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Protection of Intellectual Property (IP) in the field of microbiology is about
striking the right balance between inventors ’ interest and welfare of society
at large. The interaction between Intellectual Property Rights (IPRs) and
microbiology has a long history and patenting concomitant inventions becomes
front-page news with each breakthrough.
Patents are believed to be an award for the inventors and reward for the
investors. Without the protection afforded by patents, industrial microbiology,
as we know it, would not exist. Given the element of risk and uncertainty
involved in life sciences, adequate patent protection is even more essential to
encourage research and innovation and for the creation of a dynamic knowledge
based economy.
IP
protection in the area of biology, particularly patent protection for higher
forms of life (e.g.plants and animals),continues to be a controversial and grey
area. However, patent laws in various countries of world treat microbiology
different from biology. As scientific progress in the microbiology arena races
for- ward, crossing species barriers, posing unique challenges to the patent
system, etc., the patent system struggles to keep pace with it.
Microbiology is the study of microorganisms, which are unicellular or
cell-cluster microscopic organisms. Despite the advances in the field of
microbiology, we have probably only studied about 1 per cent of all of the
microbes on Earth.
Until 1980,patents over microorganisms were confined to processes relating to
microorganisms rather than microorganisms per se. The era of patent protection
in microbiology really dawned on June 17,1980,when the US Supreme Court in the
well-known and widely cited case Diamond v. Chakrabarty, ruled that live
organisms could be patented. Subsequently, DNA techniques by Dr.S tanley Cohen
and Dr. Herbert Boyer received a US patent in the same year claiming protection
for the method and composition for exogenous genes in microorganisms. The
floodgates for patenting of life forms opened with these two historic decisions
of the US Supreme Court. Patents on microorganisms were followed by patents on
plants in 1985 and on animals in 1988.
Prerequisites for grant of a biotechnological patent are in harmony with in
other areas of technology, i.e. novelty, non-obviousness and industrial utility.
Among these the element of “non-obviousness ” plays most crucial role for
microbiological inventions to qualify as patentable.
In
case, use of biological material is disclosed in the patent application the
source or geographical origin of such material is required to be mentioned in
the specification.
Apart from these three criteria the enablement and sufficiency of disclosure in
the written description is one of the basic concept underlying the patent
system. This requirement seeks to maintain an optimal equilibrium between
granting inventors the benefits of a patent without removing from the public
domain that which falls beyond such invention.
In
case the invention discloses use of new biological materials in the patent
application, such materials are required to be deposited in the International
Depository Authorities (IDA)
recognised under the Budapest Treaty on or before the filing of the application.
Reference to such deposit must be made in the patent specification.
Article 27 paragraph 3(b)of the TRIPS Agreement, stipulates that IP protection
be extended to microorganisms, non-biological and micro-biological processes and
plant varieties.
The
European Patent Office holds a restrictive approach and has a centrist attitude
towards biotech inventions.
EPC,
Article 52(1) defines “patentable inventions ” which do not include discoveries.
EPC, Article 53(b)excludes new plant and animal varieties from being patentable
inventions. Plants are covered by a different statute. Biotech patenting in
Europe revolves around morality issues or “ordre public ”. Legal protection for
biotech inventions is governed by EU Directive (98/44).Stem cells and stem-cell
lines that have been modified through a technical process and that are inventive
can be patented through the EPO.
The
US
is the most important and accommodating jurisdiction for biotechnology
inventions holding few, if any, restrictions on inventions in biology. In US
terms, “invention ” includes discovery and is, therefore, patentable. Plant
patents are also obtainable in the
US.
The USPTO allows utility (use)patents for human and animal therapeutics and
diagnostics. Utility is an important criteria for grant of a biotech invention
which is novel and inventive. The USPTO has time and again rejected applications
on the ground of lack of utility.
The
Indian Patent Office is reticent in issuing patent for life forms, e.g.a patent
granted to Agracetus Corp.for a method of producing transgenic cotton plants,
was subsequently revoked by the central government. But as far as microbiology
is concerned, it holds the view that microbiological inventions include
microbiological processes, novel micro-organisms per se,processes for producing
new micro-organisms through genetic engineering and the products that result out
of such processes.The term micro-organism by definition includes bacteria,
fungi, virus, plant and animal cells.
Concerns in connection with the rise of intellectual property protection over
micro-organisms can be briefly summarised as the ethics of patenting life forms,
the eligibility/ patentability of such organisms for patent protection, the
terms and conditions for access and benefit-sharing arrangements between
companies/ developing countries and indigenous peoples and local communities,
and the long term impact of these. |
