CH 2

CHAPTER 2
Evolution of Biotechnology Patent

Law
The history of patent system dates back to the seventh century BC, when
Greeks began granting short-term exclusive rights to cooks to prepare new
recipes in order that the others might be induced to labour at excelling in
such pursuits. But the global adoption of the system gradually increased in
course of time. It spread to the state of Venice in 1474, England in 1623,
the US in 1790, France in 1971, and Sweden in 1819. The first patent law
in history was that of Venetian statute 1494. Venetian statute was the
foundation for the world’s patent system. The basic policies underlying
modern patent law regimes including the quid pro quo were present in the
Venetian statute. The statute set forth the statutory requirements for the
patentability of inventions which are still relevant.
EVOLUTION OF BIOTECHNOLOGY PATENT LAW IN THE US
In the United States, Thomas Jefferson drafted the first patent statute which
was enacted in the year 1793. The Act articulated the requirements of
patentability as enshrined under the Venetian statute such as ‘utility’,
‘novelty’, and ‘non-obviousness’. The philosophy behind the 1793 Act was
that ‘the ingenuity should receive a liberal encouragement’1. The Act defines
patentable subject matter in broad terms to mean ‘any new or useful art,
machine, manufacture or composition of matter, or any new or useful
improvement thereof’. The subsequent Acts of 1836,1870, and 1874 reiterate
the philosophy outlined by the 1793 Act.
In the year 1952 the law on patents was recodified in the form of Patents
Act, 1952. In doing so, the term art was replaced with process in the definition
of the patentable subject matter. The altered definition of patentable subject
matter stands as ‘any new and useful process, machine, manufacture or
composition of matter or any new and useful improvement thereof.’2 In all
these enactments on patents, living organisms were kept out. This was not
due to any religious belief or ethical consideration, but due to the fact that
living organisms were considered to be the ‘common heritage’ of mankind
and not considered to be patentable.3
History and evolution of biotechnology patent law
The evolution of biotechnology patent law can be traced back to the United
1. Writings of Thomas Jefferson, pp. 75-6, (Washington, ed. 1871).

2. The present patent law in the US is the result of the recodification of patent laws in 1952.
3. K.R.G. Nair and Ashok Kumar, Intellectual Property Rights, New Delhi : Allied, 1994, p. 189.
20 BIOTECHNOLOGY AND PATENT LAW
States.4 The United States Constitution states:5 the Congress shall have
the power to promote the progress of science and useful arts, by securing for
limited times to authors and inventors the exclusive right to their respective
writings and discoveries.6 The plain meaning of the above provision does
not say anything about patenting of biotechnology. It merely signifies
Congress’ power to promote the progress of science and arts by granting
exclusive rights to the inventors for a limited time. The promotion of science
is the threshold of Patent Law.7 The United States Patent Act in its original
form does not say anything about patenting of biotechnology inventions. It
states that whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter or any new and useful
improvement thereof, may obtain a patent therefor, subject to the conditions
and requirements under the patent law.8
As in the Venetian statute, so also in the 1952 patent law living beings
are not considered patentable subject matter. The recent emergence of the
science of biotechnology made it possible to invent new and innovative living
beings. However, these developments of biotechnology were not expected
and no provision was made in the then existing patent laws. Before the
biotechnology era, patenting of living beings was out of all purviews. But it
was the judiciary that took initiative to interpret the existing patent law in
an innovative and liberal way, to offer patent protection to biotechnology
inventions. In fact, more than legislative initiatives, judiciary’s
pronouncements have laid the foundation for the evolution of biotechnology
patent law. The judiciary did not alter or change any provisions of existing
patent law; rather it has taken a liberal approach in interpreting patent
law. Today, biotechnological inventions do constitute patentable subject
matter to the credit of judiciary for its liberal and innovative interpretation
of patent laws. Earlier in the nineteenth century, there were moves to patent
living process in the United States. For the first time the United States
Patent Office granted a patent to Louis Pasteur on ‘yeast’ that is free from
organic germs of disease.9 It was the first incidence in the history of patent
law wherein a patent was granted on a living matter. The Patent Office
considered the invention as an article of manufacture within the meaning
of patentable subject matter under the US patent law, but the fact that the
invention claimed was a living process was not taken into account. Patent
was indeed granted on a living matter but the approach was not in favour
of granting patents on living matter or living processes.
4. Manu Luv Sahalia, Perspectives Intellectual Property Law : Many Sides to a Coin, Delhi :
Universal Law Publishing Co. Pvt. Ltd., 2003, p. 171.
5. See Donald S.Chisum, Craig Allen Nard, Herbert F. Schwartz, Pauline Newman, Scott HieffF.,
Principles of Patent Law: Cases and Materials, University Casebook Series, New York
Foundation Press, 1998, pp. 773-9.
6. US Constitution, Article 1, Section 8.
7. US Patent law as modified in August 2005
8. Section 101 of the US Patent Law.
9. US Patent No: 141,072 granted in the year 1873.
EVOLUTION OF BIOTECHNOLOGY PATENT LAW 21
Subsequently in Exparte Latimer 10 a patent claim for fibre found in the

needle of the Pinus astralis was rejected. The belief was that plants, even
those artificially bred, were products of nature for purposes of the patent
law. A general principle was set that plants were natural products and not
subjected to patent protection.11 The view taken was that patent on such
fibre would lead to patents on the trees of the forest and the plants of the
earth, which was considered unreasonable. Besides, it was thought that it
was not possible to describe plants in a written form, as new plants might
differ from old in colour and perfume that cannot be described in a written
form. Hence it was decided that plants could not satisfy written description
requirement under Section 112 of the United Sates patent statute. The
case law has postulated the following two principles:12
z Plants are products of nature though artificially bred, and are not
patentable.
z Plants are not amenable to the ‘written description requirement’ of
the patent law.
The above two principles were found to be hurdles for granting patent
protection for plants.13 Since 1930 living organisms were not considered as
patentable. However, the Plant Patents Act, 1930, relaxed the situation by
providing that the work of plant breeder in aid of nature was patentable
invention. The Act extended patent protection to certain asexually reproduced
plants, such as reproduction of plants by grafting and budding. The Act
was viewed as reflecting the legislative attention to the problems of patenting
living organisms. The Act has also relaxed the requirement of written
description by stating that reasonable written description is enough to grant
patents.14 The purpose of the Act was to solve the technical problem of
description of plants referred to in the Latimer decision (no. 10 supra). In
1970 Congress enacted the Plant Variety Protection Act, 1970, which
extended protection to certain new plant varieties capable of sexual
reproduction. It seems Congress intended to promote the agricultural industry
by encouraging patents on asexually reproduced plants.
The 1930 Act as well as 1970 Act did not show any indication of including
bacteria within the purview of the patentable subject matter. These Acts
strongly evidence a congressional limitation that excludes bacteria from
patentability. The issue of including bacteria within the purview of patent
protection was considered at the time of passing of the 1970 Act15 but the
same did not materialize.16 Soon after the passage of the Plant Patent Act,
10. December 1889, Com. pat.123.

11. Thorne, Relation of patent law to natural products, 6j.pat off. Soc. 23, 24 (1923).
12. See supra 5, p. 776.
13. H.R. Rep. No. 1129, 71st Cong., 2d Sess, 7-9 (1930).
14. 35 U.S.C Sec 162.
15. See supra 5, pp. 781-2.
16. It seems Congress had intended to include bacteria within the scope of patent protection
at the time of enacting the 1970 Act.
1930, US courts decided whether certain living things form part of the
patentable subject matter or not. An opportunity arose for the courts to
interpret the patentable subject matter under Section 101 of the patent
statute. As per the language of the patent statute patentable subject matter
encompasses any ‘new and useful process, machine, manufacture or
composition of matter or any new and useful improvement thereof’.
The term ‘manufacture’ was interpreted in American Fruit Growers Inc v.
Brogdex Co.17 The claims were for ‘coated oranges’. It was considered whether
the claimed invention comes within the meaning of the term ‘manufacture’.
The court happened to interpret the term ‘manufacture’ to mean the products
of articles for use from raw or prepared materials by giving to these materials
new forms, qualities, properties, or combinations whether by manual labour
or by machinery. The term ‘manufacture’ implies the production of new
articles by using raw materials and giving such raw materials a new form,
quality, and properties or a combination of these. In the instant case the
court rejected the claims on the ground that coated oranges were not
sufficiently modified. The court held that the claimed oranges were not
attributed considerably new qualities, properties, or a combination of these
in order to be considered as a manufacture.
The decision of the court lays down that the inventors would have got
the patent if their claimed oranges were considerably modified to posses,
new qualities, properties or their combination. It seems that in the early
part of the twentieth century itself America was inching towards patenting
of living beings. However, existing living organisms or biological resources
were used as raw materials in producing biotechnology inventions. The
resulting living being was the manipulation and manifestation of an existing
living being giving it a new look or features, which it was not. Such being the
case, it can be inferred that biotechnological inventions do come within the
meaning of the term ‘manufacture’ forming part of the patentable subject
matter.
Doctrine of product of nature
Perhaps living beings are considered as products of nature. Patents on living
things were rejected on the basis of the fact that living things are products
of nature. Product of nature is a doctrine, which patent offices and courts
have used to reject patents on living matter. The philosophy was that living
beings were products produced by nature, which belonged to all beyond the
monopoly of anybody. In Funk Brothers Seed Co. v. Kalo Inoculant Co.18 the
claim was a mixed culture of different strains, each of which was useful to
inoculate the roots of different species of leguminous plants, assisting the
plants in nitrogen fixation. Different species of root-nodule bacteria existed
in nature. Applicants made efforts to combine the different species of bacteria
in a mixed culture suitable for inoculating a range of crops. These attempts
failed because the different species inhibited each other’s effectiveness in
combination.
17. 283 US 1.11.51 S.ct, 328, 330, 75 L.Ed.801 (1931).
18. 33 US 127 (1948).
The United States Supreme Court held the patent claim as invalid on
the ground of product of nature. The Court denied including a living subject
matter within the purview of patentable subject matter and held that the
claimed bacterium was a natural bacterium that existed in nature and
there was no effort of the patentee to change its status as a product of
nature. It was observed that the patentee had not created any new bacteria.19
The Court opined that products of nature were manifestations of nature
belonging to none and were not patentable. The Court viewed that products
of nature did not fall within the purview of patentable subject matter.
Further, in Shell Development Co. v. Watson20 the expression ‘composition
of matter’ under the patentable subject matter was interpreted to mean ‘all
compositions of two or more substances and all composite articles, whether
they be the results of chemical union or of mechanical mixture or whether
they be gases, fluids, powder or solids’. As per this interpretation
biotechnological inventions do come within the meaning of composition of
matter. Biotechnological inventions entail isolating genetic material from
one species and incorporating it into an intended species or isolation and
purification of genetic material from different regions of human or animal
body. In this sense biotechnological inventions are composition of genetic
material from different species or different regions of a living being’s body.
Hence it can be inferred that the Court signalled liberalization of patent
laws to encourage new techniques and technologies. Following the suit,
Congress enacted the Patents Act, 1952, by codifying the patent laws. As an
extension of the philosophy ‘ingenuity should receive liberal encouragement’
the Act amended the contents of patentable subject matter, thereby replacing
the term ‘art’ with ‘process’. Seemingly, it was a leap forward to include
biotechnological processes and inventions within the purview of patentable
subject matter.
The discovery of DNA by Crick and Watson in 1953 laid the foundation
for modern biotechnology. In the mean time biotechnology grew as a science
of miracles with the potential of manipulating, manifesting, and producing
innovative living beings. However, till the 1960s, the United States did not
witness any major development regarding the patenting of biotechnological
inventions. The United States judiciary, which is known for its practical
approach, did not come across any such instances claming living beings for
patents. However, United States Patent Office reportedly granted two patents
on living micro-organisms in 1967 and 1968.21
Patenting of micro-organisms
The 1970s witnessed moves towards patenting living matter, which laid
foundation for the evolution of biotechnology patent law. During this time
19. 33 US 127 (1948).

20. 149 F. Supp.279, 280 (D.C. 1957) (citing 1 A.Deller, Walker on Patents, p. 55 (1st ed., 1937).
21. See supra 5, p. 78.
there were claims for patents on living matter. In Diamond v. Chakraburty22

the claim was for a genetically modified micro-organism capable of eating
crude oil spills. The inventor Chakraburty claimed both the process of
producing the bacteria and the bacteria. For the first time in the history of
patent law, a question arose whether living matter was patenable or not.
The patent office allowed process claims for the method of producing bacteria
but the claim for bacteria was rejected. Chakraburty appealed to the Patent
Office Board of Appeals, where the rejection was affirmed. The Board
concluded that patentable subject matter as enshrined under Section 101
of the United States Patent Code did not encompass living things such as
micro-organisms. The Board did not go into detail whether the invention
involved any inventive step or not. The claim was plainly rejected by stating
that patentable subject matter did not encompass living things. An appeal
was made to the Supreme Court. There was much anxiety and the whole
world was eagerly waiting for the decision.
The Supreme Court by a 5:4 majority overruled the patent examiners,
rejection of the patent and held that the United States patent statute is
broad enough to cover living organisms. The Court viewed that constitution
had granted wide powers to the Congress to promote the progress of science.
The Congress has every power to legislate with respect to the promotion
and advancement of science. It was held that the language of the patent
statute was broad enough to encompass protection to living organisms.
While determining, whether the claimed invention came within the meaning
and scope of patentable subject matter, the Court in particular considered
two terms, ‘manufacture’ and ‘composition of matter’, under Section 101 of
the patent law. The Court relied on the decision of American Fruit Growers23
while interpreting the term ‘manufacture’ and the decision of Shell
development 24 while interpreting the term ‘composition of matter’. The Court
interpreted the phrase ‘composition of matter’ to encompass living matter
produced through biotechnology. The Court observed that the claimed
bacterium was a composite mixture of the features of known species, put
together into one species. It was viewed that Chakraburty had genetically
modified the natural bacterium to possess capacity to eat crude oil spills.25
Upholding the philosophy of Thomas Jefferson, the author of the first
patent law in the United States that ‘ingenuity should receive liberal
encouragement’, it was held that the invention was a result of human
ingenuity and intellectual labour which should receive liberal
encouragement. The Court accepted the contention of Chakraburty that
the bacterium was a non-naturally occurring human-made micro-organism
which did not exist in nature automatically. Responding to the contentions
22. (1980) US SC 447 at 303.

23. 283 US 1.11.51 S.Ct, 328, 330, 75 L.Ed.801 (1931).
24. 149 F. Supp. 279, 280 (D.C. 1957) (citing 1 A.Deller, Walker on Patents, p. 55,1st ed.1937).
25. In fact natural bacterium can also eat up oil spills, but the process is slow. Chakraburty’s
genetically modified bacterium is much faster in eating the oil spills.
that living matter was a product of nature and could not be patented, the
Court held that Chakraburty’s invention was not a product of nature; it
was a product of man, the human role involved in the invention differentiates
it from a product of nature. The Court accepted that the starting point of
the invention was a product of nature, but the inventor had added his
ingenuity in making the bacterium to possess the capacity to eat up oil
spills with accuracy and pace. Naturally, the bacterium did not possess
such a feature; there was a role of human agency in making the bacterium
to possess such special skill. Therefore, the invention was a non-natural
human-made product, a result of human ingenuity and labour. The very
fact that human agency had played a role in making the bacterium to possess
special skill renders the product of nature a product of man. The bacterium
was a product of nature till human intervention whereupon it turned into
product of man.
Rejecting the argument that micro-organisms cannot qualify as
patentable subject matter until the Congress expressly authorized such
protection, the Court held that biotechnology was unforeseen by the
Congress when it enacted Section 101 on patentable subject matter. However,
the Congress employed broad general language in drafting Section 101
precisely because such inventions were often unforeseeable. The Court
highlighted the constitutional objective of promoting the progress of science
and also the philosophy of Jefferson that ingenuity should receive liberal
encouragement in interpreting the patentable subject matter to encompass
living matter. At the time of the judgment there were at least 100 patent
applications pending before the United States Patent and Trademarks Office
(USPTO) that were disposed of on the rationality of the decision. There was
a plethora of patent applications before the USPTO soon after the decision
on Chakraburty. The case had set a new trend, it began a new era of patent
law. The decision had raised the curtain for the evolution of biotechnology
patent law and it opened floodgates for biotechnology patents.
Patenting of transgenic plants
The impact of the decision on Chakraburty was such that it had not only
interpreted the patenable subject matter under Section 101 of the United
States patent statute to encompass micro-organisms but it furthered the
debate over patenting of living material including plants and animals. With
the encouragement and inspiration from the Chakraburty decision, the
scientific community, with extended enthusiasm and spirit, furthered their
research in the field of biotechnology extending its scope to cover other
living beings. The streamlined research in the field resulted in transgenic
plants. Biotechnology proved that it was quite capable of producing
transgenic plants in a hitherto unknown manner by combining the qualities
of different plants and putting them together into an intended plant. The
resulting plants were genetically modified to possess certain special features
such as high yield, resistance to pests, and capacity to withstand drought
conditions, which did not exist earlier. As the progress in biotechnology
witnessed transgenic plants claims for patenting transgenic plants and
related inventions began to increase.
Incessant filing of patent applications as such was the sequel of Chakraburty

decision. It was for the first time in 1986 in Exparte Hibberd 26 a mutant
maize plant was claimed for a patent. The patent examiner rejected the
patent application on the basis that the claim was for a living thing. The
patent examiner viewed the claimed invention as a product of nature and
decided that it was not patentable.27 However, United States Patent Board
of Appeals overturned the ruling of the examiner to grant patent on maize
mutants. The Board, relying on the principle outlined in Chakraburty that
when human ingenuity was added to a product of nature, it became product
of man, decided the claimed maize mutants as eligible for patent protection.
The Board followed the suit in Chakraburty and extended the philosophy of
Chakraburty to human-made transgenic plants.28
Soon after this decision the United States Patent Office started
entertaining patent applications claiming plants and related inventions.29
A hike in the patent application claiming transgenic plants, plant cells, and
tissues was witnessed.30 In HiBred International v. JEM AG Supply Inc.,
Supp,31 the United States Court of Appeals for the federal circuit upheld
patents on plants.32 Therefore, now plants and related inventions such as
plant cells and tissues are patent eligible. Dynamic as any science is
biotechnology is keeping a fast pace breaking new frontiers–pace so fast
that law is running behind it for regulations.
26. The decision of Diamond v. Ananda Chakraborty had its impact when a plant was claimed
for patent for the first time. The clamants contended the rationality of Diamond v. Ananda
Chakraborty where it was held that anything under the sun made by man is patentable.
Applying the same rationality claimants contended that maize mutant plant which they
claimed for paent is not available in the nature. They also contended that the plant they
are claiming is the modified form which is different from the natural form and, hence, by
applying the rationality of Diamond v. Ananda Chakraborty patent could be granted.
27. Further it was contended that there was another law, the United States Plant Variety
Rights Law under which protection can be sought rather than seeking patent.
28. See Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries,
New Delhi : Oxford University Press, First published in India 2001, Third impression 2002,
pp. 177-82.
29. With this required boost from the patent office, biotechnologists carried forth their
research in the field resulting many transgenic plants and related inventions.
30. Biotechnology showed its capacity to manipulate plants in a hitherto unknown way in
isolating and purifying generic material and in incorporating foreign genes into an intended
plant. In living beings particular genes code for features such as good yield or resistance to
pests, or capacity to withstand drought conditions. We have seen plants being capable of
giving high yield. (a few kinds of plants are capable of giving high yield when extended
water facilities and soil fertility conditions create the required environment.) We have seen
plants capable of resisting pests (Plants if exposed to pests continuously will develop resisting
capacity to pests.) And we have also seen plants having capacity to withstand drought
conditions. (Generally plants grown in desert regions and in regions where there is low
rainfall will have capacity to withstand drought condition by utilizing minimum water.)
How would it be if a single plant does possess all the above features? It is possible through
genetic manipulation, a new technique in the field of biotechnology. Genes coding for such
qualities can be isolated in different plants and incorporated into an intended plant, which
in turn possess all the features of plants from which genes are taken. This paved the way to
transgenic plants such as BT cotton, BT rice, BT soybeans.
31. 2d 794 (D.lowa 1999) No.99-1035.
32. World Intellectual Property Report, Vol.14, No. 3, 15 March, 2000.
Patenting of higher life forms : Animals

Micro-organisms such as bacteria, algae, and plants are considered as lower
life forms. Animals are considered as higher life forms in biological terms.
The capacity of animals to think and express makes them different from
lower life forms and hence they are considered as higher life forms along
with human beings. The voyage of biotechnology patent law furthered to
cover animals and related inventions.33 Once transgenic plants were given
patents, biotechnologists started trying their hands in producing transgenic
animals. The result was new forms of animals with foreign genes called
genetically manipulated animals. Initiating debate over the patenting of
animals for the first time in the history of patent law in 1987, an animal
was claimed for a patent. In Exparte Allen34 the claim was for oyster, a
genetically modified animal. The patent was opposed on the ground of
product of nature. Opponents contended that animal being a creation of
God was a product of nature and could not be patented. God was the only
owner of products of nature; man could not own it by patenting it. Meanwhile,
the patent office rejected the claim for the invention on the ground of
obviousness, i.e., lack of inventive step. On appeal, the Board of Patent
Appeals and Interferences confirmed the rejection.
However, the Board rejected to affirm that the oysters were naturally
occurring subject matter and consequently left alive the issue of patenting
of living organisms.35 In other sense the Board accepted that the claimed
oyster is a non-naturally occurring living matter, further animiating the
debate on animal patenting. Meanwhile, patent applications claiming
animals, animal genes, tissues, and other inventions relating to animal
genetic material started pouring in. There was vehement pressure from the
biotech industry to grant patents on animals in the light of its enormous
potential and utility of the claimed inventions. In this background the patent
office issued a statement revealing its stand on animal patenting. It was
stated, ‘The patent office now considers non naturally occurring non-human
multi-cellular living organisms, including animals to be patentable subject
matter within the scope of subject matter under the United States Patent
33. However, biotechnology is capable of manipulating higher life forms. Biotechnology industry
produced transgenic animals that possess qualities such as high yield of milk, flesh, faster
growth, etc. New forms of animals are produced through biotechnology by genetically
manipulating the existing animals. We have seen animals giving high yield of milk such as
jersey cows. We have seen animals giving high yield of flesh and wool such as hybrid sheep.
We also saw animals which grow fast. How would it be if all these features were found in
a single animal? It is possible through biotechnology. Genes coding for certain features in
the animals can be isolated and incorporated into an intended animals which in turn possess
all the features. At the same time genes in the animals can be removed or suppressed to get
the desired results. Genes coding for certain qualities can also be isolated and incorporated
into any living being to get the desired results. Genes in animals coding for certain proteins
are isolated and commercially produced by incorporating such genes into a bacteria or
other micro-organisms.
34. 1987 USPO 2d 1425.
35. See supra 4, p. 173.
Statute.’ Based on this policy the United States Patent Office granted the
first patent on an animal.
In the year 1988 patent was granted on a genetically engineered mouse, an
Onco–mouse, susceptible to cancer. A foreign gene, onco gene, was
incorporated into the mouse by genetically engineering it, which made it
susceptible to cancer. The mouse was useful in cancer testing. The patent
office granted patent on the ground that the invention is a non-naturally
occurring and human-made living being. The decision brought animals
within the purview of patentable subject matter. After onco–mouse was
patented, the mouse race continued and at least sixteen patents had been
granted on inventions relating to transgenic mice. The voyage of patent law
witnessed patents on transgenic sheep producing protein in its milk,
transgenic pigs that produced low cholesterol meat, and animals that
produced pharmaceuticals in bioreactors.36 The race continued and patents
were also granted on goat and cattle expressing diverse protein. The voyage
of biotechnology patent law reached a stage wherein it offered patent
protection to genetically modified or transgenic animals. As per the
observations now it is possible to build a farm of transgenic animals to
which patent protection is offered.37
Patenting of human cells and genetic material
The voyage of patent law further continues, as there were moves to patent
human genetic material. The evolution of biotechnology patent law adds
another feather in its cap by extending patenting protection to human genetic
material such as human cells, genes, and DNA.38 New techniques in
biotechnology such as recombinant DNA technology, gene splicing, and
gene manipulation made the isolation and purification of human cells, genes,
gene sequences, DNA, and DNA sequences possible. These genes, gene
sequences, DNA are called genetic material, which have now become a
subject of patent protection. Genes code for some specific proteins which
may have some medicinal value. These genes, gene sequences, and DNA
inside a cell or even cells and cell lines have been claimed for patent.
36. See supra 28, p. 164.

37. Prabudha Ganguli, Intellectual Property Rights : Unleashing the Knowledge Economy,
New Delhi : Tata Mcgraw Hill, 2001, pp. 125-6.
38. Living beings are made up of cells. Cell is a small part of every living being. There are
unicellular organisms such as bacteria, which have only one cell in their bodies. One cell
makes its whole body. There are multicellular organisms such as plants, animals and human
beings having more than one cell in their body. Cell has the capacity of self-replication.
Through replication it can grow into a number of cells. It was estimated that in human
body there are three trillion cells. The body of living beings is made of cells. Cells consist of
a genome inside which chromosomes are found made of DNA. Gene is a specific chemical
pattern on a DNA, which controls the development of specific characteristic features in any
plant, animal, and human being. Genes are found in sequences; a gene may have a number
of sequences. Isolation of genes requires isolation of each sequence. Inside the genome of a
cell there is also found nucleic acid molecules. DNA and Ribonucleic acid are known as
nucleic acid molecules that play a very important role in the replication of a cell and
transmission of genetic information.
For the first time in the history of patent law a human cell line was claimed
for a patent. The cell line was taken from the spleen of a person named John
Moore. This particular cell line was producing valuable antibacterial and
cancer-fighting proteins. The doctors of John Moore identified and isolated
the cell line and applied for patent. The United States Patent Office granted
patent on the cell line, thereby making human cells and genetic material a
subject of patents. As more and more research is being conducted in the
field and enormous utility of genetic material is being identified, a rush
began for claiming patents on specific genetic material like DNA and genes.
In Amgen v. Chugai 39 the claim was for an isolated and purified DNA sequence.
It was for the first time in the history of patent law that a human genetic
material, i.e., DNA was claimed for patent. The claimed DNA codes for a
protein called erythropoietin that boosts red blood cell production. The
invention is very much useful to the people suffering from anemia having
red blood cell deficiency. The inventors wanted to commercialize the invention
by patenting it.
Patenting of human genetic material did not attract opposition on the basis
of products of nature unlike patents on plants and animals. Oppositions
concentrated on the actual isolation, possession, and conception of the
inventions. Here the court investigated into the fact whether the inventor
has actually conceived the invention. The court defined the conception to
mean actual knowledge of the invention with its properties and reducing
the invention to successful practice. Considering the invention in the case
it was held that the conception of DNA meant actual knowledge of the DNA
sequence with its physical and chemical properties and experimenting the
DNA successfully. It was found that the inventors actually had the knowledge
of the DNA and had reduced successfully to practice, and eventually patent
was granted. As biotechnological inventions involve conception of different
genetic material or conception of different methods to isolate or employ genetic
material the definition provided for conception is very significant. It can be
said that biotechnology inventions, if actually conceived in the manner
provided in this case, will be eligible for patent. Further, in In re Vaeck the
claim related to manipulating a bacterium to insert a gene. Inventors isolated
a gene and combined it with a stretch of DNA from the bacteria and created
chimeric gene. A patent was claimed in 1991 and the same was granted.40
Following the suit in Amgen in In re Bell41 there were claims on DNA and
RNA coding for human insulin like growth factors, which play a vital role in
the mediation of somatic cell growth on the administration of growth
hormones. As it was decided in the Amgen case that human genetic material
is patentable, oppositions were not against the patenting of human genetic
material but on the specificity and inventive step involved in the invention.
39. 927 F.2d 1200, 18 USPQ 2d 1016 (Fed. Cir. 1991).

40. Brian C. Cannon, ‘Toward a clear standard of obviousness for biotechnology patents’, Cornell
Law Review, Cornell University, March 1994.
41. 991. F.2d 781 (Fed. Cir. 1993).
Patent was opposed on the basis of the prior art suggesting for a general
method for isolation of genes and DNA. The prior art was suggestive of a
general method for isolation of genes and DNA. The Federal Circuit held
that a general method for isolating genes or DNA would not render a specific
method of isolating a particular DNA coding for specific human insulin
growth factors obvious, and eventually patent was granted. Here the Federal
Circuit did set forth a principle that a general method suggested for isolating
genes, DNA, or other genetic material would not deprive the inventor, who
invents a specific method, from patent. This decision came as an
encouragement to the biotechnologists as at the time the industry was
regularly involved in isolating infinite number of human genes and DNA. If
one general method for isolating genes and DNA blocks other inventors
from patenting their specific methods, it obstructs the progress of the
industry.
A general method always may not succeed or even if it succeeds, the
results may not be accurate. However, specific methods provide for accurate
results, particularly for isolating one specific gene or DNA in the light of
infinite number of genes and DNA present in our body. This approach
provided much needed encouragement to the biotech industry.
Biotechnologists became busy in claiming patents for their specific methods
for the isolation of specific genetic material after the above decision. The
race continued and in In re Deuel42 the invention related to an isolated and
purified DNA and cDNA (composite DNA) molecules coding for Heparin
Binding Growth Factors (HBGF) were claimed. Heparin Binding Growth
Factors are proteins that stimulate cell division and facilitate the repair or
replacement of damaged or diseased tissue. Patent was opposed on the
basis of the prior art suggesting for a general method for isolation of genes
and DNA. Prior art had also suggested the protein HBGF, with its amino
acid sequences. The Federal Circuit reiterated the principle laid down in In
re Bell’s case and held that prior art suggesting a general method for isolating
DNA molecules would not render a specific method obvious.
Now it is a settled fact that human genetic material is unambiguously
patentable. There is no opposition to the patenting of isolated and purified
human genetic material. The patent law does provide protection to the
inventions of genetic material in an isolated form. The interpretation of the
patentable subject matter under the patent code in an innovative and liberal
way has brought human genetic material within the purview of patentable
subject matter. The law on the patenting of biotechnological inventions
now offers patents to ultramicroscopic human genetic material such as
genes, DNA, and like materials.
Patenting of fragments of DNA and genes
DNA is made up of sequences. In fact, a gene is the portion of DNA, which
expresses a particular protein. In turn, gene is also a composition of
42. 51 F. 3d 1552 (Fed. Cir.1995).

sequences. Isolation and sequencing of DNA requires isolation and

sequencing of its different sequences. On the same line isolation and
sequencing of gene requires isolation and sequencing of its different
sequences. The 1980s and 1990s witnessed patents on DNA and genes.
Late 1990s witnessed claims for small sequences and fragments of DNA
and genes. Essential Sequence Tag (EST) is a part of a sequence from a
cDNA molecule. Essential sequence tags are used in finding the full-length
DNA or gene. Patenting of ESTs proved controversial as it was challenged
by a variety of societies like HUGO (Human Genome Organization). HUGO
says that EST does not involve an inventive step and moreover it lacks
substantial and credible utility. Given the vehement opposition, patenting
of EST proved controversial and eventually the patent office did not prefer
to grant patents on EST.
However, arguments in support of patenting EST are that EST can be
used as probes in identifying genetic material. It is useful in identifying full
stretch of genes or DNA. As isolation of any gene or DNA starts with the
isolation of its sequences, EST being a fragment of a gene or DNA comes to
the use for identifying the full stretch of a DNA or gene. In 1997, Clinton
administration announced that the patent office would begin allowing
patents on EST based on their utility as probe. Having received the green
signal from the government, the patent office started entertaining patent
applications on EST. This resulted in a flood of patent applications claiming
EST. Subsequently, on 6 October, 1998 the first patent on EST was issued43
to Incyte Pharmaceuticals Inc. By the end of 1998, the same company filed
patent applications for over 1.2 million DNA sequences many of which are
of human origin. Reportedly by the end of 2000, the USPTO had received
patent applications on millions of gene fragments. The sheer numbers of
applications suggest that every human gene at least in part might already
be subject to a patent application.44
Patenting of biotechnological processes and methods
Not only human genetic material but also methods or processes to isolate
such material are claimed for patents. Methods of expressing specific proteins
in vitro (outside the body of animal or human) through incorporation of genes
coding are also claimed for patent. In order to produce a certain protein
coded by a particular gene, the gene is isolated and incorporated into the
intended body say, bacterium. The bacterium as a regular biological process
produces such protein for which it was genetically engineered. On the same
lines methods to produce antibodies45 from the genetic material are also
43. US patent No. 5,817,419, ‘Human Kinase Homologs’ issued to Incyte Pharmaceuticals, Inc.
44. Lislei G. Restaino, Steven E.Halpern, and Dr Eric L.Tang, ‘Patenting DNA-related inventions
in the European Union, United States and Japan: A trilateral approach or a study in contrast?’
UCLA Journal of Law and Technology, 2003.
45. Antibodies are proteins produced by the body’s immune system to fight against antigens,
i.e., foreign bodies such as disease-causing bacteria and virus. Antibodies are a class of
proteins that help defend the body against invaders such as virus and bacteria. See supra
5, p. 292.
claimed for patent. In Hybertech Inc. v. Monoclonal Antibodies. Inc.,46the claim

was for an immunoassay (method)47that utilized monoclonal antibodies to
measure the concentration of certain antigens (viruses).48 The goal was to
evolve a process for measuring the quantity of certain antigens in a given
solution. Inventors produced a method to detect antigens by employing
antibodies (proteins) produced inside the body. The invention involves a
method to produce antibodies to fight against antigens in a given solution.
Patent was granted on the invention–the first of its kind in developing a
method to employ antibodies against antigens. It was for the first time that
the patent office granted patent on a biotechnological method of employing
antibodies produced by the body’s immune system to fight against antigens.
This patent resulted in a number of patent applications claiming different
methods to raise antibodies and to employ against antigens. In In re Wards49
the claim was for an ‘immunoassay’ utilizing monoclonal high affinity IGM
(immunoglobulin) antibodies. The invention involves immunoassay methods
for the detection of hepatitis-B surface antigen by using high-affinity
monoclonal antibodies.50 The invention was a method to produce protein
against specific viruses. The Federal Circuit, relying on the reasoning of
Hybertech decision, held that though it required some experimentation in
practising the invention, the invention is patentable. This case was another
example where a method to utilize antibodies against antigens was claimed.
Perhaps the isolation and purification of genetic material is a herculean
task. In fact, genetic material is not available for easy isolation. The intended
genetic material must be identified before its different parts are isolated.51
After isolation the material needs to be purified in order, incorporate it into
an intended body for performing an intended task like producing a specific
protein. As per the latest decisions of the Court of Federal Circuit and the
decisions of the US Patent Office biotechnology processes or methods for
46. 802 F. 2d 1367(Fed. Cir. 1986), See also Chisum cases and materials on principles of patent
law, New York foundation press, New York, 1998, pp. 287-92.
47. Immunoassay means a method for detecting or measuring antigens by using antibodies
as reagents. See supra 5, p. 293.
48. See supra 40.
49. 858 F.2d 731 (Fed. Cir. 1988). Debra Z. Anderson, ‘How to enable your Biotech Disclosure
for the United States Patent Application’, Lawyers Journal, Allegheny County Bar Association,
11 July, 2003.
50. The invention was denied patent by the patent office on the ground of undue experimentation
required to practice the invention. In an appeal made to the Federal Circuit it was viewed
that the inventor had deposited the invention and the practice of the invention does require
some experimentation.
51. For example, genes are not available to be isolated. A gene is not situated at a particular
place. Gene comprises different fragments. Particular regions of DNA, which expresses
proteins, are called genes. These genes are located in the form of fragments on different
regions of a DNA. Isolation of a gene requires the isolation of its different fragments on
DNA.
isolation and incorporation of genetic material from one species to another

constitute a patentable subject matter.52
Patenting of therapies
Biotechnology has evolved new methods to treat diseases. Genetic diseases
or hereditary diseases are transmitted from parents. Hereditary diseases
are caused due to the expression of a few genes. There is no treatment for
hereditary diseases; moreover, there is no way to prevent the disease from
passing on to the offspring or next generation. However, biotechnology shows
some promising results in treating genetic or hereditary diseases. Gene
therapy is a biotechnological process that treats genetic or hereditary
diseases. The process involves suppressing or removing of the gene causing
the disease from the body. Once the gene is removed, the next generation
does not receive the gene from parents; hence the disease cannot be
transmitted. Future generations will be free from genetic or hereditary
diseases if the gene causing the disease is removed or suppressed.
Suppressing or removing the gene causing hereditary diseases is called
gene therapy. This process has become a patentable subject matter under
Section 101 of the United States Patent Code. Reportedly, the United States
Patent Office issued the first patent on gene therapy in the year 1995. To
date the United States Patent Office has issued dozens of gene therapy
patents.53
Patenting of human being or Transgenic human whether valid?
However, patent law does not encourage inventions relating to human cloning
or transgenic humans. The judiciary and also the legislature are against
such inventions. Constitutional mandate in the form of the thirteenth
amendment is adhered to in prohibiting inventions relating to transgenic
human beings. The thirteenth amendment postulates abolition of slavery
and property rights in human beings. Invention of transgenic human through
cloning fellow human being and patenting of such invention amounts to
creating property rights over human being. Holding property rights in human
beings does constitute holding them in slavery, which is prohibited by the
thirteenth amendment. Therefore, the US Patent Office believes that human
cloning is excluded under the US Constitution. 54 In Pioneer Hibred
International55 the Court of Federal Circuit held that human cloning was
excluded from the purview of patentable subject matter. However, it was
held that aspects of human cloning such as a method of making human
clone components for use in human cloning might be patentable. Initiating
52. In In re vaeck the claim related to manipulating a bacterium to insert a gene. Inventors
isolated a gene and combined it with a stretch of DNA from the bacteria and created chimeric
gene. A patent was claimed in 1991 and the same was granted. See supra 40.
53. Jasmine Chambers, ‘Patent eligibility of Biotechnological inventions in the US, Europe
and Japan: How much patent policy is public policy?’ George Washington International
Law Review, 2002.
54. See supra 28, p. 164.
55. Pioneer Hibred International v. Holden Foundation Seeds Inc., 35F, 3d. 1226.3, USPQ, 2d.
1385 (8th Cir. 1994).
the debate on transgenic human being, a patent application was filed in the
US claiming non-human chimera. Stuart Newman claimed a patent on the
invention where he incorporated a human gene into the animal, which
rendered it neither animal nor a human. It was viewed that patentabale
subject matter does not include transgenic human or non-human chimera.
The patent office held that the invention could not be patented, as it would
outrage the public order and morality. The patent office believes that
transgenic human beings are not patentable by virtue of the thirteenth
amendment to the US Constitution. Therefore, the patent was rejected and
it was made clear that patenting of humans is prohibited.56
Moving a step ahead the United States enacted legislation prohibiting
human cloning in the year 2003.57 The Act defines human cloning to mean
‘human asexual reproduction, accomplished by introducing nuclear material
from one or more human somatic cells into a fertilized oocyte whose nuclear
material has been removed or deactivated to produce an indentical living
organism.58 The Act prohibits human cloning or attempts to clone human
beings59 and prescribes ten years imprisonment as punishment for cloning.
Further, any person who acts in violation of the Act is subject to a fine not
less than US $1,000,000.60 However the Act does not restrict scientific
research in the use of nuclear transfer or other cloning techniques to produce
molecules, DNA, cells other than human embryos, tissues, organs, plants,
or animals other than humans.61 The central idea of the Act was to prevent
human being from becoming a patentable subject matter through prohibiting
human cloning.
The Act was enacted keeping in mind the enormity of the growth of
research in the field of biotechnology showing signs of cloning human beings.
One important point to be noted here is that insofar as inventions like
transgenic micro-organisms, plants, animals and human genetic materials
are concerned, utility outweighs ethics and moral concerns. However, in
case of inventions relating to transgenic human and cloning of human beings,
ethics and moral concerns outweigh utility. In the developed countries like
the United States of America the biotech industry has grown as a major
industry. Private and public entities have identified the significance of
biotechnology in the day-to-day life and have made huge investments in
the research and development of biotechnology. In the United States there
is a major upsurge in the research on human genetic material, the result
being a number of patents on human genetic material. Everyday many
56. See supra 53.

57. The US Human Cloning Prohibition Act, 2003.
58. Ibid., Section 301(1) of the Act. The Act considers human cloning as an offence and
penalizes whoever performs, participates.
59. Ibid., Section 302(a). Not less than US $1,000,000 but not more than an amount equal to the
amount of the gross gain multiplied by two if that amount is greater than $1,000,000, if
such person or entity derived any pecuniary gain.
60. Ibid., Section 302(c).
61. Ibid., Section 302(d).
genes, DNA, and other human genetic material are being patented. A plethora
of patent applications are pending before the United States Patent Office
claiming different biotechnological inventions, majority being claims on
human genetic material. It is believed that in the year 2001 alone the United
States Patent Office awarded 20,000 gene patents with another 25,000
applications pending.62
Further, with the herculean and daunting task of human genome project
it is believed that the entire human genome is decoded. With the decoding
of human genome medical science is revolutionized, and individualized cures
for many hereditary diseases are in the pipeline. Reportedly, more than
1,00,000 provisional patent applications are pending for decision at the
United States Patent Office on various segments of human genome.63
Different types of inventions ranging form transgenic micro-organism, plant,
animal, and human genetic material are being claimed for patents. Protection
is made available for different transgenic living beings except transgenic
human through patents. Today, ranging from plant and animal that can be
seen through naked eye to micro like organisms, such as bacteria, cells of
living beings, and genetic material gene, gene sequences, DNA, DNA
sequences, and also fragments of DNA and gene which can only be seen
with the help of microscopes are being patented. Also, the processes for
isolating and employing genetic material for intended purposes, processes
for genetically modifying living beings, processes for treating genetic and
hereditary diseases are being patented. The evolution of patent law on
biotechnology started with the patenting of micro-organisms and it has
reached a stage where only human beings are out of the patenting purview.
As far as the evolution of biotechnology patent law is concerned, judicial
pronouncements played a move significant role than legislative initiative.
As the lawmakers did not foresee the growth of biotechnology, there were
no provisions in the patent laws enacted decades back to offer protection to
biotechnology inventions. The legislature was not dynamic enough to react
quickly to the challenges posed by biotechnology. In the absence of legal
norms on the regulation of biotechnological inventions, in the light of growing
importance of the biotech industry, the judiciary shouldered the
responsibility of recognizing and protecting biotechnology inventions. In
fact, what the judiciary did was nothing but interpret the existing legislations
liberally in an innovative way. The United States judiciary was innovative
enough to interpret the existing patent law in view of constitutional mandates
of promoting the progress of useful arts and science for the progress of the
society. Judiciary laid down different principles and guidelines, which are
still relevant; judiciary not only guaranteed protection for biotechnology
inventions but it also followed constitutional pursuit for the promotion of
useful arts and sciences. It is due to the innovative and liberal approach
that biotechnology inventions are protected under the patent laws today.
62. Albright, M, ‘ The end of the revolution’, Gene Watch, 15.3, 2002.
63. See supra 28, p. 169; see also, www.ncbi.nlm.njh.gov/genome/guide.
However, later on legislature tried its hand with a few legislative

initiatives. Judiciary initiated the evolution of law on biotechnology, which
was followed by a legislative amendment to the patent law and also with
specific legislations on biotechnology. Given the fluctuating verdicts of the
Federal Circuit, the United States legislature appropriated the initiative to
amend the Patent Act.64 The Patent Act was amended65 to streamline the
law on biotech patents. In the same year, the United States introduced a
new legislation, “Biotechnology Process Patents Act, 1995, especially to
regulate patenting of biotechnology processes. The amendment read with
the Biotechnology Process Patents Act says that in order to be patented
both the biotechnology invention and the process to produce such invention
shall be non-obvious to the effect that there shall be inventive step involved
in both the process and the invention.66 The amendment states that a
biotechnological process using or resulting in a composition of matter is
patentable.67 Due to this liberal interpretation of the existing law by the
Federal Circuit, and the patent office granting patents on different
biotechnological products and processes, the enactment implies the
Congress’ intention to give statutory support to the patenting of
biotechnological products and processes. The amendment further specifically
states that the processes of genetic alteration of unicellular or multicellular
organisms, expression, elimination, and alteration of nucleotide sequences,
expression of physiological characteristics not naturally associated with the
said organism, cell fusion procedures yielding cell lines expressing a protein
such as a monoclonal antibody, and methods of using a biotechnologically
produced product or processes are patentable.68
The Trade Related Aspects of Intellectual Property Rights (TRIPS)
agreement states that patent protection shall be offered for micro-organisms,
plants, and animals. The agreement says that patents shall be made available
for all kinds of inventions in all fields of technology. The innovative approach
of the United States judiciary in evolving biotechnology patent law is reflected
in the agreement as the agreement postulates patenting of different
biotechnology inventions like micro-organisms, plants, and animals
including human genetic material. The contribution of the United States
judiciary in the evolution of biotechnology patent law is being internationally
recognized and adhered to in the agreement. It can be said that the TRIPS
agreement has given international recognition to the biotechnology patent
law, which has got its roots in the United States.
64. United States Patent Code (as amended in 1995).

65. Section 103 of the US Patent Act mandates the fulfilment of the requirement of non-
obviousness for the patentability of any new invention.
66. See supra 5, pp. 714. See also supra 4, p. 177.
67. United States Patent Code, Section 103, Conditions for patentablity; non-obvious subject
matter.
68. Ibid.
EVOLUTION OF BIOTECHNOLOGY PATENT LAW IN THE

EUROPEAN UNION
History of Patent Law
In Europe, German miners of the Alps seem to have been the first to develop
the notion of monopoly rights in their new processes as far back as in the
thirteenth century. The first more universal patent scheme evolved in Venice,
and then at the height of its international power, in a decree of 1474 which
rewarded inventors of new objects with a limited monopoly on condition
that the invention was disclosed to the state. In England, the Crown started
granting patents in the fifteenth and sixteenth centuries. Queen Elizabeth I
granted the earliest patent to an Italian inventor named Acountius.69 The
Crown was active in granting monopolistic privileges. However, this practice
of granting monopolies was criticized as it was abused to bestow privileges
upon favourites of the Crown. In this background the Parliament enacted
the Statute of Monopolies in the year 1624,70 which declared all monopolies
and grants by the Crown as void and contrary to law. The statute of
monopolies being the first English patent statute governed English patent
law for more than 200 years and forms the foundation of the present British
patent system.71
In the European patent legislation history there are three significant
milestones contributing to the development of substantive law on patents.
The first milestone was the Paris convention for the protection of industrial
property adopted in 1883. The convention formulates the basic tenants of
patent law in Europe. The convention was formulated as an appreciation to
the growth of intellectual property rights.72 It intends to protect industrial
properties such as patents, trademarks, designs, etc.73 Here industrial
property should be understood in its broader sense to encompass agricultural
and extractive industries and to all manufactured or natural products, for
example, wines, grain, tobacco leaf, fruit, cattle, minerals, mineral water,
beer, flowers, and flour.74 Perhaps biotechnology has its impact on all the
components of industrial property that are offered protection under the
69. Adam Hollyoak and John Torreman, Intellectual Property Law, London : Butterworths,
Second Edition, 1998, pp. 37-9.
70. See supra 5, pp. 13-6.
71. The British patent system has contributed to the development of patent law. The written
description requirement that every invention has to satisfy under the present patent law is
a contribution made by the British patent system. In Liardet v. Johnson [Jarret, English
patent system, 26 J.pal.off. Soc’y 762 (1994)] it was held that the consideration for a patent
grant was the specification of the invention. The invention had to be described in a written
form in order to get a patent. This decision set forth the present written description
requirement under the British patent system and later on it was adopted by the patent
systems throughout the world.
72. See supra 44.
73. International Legal Instruments of Intellectual Property Rights Law, Department of
Business Laws,Volumes I and II, National Law School of India University, Bangalore,
1998.
74. Article 1, sub-clause (3) of the Paris Convention on Industrial Property Rights.
Paris convention. In the agricultural sector, in the production of wines and

beer biotechnology plays a vital role. Hence it can be inferred that though
specifically not mentioned, biotechnology is covered under the convention.
The second milestone in the history of European patent system is the
Strasbourg Convention75 adopted with an objective of establishing a common
market in Europe. The convention harmonizes the substantive patent law
in terms such as novelty and inventive step.76 The third milestone in the
history of European patent legislation was the European Patent Convention
(EPC) 1973. The convention provides for common patent-granting system
in all European countries. The convention says that European patents shall
be granted for any inventions which are susceptible to industrial application,
which are new, and which involve an inventive step.77 The convention
prohibits patenting of living beings produced through essentially biological
processes, but it does not prohibit living beings produced out of non-biological
processes.78
The framers of the convention seem to have some forethought of patenting
living beings produced out of non-biological processes. In Europe even before
the adoption of the proceedings of the convention, there were claims for
patents on living matter produced through non-biological processes. It seems,
due to such instances the European Union foresaw the growth of biotech
industry and provided for patenting of living beings produced through non-
biological processes. The convention does not state the inventions that are
patentable but also the inventions that are not patentable. Discoveries,
scientific theories, mathematical methods are the few mentioned in the list
of inventions not patentable.79 Further, the convention states under Article
53(b) that Plants or animal varieties and essentially biological processes for
the production of plants and animals are not patentable. However this
provision does not apply to microbiological processes or products thereof.”80 "At
the same time the convention states under Article 53(a) that: ‘Inventions
against public order and morality are not patentable under the convention.”81
The inventions falling under exception clause do not qualify for patent though
they satisfy the requirements of novelty, industrial application, and inventive
step. Inventions which do not fall under the list of inventions not patentable
but do not come under exceptions to patenability are patentable.
When we see the other side of the coin, it seems that ‘plant and animal
varieties produced through essentially non-biological processes are
patenable’ under the convention. The convention expressly says that
microbiological processes and products are patentable. Since essentially
75. Strasbourg Convention on the unification of certain points of substantive law on patents
for invention, 1963.
76. See supra 44.
77. The European Patent Convention, Article 52(1).
78. Ibid., Article 53.
79. The European Patent Convention, Article 52.
80. Ibid., Article 53(b).
81. Ibid., 53(a).
biological processes and products thereof are not patentable it can be inferred
that all the other processes such as microbiological and biotechnological
processes and products82 thereof are patentable. On the same lines it can
also be inferred that products of biotechnological processes or inventions of
biotechnology such as transgenic micro-organisms, transgenic plants,
transgenic animals and isolated and purified human genetic material are
patentable. Even the European Patent Office believes in such an approach
as it tried to interpret the convention liberally to patent inventions produced
out of non-biological processes. These three conventions played a vital role
in streamlining the law on patents in Europe. In particular, EPC seems to
have considered the issue of patenting of biotechnological processes and
products.
Patenting of micro-organisms
In fact, Europe was ahead of the United States in patenting living beings.
In 1969 in Germany, a patent was claimed on a method for breeding doves
with red plumage.83 German patent office rejected the patent on the ground
that the method was not repeatable and the Supreme Court of Germany
confirmed the same. It was the first case where a process for producing
living matter was claimed in the European Union. Seemingly, it was the
first case to open the door to the patenting of biotechnology inventions.84
Further, in the early 1970s, five years before the United States Supreme
Court decision in Chakraburty case, the German Federal Supreme Court
upheld patent protection for new micro-organisms if the inventor were to
demonstrate a reproducible way for its generation.85 In the meantime the
European Union adopted the European Patent Convention laying down a
comprehensive framework on the law relating to patents. The above decision
of the German Supreme Court was proved controversial in view of the EPC
excluding the patenting of plant and animal varieties, or essentially biological
processes for their production. The German Supreme Court’s decision can
be viewed from the positive side of the EPC. The Convention excludes patents
for products of essentially biological processes but it does not exclude
patenting of products of non-biological processes. Therefore, it can be inferred
indirectly or impliedly that the EPC laid the foundation for patenting of
living beings.
For the first time after the adoption of the European Patent Convention,
which seemingly laid the foundation for the patenting of living beings in
82. Microbiological process is defined under the convention to mean ‘any process involving or
performed upon or resulting in microbiological material.’ See Chapter VI, Rule 23B(6) of
EPC. See also, Article 2(1)(b). Biotechnology invention is defined under the European Patent
Convention to mean, ‘any invention which concern a product consisting of or containing
biological material or process by means of which biological material is produced, processed
or used.’ See Chapter VI, Rule 23B(2) of EPC.
83. Adelman et al. (1998), p. 156.
84. See supra 28.
85. Wagner (1976), p. 335.
Genentech-I/Polypeptide expression86 a living being was claimed for patent.

The invention was a plasmid, a micro-organism suitable for transforming a
bacterial host, which included an expression control sequence, or ‘regulon’
which could enable the expression of foreign DNA as a recoverable
polypeptide. The applicants invented a general principle for enabling
plasmids to control the expression of polypeptides (proteins) in bacteria.
The European Patent Appeals Board opined that only essentially biological
processes and concomitant products are excluded under the convention,
but non-biological processes and products thereof are not excluded.
Therefore non-biological processes and the sequel products are patentable
under the convention. The Board viewed the present invention as a product
of biotechnological processes which in the opinion of the Board do not
constitute essentially biological processes. It was held that the present
invention, not being a product of essentially biological process, is patentable.
The decision of the Board represents the patent office approach in patenting
products of processes other than essentially biological processes. The
decision assured the inventors that patents are granted for products of
biotechnological processes and established the rule that micro-organisms
are patentable in the European Union.
Patenting of biotechnological processes
Essentially biological processes and the resulting products are not patentable
under the convention. However, it is viewed that non-biological processes
such as biotechnological processes are patentable along with the resulting
products. At the time when the European Patent Office Board allowed a
patent on a plasmid, the biotech industry got a setback in the United
Kingdom. The Court of Appeal in the United Kingdom in Genentech Inc v.
The Welcome Foundation 87 rejected a patent on various claims relating to
the production of a substance called human tissue plasminogen activator
(t-pa). The invention was useful in treating the disease thrombosis and
hence was considered as of great commercial value.88 The human tissue
plasminogen activator (t-pa) was produced through recombinant DNA
technology. It was viewed that at the time of the invention DNA technology
existed and at least in theory could be applied to produce t-pa as the same
technology was used to produce growth hormones, insulin, and other
valuable products of similar nature. Therefore, it was believed that there is
no inventive step involved in the invention and the patent was rejected for
lack of inventive step. This decision was feared as an anti-biotech trend
and it generated chaos in the biotech industry.89
86. (T 292\85) (1989) Journal of European Paitent office (JEPO 275).

87. (1989) R.P.C 147.
88. See Dr T. Ramakrishna (ed.) Biotechnology and Intellectual Property Rights, Centre for
Intellectual Property rights and Advocacy (CIPRA), National Law School of India University,
Bangalore, First Edition, 2003, pp. 28-9.
89. See supra 69, pp. 74-5.
However, the industry recouped this setback with the decision of the
same Court of Appeal in Chiron Corporation case 90. Chiron case holds claims
for producing vaccines, polypeptides, and antibodies through a
biotechnological process to fight against Hepatitis-C virus. Chiron owned
patents, which included claims to polypeptides, immunoassays,
polynucleotides, antibodies, vaccines, and methods of in vitro propagation of
the Hepatitis-C virus.91 Chiron was successful in identifying and sequencing
the virus responsible for causing non-A, non-B Hepatitis (NANBH). The claims
involved an immunoassay kit (method) for detecting antibodies against
Hepatitis-C virus by screening blood for the presence of Hepatitis-C infection,
a vaccine, and a method of cultivating Hepatitis-C cells.92 The invention was
considered eligible for patent as it met with the requirements of novelty,
industrial application, and inventive step. It was held that the invention
was hitherto unknown and novel; it was the first of its kind, inventing a
method to detect antibodies against Hepatitis virus to treat Hepatitis-C. The
court expressed its view that the convention does exclude only essentially
biological processes. It does not exclude non-biological processes from
patenting. The Court held that the claimed biotechnological process as being
not excluded under the EPC was eligible for patent grant. The decision
established a rule that inventions relating to biotechnological processes
were patentable.
In Genetech case the Court of Appeal was strict in applying existing
patent law on biotechnological inventions. However, the European Patent
Office Board was liberal when it encouraged patents on biotechnology
inventions in Chiron Corporation. In the absence of specificity and unsettled
legal opinion on the patenting of biotechnology inventions, courts have
adopted different approaches. The views, opinions, and approaches of judges
may differ and contradict at some given points of time. Therefore, the
approach of the judiciary may not remain the same and may change in
course of time. Judges may not hold their office for a long time, so when a
new judge assumes office, he may express a view different from the one
expressed by his predecessor. Hence, when a case of similar nature comes
before a new judge, he may express a contrary view. Genetech and Chiron
were two different strides in the evolution of biotechnology patent law in
Europe reflecting the fluctuating views of the judiciary in the absence of
specific legal norms on the issue. However, by looking into the approach of
the European Patent Office (EPO) and the decision in the Chiron case, it
can be inferred that biotechnological processes are patentable in the
European Union.
Patenting of transgenic plants
The progress of biotechnology industry in Europe resulted in research in
the production of transgenic plants. As genetic manipulation in micro-
90. Chiron Corporation v. Murex Diagnostics Ltd and Organon Teknika Ltd. (1996) R.P.C 535,
CA.
91. The patent was applied for in the year 1987 and granted in the year 1990.
92. See W.R. Cornish, Cases and Materials on Intellectual Property, London : Sweet and Maxwell
Limited, Third Edition, 1999, p. 84, See also supra 88, p. 29.
organism was a success, there ware attempts to manipulate plants

genetically. The biotech industry was successful in genetically manipulating
plants and in inventing new plants. There was encouragement for the
research in transgenic plants through grant of patents. On the basis of the
rationality in granting patents on micro-organisms and biotechnological
processes, patents were being claimed on plants produced through
biotechnological processes. European Patent Office was of the opinion that
patents might stimulate further research in the industry on transgenic
plants. The EPO was in favour of applying the rationality of patenting micro-
organisms and biotechnological processes to similar patent claims on plants
also.
In Ciba Geigy implying the stand of the EPO, the European Patent Office
Technical Board of Appeal93granted a patent on a plant. The invention was
propagating material for cultivated plant, in particular, seeds of cultivated
plants treated with a chemical agent, i.e., oxime derivative, in order to make
it resistant to agricultural chemicals. A definition of cultivated plants in the
description included all plants, which yielded substances in any form.
Propagating material from such cultivated plants comprised all reproductive
plant components, including plants, which had begun to germinate. The
subject matter of the claim was not an individual variety of plant
distinguishable from any other variety, but the claim related to any cultivated
plants in the form of their propagating material, which had been chemically
treated in a certain way.94 By referring to the exclusions under the European
Patent Convention, the Board observed that Article 53(b) of the EPC
prohibited only the patenting of plants or their propagating material in the
genetically fixed form of the plant variety. It further opined that the
propagating material claimed was not the result of an essentially biological
process, but was a non-natural process of treating cultivated plants in the
form of their propagating material with a chemical oxime derivative according
to a set formula. The Board held that the claimed invention was a non-
natural plant, which was a result of treatment with chemical agents. By
interpreting Article 53(b) of EPC restrictively the Board held that non-natural
plants did not fall within the purview of exceptions and are patentable.
It was the first case where non-natural plants produced through a
biotechnological process were claimed and patented in Europe. The decision
established a rule that non-natural plants were patentable under the EPC.
Further in 1993, in Plant Genetic Systems95 genetically modified plant cells
and seeds were claimed for patent. The invention related to the genetic
engineering of plants and seeds in order to make them herbicide resistant.
Patent protection was claimed for plants, plant cells, and seeds possessing
a foreign gene capable of resisting a type of herbicide. The invention intended
to develop plants and seeds resistant to a particular class of herbicides,
93. (1984) Journal of European Patent Office 112, Tech, Bd. App.
94. See supra 92, pp. 60-62.
95. Plant Genetic Systems/Glutamine Synthetase inhibitors (1993) 24 IIC 618.
namely, glutamine synthesis inhibitors (GSI)96. The claimed patent disclosed

the use of biotechnological techniques for the production of GSI-resistant
plants and seeds which contain heterologous DNA encoding a protein capable
of inactivating or neutralizing the abovementioned herbicides. Through this
process a new trait was added to the genetic material of a plant, which
allowed the plant to grow in the presence of GSI.97
The invention was opposed from patenting by reason of exception under
Article 53 of the EPC which states : ‘invention the publication or exploitation
of which would be contrary to “ordre public” or morality is excluded from the
purview of patent protection.’ The issues before the court for decision were
of much importance. This case happened to discuss all the provisions in
exception to patentability. Given the raging demand for patenting of living
beings including plants, the decision of the case was very significant. The
case had defined important terms under the EPC and settled many issues
that were troubling the patent office in granting biotech patents. Irrespective
of the outcome, this case had discussed in detail about what constituted
‘ordre public’ or ‘morality’, ’plant varieties’, ‘essentially biological processes’,
and ‘microbiological processes’. Expressing its view on the concept of ‘order
public’ the European Technical Board of Appeal held that ‘ordre public’
covered the protection of public security, physical integrity of individuals,
and also the protection of environment. In that sense any invention the
exploitation of which was likely to breach public peace or social order
threatening the public security or which might seriously prejudice the
environment were to be excluded from patentability as being contrary to
‘ordre public.’
Discussing on the concept of ‘morality’ it was held that ‘morality was
related to the belief that some behaviour was right and acceptable, whereas
some other behaviour was wrong. This belief was founded on the totality of
the accepted norms which were deeply rooted in a particular culture.
Therefore, any invention not in conformity with the conventionally accepted
standards of conduct pertaining to the culture, was to be excluded from
patentability, being contrary to morality. Deciding on the issue whether
patents on seeds and plants went against public order and morality, it was
viewed that seeds and plants per se should not constitute an exception to
patentability under Article 53(b) of the EPC merely because they represented
‘living matter’ on the ground that plant genetic resources should remain
the ‘common heritage of mankind’.
A survey and opinion poll conducted in Sweden and Switzerland showed
that farmers were neither willing nor against genetic engineering and
production of super crops such as herbicide-resistant plants. At the same
time the survey results showed that farmers were against patenting of
animals and plants. Considering the survey and opinion poll result the
96. However such plants could also be obtained by traditional plant selection methods. Some
plants may be naturally resistant while other may develop resistance.
97. See supra 92, p. 67.
Board held that survey and opinion poll, being subject to influences and
fluctuations within short time periods in an unforeseen manner, did not
necessarily reflect ‘order public’ or moral norms and could scarcely be
considered decisive per se. Expressing concern over genetically modified
plants and biotechnology patents, the Board opined that plant biotechnology
per se could not be regarded as being more contrary to morality than
traditional selective breeding. It was noted that both traditional breeders,
and molecular biologists, or biotechnologists, objective was to change the
property of a plant by introducing novel genetic material in order to obtain
a new and possibly improved plant. It was also observed that genetic
engineering techniques of biotechnology are more powerful and capable of
giving accurate results and control over genetic modifications. While deciding
whether plant cells and seeds do constitute ‘plant variety’ which was excluded
under Article 53(b) of the EPC, the Board held that any claim on or
encompassing plant variety was not patentable. The Board defined a plant
variety to mean any plant grouping within a single botanical taxon of the
lowest known rank characterized by at least one single transmissible
characteristic distinguishing it from other plant groupings and which was
sufficiently homogeneous and stable.98
However the Board held that genetically modified plant cells could not
be considered as plant varieties. Due to the current practice of the European
Patent Office considering plant cells to be ‘microbiological products’ it was
held that plant cells did not come within the meaning of plant variety.
Further, it was held that plant cells resulting from microbiological process99
were considered equal to bacteria and yeast, which were undoubtedly
patentable as per the current practice of the EPO.100 Interpreting the concept
of ‘essentially biological process’101 it was held that it depended on the totality
of human intervention and its impact on the results achieved to differentiate
a microbiological process from an essentially biological process. The invention
in question for the preparation of hybrid plants was an essential modification
of known biological process and it had got decisive impact on the desired
result of hybrid population. Hence, it is not an essentially biological process
and the exclusion of Article 52(b) of the EPC did not apply. It was also held
that the invention, genetically modified cells, is a result of microbiological
process which differs from an essentially biological process.
98. Plant variety is defined under Article 5 of the Community Plant Variety Rights Regulation
2100/94. Plant variety is also defined under amendments made to EPC to adopt the provisions
of the directive on the legal protection of biotechnological inventions.
99. Article 53(b) of the EPC excludes plant, animal varieties, and essentially biological processes
for the production of the above from patenting.
100. However, the Board was not convinced with the arguments that claimed plants as not the
result of essentially biological process but the result of biotechnological process. The Board
was also not convinced that the claimed plants did not constitute a plant variety within the
meaning of Article 53(a) of the EPC and rejected claims for plant on the ground that these
claim encompassed plant varieties.
101. Essentially biological process was defined under the recently enacted directive on the legal
protection of biotechnological inventions.
The board happened to clarify with regard to what constitutes a

‘microbiological process’102 and ‘products thereof’ under Article 53(b) of the
EPC. It was held that processes in which micro-organisms or their parts
were used to make or to modify products or in which new micro-organisms
are developed for specific uses were microbiological processes. The ‘products
thereof’, i.e., products of microbiological processes encompass products
made or modified by micro-organisms as well as new micro-organisms as
such. Hence, it was held that the invention of plant cells and seeds in
question being products of microbiological processes were potentially
patentable under EPC.103
This case happened to deal in detail with the exclusion provisions under
EPC. The Board defined important concepts pertinent to patenting of
biotechnological inventions. It was held that plant cells being products of
microbiological processes were patentable. However, it was decided that
the claimed plant, if, encompassed a plant variety, would remain excluded
from patenting. In Ciba Geigy, exclusions were restrictively interpreted to
allow patents on plants, but in Plant Genetic Systems, a more liberal
construction of the exclusions was made in rejecting claims over plants.
This led to the inference that plants produced as a result of genetic
engineering were not patentable since the starting point of every such
invention would be a plant variety.104
In the meantime the European Union adopted a directive on
biotechnology inventions in the year 1998.105 The directive nullified the
decision of the Plant Genetic Systems case, in saying that ‘inventions
concerning plants shall be patentable if the technical feasibility of the
invention is not confined to a particular plant variety.106 Accordingly, now
genetically modified plants are allowed patents even if they encompass a
plant variety.107 The directive requires its member states to harmonize their
law relating to the patenting of biotechnological inventions.
Soon after the European Union adopted the directive on biotechnological
invention in Novartis case108 the European Patent Office Enlarged Board of
Appeals happened to decide again on the question of patenting of plants.
The claims were for plants genetically modified to render them resistant to
fungi. The enlarged Board of Appeals ruled that so long as specific plant
varieties were not individually claimed, claim for plants should not be
excluded from patentability. Overturning Plant Genetic Systems decision,
102. Microbiological process is defined under the recently enacted directive on the legal protection
of biotechnological inventions to mean ‘any process involving or performed upon or resulting
in microbiological material’.
103. See supra 28, p. 153. See also supra 88, p. 32.
104. See supra 88, p. 32.
105. The directive on the legal protection of biotechnological inventions, 1998. The directive
was to be fully implemented in all member states by July 2000.
106. See supra 28, p. 154.
107. Article 4.2 of the directive.
108. (1998) OJEPO 149.
the Board held that a claim that encompassed more than one variety was
not excluded under Article 53(b) of the EPC. It was viewed that in the absence
of the identification of a specific plant variety in a product claim, the subject
matter of the claimed invention was not directed to a plant variety or varieties
within the meaning of Article 53(b) of the EPC. It was held that exclusion
under Article 53(b) of the EPC was applicable only where the patent claimed
a plant variety per se.109
Therefore, a patent cannot be denied only on the ground that claim
encompassed a plant variety. Claim that encompassed more than one variety
was thus patentable. The decision, however, nullified the decision in the
Plant Genetic Systems Case in holding a genetically modified plant patentable
even when it encompassed plant varieties and brought the EPC in line with
the European Union directive on the biotechnological inventions. Now, after
the decision in Novartis clarifying that patents could be granted though
claims might encompass plant varieties and the adoption of the directive
stating that genetically modified plants were patentable, plants produced
through a biotechnological process have became undoubtedly patentable
in the European Union.
Patenting of transgenic animals
Biotechnology is capable of manipulating any living being. As the impact
and influence of biotechnology in the plant kingdom was effective and
successful and deep-rooted with transgenic plants coming into being, it
happened with animal kingdom also. Efforts were made in the European
Union to manipulate animals with the aid of biotechnology. Biotechnology
was successful in changing the properties of existing animals or in
manipulating them. The result was transgenic animals and related
inventions, which were being claimed for patents. In the process of evolution
of biotechnology patent law there were claims for patents on different
biotechnological inventions such as micro-organisms and transgenic plants
– also on transgenic animals.
The evolution of biotechnology patent law took another turn with patents
being claimed on animals. For the first time in the history of Europe an
animal was claimed for patent In Harward onco mouse.110 The invention
involved a transgenic mammal,111 an animal susceptible to cancer, which
was useful in cancer testing. Inventors produced transgenic mice possessing
foreign genes (oncogenes), which made it susceptible to cancer. The inventor
claimed for a method for producing a transgenic non-human mammal
susceptible to cancer and for a transgenic non-human mammal containing
oncogenes. The method involved introducing an activated oncogene sequence
into a non-human mammal at a stage no later than the eight-cell stage.
109. See supra 28, p. 153. See also supra 88, pp. 32-3.
110. T 19/90 (1990) OJEPO 476, Tech. Bd App; (1991) E.P.O, R.525, Ex. D.
111. A mammalian is that animal that breastfeeds its offspring. Human being is also a mammal
as human beings breastfeed their offspring.
Initially, patent was refused by the European Patent Office (EPO) examining
division on the ground that the invention was against public order and
morality and also on the ground that the invention encompassed an animal
variety, which is excluded from the purview of patenting. European Patent
Convention under Article 53(a) prohibits patent protection for invention,
exploitation of which is contrary to public order and morality. At the same
time the convention under Article 53(b) prohibits inventions encompassing
animal varieties from patenting.112 The examining division interpreted the
above provision of the Convention to exclude animals from patenting. The
invention was viewed as contrary to public order and morality. Besides, the
claim for non-human mammal was considered as very broad in the light of
the invention describing only a method to produce transgenic mice.
In appeal, the EPO Technical Board of Appeal rejected the interpretation
of Article 53(a) and (b) of the EPC to exclude the present animal invention
from patentability. The Board opined that the examining division was wrong
in refusing the patent application on the ground of exceptions to patentability
under Article 53(a) and (b). As there was no specific mention of animal
invention whether patentable or not, it was inevitable on the part of the
Board to interpret the existing provisions of the Convention to decide the
issue. The Convention provides for exclusions for patenting and also
exceptions to patentability. It was opined that any invention that did not
fall under exclusions or exceptions to patentability is generally patentable.
The Board viewed that as per the language of the convention animal
inventions were not excluded from patenting. Therefore, the issue before
the court was to decide whether the claimed invention did fall under any of
the exclusions under the Convention. In this background the Board
happened to interpret and analyse exceptions to patentability under the
Convention such as ‘order public’, ‘morality’, ‘animal variety’, ‘essentially
biological process’, ‘microbiological process’, etc.
While considering exception from patentability under Article 53(a) of
the EPC on the ground of ‘order public’ it was believed that inventions of
biotechnology had too many folds which had to be considered carefully.
These included the suffering of animals, besides, possible risks to the
environment which were to be weighed with the usefulness of the invention
to mankind. The Board remanded the case to the examining division to
examine the above. The examining division viewed that ‘the development of
new technologies is normally afflicted with new risks’ and this is an
experience mankind has gained in the past. Due to this, the Board opined
that there should be careful preponderance of the risk vis–a–vis the positive
aspects of such inventions. The Board viewed that if the risk associated
with the invention was more and could not be balanced with the positive
aspects of such invention it was likely to lead to the question of ‘public
order’ and ‘morality’ and patent could be rejected. Where higher life forms
were involved in the new technology, it was not only the risk, which, must
be considered, but also the possible harm, likely to happen to such higher
life forms.
112. Exceptions to patentability under Article 53 of the EPC.
In the instant case different interests were involved which required

balancing; One, there was the basic interest of mankind to remedy
widespread and dangerous diseases; two, the environment should be
protected against the uncontrolled dissemination of unwanted genes; and,
three cruelty to animals should be avoided. If the invention caused any kind
of imbalance of environment or suffering to animal, it would be justified to
deny patents on the ground of public order and morality.113 The Board opined
that the usefulness to mankind of the present invention could not be denied.
Cancer was one of the most frequent causes of death in many countries of
the world and also caused severe suffering. Any contribution to the
development of a new anti-cancer treatment was, therefore, a benefit to
mankind and must be regarded as valuable and highly welcomed by
everybody. The present invention gave rise to a smaller number of animals
needed in corresponding conventional testing. Such being the case, the
present invention contributed to a reduction of the overall extent of animal
suffering. As there were no alternatives to animal testing in the given context,
animal test models were indispensable for cancer research. Therefore, in
the interest of mankind the invention could be allowed though it gave rise to
animal suffering.
Considering the possible risks to the environment, on the release of
genetically modified inventions the Board had taken the purpose of the
invention into account. It was viewed that the purpose of the invention was
to provide animal test models, which were to be used exclusively in the
laboratory under controlled condition by qualified staff. Such being the
case, risk of uncontrolled release would not arise except on the possible
misuse or blatant ignorance on the part of the laboratory personnel carrying
out the tests. This should not be a ground to deny grant of patent. Concluding
its discussion the examining division held that the claimed invention was
not immoral or contrary to public order due to the fact that the invention
was very useful in cancer testing. Usefulness to mankind outweighed animal
suffering.
While considering whether the invention constitutes ‘animal variety’114
within the meaning of EPC (a), which probibits animal variety from being
patented, it was viewed that the claimed invention was a transgenic animal
and did not constitute an animal variety. Considering the fact that European
patents were not granted for essentially biological process115 the Board found
that the claimed process involved insertion of an oncogene into a vector – in
the present case plasmid – which required to be microinjected into the egg
at an early embryonic stage, and this was not possible through essentially
biological processes.116 The Board viewed the claimed invention as a result
113. See supra 92, pp. 62-7.

114. See supra 88, p. 31.
115. Article 53(b) of the EPC says essentially biological processes are not patentable.
116. Bar of patenting of essentially biological processes does not cover microbiological processes.
The present invention is a result of microbiological process wherein an oncogene is inserted
into the mice at an early stage of eight cells.
of microbiological process, which is not excluded form patenting. The Board

considered ‘microbiological processes’ as an exception to the essentially
biological processes and held the same as patentable.117 It was opined that
cells and genes are microbiological material and any process which involve
microbiological material is a microbiological process.
The Board considered the argument that the claim for producing non-human
mammalian was too broad as the invention described only a method to
produce transgenic mice. It was held that ‘a biological invention is considered
sufficient, it clearly indicated at least one way in which skilled person could
accomplish it. The method need not disclose all the ways of practising the
invention on different mammals. Hence, it was held that the disclosure of a
non-natural method to produce transgenic mice is enough to practise the
method on other non-human mammals and the claim for the method of
producing transgenic non-human mammals was valid; hence, eventually
patent was granted on onco-mouse. It was for the first time in the history of
European patent law that a patent was granted on a transgenic mouse.
This case led to interpretation and discussion in detail of the various
provisions of the EPC with vis-a-vis the patentability of biotechnology
inventions. This decision cleared all doubts as to the interpretation of EPC
exclusion provisions for patenting of biotechnology inventions. With this
decision now the EPC encompassed patents to transgenic animals produced
through biotechnology.
Patenting of human genetic material
After transgenic animals it was the turn of human genetic material which
was claimed for patents in the European Union. As biotechnology achived
success in manipulating animals, its next target was to manipulate human
genetic material. Biotechnology is capable of isolating and purifying human
genetic material and exploiting commercially. Human genetic material such
as cells, genes, gene sequences, DNA, and DNA sequences and fragments
are being claimed for patents. Along with human genetic material, products
of such genetic material such as proteins, antibodies, etc., are also claimed
for patents. For the first time in Europe in Relaxin case118 the EPO happened
to decide whether human genetic material are patentable or not.119 The
claim was for a gene coding for a hormone called relaxin. The hormone was
expressed in the body of a pregnant woman during the time of delivery to
relax the body that laboured and suffered pain in delivering the baby. It
was the first case where a patent for genetic material was claimed. The
patent was opposed on the plea that human genetic material did not
constitute a patentable subject matter under the EPC.120 Further, it was
argued that patenting of human genes amounting to owning property rights
117. Microbiological processes are patentable under the convention in contrast to essentially
biological processes.
118. (1995) Official Journal of the European Patent Office 388; (1995) E.P.O R 541.
119. See Modern Law Review, 1998, p. 675.
120. Article 52.
in the human body went against ethical standards. However, patent was
granted by overweighing ethical objections as well as claim to the
patentability of human genetic material. It was held that patenting of human
genes did not go against ethics, as patenting of genes did tantamount to
patenting a human being. It was also opined that EPC did not exclude
genes in isolated and purified form from patenting.
Following the suit of Relaxin case, in Biogen v. Medeva121 again, human
genetic material was claimed for patent. As the Relaxin decision did set the
trend to patenting of human genetic material, applicants in the present
case claimed DNA molecules for patent. The invention was genetically
engineered DNA molecules containing an inset needed to produce a crucial
protein for a vaccine against the Hepatitis B virus. Patent was based on
experimental work done by Professor Sir Kenneth Murry of Edinburgh
University, in 1978. At that time there was a fair degree of knowledge about
Hepatitis-B virus, but the picture was far from clear. Patent was granted to
Biogen.122
At the instance of alleged infringement by Medeva, Biogen lodged a
complaint where Medeva counterclaimed invalidity of the patent on the
ground of lack of inventive step as prior art suggested the invention. Medeva
alleged that Biogen used known process and produced known products. In
support of their arguments Medeva took recourse to a publication by an
expert in the field on enabling the direct expression of a eukaryotic protein
in a prokaryotic cell. The UK Patent Court, holding the patent as valid,
viewed that the difference between prior art and the inventive concept was
the decision and execution of the invention. Inventive step lay in Biogen’s
execution of the idea in producing genetically engineered DNA. On appeal,
the Court of Appeal overturned the decision of the Patent Court and held
that Biogen used known and available techniques and materials in making
the invention. The Court of Appeal opined that in view of the prior art
Biogen had not developed any new processes or new products and had not
discovered anything new about the claimed process. The House of Lords
upheld the decision of the Court of Appeal later. The biotech industry was
not happy with the decision and stated that increasing the purity or quality
of known products involved immense research effort, and hence the immense
effort resulting in increasing the purity or quality of the product should be
considered.
Meanwhile, at the time when the House of Lords decided Biogen invention
as not valid, EPO Technical Board of Appeal held the patent as valid, thereby
providing some encouragement to the biotech industry. The Technical Board
of Appeal accepted the contentions of biotech industry that increasing the
level of purity or quality involved an immense research effort and hence
deserved patent. In that sense the Board held the Biogen patent as valid.
Further, the Board also opined that the Biogen invention was a major
121. (1997) R.P.C 1, HL.

122. See supra 92, pp. 89-92.
achievement in Hepatitis-B as many people were working for the same result.
The decision of the EPO Board favoured the biotech industry. However, the
House of Lords decision went against the desires of the industry. Both the
decisions came at the same time. But the decision of the EPO Board had
binding force throughout the European Union. The decision of the Board
brought human genetic material like; gene, DNA within the purview of the
patent law.
Soon after the EPO Board declared the Biogen patent on DNA molecule
as valid, in Novartis case the same EPO Board held that genetic material
such as cells and parts thereof were to be considered as micro-organisms.
It was opined that since micro-organisms were patentable in the European
Union, genetic material such as cells and parts thereof, genes, and parts
thereof, being considered as micro-organisms were also eligible for patent
protection. Reiterating the Biogen decision the Board opined that human
genetic materials are indisputably patentable throughout the European
Union.
Hence, the situation now in Europe is that living matter produced
through biotechnology such as micro-organisms, plants and related
inventions, animals and related inventions, human genetic materials such
as cells, genes, and DNA and parts thereof are indisputably patentable.
Though there are no specific legislations on patenting of biotechnology, the
existing patent laws have been interpreted in such a way as to encompass
patent protection to biotechnological inventions resulting in the emergence
of biotechnology patent law within the existing patent law. The voyage of
the emerging biotechnology patent law started with patenting of micro-
organisms. Later, the plants were given patent protection, followed by patents
on animals, and finally granting patent protection to human genetic material.
Probably, there ends the voyage of biotechnology patent law as there is a
universal conviction in prohibiting human being from the purview of
patentability. As the international society is against patenting of human
being, the quest should end with patenting of human genetic material.
Though the law has evolved on biotechnology, the international society is
worried about the regulation of the biotech industry. As it is proved that
biotechnology is capable of manipulating any living being, it may move
towards producing transgenic human beings, which is against the ethical
and moral standards of the society. Such inventions may give rise to problems
of public order. Though the international society is committed to prohibit
research on transgenic human being in the consideration of developments
in the industry, it is felt that there is a need to regulate the field by evolving
proper and adequate norms, safeguarding the ethical and moral standards
of society.
Meanwhile, in the background of enormous progress of the biotech
industry and strong demands for proper legal protection of biotechnological
inventions, and on account of the fact that there is inadequate protection
to the biotechnological inventions in the existing patent system, the
European Union adopted a directive on the legal protection of
biotechnological inventions.123 The directive is a major breakthrough in the

evolution of biotechnology patent law as it provides a blueprint on the legal
protection of biotechnological inventions. The directive acknowledges and
respects various decisions by the European Patent Office and its Technical
Board in granting patents on non-natural living beings produced through
biotechnology. The directive gives statutory recognition to the various judicial
decisions hitherto made on the protection of biotechnological inventions.
A blueprint of the European Union Directive on the Legal
Protection of Biotechnological Inventions, 1998
The directive mandates member states to protect biotechnological inventions
under their respective patent laws. It urges for modifications in the existing
patent laws in the member states to give effect to the provisions of the
directive. The directive defines concepts such as ‘biological material’,
‘microbiological process’, ‘essentially biological processes’, and ‘plant variety’
which are very significant in the light of patenting of living beings such as
micro-organisms, plants, animals, and human genetic material produced
through biotechnological processes. These definitions are important in view
of the fact that starting point of all the biotechnological inventions will be a
biological material resulting from an essentially biological process. The
directive defines different concepts as follows. The definitions are, however,
very brief.
Biological material: The directive defines ‘biological material’ to mean any
material containing genetic information and capable of reproducing itself
or being reproduced in a biological system.
Microbiological process: The concept is defined to mean any process involving
or performed upon or resulting in microbiological material.
Essentially biological process: The definition says ‘A process for the
production of plants or animals is essentially biological if it consists entirely
of natural phenomena such as crossing or selection’.
Plant variety: The directive says that the concept of ‘plant variety’ is defined
by Article 5 of Regulation (EC) No 2100/94, i.e., Community Plant Variety
Rights Regulation 2100/94.
The above regulation defines a plant variety to mean ‘a plant grouping within
a single botanical taxon of the lowest known rank.’
Inventions patentable
The directive does not specify the inventions that are patentable. There is
no illustrative or exhaustive list of biotechnological inventions that are
patentable under the directive. The directive states that inventions, which
are new, which involve an inventive step, and which are susceptible to
industrial application shall be patentable even if they concern a product
consisting of or containing biological material or a process by means of
which biological material is produced, processed, or used. In the sense of
123. European Union Directive on the Legal Protection of the Biotechnological Inventions, 1998.
The directive came into effect in July 2000.
inventions involving micro-organisms, plants and animals are patentable

under the directive. The directive declares that the biological material
produced or isolated from its natural environment by means of a technical
process as patentable.124 It implies that biological material isolated and
purified by means of some technical process is patentable. As biological
materials are not available in an isolated and purified form in the nature, it
is believed that the isolation and purification involved an inventive step. At
the same time the directive states that a biological process that involves a
human intervention possessing certain non-natural characteristics is
patentable. The directive implies that human intervention to a biological
process makes it non-biological process, which is patentable under the
directive.
Inventions not patentable125
The directive states that certain biotechnological inventions are not
patentable.126 The directive considers ethical and moral standards and at
the same time runs parallel to the EPC127 and the TRIPS128 in excluding
certain inventions from patenting. The directive goes a step ahead from
EPC and TRIPS and states that; human body and its various stages of
formation and development are excluded from the purview of patent
protection. Unlike the United States Congress, the directive does not prohibit
human cloning but it excludes human cloning from patenting.129 The directive
states that there shall not be any patent protection for the following :
(A) Plant and animal varieties.
(B) Essentially biological processes for the production of plants or
animals. However, the above provision does not apply to
‘microbiological processes’.
(C) The human body at the various stages of its formation and
development, and the simple discovery of one of its elements,
including the sequence or partial sequence of a gene, cannot
constitute patentable inventions. However, an element isolated from
the human body or otherwise produced by means of a technical
process, including the sequence or partial sequence of a gene, may
constitute a patentable invention, even if the structure of that element
is identical to that of a natural element.
(D) Inventions commercial exploitation of which would be contrary to
‘order public’ or morality, such as:
(a) Processes for cloning of human beings.
124. Article 3 of the European Patent Convention.

125. Articles 4, 5, & 6 of the European Union Directive on the legal protection of biotechnology
inventions.
126. Article 4 of the Directive.
127. Article 53(b) of the EPC.
128. Article 27(3) of TRIPS.
129. United States has enacted a specific legislation banning human cloning. See, Human Cloning
Prohibition Act, 2003.
(b) Processes for modifying the germ line genetic identity of human
being.
(c) Uses of human embryos for industrial or commercial purposes.
(d) Processes for modifying the genetic identity of animals, which
are likely to cause them suffering, without any substantial
medical benefit to man or animal, and also animal resulting
from such processes.
The directive encourages and protects various biotechnological
inventions. At the same time it excludes certain inventions on account of
public order, ethical and moral standards. It tries to balance public order,
ethics, and morality with the development and innovations of biotechnology.
Further, the directive empowers the Commission’s European Group on Ethics
in Science and New Technologies to evaluate all ethical aspects of
biotechnology.130 After going through the blueprint of the directive it can be
inferred that a biotechnological invention which does not fall under the
excluding provision of the directive were patentable on the satisfaction of
requirements such as novelty, inventive step, industrial application, and
written description. However, it may not be possible to describe a
biotechnology invention in a written form. For this reason deposit of the
invention is prescribed to compensate the written description requirement.
Given the typical nature of biotechnological invention, the directive states
that where an invention involves the use of ‘or concerns’ biological material
which is not available to the public and which cannot be described in a
patent application in such a manner as to enable the invention to be
reproduced by a person skilled in the art, the description shall be considered
inadequate for the purposes of patent law unless the biological material
has been deposited with any international depository established under
the Budapest Treaty.131 The directive says that such deposit shall be made
on or before the submission of patent application.132 Public can have access
to the deposited invention. If such deposited biological material ceases to
be available, a fresh deposit shall be made.133 Reportedly, since the early
1980s the ‘European Patent Office received around 15,000 patent
applications associated with the field of biotechnology. Some 1500 of these
applications relate to transgenic plants, 600 to transgenic animals, and
around 2000 to DNA sequences. On the basis of applicable law the office
has granted about 3000 patents on biotechnological inventions till date.134
The directive on biotechnological inventions came into being in July 2000
providing for comprehensive framework on the patenting of such inventions.
The adoption of the directive puts an end to the fluctuating and contradictory
decisions of patent offices and the EPO Technical Board in patenting
biotechnology inventions.
131. Budapest Treaty for facilitating the deposit of inventions for the purpose of patent procedure,
1977.
133. Article 14 of the Convention.
134. Gerald Karmstra, Mark Doring, Nick Scott Ram, Andrew Shead, and Herry Wixon, Patents
on biotechnological invention: The EC Directive, London : Sweet & Maxwell, 2002.
The directive streamlines the biotechnology patent law in providing for

patenting of inventions ranging from micro-organisms, plants, animals,
and human genetic material.135 It can be said that the evolution of
biotechnology patent law is complete with the adoption of the directive. The
journey of evolution of biotechnology patent law in Europe started with the
adoption of the EPC, which is believed to have, laid the foundation for
patenting of living beings. In the meantime, the decisions of the patent
office and the EPO Technical Board contributed towards the evolution of
biotechnology patent law. In the end, streamlining the provisions of EPC
and various judicial pronouncements the directive on biotechnology
inventions provides for a comprehensive set of rules on biotechnology
inventions. Now, in the European Union, patent law has been harmonized
with reference to the patenting of biotechnological inventions.136
EVOLUTION OF BIOTECHNOLOGY PATENT LAW IN INDIA
In the latter part of the nineteenth century, new inventions in the field of
art, process, method or manner of manufacture, machinery, apparatus,
and other substances produced by manufacturers were on increase in India
and the inventors became very much interested in getting their inventions
protected.137 Inventors were much concerned about the enforcement of their
inventions that others should not copy or infringe their inventions. In this
background British rulers enacted the first ever patent law in India, i.e.,
Indian Patents and Designs 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,
since 1953, there were moves to consolidate the patent law by bringing up
a new comprehensive legislation. At last in 1970, government enacted the
Patents Act of 1970. At the time of this enactment biotechnology had already
started affecting the world, particularly in the United States and in the
European Union. In these countries claiming of biotechnology inventions
for patents started in the 1960s.138
The Patents Act, 1970, highlights that an invention that satisfies the
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
135. The Directive provides for patenting of different types of biotechnological inventions such
as micro-organisms, transgenic plants, transgenic animals, and human genetic materials.
On the other hand it excludes a few biotechnological inventions such as cloning of human
being and also the human body and its elements at various stages of its development.
136. After the directive is adopted in order to implement the Directive in the EPC the
Administrative Council of the European Union inserted a new chapter entitled
‘Biotechnological inventions’ in Part II of the EPC implementing regulation and amended
the wording of Rule 28 (6) of EPC. See: Amended EPC implementing regulations, adopted
on 16 June 1999, came into being on 1 September, 1999.
137. Manish Arora, Universal’s Guide to Patents Law as Amended by the Patents (Amendment)
Act, 2002, Delhi : Universal Law Publishing Company Pvt. Ltd, 2002.
138. In fact, in the US in 1873 itself a patent was granted on a biotechnological invention.
includes any new and useful improvement of any of them.139 The Act does
not specify the inventions which are patentable, but it illustrates subject
matters that are not patentable.140 The Act in its original form141 allows
patenting of processes but it does not consider patenting of products.
Further, Indian Patents Act enacted in the year 1970 does not mention
anything about biotechnological invention. The reason was that at that
time biotechnology was not developed in India. After biotech industry started
flourishing in the United States and in the European Union some momentum
developed in India. Once patents were granted for different biotechnology
inventions in the USA and in the European Union the demand for adopting
same approach gained significance throughout the world including India.
As a matter of fact, the judiciary was responsible for the evolution of patent
law on biotechnological invention in the US as well as in the European
Union. Following some judicial 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).142 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.143 After ratifying TRIPS, India modified all its
intellectual property laws including patents law144 and started marching
towards patenting of biotechnological inventions.145
To fulfil its obligation under the TRIPS agreement to provide patent
protection to all kinds of invention in all the fields of science and technology
including biotechnological inventions, India has thrice amended its patent
law. The first amendment was made in the year 1999; this amendment was
brought into effect retrospectively from 1995. The basic objective of this
amendment was to provide for mailbox applications for agricultural and
pharmaceutical inventions. The amendment brought changes in the original
139. Section 2 of the Indian Patents Act, 1970.

140. Section 3 of the Indian Patents Act, 1970.
141. Earlier to the amendments made to the Act in 1999, 2002, and latest by 2005.
142. The TRIPS agreement is a multilateral agreement on intellectual property rights. It provides
for universal law on intellectual property rights. As far as biotechnological patents are
concerned the convention gives respect to the developments in the United States and the
European Union. It mandates all the member states to provide patents on biotechnological
inventions.
143. Article: 27 of the TRIPS agreement.
144. After having ratified the TRIPS agreement India brought up the following new legislations:
1. The Trademarks Act, 1999.
2. The Geographical Indications Act, 1999.
3. The Plant Varieties Act, 2001.
4. Amendments were made to the Patents Act in 1999, 2002, and 2005.
145. India was given ten years of transmission period to modify its laws to fulfil its obligations
under the TRIPS agreement. TRIPS came into being on 1 January, 1995, the transmission
period given to India started from 1 January, 1995 and ended on 1 January, 2005.
Act to extend patent protection to inventions relating to manufacture of

chemical substances intended for use or capable of being used as food or as
drug.146 These changes are significant in the light of the prosperity of the
biotechnology industry which were by now capable of isolating genetic
material coding for certain chemical substances in any living being which
are useful in the preparation of drugs and medicine. In fact, the 1999
amendment provides only for accepting patent applications claming for
inventions relating to agriculture and pharmaceuticals. After the amendment
thousands of applications were filed before the Indian patent offices147
claiming inventions relating to pharmaceuticals and agricultural products,
among which considerable number of applications were relating to
biotechnological inventions like chemical substances isolated from the body
of living beings. However, all these applications were kept in mailbox which
was opened on 1 January, 2005 and are now under processing.
For the second time India amended its patent law in the year 2002148
bringing major changes in allowing patenting of products of chemical,
biochemical, biotechnological process as well as micro-organism. Chemical
processes are patentable under the original Act. However, 2002 amendment
added explanation to chemical process, which states: ‘Chemical processes
include biochemical, biotechnological and microbiological processes.’149 As
chemical processes are patentable with the added explanation to it, now
‘biochemical, biotechnological, and microbiological processes are also
patentable. Biotechnological inventions concer n biochemical,
biotechnological, and microbiological processes in producing non-natural,
human-made, and transgenic living beings such as micro-organisms, plants,
animals, isolating human genetic material, and also in producing the end
products of such genetic materials. Such being the case, the amendment is
significant in encouraging and promoting biotechnological inventions in
India as it seems to cover almost all the above-mentioned biotechnological
inventions. Till the time of this amendment the term ‘invention’ under the
patent law was encompassing only processes but the amendment included
the term ‘product’ within the meaning of invention. After the amendment,
the definition to invention stands as ‘a new “product” or process involving
an inventive step and capable of industrial application.’150 After this
amendment, products as well as processes in all the fields of science and
146. Apart from all chemical substances which are ordinarily used as intermediates in the
preparation or manufacture of any of the medicines or substances defined under section
2(1)(1) of the 1970 Act, a claim for patent of an invention for a substance itself intended for
use or capable of being used as medicine or drug could be patented. See section 5(2) of the
Patents Act (as amended in 1999).
147. In India the main patent office is situated at Kolkata. However, there are regional offices at
Delhi, Mumbai and Chennai. Applicants can file their applications at any of the above patent
offices.
148. The Patens (Amendment) Act, 2002.
149. Explanation to Section 5 of the Act as amended in 2002.
150. The amendment includes the word ‘product in the definition of invention to imply that
patents are made available to products or processes’. See the definition of invention
under the Patents Act, 1970.
technology are patentable in India. The amendment brought a few major

changes in the Act, which is worth discussing here. The amendment
restructures Section 3 of the original Act, which illustrates subjects which
are not considered inventions or which are not patentable. The amendment
adds the following provisions to Section 3 of the Act, which is significant in
consideration of patenting of biotechnological inventions.151
An invention the primary or intended use of commercial exploitation
of which could be contrary to public order or morality or which
causes serious prejudice to human, animal or plant life or health or
to the environment.
Discovery of any living thing or non-living substances occurring in
nature.
Therapeutic and diagnostic or other treatment of human beings or
animals.
Plants and animals in whole or any part thereof other than ‘micro-
organisms’, but including seeds, varieties and species and essentially
biological processes for production or propagation of plants and animals.
The above-mentioned subjects are not considered inventions and are
not patentable. These amended provisions incorporate TRIPS provisions
under Article 27 in the patent law. The amendment states that micro-
organisms are patentable but plant and animal varieties and essentially
biological processes for the production of the same are excluded from the
purview of patent protection. However, it is mentioned that the above
exclusion does not apply to microbiological processes and products thereof.
In the sense microbiological processes and products thereof are patentable.
At the same time it is further stated that discovery of any living thing is not
patentable. Discovery of a living thing existing in nature does not involve
any human interference and hence is not patentable. On the same lines
natural things produced out of natural or essentially biological processes,
which do not involve any human interference, are not patentable. It implies
that a non-natural process that involves some technical interference to a
natural process is patentable. Technical interference to a natural or
essentially biological process renders it non-biological, which is patentable.
On the same lines products of biotechnological process produced through
some technical interference to natural process are non-natural, hence
patentable.
In March 2005, for the third time India amended its patent law.152 The
amendment recognizes Budapest treaty153 for the deposit of micro-organisms
for the purpose of patent procedure. Patent applications claiming
biotechnological inventions involving living matter shall be accompanied
by a deposit of the invention in any depository recognized under the treaty.
151. Sec. 3 of the Patents Act as amended in 2002.

152. The Patents (Amendment) Act, 2005, published in the official gazette of India on 5 April,
2005.
153. Budapest treaty for the deposit of micro-organisms for the purpose of patent procedure
was adopted in the year 1977. India is a party to this treaty.
As it may not be possible to describe a biotechnology invention, the treaty

recognizes the practice of depositing the invention to compensate for the
written description. In order to fulfil TRIPS mandates of providing patent
protection to biotechnological inventions, India recognized the Budapest
treaty, which facilitates the deposit of biotechnology inventions. Further,
the 2005 amendment totally omits Section 5 of the original Act which
restricted patents only to the methods or processes of manufacture. The
1999 amendment altered this section by inserting sub-clause (2), which
provided exception to the main provision for product patenting of drugs and
medicines. With the latest amendment totally omitting this section, now
both products as well as processes are patentable.154 In the field of
biotechnology, processes as well as products are claimed for patents.
Biotechnology inventions such as micro-organisms, and genetically modified
plants and animals are products of biotechnological processes. So these are
being claimed for patent. Further, methods or processes to manipulate living
beings genetically or to produce genetically engineered living beings are
also claimed for patent.
The emergence of biotechnology patent law in India can be traced back
to the TRIPS agreement and the amendments made to the patent law by
virtue of TRIPS agreement. But even earlier to implementing the TRIPS
agreement a patent on a living being was granted. Dominico, a subsidiary
of American Home Remedies, was granted a patent on a process for the
preparation of infectious bursitis vaccine. The vaccine is useful in protecting
poultry against infectious bursitis. Initially, the patent office rejected the
patent claim and an appeal was made to the Calcutta High Court.155 The
High Court held that there is no bar for patenting a claim on a living being
or living process. The Court interpreted the term ‘manufacture’ under the
patent law to include any living being or living process and directed the
patent office to grant patent. It was the first instance where a living process
was patented in India.
With the amendments made to the patent law fulfilling obligations under
the TRIPS agreement there emerged biotechnology patent law in India. Unlike
in the United States and European Union where biotechnology patent law
is a result of judicial pronouncements, in India the emergence of
biotechnology patent law is a result of ratifying international conventions
and obligations under such conventions. Having ratified the TRIPS
agreement, which mandates for patent protection to biotechnological
inventions, in India micro-organisms are now patentable. However, the stand
of India is not very clear with regard to the patenting of non-naturally
produced plant, and animals. We shall have to wait and see whether India
follows the path of the US and Europe in holding non-natural living beings
produced through microbiological, biochemical, and biotechnological
processes as patentable or not.
154. Patents Act as amended in March 2005.

155. See supra 88.
Further, research in human genetics (one among different spheres in

biotechnology) is not lagging behind too far in India. On account of enormous
potential of human genetics research there is a definite growth in the sphere
of human genetics, in India. In the absence of legal provisions on the
regulation of human genetics, the Indian Council of Medical Research (ICMR)
brought guidelines to regulate research in human genetics. The guidelines
basically focus on the ethical issues involved in human genetics and intend
to safeguard ethics and human rights in the human genetic research. The
guidelines provide for a comprehensive mechanism for the regulation of
human genetics with the establishment of ethics committees to evaluate
research in human genetics. In the absence of legal framework on the issues
and the guidelines hold good. Meanwhile, the Government of India is thinking
of introducing legislation on the basis of the guidelines issued by the ICMR.
Further, the Government of India brought DNA safety guidelines in the year
1994 to regulate the use, storage, and release of genetic material in research.
The DNA safety guidelines are considered as a pre-arrangement for ensuring
safety in usage of biotechnological products and processes, which are offered
protection by virtue of amendments made to the patent Act. The consequences
of such patenting such as use of biotechnological inventions like DNA and
gene should be regulated and safety should be ensured. The DNA safety
guidelines intend to ensure safety in using, and storing of DNA and genes
for research in biotechnology. It can be inferred that as far as biotechnology
and its regulation is concerned, India is not lagging behind too far as it has
got considerable legal mechanism to patent, regulate, and monitor
biotechnological inventions.
Many foreign biotech companies have filed patent applications in India
on different biotechnological inventions. Till date, there is no substantive
case law or patent office reports or records in India on the patenting of
biotechnological inventions. It is expected that in future there may be judicial
pronouncements and patent office reports on the patenting of
biotechnological inventions as India is turning out to be a biotech hub in
the near future. As biotechnological inventions are based on biological
sources, as the starting point of any biotechnological invention is biological
material, having enormous biological resources in India is going to generate
definite growth in the biotech industry. Recognizing the significance of the
upcoming sector of biotechnology in the present world, the government of
India has come out with certain strategic plans to boost the industry.156
Further, the Government of India has announced special assistance and
scholarships for studies and research in biotechnology to boost expertise
and manpower in the sector.157 Besides bringing changes in the patent
law to give protection to biotechnological inventions, having made all the
156. Sibal proposals to promote biotechnology, The Hindu, 15 March, 2006, p. 14.
157. Ibid.
legal arrangement, India is ready to face the challenges that may arise as
a result of biotechnological inventions and researches in different
spheres.158
On the whole the evolution of biotechnology patent law can be traced
back to the Constitution of America, which intends to foster the progress of
science and technology. The US judiciary has played an important role in
the emergence of biotechnology patent law through its interpretation of the
patent law. The liberal approach of the US judiciary was supported by the
US Patent Office by granting patents on biotechnological inventions. The
suits in US judiciary and the patent office were followed by other nations.
Initially the European Union was ahead of the US as there were patent
claims on biotechnological inventions involving life. However it was the US
judiciary which gave green signal to the emergence of biotechnology patent
law through its judgment in Chakraburty. The decision in Chakraburty is
a milestone and is the starting point in the evolution of biotechnology patent
law. The decision had its far-reaching impact where it influenced the entire
world. Even today, courts while adjudicating matters involving biotechnology
inventions, and patent offices, while granting patents on biotechnology
inventions, follow the rationality of Chakraburty.
The approach of the US is very liberal. Their philosophy is that anything
under the sun made by man is patentable. The evolution of biotechnology
patent law is heavily influenced by this philosophy evolved by Thomas
Jefferson, the author of American patent law. The European Union was
quick enough to follow the philosophy of America in liberally interpreting
the existing patent laws to provide patent protection to biotechnological
inventions. Later, the entire world including India followed the US cases by
amending their local laws or bringing suitable legislations to give patent
protection to biotechnological inventions. Meanwhile, the TRIPS agreement
also postulates patenting of inventions in all the fields of science and
including living beings produced through biotechnology. It is felt that the
coming into being of the TRIPS agreement has streamlined and uniformed
the law relating to biotechnological inventions. Though having faced strong
oppositions and objections the evolution of biotechnology patent law is
complete and all inventions of biotechnology like micro-organisms, plants,
animals, and human genetic material including different methods to produce
the same are now considered patentable.
158. India allowed filing of mailbox patent applications on agricultural and pharmaceutical
inventions from 1999. Many of those applications contain claims for biotechnological
inventions in relation to agricultural and pharmaceutical industry. On 1-1-2005 mailboxes
were opened for the processing of applications. Since 2002, by amending patent law, patents
are made available to living beings produced through biotechnology and on patent
applications living beings started pouring in. Finally with the 2005 amendment, all the
requirements for giving patent protection were fulfilled.
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CHAPTER 2

Evolution of Biotechnology Patent

1. Writings of Thomas Jefferson, pp. 75-6, (Washington, ed. 1871).

Subsequently in Exparte Latimer 10 a patent claim for fibre found in the

10. December 1889, Com. pat.123.

19. 33 US 127 (1948).

there were claims for patents on living matter. In Diamond v. Chakraburty22

22. (1980) US SC 447 at 303.

Incessant filing of patent applications as such was the sequel of Chakraburty

Patenting of higher life forms : Animals

36. See supra 28, p. 164.

39. 927 F.2d 1200, 18 USPQ 2d 1016 (Fed. Cir. 1991).

42. 51 F. 3d 1552 (Fed. Cir.1995).

sequences. Isolation and sequencing of DNA requires isolation and

claimed for patent. In Hybertech Inc. v. Monoclonal Antibodies. Inc.,46the claim

isolation and incorporation of genetic material from one species to another

56. See supra 53.

However, later on legislature tried its hand with a few legislative

64. United States Patent Code (as amended in 1995).

EVOLUTION OF BIOTECHNOLOGY PATENT LAW IN THE

Paris convention. In the agricultural sector, in the production of wines and

Genentech-I/Polypeptide expression86 a living being was claimed for patent.

86. (T 292\85) (1989) Journal of European Paitent office (JEPO 275).

organism was a success, there ware attempts to manipulate plants

namely, glutamine synthesis inhibitors (GSI)96. The claimed patent disclosed

The board happened to clarify with regard to what constitutes a

In the instant case different interests were involved which required

113. See supra 92, pp. 62-7.

of microbiological process, which is not excluded form patenting. The Board

121. (1997) R.P.C 1, HL.

biotechnological inventions.123 The directive is a major breakthrough in the

inventions involving micro-organisms, plants and animals are patentable

124. Article 3 of the European Patent Convention.

The directive streamlines the biotechnology patent law in providing for

139. Section 2 of the Indian Patents Act, 1970.

Act to extend patent protection to inventions relating to manufacture of

technology are patentable in India. The amendment brought a few major

151. Sec. 3 of the Patents Act as amended in 2002.

As it may not be possible to describe a biotechnology invention, the treaty

154. Patents Act as amended in March 2005.

Further, research in human genetics (one among different spheres in

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