This article describes and analyses the various legal regimes governing
intellectual property rights in the protection of life forms, the patent on life
forms, and plant varieties and sets forth regulatory options for national
governments to protect plant varieties while achieving other public policy
objectives relating to plant genetic resources.
A patent can be understood as an IPR relating to inventions and is the grant of
exclusive right, for a limited period, provided by the Government to the
patentee, in exchange of full disclosure of his invention, for excluding others,
from making, using, selling, importing the patented product or process producing
that product for those purposes.
Introduction
Creations of the human brain are called intellect and if they have commercial
value they can be classified as property. Intellectual Property thus refers to
inventions, industrial designs for article, literary and artistic work, symbols,
etc. The word patent has been derived from the Latin word patent-em meaning
open. The self-contradiction demands an explanation. The widest possible
dissemination of new knowledge makes the greatest economic efficiency.
But if everybody is free to access new knowledge, the inventors have little
incentive to commit resources to produce it. Intellectual Property Rights (IPRs)
temporarily transform knowledge from a public good into a private good so that
owners of intellectual property can recoup their expenditure in creating new
knowledge.
A patent can be understood as an IPR relating to inventions and is the grant of
exclusive right, for limited period, provided by the Government to the patentee,
in exchange of full disclosure of his invention, for excluding others, from
making, using, selling, importing the patented product or process producing that
product for those purposes.
Intellectual property is divided into two main categories: industrial property
rights, which include patents, utility models, trademarks, industrial designs,
trade secrets, new varieties of plants and geographical indications; and
copyright and related rights, which relate to literary and artistic works.
India and TRIPS (Related Aspects of Intellectual Property Rights)
On 16 April 1994, India signed the General Agreement on Trade and Tariff (GATT)
along with 116 other nations. The agreement also established the World Trade
Organisation WTO) which succeeded GATT.[1] Under WTO, no country has the option
to choose what part that it likes and abstain from others. The Trade Related
Aspects of Intellectual Property Rights (TRIPS) Agreement of WTO imposes a
number of rules on member countries.[2]
The TRIPS agreement ensures that patent protection is available for all the
fields of technology including agriculture, energy and healthcare.[3] Also,
members can exclude certain inventions from patentability if the exploitation of
the invention would be affecting the morality of general public.[4] TRIPS
further focussed on patentable subject matter in relation to biological
material. For example:
Plants, animals, essential biological process of production of plants and
animals may be excluded from patenting. Microorganisms per se and non-biological
and microbiological processes are patentable.[5]
Patents Act, 1970 and TRIPS Agreement
The Patent System in India is governed by the Patents Act, 1970 (No. 39 of 1970)
as amended by the Patents (Amendment) Act, 2005 and the Patents Rules, 2003, as
amended by the Patents (Amendment) Rules 2006 effective from 5 May 2006.[6] The
same is in accordance with the provisions of the TRIPS Agreement. The recent
conferment of 'product patent' along with the 'process patent' is an example of
such compatibility.
The TRIPS Agreement was formulated to bring basic level harmonisation in IPRs
laws all over the world. The provisions of TRIPS Agreement are the most
extensive and rigorous in nature. They protect all the forms of IPRs
collectively.
Patents on life-forms and living processes
Patenting of Life Forms-The Indian Stand
In India before 2002, amendment the understanding is that there is no patent
protection for invention relating to life forms. But in
Dimminaco A.G v.
Controller of patent and design,40 the Calcutta High Court held that a
process for preparation of vaccine containing live virus is patentable since the
term manufacture covers even living organism.[7]
So according to the Court even if the end product contains a live virus the
process involved in bringing out the end product becomes an invention. It may be
noted that there is no decision reported till date directly on the application
of the inventive step standards to inventions relating to biotech patents in
India.[8]
In the light of Article 27 of TRIPS the Section 3 of Patent Act, 1970 has been
amended. The definition of invention, new invention, inventive step reflects
restrictive approach to the legal protection of living materials. In the absence
of definition for plant, animal, micro organism essentially biological process,
non-biological process and plant variety its interpretation by the patent office
becomes crucial.
Since the term micro-organism can have a variety of definition which may not be
exhaustive to include genetic material, it is argued that it is safer to place
reliance upon the guiding provision in TRIPS agreement.
Another concern is that if the inventive step is going to be interpret by
considering only technical advance or economic significance, then standard of
patentability gets lowered and the same should not be allowed. Because these
factors has been used as secondary considerations and they never served as a
basis for establishing inventive step.
The 2008, patent manual incorporates provisions which is used as a guidance by
the patent office to interpret various provisions in the Act. Standing
Problem,Distance, Surprising Effect, Long Felt Need, Failure of Others,
Complexity of Work, Commercial Success, Cheaper and more economical Product and
simplicity of the proposed technological solution are considered as indicators
of inventive step in 2008 draft Manual of Patent Practice and Procedure.
Patents in micro-organisms and its conceptual issues
Can microorganisms, for instance, be patented? Prior to 1980 the answer to this
question was: NO. Microorganisms were clearly products of nature and as such
were not considered patentable. However, the era of maneuvering DNA between
organisms changed that.
The Mashelkar committee report has clearly stated that microorganisms are
patentable subject matter in India. Inventions pertaining to Microorganisms and
other Biological material were subjected to product patent in India, unlike many
developed countries. But with effect from 20.05.2003 India has started granting
patents in respect of invention related to microorganisms.
Though India was not obliged to introduce laws for patenting microorganisms per
se before 31.12.2004. Microorganisms patenting per se being considered to be a
product patent, the period of protection was 5 years from the date of grant or,
7 years from the date of filing of application for patent. Now grant of patents
for microbiological inventions is for a period of 20 years from the date of
filing.[9]
The most vital and important distinction between the legal practices of the
India and developed countries is that India (developing countries) does not
allow patenting of microorganisms that already exist in nature as the same is
considered to be a discovery as per the provisions of the section 3(d) and
therefore not patentable. But genetically modified versions of the same
microorganisms that result in enhancement of its known efficacies are
patentable.[10]
The grants of Patent in respect of Microorganisms depend upon the regulations
concerning the requirements for the deposition of Microorganisms under the
Budapest Treaty of which India has become a member, and accessibility of that
microorganism from the depositories. As per proviso (ii) to section 10(d) the
Microorganism if not being described fully and particularly and is not available
to public, the said Microorganism is to be deposited before the International
Depositary Authority under the Budapest Treaty. [4]
Conceptual Issues
India has allowed patenting of microorganisms but the Patent Act does not
provide a definition of the term Microorganisms. This has led to many debates
regarding patentability of microbes. In the absence of clear definition of
microorganism and microbiological process in the TRIPS agreement, the country
needs to draw a distinctive line between the product of human intervention
leading to novelty and those freely occurring in nature.[11]
Dimminaco case: a case in the point: Although the Indian Patent Act, 1970
does not permit patenting of microorganisms, per se, this particular case at
Calcutta High Court is a case to understand the intricacies of patenting.
Dimminaco Case 2 clarified the position relating to patentability of
biotechnology inventions, particularly in a case where a process of manufacture
of vaccine involving a living end product was involved.
The main issue in contention between the parties was whether the phrase 'method
of manufacture' used in section 2(1) (j) could be said to include a live
organism. The court, in its positive affirmation, has held that the dictionary
meaning of 'manufacture' did not exclude from its purview the process of
preparing a vendible commodity that contains a living organism.
The application of microorganisms in food is a million dollar industry today.
Since genetically modified microorganisms (a criteria that lends the human
intervention angle to satisfy one of the criteria to make the organism
patentable) is not permitted to be used in the food industry, the only source
for improving the textural and sensory properties of food is by isolation of new
strains of bacteria that deliver these properties.[12]
One need not mention the time, effort and money involved in this excercise. In
the Dairy industry, lactic cultures are used for the preparation of fermented
products and cheese whose consumption rates are increasing at a rate of 10%
annually. Suppressing the growth of these fermented products is the growth of
functional foods containing probiotic cultures. These are bacteria that when
consumed in sufficient quantities confer some beneficial attributes to the host.
The probiotic strains used in these products have been isolated after decades of
research work followed by clinical trials to prove their probiotic attributes.
Most of these strains are patented in the European Union and the United States
(where isolation of a new strain of bacteria is patentable). As a result, these
companies are marketing these products containing these microorganisms.
However, the same protection for these bacteria is not available in India. This
is not encouraging enough for the academia and industry in India to isolate
potential probiotic strains due to the absence of patent protection. Some of the
probiotic products launched in India are by companies which use strains that are
catalogued by leading international culture suppliers or by foreign companies
that have these strains.[13]
One may also run the risk of being accused by other nations of being insensitive
to the issues of promoting multilateral trade and hence of being subjected to
sanctions which may prove to be more economically ruinous in the long run.
Negative impacts of patenting of transgenic animals
The major concern that arises out of patenting of transgenic animals are that
transferring genes from one species to another transgresses the natural barriers
between them and affects the integrity of species. Species belonging to the same
group, though they may slightly vary from one region to the other based on the
environmental conditions, they primarily have the same gene pool.[14]
Ethical Issues
A number of ethical issues stem from the patenting of animals. Most of them deal
with the consequences that could arise subsequent to patenting of animals while
the other arguments focus on the religious, philosophical and spiritual grounds.
The arguments which go against the patenting of animals are difficult to prove
as many of them are factual assertions which are still to occur or to be proven.
The DNA is considered to be intimately related to the species identity and hence
no part of it should be controlled for commercial interest.[15]
In case of human beings, human DNA is unique and hence possesses intrinsic value
of a sacred kind. It can also be put as 'Human DNA bears the image of God' and
to tamper with them and own them for commercial and economic interests would
hurt the sentiments of the many.
The view that plants, animals and microorganisms comprising life on earth are
part of the natural world into which we are born and hence the conversion of
these species, their molecules, or parts into corporate property through patent
monopolies is counter to the interest of the people of the country and world,
has been taken by many.
Patents on Human Life:
A most alarming aspect of patenting life is the patenting of human genes, cell
lines and tissues. Corporate patent attorneys have lobbied the Patent office
that these products of nature are patentable once they have been isolated to
produce a form not found outside of a laboratory. For example, in 1976 a
leukemia patient named John Moore had surgery at the University of California to
remove his cancerous spleen.[16]
The University was later granted a patent for a cell line called Mo, removed
from the spleen, which could be used for producing valuable proteins. The long
term commercial value of the cell line was estimated at over one billion
dollars. Mr. Moore demanded the return of the cells and control over his body
parts, but the California Supreme Court decided that he was not entitled to any
rights to his own cells after they had been removed from his body.
Patenting of Genes
Our Genes define us, as a species as well as individuals, and hence for human
genes there are strong oppositions both on the religious and secular front.
Patents are being granted to genes despite there being many arguments for
keeping the genes in the public domain. A patent cannot be granted on a gene as
it naturally occurs. Isolation of the gene is required for it to be patentable.
The patent offices have treated genes as a new chemical compound and have
granted composition of matter patents.[17]
Thus a patent granted on an isolated and purified DNA composition confers the
right to exclude others from any method of using that DNA composition for upto
20 years from the date of filing. However Human Beings are not patentable as
human multicellular living organisms are not a patentable.
Why are genes being patented?
Genes have been used for gene therapy though it is still in the early
developmental stages. The technology used in each gene therapy will have huge
commercial value in the coming future making patenting crucial. However gene
therapy is not a patentable subject matter in India.
Morality and Patents- Is there a connection?
Patents on living organisms are morally objectionable to many. Patenting
organisms and their DNA promotes the concept that life is a commodity and the
view that living beings are gene machines to be exploited for profit. If it is
possible to consider a modified animal an invention, are patents and marketing
of human reproductive cells far behind? Patents derive from concepts of
individual innovation and ownership, which may be foreign to cultures which
emphasize the sharing of community resources and the free exchange of seeds and
knowledge.
Reason for Non acceptance of Human Gene Patenting
Patents on living organisms are morally objectionable to many people. Patenting
organisms and their DNA promotes the concept that life is a commodity and the
view that living being are gene machines to be exploited for profit.[18]
If it is possible to consider a modified animal an invention, are patents and
human reproductive cells and their marketing far behind? Patents derive from
concepts of individual innovation and ownership, which may be foreign to
cultures which emphasize the sharing of community resources and the free
exchange of seeds and knowledge. Many disputes involving patent infringement
cases emerged because of question related to obviousness, enablement or the
priority of invention that had to be decided by the courts.
More difficult were the questions about the ownership rights and privileges.
For example, in the patent Unique T-lymphocyte line and products derived
therefrom, the inventors used the spleen of a patient Mr. John Moore who
suffered from hairy cell leukemia and came for treatment to Dr. David Golde at
UCLA. As part of the treatment, his spleen was removed and Dr. Golde developed a
cell line with enriched T-lymphocytes that produced large amounts of lymphocytes
useful for cancer or AIDS treatment.[19]
Without Mr. Moore's initial knowledge or consent, but requiring his repeated
visits to the hospital, Dr. Golde and the University of California applied for a
patent on the cell line derived from Mr. Moore's spleen which was granted in
1984. Mr. Moore subsequently sued Dr. Golde and the University supreme Court.
Both the Appeals Court and the Supreme Court recognized the novelty of Mr.
Moore's claim Mr. Moore on the issue of conversion (unauthorized use of his body
part), but recognized his right to be informed of what the physician was doing
involving his health and well being. It's as irony that a person is not given
any benefit of the substance which he himself had produced, and at the same time
others are minting money from the same substance.[20]
What they say who are in favour:
That without patents society won't benefit from revelations about the molecular
roots disease. Moreover the arguments that patenting DNA promotes the view that
life is a commodity, cannot be accepted because it is not that the main aim of
the DNA patenting to earn profit or to use it for someone personal interest, on
the contrary the overall aim of the patent system is to promote the public
interest and to provide a fair reward to inventors. The patents system is said
to be justified because it provides an important incentive for the development
or new products and technologies related to healthcare.
One of the most coveted arguments which are vociferously put forward against the
patenting of life forms is that the First World patenting of Third World genetic
resources represents theft of community of biological resources.[21] Patents
held by the industrialized world on biological resources from the developing
world will serve as a tool for the North to accumulate more wealth from the
already impoverished south.
Microorganisms, plants, animals and even the genes of indigenous people have
been patented for the production of pharmaceuticals and other products.
Requiring developing nations to pay royalties to the wealthy industrial nations
for products derived from their own natural resources and innovation in
robbery.[22] Moreover the developing world has never received compensation or
recognition for these intellectual and technological contributions. Patenting
life forms will exacerbate this inequality. This bio-colonialism will continue
the pattern of a few transnational corporations profiting at the expense of
genetic resources of the third world countries.
Conclusion
Patents on life forms hinder research, indigenous economies, and genetic
diversity. No individual, institution or corporation should be able to claim
ownership over species or varieties of living organisms. In actuality, patents
enable companies to create a monopoly on a product, permitting artificially high
pricing. As a result, products such as drugs are often priced out of reach for
many of those who need them.
Patents in science promote secrecy and hinder the exchange of information. By
patenting products of research, the free flow of ideas and information necessary
for cooperative scientific efforts is reduced. Scientific materials required for
research will become more expensive and difficult to purchase if one corporation
owns the rights to the material.
Patents exploit taxpayer-funded research. The development of biotechnology rests
on 50 years of federally funded biomedical research. Corporations can make
profits on their patented products by charging high prices to the citizens whose
tax dollars supported the research and development of the products. Citizens are
unfairly being asked to pay twice for medicines and other products. Patents
promote unsustainable and inequitable agricultural policies. [23]
A disastrous decline in genetic diversity could be the result of patenting of
crop species. Patenting life forms bring with them overbearing issues of
religious and ethical values. In today's competitive and globalized world,
biotechnology revolution is affecting industry and growth in a big way.[24]
It would, thus, be in our national interest to document, protect and modify new
microorganisms isolated from various parts of our country and find their new and
improved industrial uses. However, in the clash between socialist and capitalist
centric ideologies, the betterment of the society as the prime objective should
be borne in mind before our regulatory bodies arrive at a conclusion.[25]
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(last visited December 1,, 2022).
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End-Notes:
- Sayed Qudrat Hashimy & Jackson Simango Magoge, Role of WTO in the
Promotion of Trade and IPR in Afghanistan, (2021), https://papers.ssrn.com/abstract=4043959
(last visited Feb 9, 2023
- Sayed Qudrat Hashimy, Impact of WTO Agreement Accession on Trade and a
Few Intellectual Property Rights in Afghanistan, (2021), https://papers.ssrn.com/abstract=4291992
(last visited Feb 9, 2023).
- Sayed Qudrat Hashimy, Impact of COVID-19 on the Trade in Afghanistan,
(2021), https://papers.ssrn.com/abstract=4169486 (last visited Feb 9, 2023).
- Sayed Qudrat Hashimy & Jackson Simango Magoge, Role of WTO in the
Promotion of Trade and IPR in Afghanistan, 7 Journal of Economics and
Finance (DRJ-JEF) 1 (2022).
- María Corral, Can living beings be patented?, ABG IP (2021), https://abg-ip.com/living-beings-patented/
(last visited Feb 9, 2023).
- Hashimy, supra note 2 at 45.
- Amit Singh, Critical Issues Relating to Intellectual Property Rights (IPR)
in Biotechnology: Developing Countriess Perspective and India, SSRN
Electronic Journal (2009), https://www.academia.edu/8162973/Critical_Issues_Relating_to_Intellectual_Property_Rights_IPR_in_Biotechnology_Developing_Countries_Perspective_and_India
(last visited Feb 9, 2023).
- 2103: Why life forms should not be patented, https://www.twn.my/title/2103.htm
(last visited Feb 9, 2023).
- Intellectual Property and Its Management for Animal Resources in India –
Pashudhan praharee, https://www.pashudhanpraharee.com/intellectual-property-and-its-management-for-animal-resources-in-india/
(last visited Feb 9, 2023).
- A. Parashar, Patenting of life forms: Indian scenario189 (2010).
- Virus Patents in India: A Techno-Legal Analysis, https://articles.manupatra.com/article-details/Virus-Patents-in-India-A-Techno-Legal-Analysis
(last visited Feb 9, 2023).
- The TRIPS Agreement and the patent protection of genetic resources, , in
The Protection of Biodiversity and Traditional Knowledge in International
Law of Intellectual Property 29 (Jonathan Curci ed., 2009), https://www.cambridge.org/core/books/protection-of-biodiversity-and-traditional-knowledge-in-international-law-of-intellectual-property/trips-agreement-and-the-patent-protection-of-genetic-resources/2A73E67E889B7F462412E89816532844
(last visited Feb 9, 2023).
- The Future of Patents on Genetically Modified Organisms in India,
IPWatchdog.com | Patents & Intellectual Property Law (2019), https://ipwatchdog.com/2019/04/27/future-patents-genetically-modified-organisms-india/id=108582/
(last visited Feb 9, 2023).
- Virus Patents in India: A Techno-Legal Analysis, supra note 11.
- 2103: Why life forms should not be patented, supra note 8.
- Sruthi Darbhamulla, Explained | The Indian patent regime and its clash
with the U.S. norms, The Hindu, Jun. 9, 2022, https://www.thehindu.com/news/national/explained-the-indian-patent-regime-and-its-clash-with-the-us-norms/article65464988.ece
(last visited Feb 9, 2023).
- The Future of Patents on Genetically Modified Organisms in India, supra
note 13.
- Darbhamulla, supra note 16.
- The TRIPS Agreement and the patent protection of genetic resources,
supra note 12.
- Corral, supra note 5.
- Hashimy and Magoge, supra note 4.
- Sayed Qudrat Hashimy, Protecting Geographical Indications in
Afghanistan, (2022), https://papers.ssrn.com/abstract=4324242 (last visited
Feb 9, 2023).
- Corral, supra note 5.
- The Future of Patents on Genetically Modified Organisms in India, supra
note 13.
- Singh, supra note 7.
Written By:
- Mohammad Rasikh Wasiq
- Sayed Ershad Sadat Akhlaqi
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