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INTERNATIONAL JOURNAL OF RESEARCH AND
ANALYSIS VOLUME 2 ISSUE 1
2014
FIXATION OF UNIFORM STANDARDS IN PATENTING OF
BIOTECHNOLOGY: IMPORTANCE OF JUDICIAL AND LEGISLATIVE
INTERVENTION.
*Abidha Beegum. V.S1
Introduction
Biotechnology is the science of manipulating and modifying the genetic
makeup of living matter. Therefore it promises to become an effective weapon in fighting
major evils such as diseases, malnutrition, plagues, energy deficits and pollution. Thus
biological study is considered as the way to improve technological development in
health, agricultural and industrial sectors. The emergence of biotechnology, the science of
creating new organisms with useful and commercially viable applications, has thrown
traditional concepts of patent law into turmoil2. Biotechnology research on foods, plants
and animals has been widely applauded for its therapeutic values as well as its potentials
to solve the long-standing problem of food shortage in the third world3.
Importance of the term ‘Biotechnology’
The Oxford English Dictionary gives the definitions of biotechnology as “the
branch of technology concerned with modern forms of industrial production utilizing
living organisms, and their biological processes”4. In the scientific process,
biotechnology is the alteration of molecules, genes and cells- the basic building blocks of
life – to develop useful products, processes or services such as new medicines and
therapies, cloning genetically foods and enhanced crops5. In the United States, “usage of
the word biotechnology has come to mean all parts of an industry that knowledge create,
develop and market a variety of products through the willful manipulation, on a
molecular level, of life forms or utilization of knowledge pertaining to living systems.”6
1 Assistant Professor in Law, Aligarh Muslim University, Malappuram Centre. 2 Amgen Inc. v. Chugai Pharmaceutical co., 13 USPQ 2d 1737 (1989)
3Nik Ahmed Kamal Bin Nik Mahmod, “Development of Biotechnology; The legal Challenges”, KULR,
Vol. X11 (2005) p.18
4 Oxford English Dictionary, 2nd Edition. 5 http://www.biotechinfo. Visited on 03.04.2011 6 http://www.biotechterms .org/sourcebook/save idretreieve.php3?id=230
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In short, the term biotechnology refers to laboratory manipulation of genes and the use of
living organisms or their products to change their use to improve or cure human health
and the human environment.7
Historical Initiatives
Recombinant DNA technology is the term which used to modify the basic
genetic make-up of a living organism by inserting or removing sections of DNA, a
molecule that carries hereditary information. After the first demonstration of these
techniques in 1973, their potential to produce novel characteristics into microbes, plants
and animals has been rapidly explored. Initial efforts focused on microorganisms because
of their relative simplicity of their structure. Now genetically “programmed”
microorganisms produce materials which they would not produce naturally. Eg. Drugs
such as human insulin, growth hormone and certain enzymes.
Genetic modification of plants include varieties with traits such as resistance to
herbicides, pests or diseases, enhanced nutritive content and new shade of flower
colouring. The first patented genetically modified animal, which is available for medical
research, is a mouse which is genetically predisposed to cancer – for use in testing new
drugs or chemicals for carcinogenicity. The use of recombinant DNA methods in relation
to human diseases caused by gene defects is mainly concentrated on diagnostic as well as
therapeutic applications. The first attempt to modify human body cells in a patient using
the gene transfer technique was made in the U.S. in 1984. Bone marrow cells which were
unable to produce an enzyme essential to the immune system were removed from the
patient, modified to include the gene for the missing enzyme and replaced. Though the
first attempt failed, in 1990 a similar method was successfully used to modify white
blood cells genetically. This germ line gene therapy makes many controversial issues.
Biotechnology companies consider legal protection for these innovations to be essential.
Patent protection gives the opportunity to the innovator to earn a commercial return on
the heavy investment in this research and therefore to fuel the ongoing research necessary
for further improvement in health care and nutrition etc.8
7 Peters, Pamela, ”Biotechnology: A Guide o Genetic Engineering”, Wm. C. Brown Publishers Inc., 1993. 8Patenting in Biotechnology, European Federation of Biotechnology – Task Group on Public
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Contradictions between Patenting and Biotechnology
Biotechnology distinguishes itself from the traditional mechanical and chemical
arts in the light of rigid patent law doctrines. That is the inventor must satisfy certain
requirements for obtaining patent. This includes satisfying the requirements for subject
matter patentability, the disclosure requirements for biotechnology inventions, depository
requirements of micro-organisms and non obvious requirement. The scope determines the
extent to which the patent holder may exclusively exploit or improve products and
processes, scope determination decisively impact the progress of biotechnology. Two
cases illustrated the conflicting interests involved in determining biotechnology patent
scope. The Federal Circuit Court9 in 1991 found that a patent teaching how to isolate and
extract protein from natural products, is infringed when other researchers construct the
same protein using DNA recombinant techniques.10
The patent holders exclusive right to
exploit products or processes within the scope of his patent grants him economic power.
If the patent holder believes others are exploiting products or processes within the scope
of his patent, he may sue for infringement.
Subject matter of biotechnology patenting
Naturally occurring substances, present as components of complex mixtures of
natural origin, can in principle be patented where they are isolated from their natural
surroundings, identified and made available for the first time and a process is developed
for producing them so that they can be put to a useful purpose. This applies to inanimate
substance as well as to living materials. In appropriate circumstances such substances are
not ruled out as mere discoveries but are considered as invention by the EPO(European
Patent Office) and other legal authorities.11
Micro-organisms are those molecular level organisms that existed on our planet
millions of years ago, which are the foundations upon which the building blocks of life
were build up. Naturally occurring microorganisms, including gene, gene sequences,
Perception of biotechnology, Briefing Paper 1, Second Edition, September 1996. 9 Scripps Clinic & Research Foundation v. Genetech, Inc., 927 F.2d 1565(Fed. Cir. 1991) 10 See Genetech Inc., v. Wellcome foundation Ltd. In which a U.S. court in 1990 held that a second
generation protein infringed the patent on the first generation protein. Both courts gave strong protection to
the patented inventions. 11Supra no. 7
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virus etc. are not patentable. In order to be patentable, the living form cannot be one as
existing in nature. Patent office had a practice to refuse claim relating to living organisms
except Pasteur’s case12
, as being patentable subject matter. With the development of
genetic engineering in 1970’s the patentability of living micro-organisms came into the
scene. In this scenario U.S. Supreme Court held that life, man-made micro organisms
were patentable under the U.S. law.13
In the Chakraborty case in 1980 the U.S. Supreme Court decided that a micro
organism was not precluded from patentability solely because it was alive.. Thus a
pseudomonas bacterium manipulated to contain more than one plasmid controlling the
break-down of hydrocarbons was a new bacterium with markedly different characteristics
from any found in nature and hence not nature’s handiwork but that of the inventor.
Therefore the product of nature objection failed and the modified organism were held
patentable.
Plant patents are also obtainable in U.S, Europe and Japan. In a case, followed by
the Chakrabarty’s case, it was decided that normal US utility patents could be granted for
genetically modified plants. In Europe also, patent law was considered unsuitable for
protecting new plant varieties developed by traditional breeding methods. Special
national laws of plant breeder’s rights, were therefore established in some countries as
well as the International Union for the protection of New varieties of Plants (UPOV
1961). Patent law in Europe subsequently excluded plant varieties from patentability14
.
The UPOV Convention was revised in 1991 and does not prevent dual protection by PVR
or patents. After this revision Member States ratified it and adopt it into their legislation.
In India also the Protection of Plant Varieties and Farmers Rights Act, 2001 came into
existence to provide for the establishment of an effective system for protection of plant
varieties, the rights of farmers and plant breeders and to encourage the development of
new varieties of plants it has been considered necessary to recognize and protect the
rights of the farmers in respect of their contribution made at any time in conserving,
12 35 USC, Sec.101 ( In 1873 Louis Pasteur, the French Scientist had obtained a U.S. patent no.141072
claiming yeast, free from organic germs of disease, as an article of manufacture. 13 35 USC 14 EPC Article 53(b) which excludes patent for “plant and animal varieties” as such and “essentially
biological processes for the production of “ plants and animals.
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improving and making available plant genetic resources for the development of the new
plant varieties. Moreover to accelerate agricultural development, it is necessary to protect
plant breeders’ right to stimulate investment for research and development for the
development of new plant varieties. Such protection is likely to facilitate the growth of
the seed industry which will ensure the availability of high quality seeds and planting
material to the farmers.
Animal breeds produced by traditional methods have no legal system for their
protection comparable to plant breeder’s rights. Based on the micro organism and plant
patent precedents, the US Commissioner of Patents declared in 1987 that US patents
would be granted for “non-naturally occurring non-human multi cellular living
organisms including animals” . The first transgenic animal patent was issued in 1988 to
Harvard University with claims covering the “oncomouse”, one in which an oncogene
has been introduced to make the animal more susceptible to cancer and therefore more
sensitive in testing possible carcinogens. After initial reluctance by the EPO to grant the
corresponding European Patent the European Patent was issued. The result of this genetic
modification of the mice was an increase of the probability of the development of
neoplasm particularly malignant tumours. The Harvard oncomouse patent cover in fact
all non-human mammalian Onco-animals. It has been made clear that any life form is
patentable provided that human technical intervention is required in its production. The
one exception is that human beings cannot be patented because this would lead to the
violation of the law, which prohibits slavery.
Gene patents are available in all fields of biotechnology. The patentability of
DNA sequences of unknown function is dubious and controversial. The Human Genome
Organization accepts that patents should be granted for full length genes but is against
patenting fragmentary DNA sequences having no established utility. In order to comply
with the written description requirement, a patent has to describe an invention in adequate
detail that one skilled in the art could clearly conclude that the inventor had possession of
the claimed subject matter. In Human Insulin case, the court held that the human DNA
was not described in the application in order to distinguish this DNA from any other. The
case Regents of University of California v. Eli Lilly Co., 43 USPQ 2d 1389 (1997)
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considered a suit against a manufactures of human insulin brought by Regents of
University, which held patent for recombinant DNA technology. The inventors had
isolated and sequenced only the gene for rat insulin, and patent claimed genes for all
mammalian insulin, especially human. The description was sufficient to able to isolate
human insulin gene using the method described in the patent. But it did not meet the
’written description’ requirement and it did not describe the structure of human insulin
gene.
Objections concerning patentability of biotechnology
Main objections concerning the patentability of biotechnology was that, they are
the products of nature and neither the result of a creative process nor inventions as such..
Another objections in this regard was the living organism objection. Moreover there is
another opposition relating to patentability of living organism was lack of novelty and
industrial application. Written description of invention is impossible in the case of living
organisms. Purists in the field also protest the above move as there is no reproduction of
invention. When a subject matter is not reproducible, it is not capable of industrial
application and so not patentable.
The patentability criteria depends on the degree of human intervention, which is
necessary to create such a product. In the case of Funk Brother Seed Co. v. Kalo
Innoculant Co.15
the Court held that, the new and different composition of non-inhibitive
strains which contributed utility and economy to the manufacture and distribution of
commercial inoculants is his own invention and not nature’s handwork and so patentable
under Sec. 101. The tests laid down by the court are:-
1. The law of the nature, physical phenomena and abstract ideas are not patentable
subject matter.
2. A non-naturally occurring manufacture or composition of matter - a product of
human ingenuity – having a distinctive name, character and use is predictable
subject matter.
15 447 US 303(1980)
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3. A new mineral discovered in the earth or a new plant found in the wild is not a
patentable subject matter. Likewise, Einstein could not patent his celebrated
E=MC2 nor could Newton have patented the law of gravity.
4. The production of articles of use from raw materials, giving to these materials
new forms, qualities, properties or combinations whether by hand hand labour or
by machinery is q manufacture under Sec.10116
.
Attempts in International Level
International agreements for the protection of Intellectual Property at the national
and International level has existed for over a century. The first step in this regard was
Paris Convention for the protection of industrial property in 1883.
Budapest Treaty on the International Recognition of the Deposit Procedure.
In 1980, WIPO adopted this treaty for the International recognition of the deposit
of micro organisms for patent procedure.17
The fundamental principle of patent law is
that, details of an invention must be fully disclosed to the public. For an adequate
disclosure, the invention must be described sufficiently to permit a person skilled in the
art, to repeat the invention. In the case micro organism, the written description alone is
not sufficient to repeat the invention. Moreover, when the disclosure requirement of the
organism is not vividly specified in the specification, then the written description itself
become void. The US law18
requires a written description of alone may not make it
practicable for another to practice a micro biological invention. So for patent purposes
micro organism must be deposited in culture collections. It will compensate inadequate or
the written description of the invention. The deposit culture will satisfy and supplement
the publication of the description.19
16 Elizabeth Varkey, “Law of Patent”, Eastern Book Company, First Edition, 2005. 17 Budapest Treaty, Art. 1 18 35 USC, sec.112 19 Elizabeth Varkey, “Law of Patents”, Eastern Book co., First Edition, 2005, p. 278.
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For the purpose of a patent application the deposit of micro organism must be in
an appropriate place and control. For a national patent application. The deposit of the
culture collection in the concerned country is sufficient, while in an International
application it is not sufficient. This situation led to the signing of Budapest Treaty
concerning the deposit of micro organism in 1977. To become a member of this treaty, it
is essential that the country should be a member of this Paris Convention. India being a
member of the Paris Convention, entered on 11th
August 2001, has the authority to
implement the provisions of this Treaty. After the Amendment of Indian Patent Act also
the area of patentability in relation to micro organisms is not clear. In order to get a
patent, the Act requires the deposit of biological material with the International
Depository Authority (IDA). IMI, Chandigarh, is the IDA in India for some of the
biological materials such as bacteria and plasmids.
The Budapest Treaty recognizes the depositing of samples of micro organisms for
the purpose of patent procedure in the International Depository Authority (IDA)20
. The
IDA is created in conformity to Article 7 and must comply with the requirements of Art.
7. These IDA must be located on the territory of contracting states21
. An IDA has the duty
to examine the viability, purity and permanence of cultures on deposit at reasonable
intervals or at any time on the request of the depositor.22
The new deposit shall be accompanied by a written statement bearing:-
1. The signature of the depositor and containing an indication that the deposit is made
under the Treaty.
2. The name and address off the depositor.
3. Details of the conditions necessary for cultivation of the micro organisms for its storage
and testing viability.
20 Budapest Treaty, Art.3 21 Ibid, Art. 6 22 Budapest Treaty Regulations, Rule 10.
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4. An identification reference an indication of the properties of micro organisms
which are or may be dangerous to health or the environment or an indication that
the depositor is aware of such properties.23
When the deposited organism is no longer viable, or when local law prevents the
furnishing of samples by the IDA, the IDA notifies the depositor, who has the right to
make a new deposit of micro organisms which was originally deposited.24
If all the
requirements of Rules are complied with, then the IDA shall accept the deposit of micro
organisms. The duration of storage of deposit of micro organism is at least 30 years after
the date of deposit or 5 years after the most recent request for sample, whichever is later.
Patent Co-Operation Treaty
Among the various Treaties and Conventions Patent Co-operation Treaty 1970 is
a special one regarding the depositing of patent samples. The PCT describes the manner
in which the ‘International Application’ should refer to the depositing of micro-
organisms in a culture collection.25
The references must contain:-
1. The name and address of the depositing institution in which the deposit
was made.
2. The date of the deposit of the micro organism.
3. The accession number given by the institution to the deposit.
4. Any additional matter of which the International Bureau has been notified
pursuant to Rule 13bis
7. Failure to comply with the Rule leaves the applicant at
the mercy of national laws.26
23 Ibid, Rule 6.1 24 Budapest Treaty Art. 4.1 25 PCT, Rule 13bis 1
26 PCT, Rule 13bis3
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European Patent Convention
As a Regional Convention for the protection of patents in Europe, the European
Patent Convention (EPC) established in 1973. The main benefit of the Convention is that,
in making an application for a community patent, a single application will result in a
single patent conferring patent protection throughout the member countries. Moreover the
EPC contains provision relating to patentability of micro organisms. EPC under Art.
53(b) states that European patent shall not be granted for plant or animal varieties or
essentially biological processes for the reproduction of plants or animals, other than non-
biological or micro-biological processes. This means that micro biological process and
products of micro biological processes are patentable. The depository requirements of
micro-organisms were also mentioned in the European Patent Convention.27
According to
the Convention the combination of written description and the deposit of micro
organisms must provide the information necessary for the carrying out of the invention in
appropriate cases. If any conflicts arises between the EPC Rule and provisions of
Budapest Treaty, the provisions of the Budapest Treaty will prevail.
The United Nations Convention on Biological Diversity
This Convention enacted in June 1992 and entering into force in December 1993,
aims to ensure conservation of biological diversity, sustainable use of genetic resources28
,
and the fair and equitable sharing of the benefits from their utilization. In this Convention
Art. 15 recognizes the sovereign rights of States over their natural resources, their
authority to determine access thereto, and the need for access to be subject to prior
informed consent and on mutually agreed terms. In return for providing access to its
genetic resources, a donor country should benefit through any of the three mechanisms:-
Participation in research,29
Sharing in the results of research and proceeds of commercial exploitation, and30
27 EPC, Rule 28 & Rule 28(a) 28 Genetic Resources have in the past been declared “ a common heritage of mankind to be preserved, and
to be freely available to all, for use for the benefit of present and future generations.” 29 CBD, Art. 15(6) 30CBD Art. 15(7)
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Access to and transfer of derived technology.31
The Convention recognizes a legitimate role for intellectual property in achieving these
objectives.
TRIPS Agreement and its application in Indian Law
Article 27 of TRIPS Agreement concerns the availability, scope and use of IPR in
making distinctions between materials produced by biological processes and non-
biological routes; only the latter is considered patentable. Natural material of any kind is
not patentable and Article 27(3)(b) makes it clear that Member States are entitled to
exclude plants and animals but not micro organisms from the scope of patentability.
However, it is unclear whether TRIPS permits Member States to exclude biological
substances like genes and cells. Currently, two schools of thought exist. The first school
states that there is no scientific basis to support the patenting of genes and genomes,
which are discoveries at best, while the second school states that characterization of
genes is not straight forward. So it constitute an inventive step and therefore should be
patentable. However, despite the apparent controversy, British Prime Minister Tony Blair
initiated an Anglo – American Agreement with President Bill Clinton to protect 100,000
genes of the human genome, to ensure non patentability. The agreement aimed at
preventing entrepreneurs profiting from gene patents and so the benefits of research were
freely available worldwide to combat diseases.
After the Amendment of Indian Patent Act also, the area of patentability in
relation to micro organisms is not clear. Going by the US and European precedents, it
would appear that only such micro organisms that are the result of human intervention
would be patentable. Naturally occurring micro organisms are likely to be excluded from
patentability, unless the micro organism loses its natural characteristics as a result of
human intervention.32
31 Ibid, Art. 16(1) 32 Vinod V. Sople, “Managing Intellectual Property : The Strategic Imperative”, Eastern Economy Edition,
2006, p.261.
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EC Directive on Protection of Biotechnological Inventions
The proposed draft of EU Directive on the legal protection of Biotechnological
Inventions was originally published in 1988. After several years o f debate, the European
Commission published a revised proposal in December 1995. The directive aims at
harmony in the EU between national patent laws and the EPC, and a uniform legal
interpretation on some points of special relevance to living systems.
The Directive addressed “biological material” under Article 233
. Article 3
excludes patents on the human body and its elements in their natural state, elements
isolated from the body or otherwise produced by a technical process can be patented if
they are capable of industrial application. Article 4 provides that no invention is to be
refused patent protection for the sole reason that biological material is involved.
Moreover this article provides specifically for the patentability of plants and animals and
parts of these except for “plant and animal varieties”. Natural products which have
biological utility can qualify for patent protection in certain circumstances.34
According to Article 9, inventions are not patentable where their exploitation
would be contrary to ‘ordre public’ or morality.35
A patent on a biological material covers
the first and all subsequent generations of material obtained by multiplication or
propagation provided the crucial characteristics of the original are retained36
. Patent
rights in a product become exhausted when the product is marketed by the patent owner
or a licensee. However, a product which can be multiplied biologically, the purchaser can
obviously propagate the purchased product for the purpose implied in the sale, but Article
12 forbids the resulting material being used in further cycles of multiplication or
propagation.
33 As any material containing genetic information and capable of self reproducing or of being reproduced in
a biological system. This must therefore cover living matter, viruses, genes and other type of DNA and
RNA. 34 Article 8 of the Directive confirms that patents for these products should not be ruled out in principle as
mere “discoveries”. Thus the presence of a product as part of pre-existing material is not alone a sufficient
ground for refusing a patent for it. 35 The EPC and laws of most Member States already contain a similar exclusion- Art. 53(a) . 36 ECD Article 10
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There is an important exception to the above said rule. Article 13 allowing
farmers to re-sow seed saved from the first crop. This “farmer’s privilege” in patent law
is to be limited, in order to be in line with the corresponding provision in the EU plant
breeder’s right. It provides for a royalty payment on farm-saved seed which is “sensibly
lower” than that for certified seed. Animal farmers are also free to breed from the
patented animal for renewal of their own stock.
Conclusion
After the decision in Chakrabarty’s case, the patenting of life forms and its
controversies is at its zenith nowadays. The decision in Re Hibbered37
in 1985, gives full
patent rights to plants and animals. The position is clear in the Oncomouse case also, that
is human intervention is the only criteria for making a life form product , patentable.
Such a lenient attitude is adopted by the European Courts, towards the patenting of life
forms without addressing any of the moral and ethical issues. In case of moral issues their
stand is that, the patenting of a single human gene has nothing to do with the patenting of
human life. The contention is that it is only for social purpose and it is a contribution to
the humanity as life saving drugs and such inventions have industrial application only to
solve technical problems38
.
In India, before 2002, there was no protection for patent for life forms. But
the Calcutta High Court, in Dimminaco A.G v. Controller of patent and design39
held
that, even if the end product contains a live virus, the process became invention. As noted
above, the Indian Patent Act was amended in 2005, for making it in conformity with
Art. 27 of TRIPS Agreement, to make a uniform standard. Even though the amended Act,
does not defined some important terms like plant, animal, essentially biological process
because, a variety of interpretations may be possible in the absence of a common
standard. The term “inventive step” also has to address seriously. Otherwise the standard
of patentability become lowered. Such fluctuating standards will deprive the interest of
the investors and development of the society too. The economic progress and
37 227 USPQ 2d (BNA) 443 38
“Bioethics and Patent Law : Relaxin case”, WIPO Magazine, April 2006 39 2002 Cal HC IPLR 226
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technological advancement also has to take into consideration. So it is the duty of the
legislature to look into the matter seriously, and make necessary changes by way of
amendments in the existing law. In the absence of litigation judiciary has no role in that
respect. But it should be vigilant towards the matter.
India’s post TRIPS enactment contains some interpretations for patentability of
biotechnology. For example:- the ingredients of inventive steps are:- standing problem,
distance, surprising effect, long felt need, complexity of works, commercial success,
cheaper and more economical product and simplicity of the proposed technological
solutions etc. On that ground Patent Office also has the duty to encourage higher
standards in this burning issue, without adopting a liberal attitude towards the problem
because India being one of the bio-diversity rich countries .
References
1. The Patents Act, 1970 as amended by The Patents (Amendment) Act, 2005 along
with The Patents Rules, 2003 as amended by The Patent (Amendment ) Rules, 2006
2. Patent Co-operation Treaty
3. European Patent Convention
4. TRIPS Agreement
5. UN Convention on Biological Diversity
6. Biotechnology and Patent Law-patenting living beings-Dr. Sreenivasulu, N.S., Dr.
Raju, C.B.(2008)
7. The Patents Act 1970, 1999 & 2002, along with The Patent Rules, 2003
8. Manual of Patent Practice & Procedure-published by office of the Controller
General of Patents, Designs & Trademarks
9. "Patentability of Biological Material(s) - Essentially, Therapeutic Antibodies - in
India", (2008)
10. Universal Guide to Patents Law, Manish Arora
11. Patent Law by P Narayanan-fourth edition
12. Biotechnology Patenting in India: Will Bio-Generics Lead a “Sunrise Industry”
to Bio-Innovation? (January 2008) by Janice M. Mueller
13. www.patentoffice.nic.in/ipr/patentjournal/ Annual Report
14. Dimminaco Ag v Controller of Patents & Designs and Others, [2001] AID No.1.
15. Report of Mashelkar committee “whether it would be TRIPS compatible to
exclude micro-organisms for patenting
16. R.A. Mashelkar et al., Report of the Technical Expert Group on Patent Law,
17. Conservation of Bio-diversity Act 2002 and Biological Diversity Rules, 2004.
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