Dr. Itishree
Mishra
Asst.Professor ,SNIL
SOA
University,Siksha’O’ Anusandhan National Institute of legal studies.
Abstract:
In this paper an attempt is made to reflect the
emerging social and scientific paradigm of biotechnological research and the
need for effective legal protection for such technological advancements. The
imperative study of IPR protection has been considered.
Keywords:
Biotechnology, Biochemistry,
microbiology, Bioprocessing technology, Hybridoma and monoclonal
antibody technology, Cell culture, Recombinant DNA technology, Cloning, Genomic
and proteomics, Microarray technology, DNAfingerprinting,patent,,bioproduction,Trademark,servicemark,Geographical
indication,Copyright,Patent design, sui- generics,TRIPS,biopiracy,RNA,DNA,cDNA
1.
Introduction:
Biotechnology is
as old as human civilization and has been an integral part of human life. In
traditional parlance biotechnology has been the natural process since many
centuries to produce beer, wine, curd, cheese and many other food products. The
modern biotechnology extends to all the genetic manipulation, cell fusion
techniques and the improvements made in the old biotechnological processes.
The word biotechnology describes
the convergence of two fields i.e.:-biology and technology. The creative ability
of man is fast advancing in such a direction that it has tried its best in
producing many human life and products. Biotechnology has been defined as the
integrated use of biochemistry, microbiology and engineering sciences in order
to achieve technological (industrial) application of the capabilities of
microorganisms, cultured tissue cells and part thereof.[1].It has been also defined [2]as the controlled use of
biological agent such as organism or cellular components for beneficial use.
This sphere is not only concerned with life forms such as plants, animals and
microorganism but also concerned with nonliving or dormant materials such as
seeds, cells, enzymes plasmids etc. It assumed popularity in 21st
century in technological innovation .Following is some of the vistas of modern
application in biotechnology.
1. Bioprocessing
technology:[3]
2. Hybridoma and
monoclonal antibody technology[4]:
3. Cell culture.[5]
4. Recombinant
DNA technology[6]
5. Cloning[7]
6. Genomic and
proteomics[8]
7. Microarray
technology[9]
8. DNA
fingerprinting[10]
Visualizing the above dimension
of biotechnological developments, the WEO released a list of 10 ways by which
the life can be improved through biotechnology. The list is filled with
developments related to industrial and environment biotechnology including
bio-production of sustainable chemical energy and other materials. Through
biotechnology process living organisms such as bacteria, fungus or plants can
be used to create fuels, chemicals and many other products. With the help of this
not only there was an improvements in providing security to nation’s energy as
well as it minimized the dependence on foreign sources.
In 10th annual world congress
bio-conference it has been found that industrial biotechnology has become the
core point of discussion and the issues included:-
-the sustainability of biotech sector and its
work towards R&D to commercial deployment as it requires heavy investment.
-the role of industries and that of the
govt. is in developing bio-refineries
and by product sector.
-the progress of
industries in making the cellulose fuels a commercial reality.
As it has been cited above the
faster growth of biotechnology in different area as especially in the area of
inventions is to be protected and to restrict the abuse of such inventions is a
must. To protect the human intelligence from being manipulated and to make a
global image a new law was implemented i.e. The Intellectual Property Right
.This law speak about how to protect the
intellectual property of the people, their rights through different brigades in
IPR:-
-Trademark and
service marks
-Copyright
-Patent
-Design
-Geographical
Indication
Protecting the Intellectual
property rights with regard to biotechnological innovations appears as special
and significant issues[11]
To protect the intellectual
property rights ,the TRIPS (trade related intellectual property) agreement
establishes specific standards on the availability, scope and the use of
intellectual property rights .Out of the number of articles specified ;article
27(1) and 27(2) is applicable to the area of biotechnology and plant varieties
protection. Article 27(1)[12] deal with patents
available for any inventions, whether product or process in all fields of
technology, provided that are new, involve an inventive step and are capable of
industrial application.”All fields of technology” is interpreted to include
biotechnology and is granted to all developing countries that are granted by
TRIPS to be developing countries and qualify Article 27(2) and (3) which may
allow concerned countries some control in areas where there is strong national
and public interest. Article 27(2) modifies Article27 (1) “members may exclude
from patentability inventions, the prevention within their territory of
commercial exploitation of which is necessary to protect public order, public
morality, including to protect human, animals or plant life or health or to
avoid serious prejudice to the environment provided that such exclusion is not
made merely, because of the exploitation prohibited by the law”[13].
Members
may also exclude from patentability diagnostic therapeutic and surgical methods
for treatment of humans or animals. Plants and animals other than the
microorganisms are essentially biological processes for the production of
plants and animals. It also cited out that members shall provide for the
protection of plant varieties either by patents or by effective sui- generics system or a combination
thereof. Time
and again it has been asserted that, the presence of large-scale generic drug
industry in the developing countries has adversely affected the interests of
drugs and pharmaceutical manufacturers investing huge amount money for research
and development. It is always easy to pirate a process unless the
product is protected it is not possible to protect the invented processes.[14] Further,
proponents of product patenting have always insisted that for the purpose of
economic development, to improve technology and to recoup the investment made
on R & D, so product patenting is as a must. However, those concerned with welfare of
the poor and the oppressed have vehemently argued against product patents
taking in to account and the possible impact of product patenting on health,
safety and welfare of the people.
Firstly,
for centuries, indigenous peoples in many countries have developed herbs, seeds
and plants for use as food and medicine. TRIPs gives foreign MNCs
the right to take traditional indigenous seed varieties developed by small
farmers, improve them with slight generic alterations, and patent them. In
order to use them, the people who originally developed them must buy them back
at exorbitant rates. It is sometimes described as bio piracy.[15] There has been
an epidemic of farmer suicides in some parts of India that used to be
prosperous agricultural regions before “the ecological and social disaster”
caused by bio-piracy. [16]
Secondly,
the product patenting, conferring property rights would allow a few MNCs of
technologically rich states to control access to food, medicine and
drugs.
Thirdly,
it has been claimed that intellectual property rights are well protected by WTO
at the expense of human beings is well seen by having an eye on their price
chart.
Fourthly,
product patenting through TRIPs necessarily commercialise certain aspects of
social life that should belong to non-commercial sectors. For the
purpose of preventing over commercialisation of food supply and health care
Indian law contain certain general principles of working of
patents. But there are doubts as to their efficacy to regulate
monopolistic behaviour of economically powerful patent holder. [17]
Fifthly,
some critics have asserted that product patenting would strengthen western
monopoly over technology and 20 years term would discourage research and
development in third world even though there is an assumption that the patent
system would assist technology transfer.[18]
Another
example of intellectual property protection regime is the development of crop
varieties which are protected through “plant breeder’s rights or PBRs[19]. The PBRs ensures that
the plant breeder who developed a particular variety gets the exclusive rights
for marketing the variety. Agriculture for the first time was included in the
trade related intellectual property rights (TRIPS) and TRIPS is a major concern
for developing countries. The following two major steps were taken in
consideration of PBRs:
(a) The Food and Agriculture Organization (FAO) have an
International treaty on plant genetic resources for food and agriculture. This
treaty consists of particular classes which refer to operation of farmer’s
rights.
(b) The ‘Plant Varieties
Protection and Farmer’s Rights Act 2001 agrees for the right of farmers,
breeders, and researchers. The protection is provided by making compulsory
licensing of rights, and inhibiting the import of plant varieties consisting of
‘genetic use of restriction technology’ (GURT) e.g. terminator technology of
Monsanto.
Following conditions should be fulfilled to grant protection to
the new varieties:
a) The new variety must
always be new i.e. it should not have ever been exploited commercially.
b) It should be
biologically distinct and possess different characters.
c) The new variety of
the plant must have uniform characters.
d) The distinguishing
character of new variety must be stable for generations.
e) The new variety
should have taxonomic validity i.e. systematic position, generic and species
names etc.
Recently
Utility patents for both plant and animal genetic materials, have been allowed
in some countries like USA and other member countries. This forbids the use of
patented material for further breeding. The farmers are allowed to use and save
the seeds for cultivation only after paying a fee to the patent holder.
Some concerns
have been voiced regarding the implications of IPR on the genetic diversity and
the conservation of genetic resources. IPRs will directly or indirectly affect
the food security and distribution around the globe, biological diversity and
ecological balance, employment avenues in the poor and developing countries,
and the use of new and effective agricultural practices.[20]
Looking at
the core point of discussion of TRIPS
agreement regarding the area to be patented ,yet it has to be discussed in more
details to give a legal protection from being
manipulated or pirated by any other person is as
follows:-
Patenting
Biotechnological Products:
A question, therefore, arises as
to whether patent protection can be obtained for inventions in the area of
biotechnology, which usually relates to and / or involves living things.
Furthermore, what is the position of substances like microorganisms or other
biological materials present in nature? Do they fall under the category of
discovery or invention? If they are considered inventions do these materials
fully satisfy the important patentability criteria of novelty, as they are
already available in nature? As in the case of other technological fields, the
requirement of satisfying the criterion of inventive step (non-obvious)
constitutes one of the most complex questions in the field of biotechnology.
The consideration of industrial application is yet another obstacle for
securing patents for inventions in biotechnology. [21]
Another problem in protection of
inventions in biotechnology is the difficulty of satisfying the mandatory
requirement of the condition of `sufficient disclosure'. This is due to the fact
that inventions in this field relate and / or involve, as explained above,
living entities (biological materials). Such materials are difficult to
describe in words. Therefore, it is important to know clearly how inventions in
biotechnology are accommodated within the general framework of the patent
system. [22]
Patents are
viewed as vital to protecting the commercial interests and intellectual
property rights in biotechnology. Patents are limited rights based on a claim
that a new technological invention has been created and fully communicated to
the public. Patents can cover new products, processes that creates these new
products, new processes for producing existing products and new processes
generally. While patenting of a biotechnological invention it is important that
it meets the 3 criteria’s laid down by the TRIPs to meet patentability, namely
-which are new or novel, involves an inventive step or not obvious and capable
of industrial application.[23]
-It has
been estimated that thousands of patent applications were made in respect of
micro organisms, plants and for human and animals DNA sequences.
In essence,
the India Patents Act gives only very limited protection to research-based
pharmaceutical companies. Patenting of human material in the form of gene
sequences is considered to be wrong as it amounts to commercialization of life.
Failure of the basic patent principles to cater to the needs of genetic
inventions has given rise to ambiguities for companies concerned with
bio-technology.
Gene Patenting
“Gene patenting” is a broad term referring to the
patenting of genetic sequence such as DNA and RNA and to alternate forms of DNA
such as cDNA (complementary DNA)[24].
Gene patents are a part of the broader category of biological
patents.
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. 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 up to 20 years from the date of
filing. However Human Beings are not patentable as human multi-cellular living
organisms are not a patentable subject matter under section 101[25].
The
courts have upheld claims on altered sequences, but courts and lawyers'
opinions have been mixed on upholding the use of natural sequences and
particularly the sequence itself. Patents on genes have only
been granted on isolated gene sequences with known functions, and these patents
cannot be applied to the naturally occurring genes in humans or any other
naturally occurring organism.[26]
Patenting of Micro-organisms and
Cells:
The insertion of recombinant DNA
into a host micro-organism that was held in 1973.During this period the
scientists realized the huge potential involved in directing cellular machinery
to develop new and improved products and processes. So with this technology the
process of patenting living organism came into existence[27]. The sciences dealing
with molecular biology, genetics, biophysics, cell biology and immunology have
for the last few years made startling advancement and opened up vast
possibility for the development of new and novel technologies. The grant of
patent for engineered micro-organism meant grant of product status to that
micro-organism, which revolutionised the field of biological research.[28] The member
countries have no options meaning that the protection should be by way of grant
of patents.
Patenting
Pharmaceuticals:
The
pharmaceutical industry is one of three technology-based industries in which
the patent virtually equals the product. While only a small - and
declining - number of new chemical entities are approved annually, thousands of
patents are applied for to protect variants of existing products, processes of
manufacture or, where admitted, second indications of known pharmaceutical
products[29].
Since patents confer exclusive rights regarding the production, sale and use of
the patented subject matter, they can be used to restrain competition and set
prices higher than those that would have existed if competitive products were
available. This is the very purpose of the patent system, which is generally
justified as necessary to encourage investments to develop new products and
processes. Concentration of manufacturing takes place in pharmaceuticals
industry as well as in the other branches of industry and it is characterized
by the joining of firms. However, there are several specific features in
patenting pharmaceutical products. Enforcement of the Agreement on Trade
Related Aspects of Intellectual Property Rights (TRIPS Agreement) made it
compulsory to establish in all World Trade Organization (WTO) Members patent
protection on pharmaceutical products and their manufacturing methods as well
as patent protection of drugs. WTO Doha Declaration is an essential stage in
patent protection of pharmaceutical products establishing the legal basis and
compulsory licensing system. In 2005, the European Commission completed the
Regulation of the European Parliament and the Council on compulsory licensing
of patents relating to the manufacture of pharmaceutical products for export to
countries with public health problems[30].
Patenting Biological
Materials:
A biological
patent is a patent relating to an invention or
discovery in biology. It can be a composition of matter, a method for
obtaining or using one or more thereof, or a product combining such things.
Even when a natural biological substance itself is patented (apart from any
associated process or usage), this has been permitted in the United States as
long as they are sufficiently "isolated" from their naturally
occurring states. Prominent historical examples of such patents on isolated
products of nature include adrenaline, insulin and vitamin B12. New
plants and seeds are also patentable. Isolated and manipulated cells -
even human cells - can also be patented. There has been much patenting
of genetically modified organisms. This includes bacteria, viruses, seeds,
plants, and even non-human animals. For example, a genetically modified mouse,
dubbed the Oncomouse (type of laboratory
mouse that has been genetically modified using modifications to
carry a specific gene called an activated oncogene), that is useful for studying cancer, was patented by
Harvard University[31].
Patenting of plants:
Plant patents encompass newly
found plant varieties as well as cultivated spores, mutants, hybrids and newly
found seedlings on the proviso that they reproduce asexually. It is the
propagation of a plant to multiply the plant without the use of genetic seeds.
Modes of asexual reproduction in plants include grafting, bulbs, apodictic
seeds, rhizomes and tissue culture. Specifically excluded from protection under
the Plant Patent Act are tuber-propagated plants and plants found in an
uncultivated state. In some countries
(including the United States, Australia and Europe) plants can be covered by
patent claims provided that the patent applications are able to meet all of the
necessary standards and requirements that exist in that country for
patentability. According
to the TRIPS provisions of the WTO Agreement, it is essential for member
countries to provide, in the area of biotechnology, at least protection for
microorganisms per se if they satisfy the novelty, inventive step and
utility requirements of the patent law and for the protection of plant
varieties. In the case of plant varieties, there are options, namely, either by
patents or by a sui generis system. India has opted for the latter.
Summing up, it may be said that
there are many gray areas in respect of securing protection for inventions in
biotechnology. In spite of this position, there is ample scope for the
protection of inventions falling within the area of biotechnology.
Patenting
of Animals:
Research in the field of
biotechnology has been taken a step towards patenting of animal’s .Through
various works it has been found that animals are being patented in some
countries. The first animal being, onco-mouse, for the treatment of cancer. But
in many countries like India animal patenting has been considered immoral and
unethical. It has been clearly opposed by American Anti -Vivi Section
(hereafter AAVS).In animal law section deals purely with animal’s utmost
security and protection measures. It has been cited out that wild animals can
never be utilized for any kind commercialization. Patenting of animals can be
done only on transgenic animals[32]. Recent survey states
that nearly 660 animals are already patented
such as chimpanzees, monkeys, mice, rabbits, dogs, cats, and pigs that have
been "altered" in some way, creating an incentive to profit from
hurting animals. AAVS is of the opinion that it is an unethical and
inappropriate use of the patent system to issue patents for sentient beings. A
patent was recently granted for rabbits whose eyes are intentionally damaged to
serve as a model for "dry eye" conditions in humans. AAVS has
submitted a challenged to the U.S. Patent and Trademark Office for issuing the
rabbit patent, requesting that the patent be repealed.
AAVS previously challenged
patent issued to Texas A&M University for beagles who were severely
sickened and whose lungs were then purposefully infected with a mold in order
to test new human drugs on them. That challenge resulted in a victory for the
beagles when the patent holders dropped all claims to the patent[33].Transgenic
animals are just one in a series of developments in the area of biotechnology.
Biotechnology has transformed the way in which we understand processes such as
engineering and manufacturing. Genetic manipulations at the level of DNA have
also changed long held views as to what is considered to be animal, plant and
human. In turn, these changes have made it more difficult to evaluate the ways
in which animals are used and have obscured distinctions between pure and
applied research.
A representative, but non-inclusive,
list of purposes for which transgenic animals have been used indicates the wide
ranging application of this biotechnology:
·
in medical research, transgenic
animals are used to identify the functions of specific factors in complex
homeostatic systems through over- or under-expression of a modified gene (the
inserted transgenic);
·
in toxicology: as responsive test
animals (detection of toxicants);
·
in mammalian developmental genetics;
·
in molecular biology, the analysis
of the regulation of gene expression makes use of the evaluation of a specific
genetic change at the level of the whole animal;
·
in the pharmaceutical industry,
targeted production of pharmaceutical proteins, drug production and product
efficacy testing;
·
in biotechnology: as producers of
specific proteins;
·
genetically engineered hormones to
increase milk yield, meat production; genetic engineering of livestock and in
aquaculture affecting modification of animal physiology and/or anatomy; cloning
procedures to reproduce specific blood lines; and
·
Developing animals specially created
for use in xenografting. [34]
The successful cloning of Dolly
underlines the fact that innovative developments in animal science are part of
the mainstream of biotechnology. In addition, the use of xenografts, at least
at the public health level makes animal and human welfare inseparable. The
evaluation of animal and human welfare as it may be affected by biotechnology
is a complex issue. One of the elements most notable in this process is the
absence of an informed sense of the processes involved. ACCs share the
responsibility for educating members on relevant aspects of animal care and
use. Education concerning transgenic animal care and use is of particular
importance, involving the careful consideration of the reasons for manipulating
the genome of any organism as genetic engineering is a sensitive social issue[35].
A thorough discussion of
biotechnology issues, including transgenic animals is needed, particularly to
develop some consensus as to the relative value of benefits to be obtained from
the use of transgenic animals. One of the more challenging questions is how to
account for the interests of the animals involved.
The field of transgenic animal
biotechnology is likely to become of increasing importance as the techniques
develop further and are applied to many more animal species. Welfare and
ethical concerns will also continue to evolve. Consequently, education together
with thoughtful ethical decision-making will remain the keystone of the review
of transgenic protocols.
Patenting of Cosmetic processes:
It
has been observed under Australian Law, that cosmetic processes and methods for
improving or changing the appearance of the human body or of parts of it are
not of a like kind with medical, prophylactic or therapeutic processes or
methods, and can therefore be the subject matter of a patentable invention.
Thus it was held that a process for improving the strength and elasticity of
keratinous material, especially human hair and fingernails, is a proper subject
matter of a patent[36].
Conclusion:-
The legal protection regime of
biotechnology invention contemplates that whoever
Involves
in the act of piracy i.e. illegal use of any others work and without permission
is to be
Punished.
There is a danger of bio piracy as well as threat to society of bio wars which
is more
Hazardous
than the nuclear wars and it has to be abated.
There is an immense need that every
individual or the inventor should be protected of trade secrets. But to enforce
trade secret is very difficult than to Patent. Based on US constitution, the
Patent Act, which is codified under Article title 35 of the United States
codes, regulates the requirement for obtaining a patent. Section 101 of the
Title requires that “whoever invents or discovers any new and useful process,
machine, manufactures of composition of matter may obtain a patent therefore
subject to the condition and requirements of this title. This section sets out
the three general requirements namely –novelty, usefulness and non-obviousness
for obtaining patent”. Apart from this general condition which we have studied
above there are no further statutory requirements for patentability.[37] The Patent
(amendment) Act, 2005 in India[38]also contains general
principles applicable to the working of all patented inventions. To secure the
inventions not only it included and
encouraged a patentee to merely import the patented article, but also to see
that patent rights contribute to technological innovation, and to transfer and
to disseminate technology for the mutual advantage of producers and users of
technological knowledge in a manner conducive to social and economic welfare.
The Act also ensured that the benefit of the patented invention is available at
a reasonably affordable prices to the public and for grant of compulsory
licenses in respect of patents for the reasonable requirements of the public.The ultimate goal of any intellectual property system
is the advancement of science and technology as a means of securing overall
social and economic development. By conferring exclusive rights on inventors,
the true goals of any intellectual property system are actually the advancement
of science and technology. It is expected that if additional rights are
conferred upon inventors, it would induce further inventions, enabling giant
strides in the development of technology, ultimately benefiting society.
It can be seen from the above that the intellectual property law by
protecting the rights of an inventor in his invention which actually ensures
the progress and growth of science and technology as a means of securing
economic and social development.
Even
though there is patentability there is an urgent need to make the patent system
efficacious on an equitable basis and to promote technology specific training
to patent officials, in order to inculcate the spirit of IPR.[39]
Referances:
1.
“Major
Biotechnology Issues for the U.S. Patent and Trademark Office,” Bruce Lehman, California Western Law Review,
1996;
2.
“Ownership of
the Human Genome,” S. M. Thomas,
et. al., Nature, Vol. 380, April 1996
3.
A Good Year Again, Biospectrum, June
14, 2006, at 23-30
4.
Aaron
S. K. & Jason K., “Biomarkers Unbound—The Supreme Court’s Ruling on
Diagnostic-Test Patents, New England Journal of Medicine (May 24, 2012).
5.
About the Personalized Medical Coalition, Personalized
Medical Coalition (June 19, 2012)
6.
Agreement on
Trade-Related Aspects of Intellectual Property Rights
7.
Anita V. and
David A., Harvard Journal of Law and Technology, Harvard
University, Winter 1996
8.
Annual Report
(1998) of the TRIPS Council
9.
Arriola S.R., “Biotechnology
Patents After Festo: Rethinking the Heightened Enablement and Written
Description Requirements”, 11 Fed. Circuit B.J. 919.
10.
Atkinson RC,
Beachy RN, Conway G, Cordova FA, Fox MA, Holbrook KA, Klessig DF, McCormick RL,
McPherson PM,Rawlings HRIII, Rapson R,Vanderhoef LN,Wiley JD, Young CE(2003).
Public sector collaboration for agricultural IP management. Science 11:
174–5.
11.
Bainbridge D.I.,
“Intellectual Property”, (2002), p. 373.
12.
Barton J (2003).
Non-obviousness. IDEA: J Law&Technol 43(3) in press.
13.
Behringer J. et
al, “Amgen v. Hoechst Marion Roussel: The Written Description Standard
in Biotechnology Patents”, 22 Biotechnology L. Rep. 476.
14.
Belvis,
G. (2003). Chapter 2 Overview of the Doctrine of Equivalents and § 112, 6
Equivalents, In: Intellectual Property Law Update, G. Belvis, pp. 35-66
15.
Bera,
R.K. (2009). Post-1980 World of Biotechnology Patents in the U.S. Current
Science, Vol. 96, No. 10, (25 May 2009), pp. 1343-1348.
16.
Bera,
R.K. (2009a). The Story of the Cohen-Boyer Patents. Current Science,
Vol. 96, No. 6, (25March 2009), pp. 760-763.
17.
Bera,
R.K. (2009b). The Changing role of Universities and Research Institutions in
a Global Economy: Lessons Drawn from the U.S. Biotechnology Sector. Current
Science, Vol. 96, No. 6, (25 March 2009), pp. 774-778;
18.
Bera,
R.K. (2009c). Intellectual Property Fuels a Global Sense of Competitiveness.
Current Science, Vol. 96, No. 7, (10 April 2009), pp. 898-903.
19.
Bera,
R.K. (2009d). Post-1980 World of Biotechnology Patents in the U.S. Current
Science, Vol. 96, No. 10, (25 May 2009), pp. 1343-1348.
20.
Berns,
K.I., Bond, E.C., & Manning, F.J. (Eds.). (1996). Resource Sharing in
Biomedical Research, National Academy Press, Washington.
21.
Benjamin B. D.,
Ph.D., IDEA— The Journal of Law and Technology, Vol. 35, No. 4,
1995;
22.
Binenbaum
E, Nottenburg C, Pardey PG, Wright BD, Zambrano P (2003).
South-North trade, intellectual property jurisdictions, and freedom to operate
in agricultural research on staple crops. Econ Dev Cult Change 51(2):
309–36.
23.
Bio
Patent-Japan Patent Office, Asia-Pacific Industrial Property
Centre, JIII, 1999
24.
Bio piracy: The
Plunder of Nature and Knowledge, Vandana
Shiva, South End Press, Boston, 1997.
25.
Biotechnology
Directive 98/44/EC
26.
Oliver
Mills, Biotechnological Inventions: Moral Restraints And Patent Law
(2004).
27.
Pardey PG,
Beintema NM (2001). Slow magic: Agricultural R&D a century after Mendel.
IFPRI Food Policy Report. Washington, DC: International Food Policy
Research Institute.;
28.
Pardey PG,
Wright BD, Nottenburg C, Binenbaum E, Zambrano P (2003). Intellectual property
and developing countries: Freedom to operate in agricultural biotechnology
(Brief no. 3). In Pardey PG, Koo B (eds), Biotechnology and Genetic
Resources Policies, Briefs 1–6. International Food Policy Research
Institute: Washington, DC.
29.
Parthasarathy, Community
Genet, 2005, 235
30.
Patents (Amendment) Act, 1999, No.
17, Acts of Parliament, 1999
31.
Patents
(Amendment) Act, 2002, No. 38.
32.
Patents
Act 1970, No. 39;
33.
Plant genetic
systems (1993) 24 IIC 618
34.
Poynder,
R. (2000). Internet sparks patenting controversy, IP Matters, (30 April
2001),
http://www.richardpoynder.co.uk/internet_sparks.htm
35.
Prime T., “European
Intellectual Property Law”, (2000), p. 174.
36.
PTO Comr,
11-02-1985, 226 USPTQ
37.
Pushpa M. Bhargava, The Social,
Moral, Ethical, Legal and Political Implications of Today’s
Biological Technologies: An Indian Point of View, 1 Biotechnology J. 34, 37
(2006)
38.
Qaim M, de
Janvry A (2002). Bt cotton in Argentina: analyzing adoption and farmers’
willingness to pay. Paper Presented at the American Agricultural Economics
Association in Long Beach, July 28–31.
39.
Quillen CD
(2002). Continuing patent applications and performance of theUSpatent
office-extended. Federal CircuitBar J 12(1): 35–55.
40.
R.A. Mashelkar
et al., Report of the Technical Expert Group on Patent Law Issues, Dec. 2006
41.
Rajendra K. Bera (2012). Biotechnology
Patents: Safeguarding Human Health, Innovations in Biotechnology, Dr. Eddy
C. Agbo (Ed.), ISBN: 978-953-51-0096-6,
42.
Reichman,
J.H. & Dreyfuss, R.C. (2007). Harmonization without Consensus: Critical
Reflections on Drafting a Substantive Patent Law Treaty, Duke Law
Journal, Vol. 57, No. 1, pp. 85-130.
43.
Rose AK (2002b).
Do WTO members have a more liberal trade policy? National Bureau of Economic
Research. Working Paper 9347.
44.
Ryan MP (1998). Knowledge
Diplomacy: Global Competition and the Politics of Intellectual Property.
Brookings Institution: Washington, DC.
45.
Samantha
A. Jameson, A Comparison of the Patentability and Patent Scope of
Biotechnological Inventions in the United States and the European Union, 35
AIPLA Q.J. 193, 215 (2007).
46.
Science Magazine
Symposium of Patenting DNA, Vol. 280, No.
5364, May 1998:
47.
Sean D. Murphy, Biotechnology
and International Law, and 42 Harv. Int'l L.J.
48.
Sen A., Clear and Complete
Disclosure in Biotechnology Patent Applications – A Comparison of the Laws in
the USA, Europe and India, HANSE LAW REVIEW (HanseLR) [Vol. 2 No. 1 [2006]
International Law, 91
49.
Serum
Institute of India Ltd. Homepage, http://www.seruminstitute.com/ (last visited
Jan. 24, 2008).
50.
Shardul
Shroff & Dev Robinson, India’s Biotech and Software Renaissance,
Managing Intell. PROP., July/Aug. 2005, at 76-77.
51.
Shim Y.G., “Intellectual
Property Protection of Biotechnology and Sustainable Development in
International Law”, 29 N.C. J. Int'l L. & Com. Reg. 157.
52.
Siede R.K. &
Smith F.A., “Intellectual Property Protection and Biotechnology”, 67 – Jun, N.Y. St. B. J. 52.
53.
SIPO
Guidelines for Patent Examination (2010).
54.
Smith P (2002). Patent
rights and trade: Analysis of biological products, medicinal and botanicals,
and pharmaceuticals. Am J Agric Econ 84(2): 495–512.
55.
Smith,
J.E. (2009). Biotechnology, (5th edition), Cambridge University Press,
Cambridge.
56.
Spence M., “Patents
and Biotechnology”, 113 LQR 368 at 373.
57.
Stephen
H. Schilling, DNA as Patentable Subject Matter and a Narrow Framework for
Addressing the Perceived Problems Caused by Gene Patents, 61 DUKE L.J. 731,
741 (2011).
58.
Streltzer A., “U.S.
Biotechnology Intellectual Property Rights as an Obstacle to UNCED Convention
on Biological Diversity: It Just Doesn’t Matter”, 6 Transnat'l Law. 271.
59.
Tansey G.
(1999), Trade, Intellectual Property, Food and Biodiversity: Key issues and
options for the 1999 review of Article 27.3(b) of the TRIPS Agreement,Quaker
Peace and Service.
60.
The
Fate of Gene Patents under the New Utility Guidelines, DUKE L. & TECH. REV.
8 (2001).
61.
The Patent
Rules, 2003
62.
The Patents Act
1970, 1999 & 2002
63.
The Patents Act,
1977
64.
The
quote is from John Sulston, How science is shackled by intellectual property,
The Guardian, 26 November 2009.
Web Sites:
65.
http://content.nejm.org/cgi/reprint/356/6/541.pdf.
66.
http://dbtindia.nic.in/aboutdbt/about.html
68.
http://dbtindia.nic.in/programmes/patent/
patent.html
69.
http://dipp.nic.in/acts/Joint_Statement_of_Intenton_bilateral_cooperation_between_India_and_the_UK_on_IPRs_witUK.pdf.
70.
http://dipp.nic.in/acts/MOU_of_bilateral_cooperation_with_epo.pdf.
71.
http://dipp.nic.in/acts/MOU_with_ministry_of_economy_France.pdf.
72.
http://docsonline.wto.org/DDFDocuments/t/WT/Min01/DEC2.doc.
73.
http://economictimes.indiatimes.com/articleshow/576519.cms.
[2]
Dr.Sanju Thanvi,”Intellectual property and biotechnology”Nov2012, vol 3, LP,
65.
[3]
It is
process that uses complete living cells or their components (bacteria, enzymes,
chloroplasts) to obtain the desired products. www.wikipedia/bioprocess,April
2013.
[4]
It is used
in production of Hybrid cells. These cells are produced by fusing B lymphocytes
with tumor cells and they are called myeloma cells. Thus these cells have the
capability to produce antibodies due to B-lymphocytes cells and has the
capability to divide indefinitely in the culture due to presence of tumor cells
.these are cultured in the laboratory using mouse peritoneal cavity and these cells
produce monoclonal antibodies and overall it is said to be hybridoma technology.
www.biotecharticles.com/others-articles/Hybridoma-technology,April
2013.
[5]
This branch
has developed from called toxicology and this branch deal with poison .When
poison is administered into the living organism. With help of this technique
many anti cancer, clinical drugs and pesticides are prepared. By applying the
toxicology cell culture is needed in which the cells are grown and maintained
at an appropriate temperature and gas mixture (typically 37 degree centigrade,
51%Co2 for mammalian cells) in a cell incubator. www.toxicologyguide.com/943-cell-culture-technique/April
2013.
[6]
This technology
helps in isolate and clone single copy of a gene or a DNA segment into an
indefinite number of copies, all identical. This new combination of genetic
material or rDNA molecules are introduced into host cells where they propagate
and multiply and this is termed to “Genetics engineering”. www.biotechnology4u.com/basic-concepts/recombinant_dna,April
2013.
[7]
All the individuals derived by asexual
reproduction from a single original individual. In molecular biology, a strain
of organisms that carries a particular DNA sequence. A plasmid or a phage that
carries an inserted foreign DNA to be introduced into a host cells. www.biotech-now.org/enviromental.ind,April2013.
[8] The study of the structure and function of
genomes. Large scale characterization of the entire protein, complement of
cells, tissues, and organisms is called proteomicswww.forumblog.org/feb,2013 .
[9]
Large number of DNA spots present on a glass
slide representative of the total mRNA of a cell, used for detecting expression
patterns.
[10]
A technique for the identification of
individuals based on the small differences in DNA sequences.
[11] Biotechnology
is the injection of scientific knowledge into the manufacturing processes by
which marketable goods are made out of biological phenomena. It involves the
study of method by which living resources (plant, animal, microbial), can be
tailored to generate industrial processes and move specimens for use in
agriculture, forestry, horticulture, medicine, health and environment.
Biotechnology has been defined as, “The application of scientific and
engineering principles to the processing of materials by biological agents to
produce goods and services”. Biotechnology is the ‘engineering’ of
genetic materials towards practical ends, such as medical and veterinary
advances, modified crops and improved animal breeds. Applications for patenting
were filed for human and animal DNA sequences, or for new gene therapies and
medicines or for both.
[12]TRIPS
Agreement, N.K Acharya “Text book on Intellectual Property Rights”3rd
edition.
[13] http://www.public-perception –issues in
Agricultural and environmental biotechnology, September 1, 2013.
[14]
Philip
W.Grubb, Patents for Chemical, Pharmaceuticals and Biotechnology, (Oxford: Oxford
University Press, 2000), p.219.
[15]
A.K Rajaraman, Adv Madras High Court ’Product Patenting: Promises and Perils’
lCI, vol 3, Nov 2012.
[16]
ibid
[18]
Ibid.
[19]
PBRs Act 2000-statement and object-1.In order to provide for the establishment
of an effective system for the protection of plant varities.2.right of farmers
and plant breeders .3.to encourage the development of new varieties of plant
and to right of farmers in respect of their contribution at any time in
conserving, improving and making available in plant genetic resource for the
development of new plant varieties. http://www.plantauthority.gov.in/pdf,September,2013
[21]
http://www.jstor.org/stable/440987
[23]
P.kVasudev,”Patenting biotech products-complex issues “Economic and political
weekly, vol35, No.42.
[25]Ibdi,http:/www.ipsustralia.gov.au/get-the-rights-ip/patents/about-patents/what-can
–be-patented.
[26]
American Medical Association Report
[27]
http://www.lexorbis.com,Feb13,2012.
[28]
http://www.lexorbis.com/pdf/patenting-micro-organism.pdf,April30,2005
[29]
http://www.pharmainfo.net/reviews/patent-system-pharmaceuticals,April02,2013.
[30]
ibid
[31] http://www.issues.org/17.4/barton.htm,August25,2013.John.H.Barton”Patenting
Agriculture,September,2013
[37]
Ms.Geetika Walia,’software patenting –a challenge’March,2013vol-4LPP-34
[38]
http://www.nipo.in/images,Sep,2013.
