INTERNATIONAL JOURNAL OF RESEARCH AND ANALYSIS …ijra.in/uploads/41723.4423895486fullpaper_Abidha Beegum. V.S.pdf · ANALYSIS VOLUME 2 ISSUE 1 2014 FIXATION OF UNIFORM STANDARDS

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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

http://www.biotechinfo/

http://www.biotechterms/

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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.

http://www.patentoffice.nic.in/ipr/patentjournal

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INTERNATIONAL JOURNAL OF RESEARCH AND ANALYSIS …ijra.in/uploads/41723.4423895486fullpaper_Abidha Beegum. V.S.pdf · ANALYSIS VOLUME 2 ISSUE 1 2014 FIXATION OF UNIFORM STANDARDS