Biotechnology and genetic engineering have enabled the creation of new life
forms, as well as the evolution of existing ones. The keywords of current
scientific advancements and study include stem cell technology, somatic cell
hybridization, genome technology, gene treatment, and cloning.
agriculture, and human healthcare have all seen substantial advancements in
these fields, with drugs like insulin, erythroprotein, and interferon now being
manufactured on a commercial basis. Disease-resistant plant varieties, hybrid
seeds and plants, nitrogen-fixing microorganisms, new plant varieties with
shorter life cycles, and other advances in agriculture and human life science,
such as organ reconstruction and life creation through cloning, biotechnology,
and genetic engineering, are having a long-term impact on human life.
A part of
the scientific community claims that the danger of commercialising most of these
scientific advances can result in substantial and irreversible environmental
damage. Others believe that patenting in such places should be prohibited in
order to protect biodiversity and indigenous people's rights. Some detractors of
cloning and organ reconstruction technologies fear that the benefits will
outweigh the risks to nature.
The reasons against patenting life forms have been
grouped into the following categories: ethical and religious concerns,
environmental ramifications, economic considerations, and legal difficulties.
This paper has also sought to examine if life has intrinsic values and whether
patenting biological forms contradicts those values. The study finishes with
several key recommendations on the patenting of living organisms.
To begin, the most apparent point of contention is whether or not biological
forms should be patentable. If the conditions as they are today are followed
correctly, the solution is obvious. There is no creative step in a natural
living form, hence it cannot be patented. Because the notion of caging is not
new, a caught biological being is likewise not patentable, though a new and
ingenious design of cage might be. A changed living form can be patented, but
only in terms of the modification itself.
There have been fast advances in genetic engineering and other life sciences
since the discovery of the double-helix structure of DNA in 1953. Thousands of
patents for rights relating to DNA sequences have been issued as a result of
this growth in research commercialisation. The patenting of living forms and
genetically engineered organisms is the most recent area of debate. Living
organisms are special in that they can be patented for a variety of reasons:
First and foremost, the innovation is alive.
That is, in certain cases, the
innovation can duplicate itself. Furthermore, the invention may not always be
fully defined for patent specification reasons. As a result, parties have been
forced to deposit their inventions in order to get a patent. For many years,
stakeholders in India have been perplexed by the patenting of biological forms.
The Indian Patent Office has developed through time to develop a number of
measures to address the challenges of life-form patenting. Even if the measures
have helped to alleviate some of the confusions, there is still more to be done.
The Indian government's view on life-form patenting has evolved throughout time.
A few decades ago, India was opposed to issuing patents to living things. The
same may be seen in India's call for a review of TRIPS Article 27.3 and support
for the African group's request for a review of Article 27.3, which indicated
that patents on life, including those on microbiological processes, should be
barred. TRIPS, on the other hand, has instructed member nations to grant patents
to all technology and microbes. Amendments to the Indian Patents Act, 1970 were
modified between 1999 and 2005 to comply with TRIPS directives and to meet
India's international commitments under TRIPS.
In today's world of progress, nothing is beyond the reach of the law, which has
served as a watchdog for mankind, keeping everyone in line and safeguarding one
another. Now that the world is progressing and a plethora of inventions are
being introduced to mankind, there is a high risk of confusion regarding object
identification, for which the importance of intellectual property rights is
deemed necessary, and with reference to this paper narrowing down the focus to
the importance of intellectual property rights in the field of biotechnology.
Because scientific advancements are covered by patent rules, this study focuses
on a specific branch of research, biotechnology. "Biotechnology" is just a new
word for an old concept: technology based on the use of other living
creatures (i.e., biology-based technology), particularly in agriculture, food
science, and medicine. "Biotechnology" is defined by the United Nations
Convention on Biological Diversity as "any technical application that employs
biological systems, live creatures, or derivatives thereof to manufacture or
change goods or processes for specified applications."
In this paper, the author
discusses the importance of intellectual property rights in the field of
biotechnology and how these laws have evolved in the face of a great deal of
criticism with the help of case law. Later in the paper, the author discusses
the ethical implications of patenting biotechnological innovations, as well as
the TRIPS agreement and its application in the biotechnological arena.
Evolution Of Patent Laws In Biotechnological Arena
Patents on live organisms were first denied on the grounds that they were
natural products, as defined by the theory of nature. The thought behind this
denial was that living beings were natural products that belonged to everybody
and were outside the monopoly of anybody.
The claim in Funk Brothers Seed Co. V Kalo Inoculants Co
. was a mixed culture
of different strains, each of which was useful in the inoculation of roots of
various species of leguminous plants that were helpful in nitrogen fixation
(various types of root- nodules were present in nature), and the applicants
tried to combine the various species in order to develop a mixed culture
suitable for inoculation of a wide variety of crops, but their attempts failed.
The patent claim was declared invalid by the USSC because it was a natural
substance. The court determined that the patent claim's subject matter was a
natural product, that no efforts were taken to change its status from natural to
man-made, and that the only person who has authority over natural items is GOD.
The Supreme Court determined that natural goods do not qualify as patentable
The patent claim in Diamond V. Chakraburty was for both the procedure and the
final product of a genetically engineered micro-organism capable of consuming
crude oil spills. For the first time in the history of patent law, the question
of whether or not a natural object can be patented was addressed in this case.
The claimant, Chakraburty, was granted a patent on the trade secret or process,
but no patent was granted on the actual bacteria developed on the grounds that
it was a natural product that did not fall within the ambit of patentable
subject matters, which prohibits all living objects from being patented, and
bacteria, as a micro-organism, does.
Further, in Shell Development Co. V Watson
, the term "composition of matter"
was interpreted and given a broad meaning, stating that all compositions of two
or more substances and all composite articles, whether a result of chemical or
mechanical union or being a gas, a solid, or a liquid, are patentable subject
Now, according to this view, natural substances, including
biotechnological inventions, fall under the definition of composition of
materials, i.e., biotechnological creations are genetic compositions from
various species or sections of a living being's body. Later in the same case,
the supreme court overturned the previous judgement by a 5:4 majority, stating
that the congress has all the rights to promote scientific development and
innovations, and that excluding the development of bacteria would negate the
entire purpose of encouraging scientific developments, because science
encompasses not only physics and chemistry, but also biology, zoology, botany
science, and a variety of other subjects, including the study of living
Later, in HiBred International V JEM AG supply Inc. Supp
, the US court of
appeal for the Federal Circuit upheld patents on plants, stating that
biotechnology is one of the fastest growing fields of science, breaking new
frontiers at such a rapid pace that law is lagging behind in order to regulate
it. The effectively utilized of patent law extends from plants and animals to
the patenting of human genetic material, i.e., the period of contemporary
biotechnology began adding another feather to its cap with the discovery of
The claim for extracted and purified DNA sequence in Amgen V. Chugai
. A HUMAN
genetic material, i.e. DNA, was claimed for patent for the first time in the
history of patent law. The alleged DNA codes for erythropoietin, a protein that
stimulates RBC synthesis, which is beneficial to patients who suffer from
anaemia, or a lack of RBCs. The creators wanted to patent the invention in order
to make it commercially viable.
It's strange that the patenting of human genetic material, i.e. DNA, did not
draw criticism because it's a natural product, as it did with plants and
animals. Instead, the opposition's main focus was to see if the inventor had
imagined the innovation for real. The innovators were discovered to have
knowledge of DNA and had effectively reduced, and a patent was given in support
of the same. It was decided that the idea of DNA entailed genuine knowledge of
the DNA sequence, as well as its physical and chemical properties, as well as
testing with the DNA, which had been effectively reduced to practise, and a
patent was finally awarded. After reading this story in particular, it is clear
that biotechnology is a good thing.
The question arose in Harvard College V. Canada (Commissioner of Patents) as
to whether higher life forms are susceptible to patent law or not. It was
decided that it is the responsibility of the patent office to determine whether
a patent application meets the requirements of innovation, non-obviousness, and
usefulness set out in the patent statute. According to S.2,
The patentability of
genetic material is a complicated problem under the Patent Act of Canada, and
therefore necessitates a well designed patent application.Responses from the
legislature It was also said that, given the importance of information and
technology. A compulsory licencing framework for biomedical and biotechnology
discovery and developmnt. It is necessary to build commercial and public
research businesses. Further a patent pool for genetic patent must be
contemplated, considering the benefits possible from regulated technology patent
The phrase "manufacturing" was given a broad interpretation in American Fruit
Growers Inc. v Brogdex Co
., where the claim was for "coated oranges." In
this instance, the word "manufacture" was construed by the court to encompass
the creation of goods for use from raw or prepared materials by giving them new
shapes, characteristics, attributes, and combinations, whether by manual labour
or equipment. The term used here was more of an economic one, i.e. manufacturing
refers to the creation of new goods from raw materials by giving them a new
shape, quality, or property, or a combination of these.
Reading the decision, it may be deduced that, unlike in the past, when live
items were not subject to patent law, existing living creatures are now being
exploited as raw materials in the development of new biotechnology inventions.
The modification and manifestation of a resultant live entity to give it a new
look, feature, or property that it did not have before was the end product or
the ensuing living item.
As a result of the decision, biotechnological
inventions fall under the definition of "manufacturing
" and hence qualify as
patentable subject matter.
Further, The USPTO Board of Patent Appeals and Interferences determined that
seeds, plant tissue cultures, and plants were patentable subject matter for
utility patents in the case of Ex Parte Hibberd. The Supreme Court stressed the
patentability of plants in the case of J.E.M v. Pioneer in 2001, finding that
newly established plant breeds are within the range of patent able subject
matter under 101 and that 101 is not limited by the Plant Patent Act or the
Plant Variety Protection Act.
What Could Go Wrong In Patenting Lifeforms?
Nature's creation, which includes everything that has life on our earth and is
considered holy, has its own integrity. Patenting transgenic animals by
transferring genes from one species to another violates natural boundaries and,
as a result, the integrity of those species. Because DNA is thought to be
strongly tied to species identification, no portion of it should be controlled
for commercial purposes.
Many people believe that the plants, animals, and
microbes that make up life on Earth are part of the natural environment into
which humans are born, and that turning these species, their molecules, or
components into corporate property is against the public interest. Prior to
2002, there was a shift in India's understanding that ideas linked to biological
forms were not protected by patents. The Calcutta High Court, however, concluded
in Dimminaco A.G v. Controller of Patent and Design
that a process for preparing
a live viral vaccine is patentable since even living entities are covered by the
According to the Court, even if the finished product
contains a live virus, the method involved in pulling it out becomes an
invention. It should be emphasised that no judgement has been made specifically
on the application of inventive step requirements to biotech patent inventions
in India to yet. Microorganisms can be patented in India, however there is no
definition of the word under the Patent Act. This has sparked far too many
debates over the patentability of microorganisms. Due to the lack of an uniform
description of the microorganism and microbiological process in the TRIPS
Agreement, it is necessary for the nation to create a distinction between the
outcome of unique human activity and that which occurs naturally.
Moral And Ethical Issues
The core of morality, i.e. the basic ideas indicating what is good and bad, is
known as morality. Now that biotechnology is one of the most rapidly increasing
fields of scientific and industrial innovation in modern times, it has earned a
position in the public debate, particularly in terms of the ethical ideals
linked with it.
The main difference between patenting biotechnological
innovations and patenting other fields is that patenting biotechnological
innovations has introduced ethics into the Patent Laws, as a number of ethical
questions have been raised while deciding whether or not to grant patents in a
number of cases, most notably on the grounds that biotechnological innovations
are products of nature, as defined by the Doctrine of Product of Nature.
living beings are created by God and are beyond the control of human brains, and
God is the sole owner of any and every living object present on this planet,
thus are vested with inherent dignity and integrity, and attempting to modify
these inherent characteristics and to patent them takes away this dignity and
integrity, which is basically going against God's wisdom.
The patenting of higher life forms such as human cells, genes, mice, and other
living things has sparked a slew of ethical concerns. Many of them are religious
in nature, believing that patenting God's creations reduces them to simple
material items and lowers the God-given dignity of living forms by making them
one's personal property. However, there should be some form of check on humans
who try to play God by inventing new technologies and obtaining patents on them.
The European Court of Justice addressed this problem in the Relaxin
The claim was for the patenting of human gene encoding for Relaxin in
this case. The patenting of a single human gene, it was decided, has nothing to
do with the patenting of human existence. Here, the claim was for patenting
human gene encodes for Relaxin. It was held that patenting of a single human
gene has nothing to do with patenting human life. Even if every gene in human
genome were cloned it would be impossible to reconstitute a human being from the
sum of its gene. And such patent do not confer any right over any individual
The tissue is taken with consent within the framework of gynecological operations. Many life saving substances were isolated in this way
and thus serve social purpose, by contributing to humanity, life saving drugs
and such inventions are industrially applicable technical solutions to a
technical problem. Hence, they are patentable. Thus, using DNA technique gene
was cloned making it possible subsequently, to produce synthetic Relaxin a
hormone which relaxes the uterus during the child birth. Until it was isolated,
gene coded for Relaxin was unknown hence, it was held that it is not mere
Moving on to the TRIPS agreement, which includes ethics, morals, and public
order, new reasons for excluding patentability of any innovation have
emerged. Not only that, but the agreement also states that innovations that
harm the health of animals, plants, or any other living creature for that
matter, or even worsen environmental circumstances, are subject to patentability
People who argue against patenting living organisms argue that
patenting any type of living organism violates the main purpose of the TRIPS
agreement on ethical grounds, whereas those who argue in favour of patenting
living organisms argue that while the TRIPS agreement prohibits patenting of
natural plants, animals, and human genetic material, it does not prohibit
patenting of non-natural, genetically engineered plants or a living organism.
Hence it can be said that patents should be granted to all those who engage into
an extensive research work and develop something new provided that the ethical
and moral grounds and the inherent natural rights of any living being remain
intact not are not violated.
Intervention Of TRIPS
The origins of biotechnology may be traced back to the early phases of its
development, when the fermentation process was initially employed to prepare
food before being used to the production of alcohol and other therapeutic
products. Modern biotechnology began with DNA methods and the cloning of live
beings, and has now advanced into nanotechnology, which has opened up new
frontiers for the human race to explore and exploit.
Patents cannot be made
universal, i.e., rules pertaining to IPR in Biotechnology must be bifurcated
according to the demands of the industries and the profit and loss they would
make from these arrangements in both developed and developing nations.
Developing nations are still not in the league of "countries with enough
resources" to carry out their research and development, putting them at a
disadvantage, and wealthy countries have a monopoly on the Biotechnology market.
Countries like India, which is growing and has recently signed the TRIPS
agreement, have had its IPR regulations relaxed so that they may compete with
industrialised countries while profiting. The fundamental motivation for this
relaxation was to allow emerging markets to register more patents, as evidenced
by the fact that after India joined the TRIPS agreement, over 1400 patent
applications were submitted to the government for clearance.
After the United
States, this was the country with the second-highest number of applications.
Patent rules in developing countries should be tailored to inventors'
requirements so that they can innovate their ideas, and access to national and
international resources should be made available to expand the capital market
for biotechnology patents.
The US and the EU had a disagreement on the question of patenting
biotechnological inventions during the Uruguay Round TRIPS discussions. On the
one hand, the US felt that everything under the sun produced by man, save human
people, was patentable; on the other hand, the EU disagreed and opposed bringing
biological organisms under patentability. Because the argument between the
two international players had not been resolved, WTO members in Europe agreed to
a limited agreement (under Article 27.3(b)) while agreeing to reexamine the
issue four years after the TRIPS Agreement took effect.
Article 27 of the TRIPS
Agreement defines which inventions nations are required to patent and which
inventions are exempt from patenting. This article also stipulates that a patent
must be available for both the product and the process, whereas Article 27.3(b)
allows governments to exclude plants, animals, and essentially biological
processes from patentability. There isn't a clear bifurcation under TRIPs with
regards to microbiological process and essentially biological process and thus
are subject to varied interpretation by experts in same and different
jurisdictions, which calls for anothet controversy.
India's Post Trips Agreement Regime
India is one of the signatories to the TRIPS agreement, and its rules are in
line with those of other nations. To be completely compliant with TRIPS and
other nations' regulations, the Patent Act required to be amended. Until date,
the patent regulation structure has been extremely tight, and its reach has been
limited in sectors such as biotechnology. The TRIPS agreement provided
developing nations with a new path forward by disseminating information and
boosting people's access to diverse technologies and research projects.
Developing nations were encouraged to sign the TRIPs agreement, obey WTO
regulations, and provide leeway for their own legislation within that framework.
Although the Indian Patent Act has a limited scope, the World Trade Organization
(WTO) has established a larger framework to include product patents and all
associated disciplines. The WTO allows patents in life forms if any innovative
step is made in conjunction with a readable subject-matter of invention, while
the Indian Patents Act prohibits patenting of higher life forms. The WTO
provides for a 20-year patent life, but the Indian Patents Act did not catch up
until the third amendment; previously, the patent term was just seven years.
the biological space, the key locations where the problem exists are:
- No clear bifurcation between discoveries and inventions has been done
- Scope of patentability in higher life forms like plants, animals
- Scope of patentability in lower life forms � microbial organisms
- Condition of depositions covering living organisms connected with
The Patent Act was drafted by the Indian government with the TRIPs agreement's
ambiguities and ramifications in mind. Government policies combat piracy and
assist national enterprises in gaining access to and participating in different
technical breakthroughs, as well as investing their money in something that
would earn them profits and provide them with patentability over items created
under the TRIPs agreement. The major goal is to achieve maximum enforcement of
IPR-related international laws and regulations in compliance with international
authorities so that no claim over previously patented items occurs in the
In current age of Information Technology, new advancements in any branch of
technology are unavoidable. As a consequence of the expansion in the IT
industry, such as Bioinformatics, new developments are taking place,
particularly in the field of Biotechnology. Since the patent has evolved as a
powerful weapon for protecting intellectual property in the realm of
biotechnology, care must be taken not to hinder further development and healthy
competition by permitting apparent items to be monopolised.
The lack of specific
standards for obviousness and degree of unpredictability of art complicates the
process of obtaining a patent for biotechnology technologies. Because of many
causes such as technological advancements and changing dimensions of law and
judiciary, the product of nature theory is becoming not only outmoded, but also
restricted in its applicability, particularly in emerging and developed nations. TRIPs do not necessitate patenting natural products, although a more isolated or
modified form of any microorganism may fall within the patentability criteria of
While WTO members may have differing perspectives and interpret these
compliances in various ways, a nation cannot prevent another country from having
a different viewpoint on the same topic. The implementation of varying
patentability rules in the realm of biotechnology will have a significant impact
on investors and the industry's future development. As a result, it has an
impact on the country's technical progression and, as a result, its economic
development and scientific progress.
Granting patent protection to conventional
improvements or technological advancements without true innovation, on the other
hand, slows development and may, in the case of patents combining previously
known parts, rob earlier innovations of their value or utility. As a result, the
patent office and the courts must exercise extreme caution and vigilance while
ruling on biotech patenting's conceptual concerns.
To address the shortcomings
in the realm of IPR, the authors provide the following recommendations:
- As shown in the paper, patenting of various biotechnological inventions
has been accepted over time, with the exception of transgeneric human beings;
therefore, it is preferable if local statutes are modified in a way that also
considers the ethical and moral standards of the society to exclude transgeneric
- After reading the TRIPS agreement, it is clear that an international
declaration or convention prohibiting the use of cloning for the
reproduction of not only humans, but also animals and microorganisms, might be approved.
- Given the dynamic nature of biotechnology, where some or all changes
occur on a regular basis, the time term for patent awards in India should be
decreased and the whole bureaucratic procedure should be modified, and
patents should be awarded within three years.
- Because of the technicalities and complex nature of Biotechnology, an
expert committee based on the field in which the patent is to be granted
should be included. The TRIPS agreement can be amended to mandate compulsory licencing
in the field of Biotechnological patenting if certain conditions are met.
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