You are on page 1of 13


(National Monthly Journal, I.S.S.N 23216417)


The intellectual property rights is the important field in protecting the intellects of a person, it
is the exclusive right given to the owner for its intellectual work meaning the hard work and
effort for the protection of the inventive work of that person. Here invention means the works
which never had existed in nature before which is completely new. Since the IPR protection is
only granted to the inventions not for the discoveries, in the case of biotechnology innovation
is difficult to say whether the new life formed is in form of gene, DNA, cell etc. is a scientific
discovery or technological invention. A substance freely occurring in the nature if merely
found or discovered is not patentable. Biotechnology basically deals with genes, medicines,
agriculture, and industriesetc., which are of the commercial value. The Indian government has
entered into a number of biotechnology co-operation agreements with various countries in an
effort to foster additional growth in this sector. Several State Governments such as Karnataka,
Tamil Nadu, Andhra Pradesh, and Maharashtra have taken out their specific policies to boost
the biotechnology sector in their respective areas. Some of the key steps taken by the State
Governments include announcing separate Biotechnology Policy for their States, setting up of
Task Forces with experts to guide them on policy issues, setting up of exclusive Biotechnology
Parks with agriculture and health biotechnology as key areas. The city of Bangalore, located in
the State of Karnataka and known as the emerging as the hub of Biotechnology industry in
India. In the given paper we will be dealing with the concept of the biotechnology, kinds of
biotechnology protection in IPR and also various case laws dealing with these fields in IPR.
The current analysis will be the recent scenario of the IPR laws that are protecting the
Keywords: concept of biotechnology, types, legal framework and current analysis


IPR is the outlet of law used to describe the law which shelters the application of ideas and
information which are of marketable value thus it covers the law relating to patents, copyright,
trademark and trade secret and other similar rights.
The role of IPR has a crucial issue to deal
on the field of biotechnology, now here comes the question as to what is biotechnology.
Biotechnology is the important field where its inventions shall play important role in the future
particularly in agriculture, medicines, protection of the biodiversity etc., biotechnology is
mainly concerned with the living organisms, the inventions that are made out of the particular
parts of these organisms and which further helps or modifies the product to improve the plants
or the animalsor develop microorganisms for the specific uses. In normal layman terms the
development of the genetic resources is called the biotechnology. So here comes the question
as to what is genetic resources? The genetic resources basically refer to the genetic material of
definite or potential value. Genetic material is any plant, animal, microbial or origin containing
functional units of heredity.

Modern biotechnology is about 50years old and last epochs took anincredible development.
Concept of biotechnology involves clean biological science (genetics, microbiology, animal
cell culture, molecular biology, bio-chemistry, embryology, cell biology etc.). A noteworthy
contribution has been made by the understanding of the ethnic peoples and the traditional
farmers in the development of the new crops types and biodiversity conservation, which also
an important aspect in the biotechnology development. With regards to the legal protection of
biotechnology, it basically has very complex position in general and agricultural biotechnology
however no internationally accepted guideline for the supervision of IPR and extensive range
of opinion exists regarding the effectiveness of IPR in the area of biotechnology. It has been
notified by the department of agriculture and resource economics that the role of intellectual
property rights has become a key issue in agricultural and resource economics over the past
two decades. The variations in biotechnology and intellectual property protection that have
occurred since 1980 make private enterprise possible for the first time in many broad research
areas in agriculture and the health sciences. As the scope and power of IPRs in biotechnology
has grown, their international reach has expanded. These developments raise many

Cornish William, The intellectual property rights ( 5
edition , Thomson 1989)
World intellectual office, see: ( last seen 10
august 2014

mesmerizing and important issues optimal patent design and licensing, the implications of IPRs
under cumulative innovation, typical of agriculture and biotechnology, the effects of the TRIPS
agreement on developing countries, the effects of IPRs on monopolization of key sectors, and
the optimal way to ensure that the poor of the world have access to pharmaceutical products
including AIDS drugs.

Types of biotechnology:
Biotechnology inventions are basically the inventions of human mind and are generally the
result of significant research, innovative effort and the investment in the classy laboratories.
Though patenting the biotechnology has been complemented with controversies.

Biotechnology includes the changeability amongst living organisms, covering all springs
including, inter-alia, terrestrial, marine and other aquatic ecosystems. In the developing
countries, which are “capital poor” and “resources rich” plant genetic resources and other
forms of biodiversity contribute significantly to this richness. The access to those resources and
associated traditional knowledge can substantially benefit formal scientific research centers as
well enterprises.
Thus we can divide this particular concept into two categories:
1. Agricultural biotechnology.
2. General biotechnology(industrial, preventive and therapeutic medical, regenerative and
genomic medicine, pharma-geomics, bioengineering and nanotechnology, bio-
informatics and IT enabled biotechnology, clinical biotechnology and research

Agricultural biotechnology:
Agriculture is one of the important sector in building up of the country’s economy andother
aspects like conservation of biological diversity. It’s for the first time that in many broad
research areas in the agriculture intellectual property protection has been occurred. Agricultural
biotechnology is increasing in its exclusive nature, the proprietorship of IPR in the agriculture
is now an issue in development of products and transfer of the technology to the developing

Department of agriculture and resources economics, see: ( last seen 10

august 2014.
Worldwide IPR official website, see: ( last seen 10
AlikhanShahid and MashelkarRaghunath, intellectual property and competitive strategies in 21
Ed.Wolters Kluwer)

countries. Researchers of the biotechnology now need to consider IPR as an important factor in
there research especially where the main aim is product development therefore there is
necessary for the scientists join the developing countries to develop strategic plans in handling
there IP concerns.
Protection of breading of seeds, crops etc. can be patented if they are
traditionally of commercial value.
The most important contrivance for lawfully protecting agricultural innovations are plant
breeders rights (PBR) and patents (extended to cover plants animals and microorganisms).
Other forms of protection can be provided through trademark, trade secrets and copyrights.
Substitutions to these include material transfer agreements (MTAs) of a private contractual
nature. If no form of protection is taken, then research results are commonly placed in the
public domain, mostly in the form of publications, making fallouts available to all without
restraints on use
a) PBR- the plants breeders right are used to protect new varieties of plants by giving
limited marketable rights for about 20 -25 years to market a new variation or its
reproductive material. The variety must be “novel, distinct, uniform, and stable.” This
protection prevents anyone from growing or selling the variety without the owner's
permission. Exemptions may be made, however, for both research and use of seed
saved by a farmer for cultivation.
b) Patent - A patent is a limited right or exclusive right that is given to an inventor to
exclude all others from ‘making, using, selling or offering to sell the invention’ in the
country that granted the patent right, and importing it into that country. In agricultural
biotechnology, patents may cover, for example, plant transformation methods, vectors,
genes, etc. and in countries that allow patenting of higher life forms, transgenic plants
or animals. Patents are the most critical form of protection for agricultural
biotechnology and considered to be the most powerful in the IP system. Patents are
temporary, generally about 20 years, and are country specific (Binenbaum et al., 2000)
General biotechnology:
Biotechnology in general includes all other substances or elements other than the plants
category, includes all other living organisms like micro-organisms animals. Includes in combat
of the DNA technology molecular marker in breading of animals. Inventions the commercial

International service for the acquisition of Agri-biotech applications,
see:( last seen- 10
august 2014
International service for acquisition of Agricultural-biotechnology application
see:( last seen- 15
august 2014

exploitation of which would be contrary to order public or morality, such exploitation shall not
be deemed to be so contrary merely because it is prohibited by the law or regulation in some or
all of the contracting states.

i. Industrial biotechnology-Industrial biotechnology is a set of practices that use living
cells (such as bacteria, yeast, algae) or component cells like enzymes, to generate
industrial products and processes. Products include biomass-based materials such as
fuels and chemicals, while processes include the treatment of waste water and energy
efficiency measures. For example, microbes (yeast) or enzymes are used to produce
beer and wine as well as dairy goods such as cheese. However, biotechnology is being
increasingly applied to improve manufacturing processes and to solve environmental
problems. Industrial biotechnology can be used to:
 Create new products, such as plant-based biodegradable plastics;
 Replace petroleum-based feedstock’s by processing biomass using bio refineries to
generate electricity, transport fuels or chemicals;
 Modify and develop new industrial processes, such as by using enzymes to reduce the
amount of harsh chemicals used in textiles and the pulp and paper industry;
 Reduce the environmental impact of manufacturing; for example by treating industrial
wastewater onsite using biological mediums such as micro
 Provide water savings through more efficient processes such as using enzymes to
break down chemicals and reduce subsequent washing steps in the textile industry.

Patentability of microorganisms, the law complied with the requirement of article 27.3(b) of
the TRIPS Agreement .The exclusion of inventions which represent .The ‘discovery of any
living thing or non-living substance occurring in nature’, consists of ‘traditional knowledge’ or
of ‘known properties of traditionally known components’ would lead to the exclusion from
patentability of some biotechnology-based inventions. The Patents (Amendment) Ordinance,
2004, later replaced by the Patents (Amendment) Act, 2005 (Act 15 of 2005) introduced the
third set of amendments to the 1970 Patent Act. The key modification was the introduction of
product patents for fields of technology previously excluded from protection. This Amendment
introduced a new provision (section 3(d)) aimed to prevent the grant of patents on ‘minor’ or
‘frivolous’ inventions. Although the main objective of Section 3(d) has been the avoidance of
what have become common ‘ever greening’ practices in the pharmaceutical industry, this

EPC, article. 53(a)
Australian government department of the Industry
see:( last seen-
august 2014

provision has apparently not been an absolute barrier against the patenting of variants of
existing products, such as polymorphs.

ii. Nanotechnology- As an emerging science in its infancy, nanotechnology promises the
nano-scale manufacture of materials and machines made to atomic specifications. It is a
field at the junction of chemistry, physics, biology, computer science and engineering.
Types of IP(intellectual property ) protection that is granted to this Nano technology are
patents, copyrights, trade secrets, mask work and trademarks. IP rights are basically to
protect under various federal and state legal laws and without protection the property
falls under the public domain and may be used by any party without a license.

Legislative framework:

A) TRIPS: In the other fields of the technology there is a need for the protection of the
biotechnology. The legal needs for the protection of the biotechnological inventions is
because these inventions are the result of the man intellectual minds and these are
generally the result of a man’s handwork, effort and his keen research in these
traditional laboratories. The legal framework is very sensitive and very complex in the
case of biotechnology because of the technical and ethical issues involved in it. TRIPS
or the trade related aspects had competent patent system in India regarding the fields in
the biotechnology , Article 27.3 (b) of TRIPS excludes biological processes for the
production of plants or animals as a patentable subject matter, but patents can be
granted to the microorganisms, non-biological, and microbiological processes used in
the production of plants and animals.
This covers even the gene sequences, which
may be for a particular character, or a marketer or genetic markers or similar ones. With
the increase of transgenic exploration both in public and private research organizations,
the issues of royalty payments, material transfer agreements (MTA), and legal
obligations and covers are to be clearly understood. IPR protection of new life forms

TRIPS article 27.3(b)
Results of Uruguay round, Article 27 of TRIPS agreement diverging views of developed and developing
countries towards patentability of biotechnology
WIPO official site on TRIPS agreement, Article- 27.3(b)

raises a number of difficult technical and ethical issues because of which the
patentability of new biological forms and processes is still not accepted in many
countries. Indian Patent Act 1970 defines patentable invention as a new product or
process involving an inventive step and capable of industrial application
Article 27 (3)(b) of TRIPs agreement allows members to exclude from patent protection,
plants and animals other than micro-organisms; and biological processes for the production
of plants or animals other than microbiological processes.
TRIPs provide option to
member states guarding new plant variety by means of patent or sui generis system or both.
India opted for sui generis protection and legislated “Plant Varieties Protection and
Farmers Right Act-2000” that enables the farmer to save, use, sow, re-sow, exchange, or
share the seeds of protected variety, besides offering protection on farmers' variety, extant
variety and essentially derived variety. The Indian Biotechnology sector is poised for a
tremendous growth and IP protection is necessary for India to make it to the top as a global
competitor. Human health biotechnology products account for about 60 percent of the
domestic market, while bio-drugs, vaccines and diagnostics have significant market shares
as well.
Intellectual Property (IP) is central to the biotechnology industry, and brings with it a
dimension, facilitating collective activity, whether it is a drug discovery or clinical or market-
related trials. Essentially, collaborative activity is the synergy between India's ability to provide
conditions for research, clinical trials and development, technical lead and capital availability
in developed nations. The successful translation of these synergies into commercially viable
applications and marketable products critically depends on the compatibility of regulations that
deal with the registration and protection of intellectual property, originating from the
collaborative process. Affordability and accessibility to the products of biotechnology are also
the two key factors central to the advancement of this sector. Policies that foster a balance
between sustaining innovation and facilitating technology diffusion has been addressed with
substantial progress in terms of support for R&D, human resource generation and infrastructure
B) Biotechnology enablement in patent:In India biotechnology protection can only be
attended by the help of patent protection
. There are certain characteristics associated
with biotechnology that distinguishes it from other forms of patentable subject matter.

Article 27(3) (b) of the TRIPS agreement.
As per the Dua reports

Biological inventions are described more in functional terms. Patent law was intended
to satisfy the requirements of the industrial technology. Industrial technology is
mechanistic and an applicant for the biotechnology patent finds it difficult to satisfy the
requirements for obtaining the patent protection. With the advancement in the
biotechnology development, industrial property laws were to be suitably modified to
match the needs of science and the industry. The requirement of filing a specification
has to be satisfied in the case of microorganisms as well.

An application related to the production by the genetic engineering of a polypeptide called
interleukin-3, believed to control immune response in mammals. It was held that the correct
approach was to consider the description and the claims in specification in the eyes of the
skilled persons in the art. Through the applicant need not have to restrict his claims must be
properly supported by the description of the invention in the specification. To decide whether
the claims are supported by the description, it is necessary to ascertain what is in invention
which has been described in the specification.
A person wishing to make invention will first
have to obtain the invention after the research in nature, which might take years. Though this
concept proved wrong, the skilled person would only be able to identify the new strain and
description will not be sufficient to enable to him to get it. The House of Lords held that the
patentee was not obliged to supply the microorganisms that he had described to the public. The
claimed invention was a new antibiotic, the process of which required the use of a particular
micro-organism as the starting material. The micro-organisms had been deposited in the culture
collection before the filing date, but was not made available to the public until and after the
filing date and the publication date.

The deposit of the microorganisms was considered as a supplement the written description.
The European patent office (EPC) recognized this need and included provisions in the rules to
this effect. It was the EPC which first incorporated the provisions for the deposit of the
microorganisms. Microorganisms are patentable under EPC.

C) Necessity of international treaty and conventions:
There are three important treaty for the international protection of biotechnology in the
sphere of IPR. The Paris convention for the protection of the industrial property, the

Verkey Elizabeth, law of patent, (2
edition: Eastern book company)
Schering Biotech corporations application, 1993 RPC 249
American Cyanamid co. (Dann’s) patent, 1971 RPC 425
EPC, Article- 53(b).

Budapest treaty on international recognition of the deposit of the microorganisms for
the purpose of the patent procedure, and the patent co-operation treaty.
 Paris convention- the Paris convention was signed in the year 1883 by 11
countries but now majority of the countries are parties to it who have
intellectual property rights laws in their country. The convention covers the
patent and defines them so broadly that it permits application to any forms of
the industrial patents granted under the laws of the convention countries. The
most important practical result of the convention is the concept of national
treatment that it is possible to claim priority from an application made in a
convention country for all the subsequent convention countries within 12
months of the original filing agreement.

 Budapest treaty- Except for US, almost all the countries have early publications
of the patent application after 18 months from the priority date. The deposited
strain must be available from this time. The applicant has, thus, to make the
invention available to the public including his competitors before any assurance
that he will obtain the patent protection. A person who obtains a sample of the
deposited straight after the early publicationhas to give an undertaking that he
would use the strain only for the experimental purpose and would not give it to
the third party. Most of the states require, in addition to the deposits, a written
description. The treaty allows the deposits of the biological material with an
international depositary authority (IDA), which will be accepted by the second
country as a valid deposit.
As a consequence of requirement the TRIPS
agreement, The Indian Patent act has been amended providing that, in the case
of mentioning biological material in the specification which may not be
described in such a way as to satisfy the requirements for the specification, the
application shall be completed by depositing the material in IDA under the
Budapest Treaty.
The Budapest treaty was entered into for the international

Articles of the paris convention , Art-1- definition of industrial property,
Art-2-3- national treatment,
Art-4- right to priority,
Art-4 bis to 5 quarters- patents,
Art 5B, 5D, 5bis (1) and 5quiquies- industrial design,
Art 5C,5D, 5bis(1), 6 to 7 bis 8, 9, 10ter- trademarks , trade names etc.
Art 10bis- unfair competition
Budapest Treaty, Art. 3(1)(a)
Refer to the Indian Patents Act, 1970, section 10(4). Proviso(2), Indian patent act- sec-10.proviso2- if the the
applicant mentions biological material in the specification which may not be described in such a way as to satisfy

recognition of the deposit of the micro-organisms for the patent procedure.

The Treaty requires the deposit to be accompanied by a written statement
stating that the deposit is made under this treaty, name address of the depositor
and details of the conditions necessary for the cultivation of the
microorganisms, for its storage and for testing its viability.

 Patent co-operation treaty- The Patent Cooperation Treaty (PCT) is a
multilateral patent law treaty which was entered into in 1970. The PCT protects
an originator of a member country by certifying priority for his or her inventions
over all or any inventor from countries which are not member. Member
countries are not under anduty to file separate applications for their inventions.
According to the PCT, the Patent and Trademark Office acts as a Receiving
Office (RO) for international applications filed by nationals or residents of the
U.S. In accordance with any agreement made between the U.S. and another
country, the Patent and Trademark Office may also act as a RO for international
applications filed by residents or nationals of such country who are entitled to
file international applications. The Patent and Trademark Office also performs
all acts connected with the discharge of duties required of a RO, including the
collection of international fees and their transmittal to the international bureau.
International applications filed in the Patent and Trademark Office should be in
the English language. [35USCS § 361]
Part III

clauses (a)and (b)and if such material is not available to the public (ii) if the applicant mentions a biological
material in the specification which may not be described in such a way as to satisfy clauses (a) and (b), and if such
material is not available to the public, the application shall be completed by depositing the material to an
international depository authority under the Budapest Treaty and by fulfilling the following conditions, namely:—

(A) the deposit of the material shall be made not later than the date of filing the patent application in India and a
reference thereof shall be made in the specification within the prescribed period;
(B) all the available characteristics of the material required for it to be correctly identified
or indicated are included in the specification including the name, address of the depository institution and the date
and number of the deposit of the material at the institution;
(C) access to the material is available in the depository institution only after the date of the
application of patent in India or if a priority is claimed after the date of the priority;
(D) Disclose the source and geographical origin of the biological material in the
specification, when used in an invention.
Budapest Treaty, Art-1
Budapest Treaty, Rule 10

The Louis Pasteur received a patent in 1873 claiming a yeast free organic germs of disease as
an article of manufacture.
Supreme Court of united stated had Longley granted patent to the
living organisms in the year 1980 that was the invention of the scientist Dr.Anandachakroborty
which was found to meet the requirement in the patent, i.e. novelty, utility, and non-
obviousness. The invention consisted of genetically engineered bacterium which was capable
of degrading the oil spills. The invention was new and did not exist in nature.
In the early case there was a case Genentech case
, which dealt with the recombination of the
DNA technology and gave rise to the complex discussion. But this was still primarily a case on
the patent law and one that dealt with by the patent lawyers. The discussion then moved on to
include ethical, moral and environmental issues by the time cases such as Onco mouse
plant genetic system came around. Ethical moral and the environmental elements had one way
or the other found their way into the debate also into the legal part of it. US patent and
trademark offices (USPTO) genetically modifies plant cells, seeds, plant tissue culture which
can be patented, the ruling is effectively an extension of Diamond v. Chakrabarty, which dealt
specifically with the genetic modification of microorganisms. The patenting of genetically
altered plants becomes a practical legal issue requiring deliberation and decision when
scientists Kenneth A. Hibberd, Paul C. Anderson, and Pauline Hubbard of Molecular Genetics,
Inc. of Minnetonka, Minnesota, apply for intellectual property protection on a variety of corn
that has been modified to contain more tryptophan, an amino acid. The Ex parte Hibberd
decision results in a patent (No. 4,581,847, "Tryptophan Overproducer Mutants of Cereal
Crops") that lays the groundwork for further patenting of GM plants
In 1897 ExparteAllencase the key issue was the patentability of the polyphonic pacific coast
oyster that had an extra sets of chromosomes. Applicant sought patent to the method of
inducing polyphonic in oyster as the product by process
. USPTO rejected the patent
application on the grounds ofobviousness on 1988 USPTO issued 1
patent on transgenetic
non- human animal Harvard mouse.

Cloning is the recent process of transferring the nucleus of an adult multicellular organism to
an unfertilized egg of the same species. The recent experimentation in the science of

US patent No- 141072 on July 1873
Genentech Inc’s patent [1989] RPC 147
Case T 0019/90-3.3.2, 3
October 1990,opposition division, case V0006/92,3
april 1992,examination division,
europen patent no. EP85304490
Expartehibberd, see: ( last seen- 20
august 2014
2 U.S.P.Q. 2d (BNA) 1425, see: (
51.pdf)last seen: 20
august 2014
US patent no- 4,736,866

biotechnology resulting in the creation of the clone of dolly.
Many countries like J apan and
US etc. Do not allow the cloning of the embryo of the human beings which will cause chaos in
the human society. IPR protection of new life forms raises a number of difficulties technical
and ethical issues because of which the patentability of the new biological forms and process is
still not accepted in many countries

Part IV

Though the recent development in biotechnology has tremendous growth in the field of
economy, conservation of the biodiversity, plant variety, cell culture etc.., the need for the
protection of the biotechnology has become an important focus, India has international
protection of the biotechnology by the means of international agreement as discussed above
TRIPS, the patent act which has been enacted for the protection of the new inventions, which
also includes protection of the micro-organisms plant variety etc. there is a vast change as in
growth taking place in this country. Approximately, 60% of the industry is devoted to human
health applications, 10% to agricultural biotechnology and 30% to industrial applications,
bioinformatics and genomics. The Recombinant DNA (DNA) technology is being successfully
used in various sectors such as agriculture, health care, process industry and environment
management. The current focus is on genomics, proteomics, transgenic, stem cell research and
product development. The opportunities in India has increased Foreign companies may partner
with India at the drug discovery stage of research, and use the Indian companies for contract
research and manufacturing. This is because an increasing number of large pharmaceutical
companies are finding it difficult to conduct the entire drug discovery process-in-house. India
on the other hand provides a cheaper infrastructure. This has given rise to contract research
organizations specializing in drug discovery services. Contract research services are largely
focused on molecular biology, bioinformatics, genomics & stem cell research. Clinical
research and trials are expected to grow exponentially over the next 5 years. There are
tremendous opportunities in India for data-mining, gene annotation, and the development of

mammal sheep was created in 1997 by cloning.

software interfaces. These require enormous computing power for which India has established
its supremacy. Foreign companies may form joint ventures with Indian companies, or enter
into technology transfer agreements or strategic research partnerships with key research
institutions. The Indian market provides opportunities to produce and sell vaccines and
therapeutics that respond to the needs of the millions of poor in India. In the agricultural
biotechnology sector, with the approval for commercial release of first genetically modified
product (Bt Cotton), India is expected to approve other crops, including mustard, soya-beans,
corn and potatoes, in the near future.

The growing research and development activities in the field of biotechnology are now the new
addition to the intellectual property regime. Very serious efforts are being made in order to
increase these inventions which involves more of the living organisms, this has now become
the most provocative issue the standard text of the patent laws are obstacle for the grant of
these patents to the biotechnology inventions and original. The non-grants of the patent
encourages uncontrolled privacy and new inventions and the original owners suffers economic
loses. TRIPS agreement seeks to enforce the patent law around the world including the
biotechnological inventions. It can be concluded that, genetically modified microorganisms
and even higher level animals like mammals can be patentable under the Patent laws of several
Countries. The WTO, under TRIPs Agreement seeks to enforce US type patents in all the
member countries.