Concept of Biotechnology
For human development, it is important to invent products in the field of
biotechnology. The biotechnological field has resolved several problems. The
inventions of biotechnology have branched out of several fields. Geoffrey Carr
said, "biotechnology can transform humanity provided humanity wishes to be
transformed.
"Biotechnology is an area that involves living organisms in order to develop or
make products. It also includes any technological application that uses
biologica'systems or living organisms to modify a product or process for a
specific purpose. Biotechnology includes DNA techniques and analysis of genetic
information.
In India, the patent office has issued guidelines related to biotechnology and
the intention behind this is to establish uniform practices for the examination
of the application of biotechnology patents. The guidelines can be revised by
the office of patents. The revision can be based on interpretations by the court
of law, legal amendments, and valuable ideas from the inventor.
Biotechnology Patent in India
In India, the patent act was enacted in 1856. The act has been modified and
amended several times. One of the major amendments came into being in 1970 which
has satisfied the international norms of the patentability of an invention and
covers novelty, inventive steps, and industrial application. Patent act 1970,
has not covered inventions related to biotechnology and the protection of such
inventions.
The high court demanded to amend the patent act 1970, in order to include
biotechnology inventions in India because, at the same time, the US patent
office and European patent office have been observing an increase in the number
of biotechnology inventions. In 2002, an amendment related to biotechnology
patents came into being, which explicitly included biochemical, biotechnological
processes, and microbiology.
In
Diamond v. Anand Chakrabarty[1], A genetically modified organism was
developed by a biochemist and that organism has the capability to decompose
crude oil. His application was rejected initially but after the appeal, the
patent was granted by the court to the inventor. The order states that the claim
of the inventor is for a non-naturally occurring composition of a matter a
product of human inventiveness. This was a well-known case in the field of
biotechnology.
In
Dimminaco A.G. v. Controller of Patents and Designs[2], Dimminaco
applied for a patent as he has invented a process of preparing a live vaccine to
combat Bursitis which is an infectious poultry disease. The patent office
refuses to grant a patent. He filed an appeal in the High Court of Calcutta, the
court held that there is no statutory bar in accepting a manner of manufacturing
a product that contains a living organism. It can be patented.
Basic requisites for obtaining a Patent in biotechnology in India
In order to get a patent in India, an invention must be novel. There must be an
inventive step and there must be an industrial application of the invention.
There are some inventions that are excluded from patentability under section 3
of the patent act.
Section 2(1) (j), this section talks about novelty, inventive steps, and
industrial applicability of products or processes.
Section 10(4) and rule 13 (8) of the Patent act talk about the deposition of
biological material if that material is not available to the public or it cannot
be described adequately. The material must be deposited according to the
Budapest treaty. It must be deposited with an international depository
authority. Microbial culture collection Pune, Microbial type culture collection,
and Gene bank Chandigarh are the international depository authorities located in
India.
Inventions that are non-patentable in IndiaSection 3 and 4 of the Patent Act 1970, explains inventions that are
non-patentable in India. These are the inventions that are non-patentable under
biotechnology Patents in India.
- Section 3 (b) focuses on Inventions contrary to morality or which can cause serious prejudice to human, animal, or plant life.
- Section 3(c) talks about the inventions related to the discovery of any living thing or non-living substance offered in nature.
- Section 3(d) talks about the invention which is related to the mere discovery of a new form of a known substance and it does not result in any kind of enhancement of known efficacy or which is a mere discovery of a new property or new use for a known substance.
- Section 3(e) focuses on the invention which is related to mere admixture.
- Section 3(h) is related to the methods of agriculture.
- Section 3(i) talks about the method of treatment and diagnosis.
- As per section 3(p), invention which includes traditional knowledge is non-patentable.
TRIPS Agreement on Patentability of inventions related to biotechnology
Article 27 of the TRIPS Agreement prevails in every member country. This article
explains that an invention must have novelty, inventive steps, and industrial
application. Article 27(2) of the TRIPS Agreement states that the country may
not grant a patent to any invention which are against public order or may
prejudice plant animal, and human life. According to Article 27(3), countries
may exclude from patentability those inventions which involve diagnostic,
therapeutic, and surgical methods along with animals and plants except
microorganisms.
There is a lack of clarity in the TRIPS agreement in relation to microorganisms
and microbiological processes. TRIPS Agreement fails to explain whether a
product that is produced by a known microorganism is entitled to be patented or
not. Countries have to create a distinction between the product of human
intervention and products that are freely occurring in nature.
Issues related to the patentability of biotechnology inventions
An Invention must be no one and non-obvious in nature in order to get a patent
but in the case of biotechnology inventions, the product already exists in
nature. It is also considered unethical to convert this naturally occurring
subject matter into private property.
In biotechnology, it is very difficult to fulfill the criteria of patentability.
Identifying Novelty in living beings is a tough task. As scientists apply
similar techniques in order to isolate individual gene sequences, it becomes
tricky to identify non-obviousness in the field of biotechnology.
In the case of biological materials, there is controversy. Some people state
that biological materials are mere discoveries, so therefore they are not
patentable, others argue that certain biological materials are man-made
inventions, so patents should be granted.
If there is a lack of utility the patent application has been refused. For
biotechnology innovations, utility standards have been raised. It is very
difficult to get patents for human genomes since human genes occur naturally so
they are not invented but discovered.
Another issue with biotechnological inventions is that biological materials are
capable of reproducing. It means that it is capable of changing forms. This lead
to the question of whether the patent includes the shift or stops at the
original state.
Currently, patent law has failed in providing sufficient protection for
biotechnology inventions. It is very difficult to accurately describe,
genetically engineered inventions. It is possible that a patent can be granted
to a patentee who does not deserve it in the case of biotechnology innovations.
Conclusion
It is evident that the field of biotechnology needs to be explored in India. It
is needed that the interest of inventors must be protected. The inventions of
the people who are working in the field of biotechnology and inventing products
must get protection under patent law. There is a need to enable inventors and
inventions to compete globally. There is a lack of guidelines for patents in
biotechnology.
In recent cases, it has been clarified that biological materials which are
prepared in labs and not present in the natural environment have earned some
rights of patentability. Biotechnology patterns were introduced in India in
order to protect the rights and interests of inventors.
End-Notes:
- 447 U.S. 303, 100 S. Ct. 2204 (1980)
- (2002) I.P.L.R. 255 (Cal)
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