Open Access Research Article
LEGAL AND ETHICAL CONSIDERATIONS IN BIOTECHNOLOGY
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Article Details
LEGAL AND ETHICAL CONSIDERATIONS IN
BIOTECHNOLOGY
AUTHORED BY
- MRUNALI BALASAHEB KHAVALE
Roll No. – 43
Div - A Semester – III 2024-2025
DEPARTMENT OF
LAW LL.M. – II
P.E.SOCIETY’S
MODERN LAW COLLEGE
(Ganeshkhind,
University Circle, Pune)
ABSTRACT:
The use of biological processes to solve issues is known as
biotechnology, and it has advanced quickly in recent years. With
its abundant biodiversity and developing scientific capacity, India has become a major force in the world of
biotechnology. But the speed at which innovation
is developing has also brought up important moral and legal issues.[1]
This article examines the intricate
relationship that exists between law and biotechnology. It looks at the laws that
control biotechnology, such as those pertaining to intellectual property, oversight, and the environment. Biotechnology is a
comprehensive word which apply to a variety of
biotechniques & bio methods. It's an area with a lot of different subfields.
KEYWORDS: Biotechnology, Intellectual Property Right, TRIPS agreement, Ethical
Implication, Legal Framework, Patent.
INTRODUCTION:
Understanding biotechnology may be done by separating “bio” from
“technology”. Use of biological processes
is known as “bio”, whereas
“technology” refers to solving problems or producing valuable goods. The
use of biological processes to solve issues is known as biotechnology, and it has advanced quickly in recent years.
With its abundant biodiversity and developing scientific capacity, India has become a major force in the world of biotechnology. But the speed at which
innovation is developing has also brought up important moral and legal issues.
MEANING AND HISTORY OF BIOTECHNOLOGY:
Biotechnology describes as "Body of knowledge related to the use of organisms, cells or cell-derived constituents for the purpose of developing
products which are technically, scientifically and clinically useful.
Alteration of biological function at the molecular level (i. e., genetic engineering) is the central focus;
laboratory methods used include transfection and cloning technologies, sequence
and structure analysis
algorithms, computer databases, and gene and protein structure
function analysis and prediction.[2]
Biotechnology is also defined by the U.S. Office of Technology Assessment
as "any technique using organisms and their components to make products,
modify plants and animals to carry desired
traits, or develop
micro-organisms for specific
uses". Biotechnology has existed ever since humans began domesticating micro-organisms, plants and animals.
ANCIENT BIOTECHNOLOGY:
Ancient biotechnology can be described
under the following
subheadings:
a) MICRO-ORGANISMS: As far back as 8000 years ago, our
ancestors knew that certain foods and
drink changed during storage, sometimes in tasty ways. Fruit juice would become alcoholic to produce wine; dough
would rise and produce pleasing aromas and tasty
bread when baked; and milk would sour and curdle to produce cheese. Long before this fermentation process had a name,
ancient people learned to control the process by controlling ingredients, temperature and time.
b) PLANTS: Stone-age farmers
began by planting
seeds of wild plants. Later they selected the most productive of their
domesticated plants to provide the next year’s seed stock. Over thousands
of years, this process gave rise to most of today’s crops.
c) ANIMALS: Man’s symbiotic relationships with animal’s date to the beginning of recorded history as well. Virtually every society depended to
some extent on food- producing
animals, beasts and pets. Today, we still rely on animals for much of our
food, fibre and pets.
MODERN BIOTECHNOLOGY:
Modern biotechnology was initiated with the development of recombinant DNA
technology, or genetic engineering and monoclonal antibody technology. They are described in brief in the following
sections
(a)
GENETIC ENGINEERING:
Genetic engineering became possible as biologists deepened
their understanding of deoxyribonucleic acid, or DNA, the molecule
that codes the instructions for growth, maintenance and reproduction of all living things. Each instruction is called a gene.
Many genes (100,000 to 300,000) make up an organism's genome, its entire instruction manual. Each gene is a
blueprint for a single protein. Proteins are natural substances that give living things their structure and control
their functions. Enzymes, antibodies, some hormones are proteins. Genetic
engineering is a process by which
biologists combine the gene(s) of one organism (the donor) with the genome of
another organism (the recipient). The
resulting organism is genetically altered to produce a new gene product, be it human insulin, antisense
RNA, or an industrial enzyme.
The resulting organism can
pass this alteration to its offspring, thus insuring an endless supply of
transgenic organisms.
(b)
THE DNA REVOLUTION:
Rapid advances in the field of molecular biology have brought
revolutionary change in human and
veterinary medicine, agronomy, animal science, environmental science,
and even patent law. Recombinant DNA technology, also known as gene cloning,
revolutionized the study of molecular
biology. Genes can be isolated, amplified, sequenced, and expressed in a different host cell.
This process yields large quantities of a gene product. Specific
DNA fragments are routinely cut from the chromosome,
inserted into a vehicle called a vector DNA, and placed in a host cell. When the host cell divides, this
recombinant DNA molecule replicates, producing a clone (a genetically identical copy).
COMMERCIAL BIOTECHNOLOGY:
Biotechnology is a technology comprised of many scientific disciplines
(e.g., microbiology, biochemistry,
genetics, molecular biology,
chemical engineering) that are applied
to the production of commercial products by living organisms. Biotechnology is utilized by a diverse
group of companies with the shared mission of
using biological processes
to develop products to meet human needs.
a)
PLANT BIOTECHNOLOGY:
Biotechnological developments and genetic engineering are revolutionizing agriculture. Some major benefits of this
revolution will be crops that are resistant to
pests and disease, livestock that are resistant to viruses, and microbes
to increase resistance to frost
damage. These benefits will increase food production. Transgenic plants are created by integrating new DNA
into a plant's DNA to become a permanent part of the plant's
genome. Seeds, tissues
or cells are transformed and then regenerated into a whole plant. Transgenic
plants can be used to study how a plant controls the transcription and translation of its genes. Many plants are being genetically manipulated.
b)
ANIMAL BIOTECHNOLOGY:
Biotechnology has affected
animals in many significant ways.
Genetic engineering has enabled scientists to transfer genes across species,
families, and even kingdoms.
These evolutionary boundaries, which were obstacles in the past, are now
readily crossed with modern gene
transfer methods that allow the transfer of DNA into living cells and fertilized eggs of animals.
Transgenic animals not only provide invaluable
research tools for studying gene regulation and disease, but they may be
genetically modified for the production of pharmaceuticals, vaccines,
and rare chemicals.
Major goals include the generation of livestock that are more
economically produced and products that are more nutritious to the consumer.
Genetically engineered
livestock will yield important products in milk or blood for treating a variety of
human diseases and health needs.[3]
LEGAL FRAMEWORK:
Biotech bodies in India, including the Department of Biotechnology (DBT),
the Indian Council of Medical
Research (ICMR), and the Council for Scientific and Industrial Research (CSIR),
are among the largest bodies.
The Biotechnology Regulatory Authority of India (BRAI) is a planned
regulatory organisation to control the use of genetically modified
organisms (GMOs). The Office of the Controller General of Patents,
Designs and Trademarks (CGPDTM),
generally known as the Indian Patent Office, is an agency under the
Department for Promotion of Industry
and Internal Trade that administers the Indian Law of Patents,
Designs and Trademarks.
IMPACT OF IPR ON BIOTECHNOLOGY:
Intellectual Property Rights has a
very important role in this sector.
IPR protects the rights of the inventor from any company
that no one other than the
inventor/founder can use the name of the substance
or the company without the permission of the company.
In the case of biotechnology,
the IPR can help the inventor/founder to keep his name associated with that product
forever. And if some other person tries to take credit for that work, then the rules of IPR will restrict
him from doing so. It helps the companies in retaining their patents, trademarks, and their trade secrets. It helps in pharma companies that if a
certain company holds IPR related to
a drug then that company only can sell the drugs by a specific name, no other companies have the right to sell that drug by that name.
Such as only the company Reckitt
and Colman can use the name Disprin in selling their tablets for headache, no other companies have the right to sell
any medicine in that name. But other companies can use the name of the
compound found in that medicine
because the compound of the
medicine is the same for everybody. So, IPR has a very important impact in this sector and without it, no companies
will be able to establish their ownership. It restricts the chances of conflict between the companies
and provides an equal platform for everybody to perform.[4]
IPR AND BIOTECHNOLOGY:
Trademark, copyright, patent, GI, industrial designs are some of the
forms of IPR. But the most popular
form of IPR corresponding to biotechnology is patent. Section 3 of patent act 1999 gives a list of the things that are not inventions. In this section, subsection (d) of Section
3 says that mere discovery of a scientific principle or the formulation
of or discovery of any living thing
or non-living substance occurring in nature cannot be termed as inventions and therefore
are not liable to get patented.
And subsection (j) of Section 3 says that plants and animals 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 plants and animals are not patentable inventions. Thus, the Patent Act 1999 protects the usage of
microorganisms in inventions. But those
need to be an invention rather than mere discovery. Thus, the use of
microorganisms to process subject
matter to prepare utilized products
with the help of
the human brain and technological
support is protected under the biotechnological patent, under the Patent Act
1999. Biotechnology includes
scientific and industrial strictness to utilize living and biologically active material in the final product.
HISTORY OF PATENT LAW:
|
1856
|
The Act VI of 1856 on protection of inventions based
on the British Patent.
|
|
|
Law of 1852. Certain
exclusive privileges granted
to inventors of new
|
|
|
manufacturers for a period of 14 years.
|
|
1859
|
The Act modified as act XV Patent monopolies called exclusive privileges
|
|
|
(making, Selling
and using inventions in india and authorizing others
to do
|
|
|
so for 14 years from date of filing
specifications).
|
|
1872
|
The Patterns
& Designs Protection Act.
|
|
1883
|
The Protection of Inventions Act.
|
|
1888
|
Consolidated as the Inventions & Designs Act.
|
1911 The
Indian Patents & Designs Act.
Ø This Act was further amended in 1920
to enter into reciprocal arrangements with UK
and other countries for securing priority. In 1930, further amendments
were made to incorporate, inter-alia,
provisions relating to grant of secret patents, patent of addition, use of invention by Government, powers of
the Controller to rectify register of patent
and increase of term of the patent from 14 years to 16 years. In 1945, an amendment was made to provide for filing of
provisional specification and submission of complete specification within nine months.
Ø
After Independence,
it was felt that the Indian Patents & Designs Act, 1911 was not fulfilling its objective. It was found
desirable to enact comprehensive patent law owing to substantial changes in political and economic conditions in
the country. Accordingly, the
Government of India constituted a committee under the Chairmanship of Justice (Dr.) Bakshi Tek Chand, a retired Judge of
Lahore High Court, in 1949 to review the patent
law in India in order to ensure that the patent system is conducive to the
national interest.
|
1999
|
On march 26, 1999 Patents (Amendment) Act, (1999) came into force
|
|
|
from 01-01-1995.
|
|
2002
|
The Patents
(Amendment) Act 2002 came into force from 20th may 2003
|
|
2005
|
Patenting of biotechnology invention in India:
Biotechnology has a vital role in covering
and touching lives in various
aspects. Biotechnology in
recent years has created unprecedented opportunities not only for humankind but also for industrial development. It
has become the world’s fastest growing technology. The pharmaceutical and agricultural sectors in India, a developing nation, are built in part
on advanced biotechnology.
General rules for patent:
The Indian Patent Act of 1970 established the following criteria
for a technique or product to qualify
for a patent:
1.
Inventive step- For
a product or technique to qualify for a patent
in India, it must be novel and involve an inventive step.
2.
Capable of industrial application- It is possible to patent an innovation in India that relates to a good or a method that is applicable to the industry.
3.
Novelty- This means that prior to the date of the application, the invention must not have been disclosed
to the public, not even by the inventor.
4.
The patent
must not, however, come under the definition of an
invention that is not patentable, as
stated in Chapter 2 (Inventions Not Patentable) of the Indian Patents Act, 1970.
Landmark cases in biotechnology Patent Law:
1.
Diamond vs. Chakrabarty
Diamond vs. Chakrabarty is a landmark case in biotechnology patent law that established
that genetically engineered microorganisms are patentable subject matter. This decision, issued by the Supreme Court
of the United States in 1980, had a profound
impact on the biotechnology industry
and paved the way for the patenting of other living
organisms.
Facts: The case involved Ananda Chakrabarty; a microbiologist who developed a genetically
engineered bacterium capable of breaking down crude oil. Chakrabarty filed for a patent on his invention, but the
Patent Office rejected his application, arguing that living organisms were not patentable. Chakrabarty appealed the decision to the Supreme Court.
Decision: The Supreme
Court held that genetically engineered microorganisms are patentable subject matter because they are
“new and useful” inventions under the Patent
Act. The Court reasoned that the bacterium was not a product of nature,
but rather a “human-made invention” that was the result of Chakrabarty’s “ingenuity and hard work.” The Diamond v. Chakrabarty decision had a number of important
implications for the biotechnology industry.
A.
First, it opened the door to the patenting
of other living organisms, such as genetically engineered plants and
animals.
B.
Second,
it provided a framework for determining which living organisms are eligible for patent protection.
C.
Third, it helped to establish the United States
as a leader in the field
of biotechnology.
Despite these concerns, the Diamond
v. Chakrabarty decision remains a landmark case in biotechnology patent law and has played a major role in the
development of the biotechnology industry.[6]
Facts: Monsanto Biotech
Pvt Ltd (India), is the Indian joint venture of Monsanto.
This company has been licensing its biotechnological products to various seed companies in India.
Monsanto licensed its patent IN214436
to Nuziveedu Seeds and its subsidiaries Prabhat
Agri Biotech and Pravardhan Seeds on 21/2/2004
which was relating
to BT cotton in which there was recombination of DNA due to which the plants became resistant
to bollworms. Due to the refusal by Monsanto to reduce
the special compensation which was payable by the Indian companies under the license,
the Indian Companies
stopped paying royalties. Thus, Monsanto filed the petition
for violation of registered patent before the High Court of Delhi.
The plaintiff claimed that their patent is the man-made NAS(Nucleotide Acid Sequence, Bt gene), which is useful for killing bollworms when
it is inserted in cottonseed. And the respondent claim was that NAS was just a chemical composition that is not capable of
reproduction and not a man-made inventive microorganism, which can be useful for industrial application.
Decision : The Division
Bench of the Delhi High Court rejected the application on the ground that the said invention was not patentable subject
matter under section 3(j) of patents
act, 1970. The Supreme Court in this case set aside the order of the division bench and held that the validity of the
patent cannot be on the basis of prima
facie examination. The Hon’ble Apex court then reverted back the matter back to the single bench
of the Delhi High Court to be decided on the basis of expert advice
and evidence. Though
the decision of the Delhi
HC may not have any significance for the immediate parties, since the
patent period already expired in
2019, it would definitely establish the law for future applications for
similar inventions.
The decision has also been criticised by some, who argue that it could lead to the patenting
of human beings
or other higher
life forms. Others have raised concerns about the potential impact of gene patents on biodiversity and the environment.[8]
INDIA IN RELATION WITH TRIPS:
In reference to the patentability of biotechnological inventions, the
Patents (Amendment) Act, 2002, provided substantial changes to
Indian patent law. The law met
the requirement of article 27.3(b) of the TRIPS AGREEMENT by specifically providing for the patentability of microorganisms.
India joined the World Trade Organisation (WTO) in 1995. Under the WTO, member countries had to comply with the
TRIPS (Trade Related Aspects of Intellectual
Property Rights) Agreement. It is a multilateral agreement
of the World Trade Organisation in relation to intellectual property
rights (IPR). Under the TRIPS Agreement,
every member country had to shift from process patents to product patents. India formally became a signatory member
of the TRIPS Agreement in 1995 when it joined
the World Trade Organisation (WTO) (Trade-Related Aspects of International Property
Rights). India needed to
change its current patent system to comply
with TRIPS, subject to a few
transitory provisions allowed for developing nations in Article 65 of TRIPS.
The TRIPS Agreement, to which India is a party as a member of the World Trade Organisation (WTO), mandates that
biotechnological inventions, including plant
varieties, receive some level of protection. For different member countries, different time periods were given in order to comply with this agreement. The developed countries
had to comply within a period of one year. For developing countries like India,
the time period was 5 years. Within 5 years,
they had to comply with
this agreement. In case of any
emergency, the developing countries can extend the time period to another 5 years along with the existing 5 years,
making it 10 years. For least developed countries
(LDC), the time period given was 11 years.[9]
According to the TRIPS Agreement, every member country has to shift from process patents to product patents. The
TRIPS-mandated process of extending the term
of Indian chemical
(including biotechnological) patents
from seven to twenty years from filing, along with a shifted
burden of proof for alleged infringement of process patents, will cooperate with the country’s biotechnology
industry’s goal of setting the global standard
for the production of generic biologics.[10]
ETHICAL IMPLICATION IN BIOTECHNOLOGY:
The field of ethics tells us to give explanations for our actions and
describe our intention. The intention
to do good does not matter, what matters is that, a reason should be given on why that particular
action is being done and what is being done. The field of biotechnology needs to address
three main areas:
A. Incentives- the way scientists
are promoted to research.
B. Intentions- end results of that research.
C. Actions- prospective applicability of the research.
The benefits of biotechnology are advertised largely
but its risks are not covered
properly. We cannot remain ignorant about the social, legal and ethical
concerns of biotechnology. The ethical concerns related to gene patenting
are:
Human cloning- for the sake of utility
one should not alter the genetic structure. Humans cannot be used as
a commodity. Genetic material is a
common heritage and one cannot have a
monopoly over it. Crossing biological
borders and exchanging genetic
material is not ethically correct. An example is the “Dolly” sheep where the human genes were inserted into the animal genes. Genetically modified living things will be considered not less than a
commodity, so all the intrinsic value will be lost. The exploitation of women is brought about when biotechnology is
used in reproductive biology. Many embryos are taken for doing various
researches such as stem cell research.
There are debates concerning that due to human cloning there can be the creation of slaves. Humans are used as a
subject in many research institutions, the concern should
be taken before
conducting the research
and all the procedures should
be explained before any experimentation[11].
1.
Bioethics:
Bioethics considers the ethical issues raised in biology and medicine,
and especially those raised
by human activity
in society and the environment using biotechnology.
Bioethics considers issues affecting all living organisms and the environment,
from individual creature to the level
of the biosphere in complexity. All living organisms are biological beings, and share a common and intertwined biological
heritage. The term bioethics reminds
us of the combination of biology and ethics, topics that are intertwined.
Bioethics especially includes medical and environmental ethics. The word was mainly applied for issues of medical
ethics in the 1970s and 1980s, but the 1960s
and 1990s saw much more
attention on environmental ethics.
Agricultural systems include
economic, environmental and human interactions. To resolve the issues, and develop ideals or principles to help us do
so, we must involve anthropology, sociology,
biology, religion, psychology, philosophy, and economics; we must combine
the scientific rigor of biological
data, with the values of religion and philosophy to develop a world-view. Bioethics
is therefore challenged to be
a multi-sided and thoughtful approach to decision-making so that it may be relevant to all aspects of human life.[12]
2.
Beneficence :
One of the underlying philosophical ideas of society is to pursue
progress. The most cited
justification for this is the pursuit of improved medicines and health. It has
often been 5 assumed that it is
better to attempt to do good than to
try not to do harm. A failure
to attempt to do good, working for people's best interest, is taken to be a sin
of omission. Beneficence is the
impetus for further research into ways of improving health and agriculture, and for protecting the environment. Beneficence supports the concept
of experimentation, if it is performed to lead to possible benefits.
The term beneficence suggests more than actions of mercy, for which charity would be a better term. The principle of
beneficence asserts an obligation to help others further their important and legitimate interests. It means that if you
see someone drowning, providing you
can swim, you have to try to help them by jumping in the water with them. It also includes the weighing of
risks, to avoid doing harm. Governments have a
duty to offer their citizens the opportunity to use new technology,
providing it does not violate other
fundamental ethical principles. Just what the definition of fundamental ethical principles is may be culturally
and religiously dependent, especially in the way that they are balanced when opposing principles conflict. Beneficence also asserts an obligation upon those who possess life-saving technology, in medicine
or agriculture, to share their technology with others who need it.
3.
Confidentiality:
The emphasis on confidentiality is very important. Personal information should
be private. There may be some
exceptions when criminal activity is involved or when third parties are at direct risk of avoidable
harm. It is very difficult
to develop good criteria for exceptions, and they will remain rare. A feature of the ethical use of new genetics is the privacy of genetic information.
This is one of the residual features of the existing medical tradition that needs to be reinforced. It is
not only because of respect for people's
autonomy, but it is also needed to
retain trust with people.
If we break a person's
confidences, then we cannot be trusted. If medical insurance companies try to take only low risk clients by
pre-screening the applicants, there should be the right to refuse such questions (Holtzman, 1989).
The only way to ensure proper and just health
care is to enforce this on
employers and insurance companies, or what is
a better solution, a national health
care system allowing all access to free and equal medical treatment.
4.
Environmental Ethics:
Humans also have interactions with the
environment, and in fact depend upon the health
of the environment for life. The easiest way to argue for the protection of the environment is to appeal to the human dependence upon it. There are also
human benefits that come from
products we find in nature, from a variety of species we obtain food, clothing, housing,
fuel and medicine.
The variety of uses also supports the preservation
of the diversity of living organisms, biodiversity. As we have learnt, the ecosystem is delicately balanced, and the
danger of introducing new organisms into the
environment if that may upset this balance
is another key issue raised by genetic
engineering. However, we have been using agricultural selection for 10,000 years, so the introduction and selection of improved and useful microorganisms, plants and animals is nothing new, and we should learn from mistakes of the past.
Nature has life; thus it has some value, looking at the world is a religious view, that God made the world so the world has value, and we are stewards of the planet,
not owners. This paradigm
can make people
live in a better way than if they look at the world only with the paradigm of human benefit.[13]
Suggestion:
1. Privacy and Data Protection: Examine the implications of biotechnology for data privacy
and protection, especially in the context
of genetic information.
2. Equity and Access: Investigate the potential for biotechnology to exacerbate social inequalities and explore strategies
for ensuring equitable
access to its benefits.
3. Public Trust: A
lack of public trust in regulatory agencies or biotechnology can hinder the effective implementation of ethical
guidelines.
4. Global Inequalities: The benefits and risks of biotechnology may not be distributed equitably, leading to ethical
concerns about social justice.
5. Dual-Use Technology: Biotechnology can have both beneficial and harmful applications. Ensuring that safeguards are in place to prevent
the misuse of biotechnology is a significant challenge.
Conclusion:
In order to maintain a check and balance on the advancement of biotechnological material (e.g. gene patenting) legal,
ethical and moral criteria must to be taken into consideration. Through the employment of bacteria and viruses,
the biotechnological innovation has
the potential to create a biological weapon with global devastation. The development of such an invention will have detrimental impacts on both the environment and people. The biosafety
principle is in danger due to the possibility of transgenic animals being released into the wild and causing ecological disruption. The government
should ensure that a discussion about what inventions should be protected by patents, which inventions should be
permitted to reach the market, and whether cooperation is necessary takes place
in order to effectively regulate what is
being invented.[14]
Clear guidelines and
institutional safeguards should be put in place, and effective means of control should be
guaranteed, coupled with transparent information aimed at the public. Patent applicants, on their side, should
develop a sort of ethical sensibility and weigh the possible socio-political impacts of their inventions.
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3178936/ last seen dated
19/08/2024
[2] https://www.iipta.com/role-of-ipr-in-biotechnology-industry/ last seen dated
19/08/2024
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3178936/
Last seen dated 19/08/2024.
[4] https://biotechnology-trade-laws/#Impact_of_IPR_for_biotechnology
last seen dated 21/08/2024.
[5] https://ipindia.gov.in/history-of-indian-patent- system.htm#:~:text=The%20first%20legislation%20in%20India,disclose%20secret%20of%20their%20inventions.
Last seen dated
[6] Diamond v. Chakrabarty, 447 U.S. 303
(1980).
[7] Monsanto Technology LLC v. Nuziveedu and Ors. is Civil
Appeal No. 6472 of 2004
[8] https://what-are-the-different-issues-regarding-ipr-in-biotechnology/#IPR_involved_in_biotechnology
last seen dated 22/08/24
[9] Amie Barcombe; Jordan M. Gringauz; Maeve O’Flynn;
Amanda K. Murphy, Ph.D.; Craig Slater, Ph.D., Patentability in US and Europe, May
15, 2024,https://www.finnegan.com/en/insights/articles/how-clinical-
trials-affect-patentability-in-us-and-europe.html last seen on 20/08/24.
[10] https://biotechnology-patenting-in-india-and-a-comparison-with-the-us-
perspective/#:~:text=inventions'%20commercial%20potential.-
,India%20in%20relation%20with%20TRIPS,for%20the%20patentability%20of%20microorganisms
last seen dated 22/08/24
[11] https://legal-social-and-ethical-implications-of-gene-patenting-2/#Ethical_implication_of_gene_patenting
Last seen dated 23/08/2024.
[12] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3570997/
last seen dated 23/08/2024.
[13] Modern Biotechnology: Legal, Economic
and Social Dimensions, Biotechnology, Volume 12, ed. D. Brauer (Weinheim, Germany:
VCH, 1995). Author: Darryl R. J. Macer
[14] https://www.legaleech.com/blogs/patents-on-biotechnology-and-related-laws-in-india
last seen dated 24/08/2024.
Article Information
LEGAL AND ETHICAL CONSIDERATIONS IN BIOTECHNOLOGY
Authors: MRUNALI BALASAHEB KHAVALE
- Journal IJLRA
- ISSN 2582-6433
- Published 2024/09/09
- Issue 7
About Journal
International Journal for Legal Research and Analysis
- Abbreviation IJLRA
- ISSN 2582-6433
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