Biotechnology project

CONJUNCTION OF BIOTECHNOLOGY & PATENT LAW: PATENTING OF LIVING FORMS Page 1
CONJUNCTION OF BIOTECHNOLOGY & PATENT LAW: PATENTING
OF LIVING FORMS
SUBMITTED TO- BANHITA SARKAR MAAM
SUBMITTED BY- VEEREN SINGH
MD. ARHAM REZA
& NAVAL JAISWAL
SUBJECT- BIOTECHNOLOGY AND PATENT LAW
COURSE- B.COM LLB (Hons.)
SEMESTER- 10
SESSION- 2015-20

CONTENTS
Page No.
A. Introduction 4
B .What is Biotechnology 5
C. Biotechnology and Patents 7
D. Biotechnological Inventions as per TRIPS and its effect on Indian Patent Law 9
E. Indian Scenario regarding Biotechnology 11
F. Patenting of Micro-organisms and Cells 16
G. Patenting of Animals 19
H. Transgenic Animals and Patenting 19
I. TRIPS and Biotechnology Patenting 20
J. The Importance of Biotechnology Patents 22
K. Conclusion 24
L. Bibliography 25

Abstract
The growing research and development (R&D) activities in the field of
Biotechnology are a new addition to Intellectual Property Regime. Serious efforts are
being made to increase the number of inventions and filling of applications for
patents. The inventions, which involve more of living organisms, became
controversial issues.
The standard tests of patent law i.e. novelty; non-obviousness and industrial use are
obstacles for grant of patents to the biotech inventions. Non-grant of patents
encourages uncontrolled piracy of new inventions and the original owners suffer
economic losses because of low returns on their huge investments in the research.
Thus there must be a conjunction between the Biotechnology and Patent Law. This
involves patenting of living forms also.
The Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement seeks
to enforce patent laws around the world including biotechnological inventions. In
India, the existing patent laws were amended to comply with the Trade Related
Aspects of Intellectual Property Rights (TRIPS) agreement. But do we provide
protection to the genetically modified animals is the question of the day. We need to
know the procedure of patenting them, if it is so important to patent them. We also to
see the moral issues involved in it.

A. INTRODUCTION
For thousands of years human beings have exploited biological resources for medical,
agricultural and other purposes. Modern biotechnology is only the latest fashion by
which man is able to use his natural environment to feed, cure and house him. In the
last decade the application of modern biotechnology for agricultural, ecological and
medical purposes has sparked great hoes for the extent to which man can explore and
exploit biological resources for his wellbeing. Biotech inventions are gaining
popularity as they help identify the root cause of chronic diseases and suggest
remedies.
Biotechnology is a new area of science that compounds life sciences of chemical
sciences. Genes in plants, providing for certain special features, would be isolated and
put together into one plant with the help of biotechnology. Through the process of
biotech by manipulation of genes new variety of animals can be invented. These new
variety of animals can be used for different purposes such as production of medicines,
for experimental for testing of medicines and treating methods.
Earlier patents were not granted to genetically modified organisms and other
products derived from living systems. With the advancement of the technology,
protection of biotechnological invention also started. But protection to the inventions,
which involve more of living organisms, became more complex and controversial.
The standard tests of patent law are obstacles for grant of patents to the biotech
inventions.
Non grant of patents encourages uncontrolled piracy of new inventions and the
original owners suffer economic losses because of low returns on their huge
investments in the research. Now the Trade Related Aspects of Intellectual Property
Rights (TRIPS) agreement seeks to enforce U.S. style patent laws around the world.
This agreement covers everything from pharmaceuticals to information technology
software and human gene sequences. It has also an impact of extension of patent
protection to genetically modified organisms in India.

B. WHAT IS BIOTECHNOLOGY
The word “biotechnology‟ was actually coined early in the 20th century by an
agricultural engineer from Hungary, named Karl Earky, who explained it in such a
way that the technology which include all such work by which the products are
produced from raw materials with the aid of living organisms. Subsequently, over the
period, the definition of biotechnology acquired a confusing status due to various
interpretations11
.
Classical biotechnology may be defined loosely as the production of usual products
by living organisms, and as such it has been with us for a long time. The first official
broad definition given by the US Office of Technology Assessment states,
“biotechnology includes any technique that uses living organisms (or parts of
organisms) to make or modify products, to improve plant or animals or to develop
microorganisms for specific use”2
. Biotechnology can be traced back to various
stages of its development. the first generation of biotechnology can be based on the
traditional knowledge in various tribes like preparing fermented foods, medical
distillates etc. second generation of biotechnology may be considered when the
utilisation of microorganisms started on industrial scale during the Pasteur era which
involved mass production of alcohol, fermentation of antibiotics, development of
classical vaccines like for cholera, typhoid, yellow fever etc. The third generation of
biotechnology, as distinct from classical fermentation technology, began in 1970s
with the two basic techniques of recombinant DNA technology and Hybridoma
technology. In the first of these, also referred to as gene splicing or genetic
engineering, genetic material from an external source is inserted into a cell in such a
way that it causes the production of a desired protein by the cell; in the second,
different types of immense all are fused together to form a hybrid cell line producing
monoclonal antibodies.3
The fourth generation of biotechnology would see further advances where
interdisciplinary techniques like information technology and nano-technology would
get involved in further advancement of this discipline, especially utilising the
bioinformatics which is the foundation of modern biotechnology. Bioinformatics can
be broadly defined as the use of computers to handle biological information.
1. Dr. K. K. Tripathi, Biotechnology and IPR Regime: In the Context of India and Developing Countries, “Biotech
Patent Law”,1st Ed.( the Icfai University Press,2007) p.,187
2. Philip W. Grubb, Patents for Chemical, Pharmaceuticals and Biotechnology, 4th Ed, (New Delhi: Oxford
University Press) 2006. P. 245-246
3. http://www.iprcommission.org

Biotechnology is thus the science of developing techniques for the application of biological
processes and organisms to the production of materials of use in medicine and industry. Viewed
from one perspective, biotechnology is no more than an aspect of chemistry in that the raw
material of biotechnology and its products most commonly DNA (Deoxyribonucleic Acid) and
polypeptides, or proteins, for which these DNA (Deoxyribonucleic Acid) sequences, or genes,
code are merely chemicals, albeit that many of them occur in nature.
Certain aspects of biotechnology law have become an especially controversial area of patent law,
especially so in Europe, and particularly so in relation to patents on genes or on living organisms
such as genetically modified animals. Much such controversy ignores the fact that the patent
system has been protecting inventions in this field for many years.
For example in relation to naturally occurring but newly discovered living organisms, such as
certain yeasts or microbes that have value as the source of medicinal products such as
antibiotics, and that many patents with claims to genes in them, are now so old that they have
now expired. The consequences of the development in the 1970’s of recombinant DNA
(Deoxyribonucleic Acid) technology, a tool for genetic engineering have however posed
problems for the patent system.
Certain of these problems such as the ‘product of nature’ issue encountered by attempts to
patent material of natural origin, are inherent in any patent system. In the latter part of the 19th
century, new inventions in the field of art, process, method or manner of manufacture,
machinery, apparatus and other substances produced by manufacturers were on the rise in India
and inventors became very interested in getting their inventions protected. Inventors were much
concerned about the enforcement of their inventions that others should not copy or infringe their
inventions.

C. BIOTECHNOLOGY AND PATENTS
In this background the British rulers enacted the first ever patent law in India, i.e., Indian
Patents Act, 1911 to offer patent protection to the inventions. Later, in the light of changing
economic and political scenarios the Act was thought as not comprehensive and outdated. After
independence, there were moves to consolidate the patent law by bringing up a new
comprehensive legislation. At last in 1970, the government enacted the Patents Act, 1970.
The Patents Act, 1970 highlights that an invention that satisfies universally accepted
requirements of patentability such as Novelty, Inventive Step and Industrial Application is
patentable. The Act defines Invention to mean ‘any new and useful art, process, method or
manner of manufacture, machine, apparatus or other articles produced by a manufacturer and
includes any new and useful improvement on any of them’. The Act does not specify the
inventions which are patentable, but it illustrates subject matters that are not patentable.
The ownership and exploitation of intellectual property rights are the key factors in determining
the success of any technological invention introduced in the market that provide the means for
technological progress to continue or to be made thereby support the competitiveness of the
industry of the country. The regulatory mechanisms in IPR have their own problems in the
coming scenario of emerging technologies especially in biotechnology.
Biotechnology is the result of efforts of intellect, the application of human intelligence and
knowledge to the biological processes. These human intellectual efforts deserve protection. The
new plans, animal varieties, new methods of treatments, new crops producing food articles as
such are the inventions of biotechnology. These inventions have to be protected for obtaining the
fruits of biotechnology.
Biotechnology has based a whole new industry and patent protection for biotechnological
inventions is of immense commercial importance. But patent law and practice have had serious
difficulties in keeping up with the rapid scientific progress in this field and issues such as
inventions steps, sufficiency of disclosure and permissible breadth of claims have proud
troublesome. There has been much litigation of biotech plants and courts have found it difficult
in such a rapidly moving field to determine what the general knowledge of the skilled person was
at the time invention was made. A procedure to find and clone a specific gene and to express it in
a suitable has may have been a breakthrough at the time when it was first done and purely
routine work, not many years later. There is also the problem of opposition by special interest
groups against anything to do with genetic engineering and particularly against the existence of
patents in this area4
.
2
4. 4 C.B.Raju, Intellectual Property Rights, 1st Ed., (New Delhi: Serials Publications), 2006.

3
The Act however did not mention anything about biotechnology inventions and the reason for
such was that at that time the biotechnology industry was not developed in India and was in a
nascent stage the world over as well.
Once the patents were granted for the different biotechnology inventions in the U.S., as well
as in the E.U. (European Union) the demand for adopting the same approach gained
significance throughout the world including India. The judiciary has been responsible for the
evolution of patent law on biotechnology inventions in the U.S. as well as in the European
Union.
Following such intervention patent laws were suitably amended and efforts were made to grant
patents on biotechnological inventions. This momentum set new trends in the history of patent
law and influenced the adoption of international conventions like Trade Related Intellectual
Property Rights (TRIPS).
The agreement states that patents shall be made available to all types of inventions in all fields of
science and technology. The agreement mandates patenting of biotechnology inventions in the
member states. After ratifying TRIPS, India modified all its intellectual property laws including
patents law and started marching towards patenting of biotechnological inventions.
i
3

D. BIOTECHNOLOGICAL INVENTIONS AS PER TRIPS AND ITS EFFECT
ON INDIAN PATENT LAW
India has amended the Patents Act, 1970, three times in a span of five years. The first was in
the year 1999, to give effect to the provisions of the Trade Related Intellectual Property Rights
(TRIPS).and thereby meet the first deadline, and some of these provisions were made
retrospective from 1995.
The second amendment was made in 2002 and brought the Indian law in substantial compliance
with the Agreement. The third amendment was brought about in December 2004, which came
into force from 1 January 2005 to make the Patents Act fully the Trade Related Intellectual
Property Rights (TRIPS) compliant. The deletion of Section 5 of the Indian Patents Act, 1970
was important to allow product patents in the area of biotechnology, chemicals and
pharmaceuticals.
Article 27(1) of the Trade Related Intellectual Property Rights (TRIPS) Agreement clearly
states that patents should be granted for inventions in any field of technology without
discrimination, subject to certain clauses.
This implies that biotechnological inventions are patentable subject matter. The patenting of
genes or DNA (Deoxyribonucleic Acid) sequences is popular in the U.S., the E.U. and Japan.
However, patenting of genes or DNA sequences per se was not allowed in India until January
2005, but processes involving recombinant DNA technology to produce proteins involving a
gene or a DNA sequence was patentable subject matter. Product patents for DNA, RNA or
genetic inventions are patentable subject matter from January 2005 following the third
amendment.
The basic criteria for a patent to be granted are Novelty, Non Obviousness (Inventive Step) and
Utility. For a patent to be granted in India it should not be covered in the negative list in Section
3 of the Indian Patents Act 1970,which provides an extensive list of what are not inventions
under the Indian Patents Act. The inventions related to DNA molecules or sequences must not be
contrary to public order and morality.

An important exclusion in Section 3 (c) of the Indian Patents Act 1970 is that the discovery of an
invention is not patentable subject matter. Therefore, the question of whether a DNA sequence is
a discovery or an invention must be addressed first. This is based on an assumption that genes
are naturally occurring; these are discoveries, and not inventions. There are no case laws in India
regarding discovery.
In Europe also ‘discoveries’ are not patentable subject matter. There are not many case laws in
Europe either. The European Community (EC) has however, issued directives and guidelines
regarding discoveries. The guidelines and rules of the European Patent Office clarify that DNA
(Deoxyribonucleic Acid) or gene sequences are patentable subject matter as these are considered
synthetic molecules isolated from the organisms and characterized and produced as recombinant
molecules or synthetic molecules containing the information as in the natural genes.
The position in the US regarding discovery is different as compared to India and Europe. Under
the US Law, Section 101 reads “Whoever invents or discovers and new and useful process,
machine, manufacture, or composition of matter, or any new and useful improvement thereof,
may obtain a patent there for, subject to the conditions and requirements of this title.”
In the case of Funk Brothers Seed Co. v Kalo Inoculant Co., 5
the patent involved a process for
inoculating leguminous plants with strains of naturally occurring bacteria to allow the plants to
fix nitrogen from the air. Wherein the Court laid down that, the claimed inventions are a
‘discovery of the phenomena of nature’, and therefore genes should not be patentable. A gene is
not an ‘invention.’ However, while the Court never explicitly overrules Funk Brothers, it limited
its holding in a subsequent decision.

4
E. INDIAN SCENARIO REGARDING BIOTECHNOLOGY
India is among the top 12 biotechnology destinations in the world and has the third-biggest
biotechnology industry in Asia-Pacific. India’s biotechnology industry is evolving rapidly and
growing at a compound annual growth rate of 20%. As per Biospectrum’s 11th Annual Indian
Biotechnology Industry Survey, the Indian Biotechnology industry grew by 15.1% from
2012 to 2013, increasing its revenues to $3.81 billion.
Further, the market size of the sector is expected to increase to $11.6 billion by 2017. This
rapid growth is attributed to a range of factors, including heightened demand for healthcare
services, intensive Research and Development (R&D) activities and strong Government
Initiatives. India is a huge market for Biotechnology Products and Services due to its Billion-
Plus Population and increasing economic prosperity.
The domestic industry is now moving into innovation, with companies focusing on strengthening
their Research and Development (R&D) development capabilities. In its 12th Five-Year Plan,
the Indian Government aims to spend $3.7 billion on the Biotechnology Sector, compared
to $1.1 billion in the 11th Five-Year Plan.
The Indian Biotechnology Industry can be divided into five key segments: -
1. Bio-Pharmaceuticals;
2. Bio-Services;
3. Bio-agriculture;
4. Bio-industrial; and
5. Bioinformatics.
Bio-pharmaceuticals accounts for the largest market share, with over 60% of the total
revenues.
5. Funk Brothers Seed Co. v Kalo Inoculant Co.333 U.S. 127 (1948)

Patent filing trends-
The 2014 Indian Patent Office (IPO) annual report stated that approximately 43,000 patent
applications were filed between April 2013 and March 2014. Over 2,300 of these related to
biotechnology and other related fields (eg, biochemistry, microbiology, biomedical devices and
chemical or biological inventions related to traditional knowledge). Although the report indicates
no criteria for patent selection in these fields, it gives a preliminary indication of biotechnology
patenting activity in India. Although patent filing in India in general has increased in the last few
years, biotechnology patent filing has decreased .This is consistent with the global trend. Among
other things, it could be attributed to more stringent criteria for patentability and grant of patents
in this domain.
Patentable subject matter
Under the Patent Act 1970, every invention must pass a two-step test in order to be patentable –
namely, it must:-
i. Not fall in any of the categories specifically excluded under Section 3 of the Patent
Act 1970; and
ii. Pass the well-known three-pronged test of Novelty, Inventive Step and Industrial
Applicability.
The following are the excluded biotechnology-related inventions:-
a. Section 3(b) of the Patent Act 1970 - Inventions contrary to Public Morality
Inventions for which the primary or intended use or commercial exploitation is contrary
to public order or morality or which cause serious prejudice to human, animal or plant
life or health or to the environment are unpatentable.
Examples include genetic modification of animals which results in suffering of the
modified animal without any substantial medical or other benefit, and inventions causing
adverse environmental impact.

b. Section 3(c) of the Patent Act 1970 – Discoveries, things isolated from nature, plants
and animals
Discoveries of living things or non-living substances occurring in nature are not
patentable subject matter. Thus, micro-organisms isolated from nature and DNA
(Deoxyribonucleic Acid), RNA (Ribonucleic Acid) or proteins isolated from living
organisms are unpatentable. Although naturally occurring micro-organisms are
unpatentable, genetically modified micro-organisms and vaccines are patentable, subject
to other requirements. Synergistic compositions of new or known micro-organisms can
also be patentable, as can processes for isolating such substances. To remove any
ambiguity, the act was amended in 2002 to include “biochemical, biotechnological and
microbiological processes” within the definition of potentially patentable chemical
processes. It is stated thus that if the end product is a commercial and vendible entity, the
presence of the living organism in the end product cannot be a bar to the patentability of
the process.
Plants and animals or their parts – including seeds, varieties and species – are
unpatentable. Further, essentially biological processes for the production of plants or
animals (eg, conventional methods of plant breeding and tissue culture techniques) are
also unpatentable.
5
Although the act does not define an ‘essentially biological process’, in Monsanto
Technology LLC v. Nuziveedu & Ors6
, the Intellectual Property Appellate Board (IPAB)
provided some guidelines on what constitutes one. The patent application under
consideration claimed a method of producing a transgenic plant.
Although the patent application was rejected on other grounds, the Intellectual Property
Appellate Board (IPAB) overturned the IPO’s objection that it was an essentially
biological process. The IPAB agreed with Monsanto’s submission that the plant cell in
the claimed process was transformed as a result of human intervention in the manner
claimed in the application, and was therefore patentable. Thus, although genetically
modified plants or seeds are not patentable in India, processes for the genetic
modification of plants are patentable.
Further, a sui generis system for protection for plant varieties is available under the
Protection of Plant Varieties and Farmers’ Rights Act 2001.
5
6. Monsanto Technology LLC v. Nuziveedu & Ors. A.I.R. 2019 S.C. 559

c. Section 3(d) of the Patent Act 1970 – New Forms or Uses of Known Substance
A new form of a known substance is unpatentable unless it differs significantly in
properties with regard to the known efficacy. This provision essentially prevents the
evergreening of patents through trivial modifications or incremental innovations.
However, its interpretation has been the source of polarising debate among legal
professionals, academics, non-governmental organisations and pharmaceutical
companies.
The Supreme Court provided some guidelines for the interpretation of the scope of this
section in its well-known Glivec judgment7
. The Court observed that the provision sets a
higher invention threshold for medicines and drugs and other chemical substances. The
term ‘efficacy’ is not defined in the Act. The court held ‘efficacy’ to mean “the ability
to produce a desired or intended result”.
The efficacy test depends on the function, utility or purpose of the product under
consideration. Thus, a medicine will undergo a test for therapeutic efficacy. A mere
change of form of a chemical substance with properties inherent to that form would not
qualify as enhancement of efficacy of a known substance. However, beneficial physico-
chemical properties such as better flow ability, process ability, thermodynamic stability
and lower hygroscopicity have nothing to do with therapeutic efficacy. Even increased
bioavailability might not pass the test laid down by Section 3(d) of the Patent Act 1970,
since it does not necessarily lead to an enhancement of therapeutic efficacy; whether it
does so in any given case must be specifically claimed and established by research data.
Under Section 3(d), the mere discovery of any new property or new use of a known
substance is also unpatentable. Therefore, a second therapeutic effect of a known drug is
unpatentable. The Court held that a claim for a method of producing heat, salt and
drought-tolerant transgenic plants using cold shock protein was rejected under Section
3(d), since the cold-tolerant property of cold shock protein was already known in the art.
6
7. Novartis v. Union of India, Civil Appeal No. 2706 –2716 of 2013 before the Supreme Court of India (2013)

7
d. Section 3(e) of the Patent Act 1970 – Mere Admixture
The mere admixture of two or more previously known substances is unpatentable, unless
it is shown that the combinative effect of such substances is more than the sum of their
individual effects.
In other words, such a combination should result in a synergistic effect. The synergism
must be properly demonstrated in the complete specification by providing appropriate
experimental data.
e. Section 3(i) – methods of treatment and diagnosis
The act does not prevent patenting of pharmaceuticals and medical devices. Thus,
medicinal compounds, drugs, formulations, stents, surgical sutures and staplers are
patentable.
However, Section 3(i) precludes from patentability:-
 Any process for the medicinal, surgical, curative, prophylactic, diagnostic,
therapeutic or other treatment of human beings; or
 Any treatment of animals which renders them free of disease or increases their
economic value (or that of their products).
7

F. PATENTING OF MICRO-ORGANISMS AND CELLS
Patents on biotechnological processes date from the early days of the United States. Louis
Pasteur received a patent for a process of fermenting beer. Acetic acid fermentation and other
food patents date from the early 1800s, while therapeutic patents in biotechnology were issued as
early as 1895. The development of recombinant DNA technology (rDNA), i.e., the controlled
joining of DNA from different organisms has resulted in greatly increased understanding of the
genetic and molecular basis of life.
Following the first successful directed insertion of recombinant DNA into a host micro-organism
in 1973, scientific researchers began to recognize the potential for directing the cellular
machinery to develop new and improved products and processes in a wide variety of industrial
sectors. Many of these products were micro-organisms (microscopic living entities) or cells (the
smallest component of life capable of carrying on all essential life processes).
With the development of recombinant DNA technology, the potential of patenting the living
organism resulting from the technology arose. Prior to 1980, patents were not granted for such
inventions, deeming them to be “products of nature” and not statutory subject matter.
Although patent applications were rejected if directed to living organisms per se, patent
protection was granted for many compositions containing living things (e.g., sterility test devices
containing living microbial spores, food yeast compositions, vaccines containing attenuated
bacteria, milky spore insecticides, and various dairy products). In the absence of congressional
action, it took a catalytic court decision to clarify the issue of patentability of living subject
matter.
The Supreme Court’s single foray into biotechnology occurred in 1980 with its ruling in the
patent law case of Diamond v. Chakrabarty8
.8
Chakrabarty had developed a genetically modified
bacterium capable of breaking down multiple components of crude oil. Because this property
was not possessed by any naturally occurring bacteria, Chakrabarty invention was thought to
have significant value for cleaning up oil spills
9
8 . Diamond v. Chakrabarty 447 U.S. 303 (1980).
9

Chakrabarty’s claims to the bacteria were rejected on two grounds:-
1. Micro-organisms are “products of nature;” and
2. As living things, micro-organisms are not patentable subject matter.
Following the two levels of appeals, the case was heard by the U.S. Supreme Court, which in a
5-4 ruling, held that a live, human-made microorganism is patentable subject matter. The
Chakrabarty decision provided great economic stimulus to patenting of micro-organisms and
cells, which in turn provided stimulus to the growth of the biotechnology industry in the 1980s.9
The legal framework of patenting microorganisms in most countries was that though they are not
specifically excluded from patentability, microorganisms were not granted patent protection on
the ground that it was contrary to natural laws. Section 3(j) of the Patents Act 1970 allows for
patents for microorganisms.
It is worded in the form of an exception to an exception. The permissibility of patenting
microorganisms was considered in Dimminaco AG v Controller of Patents and Designs10
, a case
which involved an invention relating to a process for preparation of infectious Bursitis vaccine
for protecting poultry.
The Assistant Controller of Patents and Designs rejected the application on the ground that it did
not constitute an invention under Section 2(1) (j) of the Patents Act 1970, holding that the
process of preparing the vaccine which contains a living virus cannot be considered as
‘manufacture’ under the old definition of invention. The Assistant Controller further held that the
vaccine with living organisms cannot be considered a substance. 10
9. http://www.fas.org/ota/reports/8924.pdf
10. Dimminaco AG v Controller of Patents and Designs (2002) I.P.L.R.255(Cal)

An inanimate object can be described as a thing or item but not as a living one. Microorganisms
cannot be considered an inanimate substance as it cannot be converted physically or chemically
to any other product. On an appeal preferred under Section 116 of the Patents Act 1970 to the
Calcutta High Court, the court took into account the practice of the Patent Office in granting
patents for end products containing living virus and quashed the order of the Controller and
directed the reconsideration of the patent application.
The case was decided under the provisions of the Patents Act before the Patents (Amendment)
Act 2002 came into force. The said Amendment introduces Section 3(j) which allows patents for
microorganisms. The decision in the Dimminaco case considers the practice of the Patent Office
in granting patents for end products containing living virus and arrives at its conclusion to allow
patents for microorganisms on the basis of such practice. The controversial question pertains to
how microorganisms are to be defined. By a broader definition, it will include any microscopic
organism.
A narrower definition of the word would limit the definition to only unicellular organisms. The
narrow definition of microorganism confines the application of the definition to organisms such
as viruses, algae, bacteria, fungi and protozoa. It would exclude cell lines, genes and gene
sequences.
Since the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement approves
patents for microorganisms, member countries of the World Trade Organization (WTO) have
shown a tendency to expand the scope of the microorganism and microbiological process to
include genetic material and plants and animals.
However, the TRIPS Agreement does not define the term ‘microorganisms’, leaving the
member countries with the necessary flexibility to decide the kinds of microorganisms that will
be entitled to protection. The Patent Office is unlikely to grant protection for microorganisms
which are living entities of living origin.

11
G. PATENTING OF ANIMALS
The first animal patent was issued in April 1988 to Harvard University for mammals genetically
engineered to contain a cancer-causing gene (U.S. 4,736,866). The patented mouse was
genetically engineered to be unusually susceptible to cancer, thus facilitating the testing of
carcinogens and of cancer therapies. Specifically, the patent covers “a transgenic non-human
eukaryotic animal (preferably a rodent such as a mouse) whose germ cells and somatic cells
contain an activated onco gene sequence introduced into the animal which increases the
probability of the development of neoplasm (particularly malignant tumors) in the animal.”
The claim in this patent was a transgenic non-human mammal all of whose germ cells and
somatic cells contain a recombinant activalid Onco gene sequence introduced into the said
mammal or an ancestor of the said animal at an embryonic stage.
The rat race continued and at least 16 patents have been awarded on inventions related to
transgenic mice as models exhibiting specific pathologies, such as ulcers, photo Parkinson‟s
syndrome, inflammation, sickle cell anaemia, Alzheimer‟s disease, HIV infection, Cutnieous
melanoma, leukaemia, thrombocytopenia etc10
.
12
H. TRANSGENIC ANIMALS AND PATENTING
Most potentially patentable animals are likely to be transgenic animals produced via
recombinant DNA techniques or genetic engineering. Transgenic animals are those, whose DNA
or hereditary material has been augmented by adding DNA from a source other than parental
germplasm, usually from different animals or from humans.
Laboratories around the world are conducting research that involves inserting genes from
vertebrates (including humans, mammals, or other higher organisms) into bacteria, yeast, insect
viruses, or mammalian cells in culture. A variety of techniques, most developed from early
bacterial research, can now be used to insert genes from one animal into another. These
techniques are known by a number of exotic names: microinjection, cell fusion, electroporation,
retroviral transformation, and others.
11. http://www.slwk.com/SLWK/web/company/papers/paper 14.html

I. TRIPS AND BIOTECHNOLOGY PATENTING
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”. This philosophy has done well to the country in general and to the society in
particular, in the long run by enabling access to such creations and knowledge to all without
discrimination. But in recent times the industrial countries are busy in the protection and
privatization of inventions in the area of living objects or substances such as patenting of
microorganisms and animals. Such steps were generally not accepted by the developing
countries including India.
However, Trade Related Aspects on Intellectual Property Rights (TRIPS) agreement encourages
protection of knowledge and it seeks to enforce US style patent laws around the world. This
agreement covers everything from pharmaceuticals to information technology software and
human gene sequences, and is emerging as a major issue dividing North and South. TRIPS
agreement forces all countries to accept a medley of new biotech patents covering genes, cell
lines, organisms and living processes that turn life into commodities.
Governments all over the world have been persuaded into accepting these patents on life‟ before
anyone understood the scientific and ethical implications. The patenting of life-forms and living
processes is covered under Article 27.3(b) of TRIPS. The TRIPS Article 27.3(b) is designed to
allow the broadest categories of patents from genetic engineering and other new biotechnologies.
The patenting of life forms and living processes is covered under Article 27.3(b) of TRIPS.
In India, as it is mandatory for all the member countries of the World Trade Organization
(WTO) to adopt the agreements of WTO, the Ministry of Science and Technology has issued
guidelines “Instructions for Technology transfer and Intellectual Property Rights”, which would
help in enhancing the motivation of the scientists, research institutions and universities in various
research and development projects funded by various departments of the Ministry of Science and
Technology.

The salient features of these guidelines are as follows:-
a) Ownership of Intellectual Property: - The institution shall be encouraged to seek
protection of IPR rights in respect of the results of R&D. They may retain the ownership of
such IPRs. Institution means any technical, scientific and academic establishment where the
research is carried through funding by central or state governments
b) Transfer of Technology: - The institutions would take necessary steps to commercially
exploit patents on exclusive or non-exclusive basis.
c) Royalty to Inventors: - Owner institutions are permitted to retain the benefits and earnings
generated out of the IPR. Institutions may determine the share of the inventors and other
associated persons from such earnings. However such sharing is limited to one third of such
earnings.
d) Norms for the Private Industry: - IPR generated through joint research by institutions and
industrial concerns through joint research efforts can be owned jointly by them on mutually
agreed terms through a written agreement. The institution or industrial concern may transfer
the technology to the third party for commercialisation on exclusive or nonexclusive basis.
e) Patent Facilitating Fund: - The owner institution shall set apart not less than 25% of the
revenues generated from IPR to create a patent facilitating fund. The fund shall be 13
utilised
by the owner for updating the inventions, filing applications for new patents and protecting
the IPR against infringement and for building the competency in the area of IPR and related
issues.
f) Information:- the institution shall submit the information relating to the details of the
patents obtained the benefits and earnings arising out of the IPR and the turnover of the
products periodically to the Department/ministry, which has provided the funds.12
12. Tripathi K. K., Biotechnology: Government of India Initiatives, Saketlnd Digest,Feb.2002.pp.49-53

J. THE IMPORTANCE OF BIOTECHNOLOGY PATENTS
The industries that utilise biotechnology are convinced that intellectual property protection
should be obtainable for the inventions that stem from research and which have commercial
potential. Biotechnology research workers in academic institutions increasingly share this view
because of their need for research funding which is in part conditional on patentability.
But many people are not in favour of biotechnology patents. For many such groups “patenting
life” is considered unethical in principle. The opposition extends also to possible structural
change in the agricultural industry which might stem from biotechnology and especially from the
acquisition by the larger corporations of legal rights on the advances that are being made.
A legally permissible ground of objection is that genes are naturally occurring entities and that
the methods for transferring them to plants or animals are well-known and straightforward. This
is a challenge to the inventiveness content of the particular patent at issue; it is an argument that
industrial competitors will sometimes use against each other’s patents but so far it has not
achieved a high success rate.
The argument also lies at the heart of the moral objections many with religious beliefs have to
patenting genes. They regard claims of invention, instead of discovery, tantamount to claiming to
be God. Some feel that patenting living things change the relationship between humanity and the
rest of nature.
This is particularly sensitive as regards animals, where patents are seen as conferring
“ownership”, thereby undermining the animal’s right to independence of being and relegating it
to the status of a mere object.

However, plants and animals are owned by the farmers who produce them and use them as
agricultural commodities. All such owners, whether of patented or unpatented organisms, are
bound to respect animal welfare legislation.
The objection to animal suffering may also apply to the genetic modification of farm animals.
One early experiment to insert a growth hormone gene into a pig in order to increase growth rate
succeeded but caused severe unforeseen side effects including arthritis.
Animal welfare groups argue that patents will encourage more research on animal genetic
modification, which they oppose on grounds of possible suffering and of principle. Intended to
prevent undue suffering, legislation requires the granting of animal experimentation licenses and
full disclosure of the experimentation.
The patentability of genes and other nucleic acid sequences is justified on the ground that they
have been subject to a microbiological or non-biological process, i.e., gene sequencing, which is
itself a standard process patentable and patented under existing patent laws for invention. So, the
actual patented entity is the nucleic acid sequence itself and its putative function.
However, the DNA or RNA sequence is subject to change by mutation, deletion, insertion and
rearrangement. The patenting of genomes raises the question of the function of the genomes.
Again, the isolated genome can do nothing by itself, while its "function" in the organism cannot
be considered separately from the totality of the organism.

K. CONCLUSION
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 World Trade
Organization (WTO), under TRIPS Agreement seeks to enforce U.S. type patents in all the
member countries.
The Patent Act provides no inclusive definition of patentable subject matter, providing only a list
of what is considered unpatentable. Unfortunately, these exceptions can be vague, leading
sometimes to uncertainty – and this is especially true for biotechnology inventions, due to the
complex nature of the technology. Innovators, investors and patent practitioners must analyse
their inventions in light of Indian patent law before making any strategic decisions regarding
patenting in India.
A steady progression of case law marks the way by which patent protection has been expanded
to include living organisms. While formal patent law is about 500 years old, it is only in the past
130 years that it has begun to enter the area of biotechnology. The first step in the expansion of
patent law turned out to be something of a false start. In 1873, Louis Pasteur received a patent for
his claim to yeast free from organic germs of disease, as an article of manufacture. This was the
first patent on a microorganism and the first patent on a living organism. It took over 100 years
for the next patent on a microorganism to be granted.
Patents are a form of reward for human ingenuity in the form of monopoly rights. Biotechnology
inventions, a result of human ingenuity to the biological processes too deserve patent protection.
Biotechnology and patent thus go hand in hand there is a conjunction between the biotechnology
and patents. Biotechnology deserves to be patented, subject to certain moral conditions. The
general public plays a very important role in defining patent principles based on their perception
of morality in granting patents on biotechnology and specifically gene based inventions.

L. BIBLIOGRAPHY
1. Biological Diversity Act,2002
2. The Patents Act, 1970
3. Law Relating to Intellectual Property Rights by V.K. Abuja
4. Tripathi K. K., Biotechnology and IPR Regime: In the Context of India and Developing
Countries, “Biotech Patent Law”

Biotechnology project

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Biotechnology project

Similar to Biotechnology project (20)

Recently uploaded

Recently uploaded (20)

Biotechnology project