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 articles, 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
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 for 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
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. Under WTO, no country has the option to
choose what part it likes and forgo from others. The Trade-Related Aspects of
Intellectual Property Rights (TRIPS) Agreement of WTO puts several rules on
The TRIPS agreement ensures that patent protection is available for all the
fields of technology which includes agriculture, energy and healthcare. Also,
members can eliminate certain inventions from patentability if the exploitation
of the invention would be affecting the morality of the general public. TRIPS
further focussed on patentable subject matter about biological material.
- Plants, animals, essential biological processes of production of plants
and animals may be eliminated from patenting.
- Microorganisms per se and non-biological and microbiological processes
Patenting of life forms
To begin with the most obviously contentious subject, should life forms be
patentable? Logically, the answer is straightforward if the criteria as they now
stand are followed accurately. A life form as it occurs in nature is not
patentable because there is no inventive step. A captured life form is also not
patentable, because the concept of caging is not novel (though a new and
ingenious design of cage might be). A modified life form is patentable, but only
as far as the actual modification is concerned.
This view is intermediate between current patent practice, which has allowed
excessively broad claims on the strength of a limited modification (cotton, for
example), and the vitalist position that nothing to do with life should be
patentable. Neither of these extremes makes sense. To think about this wide gap
of opinion, helps to project forward to the time (probably sometime during this
century) when new life forms will be synthesised from scratch.
Such life forms will surely be inventions, and therefore patentable. We shall
understand them fully, so the mystical element will be gone (incidentally,
that's not to say there should be no sense of wonder at such an accomplishment).
Before that point, it will be commonplace to modify life forms so extensively
that their origins are unclear. These projections warn us that appeals to
morality to prohibit the patenting of life forms will not in the end be
sustainable. But that is not to say that the issue is trivial, just that it
cannot be dealt with at the level of patent claims.
Conflicts arise because under the current exclusive-rights system, possession of
a patent confers too much power. We therefore need to institute stricter
controls on use. Until that has been done, it is better to retain an illogical
but precautionary position on claims.
Patents on life forms and living processes
In India before the 2002, amendment the understanding was that there was no
patent protection for inventions 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 the preparation of a vaccine containing live virus is patentable since the
term manufacture covers even living organism. Even if the end product contains a
live virus the process involved in bringing out the end product becomes an
invention according to the court It may be noted that there is no decision
reported to date directly on the application of the inventive step standards to
inventions relating to biotech patents in India.
In the light of Article 27 of TRIPS Section 3 of the Patent Act, 1970 has been
amended. The definition of the invention, new invention, and inventive step
reflects a restrictive approach to the legal protection of living materials. In
the absence of a definition for plant, animal, microorganism essentially
biological processes, non-biological process and plant variety its
interpretation by the patent office becomes crucial. Since the term
micro-organism can have a variety of definitions which may not be exhaustive to
include genetic material, it is argued that it is safer to place reliance upon
the guiding provision in the TRIPS agreement.
Another concern is that if the inventive step is going to be interpreted by
considering only technical advance or economic significance, then the standard
of patentability gets lowered and the same should not be allowed. Because these
factors have been used as secondary considerations and never served as a basis
for establishing inventive step.
The 2008, patent manual incorporates provisions which is used as a direction by
the patent office to interpret various provisions in the Act. Standing Problems,
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 indicators of inventive steps
in 2008 draft Manual of Patent Practice and Procedure.
Patents in micro-organisms and their conceptual issues
Can microorganisms, for instance, be patented? Before 1980 the answer to
this question was: NO. Microorganisms were products of nature and as such were
not considered patentable. However, the era of manoeuvring DNA between organisms
The Mashelkar committee report has clearly stated that microorganisms are
patentable subject matter in India. Inventions about Microorganisms and other
Biological material were subjected to product patents in India, unlike many
developed countries. But with effect from 20.05.2003 India has started granting
patents in respect of inventions related to microorganisms, though India was not
obliged to introduce laws for patenting microorganisms per se before 31.12.2004.
Microorganism patenting per se is 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 an patent application. Now grant of patents for microbiological
inventions is for 20 years from the date of filing.
The most vital distinction between the legal practices of India and developed
countries is that India (developing countries) does not allow the patenting of
microorganisms that already exist in nature as the same is considered to be a
discovery as per the provisions of 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.
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 the accessibility of
that microorganism from the depositories. As per proviso (ii) to section 10(d)
the Microorganism is not being described fully and particularly and is not
available to the public, the said Microorganism is to be deposited before the
International Depositary Authority under the Budapest Treaty.
Negative impacts of patenting of transgenic animals
The major concern that arises out of patenting of transgenic animals is 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.
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. A disastrous
decline in genetic diversity could be the result of patenting of crop species.
The genetic diversity inherent in living systems makes patent claims difficult
to defend. The development of genetically uniform organisms would make it easier
for corporations to maintain their patent claims. Biotech companies holding
broad-spectrum patents on food crops will lure farmers to grow modified
varieties with promises of greater yields and disease resistance. However,
numerous examples worldwide show that improved crops have failed to hold up to
corporate promises, and led to the loss of the rich diversity of traditional
The First World patenting of Third World genetic resources represents a theft of
community resources. Patents held by the industrialized world on resources from
the developing world will serve as a tool for the North to accumulate more
wealth from the already economically 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 wealthy industrial nations for products derived from their
own natural resources and innovation is robbery.
Patenting life forms bring with them overbearing issues of religious and ethical
values. In today's competitive and globalized world, the biotechnology
revolution is affecting industry and growth significantly. 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 society as the prime objective should be borne in
mind before our regulatory bodies conclude.