain provisions of the Indian Patents Act, particularly those related to the
patentability of biotechnological inventions. While not specifically about gene
patents, this case raised broader questions about the scope of patent
protection for biotechnological innovations in India.
Monsanto Technology LLC v/s Nuziiveedu Seeds Ltd. & others[6] :This case involved disputes between
Monsanto and India seed companies over the patenting and licensing of
genetically modified cotton seeds. While primarily focused on plant biotechnology
and seed patents, it underscores the complexities and controversies surrounding
intellectual property rights in the biotechnology sector in India.
Dimminaco AG v/s Controller of Patents & Designs, [7] the Patent Act was amended to include
“biotechnological and microbiological processes” within the ambit of
patentability.
Conclusion
In conclusion, the landscape of gene patents is a complex and evolving
domain that encompasses both legal and ethical considerations. The advent of
gene patenting has brought forth significant advancements in biotechnology and
healthcare, yet it has also sparked debates surrounding ownership, access, and
ethical implications.
From a legal standpoint, the patentability of genes is governed by
national laws, international treaties, and judicial interpretations. In India,
the Patents Act,1970 and associated Patent Rules,2003 lay down the framework
for gene patenting, with stringent criteria for patent eligibility,
particularly regarding naturally occurring genetic sequences. Judicial
decisions, such as the Novartis case, have further shaped the legal landscape
by highlighting the importance of novelty and inventive step in patent
applications related to biotechnology.
International treaties like the TRIPS Agreement and the Paris Convention
aim to harmonies intellectual property standards globally, yet they leave room
for interpretation and implementation at the national level. Countries like
India have undergone significant legal reforms to align with international standards
while balancing public interest considerations.
Looking ahead, policymakers, researchers, healthcare providers, and
industry stakeholders must work together to address the ethical concerns
associated with gene patenting while promoting innovation and scientific
progress, this requires a delicate balance between protecting intellectual
property rights and ensuring equitable access to healthcare and genetic
information. By developing ethical frameworks and policies that prioritise the
well-being of patients and uphold principles of justice, equity, and autonomy,
we can navigate the legal and ethical landscape of gene patents responsibly and
sustainably.
[1] M S, Dr.S. (2023) Gene
Patenting - Types, Challenges, Pros, and Cons, icliniq. Available at: https://www.icliniq.com/articles/genetic-disorders/gene-patenting/
(Accessed: 02 March 2023).
[2] Byjus
(2018) Gene definition, byjus. Available at: https://byjus.com/biology/gene-definition/
(Accessed: 2018).
[4]
[2013] 13 S.C.R. 148
[5]
(2013) 6 SCC 1
Article Information
NAVIGATING THE LEGAL AND ETHICAL LANDSCAPE OF GENE PATENTS: AN ANALYTICAL RESEARCH
Authors: SIMRAN GAHLOT
- Journal IJLRA
- ISSN 2582-6433
- Published 2024/05/19
- Issue 7
About Journal
International Journal for Legal Research and Analysis
- Abbreviation IJLRA
- ISSN 2582-6433
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