INTELLECTUAL PROPERTY RIGHTS

Project on:
PATENTING IN BIOLOGICAL INVANSION IN INDIA:
PRACTICE AND PROCIDURE

NATIONAL LAW UNIVERSITY ODISHA

Under the guidance of:
Mr. Amrendra Kumar Ajit
Assistant Prof. (Law),
National Law University Odisha

Group Code:
Submitted by:
RAMESH KUMAR

(2012/B.A.LL./040)

Semester VII
(For Internal Assessment Purpose Only)

ACKNOWLEDGEMENT
It is with deep reverence and utmost respect that we, Abhay sharma and Ramesh kumar, pay
a humble vote of thanks to Amrendra Kumar Ajit without whose exceptional guidance and
expert inputs, this paper would not have been successfully completed. Amrendra Kumar
Ajit has been instrumental in guiding us to write this paper with appropriate ease and has
been extremely co-operative with us throughout the length of time while this paper was in the
process of completion. We extend my deep and humble gratitude to him for guiding us to
successfully complete this paper.

DECLARATION

The text reported in this project is the outcome of our own efforts and no part of this project
assignment has been copied in any unauthorized manner and no part of it has been
incorporated without due acknowledgement.

(RAMESH KUMAR)

Dated:

Table of Contents
RESEARCH METHODOLOGY..................................................................................5
INTRODUCTION........................................................................................................6
DEVELOPMENT OF BIOTECHNOLOGICAL PATENT IN INDIA..........................7
BIOTECHNOLOGICAL PATENTING IN INDIA.......................................................9
DIVERSE NATURE OF BIOTECHNOLOGY.........................................................9
DIFFICULTY TO PROVE INVENTIVE STEP......................................................10
DIFFICULTY IN DUPLICATION..........................................................................10
TRIPS REQUIREMENTS IN BIOTECHNOLOGICAL PATENTING......................12
DO WE NEED BIOTECHNOLOGICAL PATENTS?................................................14
CONCLUSION...........................................................................................................16
BIBLIOGRAPHY.......................................................................................................17

RESEARCH METHODOLOGY

RELEVANCE AND SIGNIFICANCE OF THE TOPIC:

This project deals with the laws relating to patenting of Biotechnology in India. The project
tries to show the process development of Biotechnological Patents in these two countries with
the help of various case laws. Further, it focuses on various limitations with recommendations
attached while patenting biotechnological inventions.
OBJECTIVES:
Following are the objective kept in mind while writing this project

Prevailing laws on Biotechnology Patents in India.

Significance of the case of DIMMINACO A.G. V. CONTROLLER and VANDANA SHIVA

AND

ORS. V. UNION OF INDIA AND ORS

RESEARCH QUESTIONS:
1. WHETHER

ANY

REFORMS

ARE

REQUIRED

IN

THE

PRESENT

LAWS

RELATED

TO

THERE ARE ANY SIGNIFICANT DIFFERENCES IN THE

LAWS

RELATING TO

BIOTECHNOLOGICAL PATENT IN INDIA?

2. WHETHER

BIOTECHNOLOGICAL PATENS IN INDIA?

SOURCES:
The researcher has used the secondary research methodology like books, web resources
research reports, newspaper, magazine and journal content, to carry out the research.

CITATION:
Bluebook (19th Ed.) Citation is being followed

INTRODUCTION

Patents are a division of the larger field of law known as intellectual property law and it is
recognized that some types of intellectual property should be granted legal protection. A
patent is a contract between the government and an inventor under which, in exchange for the
inventor's complete disclosure of the invention to the public, the government grants the
inventor the sole rights to prohibit others from making, using, selling or offering for sale the
claimed invention for a limited period of time, in general twenty years after the date that the
application for the patent was filed.1 Biotechnology is the science of developing techniques
for the application of biological processes and organisms to the production of materials used
in medicine and industry. Initially, biotechnology was concerned only to the production of
useful products (like antibiotics, cheese etc) by employing micro-organisms (like fungi,
bacteria etc). Modern biotechnology corresponds to the use of genetic engineering to modify
bacterial cells to produce completely new substance like the use of hybridoma technology in
producing monoclonal antibodies. Biotechnology can be classified into two categories:
industrial biotechnology and agricultural biotechnology. Chemical and pharmaceutical
substances that are imitative from or processes pertaining to plant or animal kingdom is
called as industrial biotechnology, while agricultural biotechnology involves the use of
genetic engineering to develop new plants and animal varieties.2
Biotechnology includes living organisms such as plants, animals, micro-organisms, as well as
non-living biological material, such as seed, cells, enzymes and plasmids. Biotechnological
invention falls into three categories namely: they are the processes for the creation or
modification of living organisms and biological materials; the results of such process; and the
use of such results.3 This project will specifically deal with the laws prevailing in India and
Europe in patenting of bio-technologies with relevant case laws. It also focuses on some
limitations with recommendations attached while patenting Biotechnologies

1 GEORGIOS I. ZEKOS, Patent Law in Cyberspace Era, Electronic Communication, 281-309,

(2002).
2 Feroz Ali Khader, The Law Of Patents-With A Special Focus On Pharmaceuticals In India,
99 (2007).

3 WIPO, Background Reading Material on Intellectual Property, Geneva, 375 (1988).

DEVELOPMENT OF BIOTECHNOLOGICAL PATENT IN INDIA

The Patents Act 1970which defined invention as any new and useful art, process, method or
manner of manufacture, machine, apparatus or other article, substance produced by
manufacture and any new and useful improvement of any of them.
There were no product patents offered for substances which were intended for use or were
capable of being used as a food, drug or medicine in addition to products of chemical
processes. Moreover, living organisms and biologically active material which included
recombinant DNA and the processes relating to their preparation were also not patentable.
Biotechnological inventions were not mentioned in the Act as this industry was not developed
in India.4 However, as the industry began to prosper worldwide and patents were granted in
US and European Union set new trends in patent law. This led to adoption of Trade Related
Intellectual Property Rights which stated that patents should be allowed for all kinds of
inventions related to science and technology. In order to fulfil the obligations of the
agreement India amended the laws related to patent thrice.
The first amendment was made in 1999 with a retrospective effect from 1995 with an aim to
provide for mailbox application for inventions concerning agriculture and pharmaceuticals.
This resulted in protection of manufacturing of chemical substance which can be used as food
or drug.5 This was a boon to the biotechnological field as they were now competent of
secluding genetic material coding for specific chemical substances in living beings beneficial
for preparation of any medicine or drug.
The second amendment was made in 2002 which allowed patenting of product of process of
chemical, biotechnology and biotechnological including micro organism. This also aimed to
incorporate article 27 of TRIPS Inventions in relation to patentable biotechnological can be
generally categorized as Products in the form of chemicals, microorganisms, plant extracts,
4 Ott, Robyn, Applying The Patents Act To Living Materials In India, 2 OKLA. J. L. & TECH. 17
(2004). Available at http://www.okjolt.org/images/pdf/2004okjoltrev17.pdf, Last updated on
15thOctober, 2014.
5S.P. Srivastava, Patenting of Micro-Organism in India: An Overview, SSRN. Published at
www.legalserviceindia.com.

fermented material; processes/methods for using useful products and compositions

formulations of product such as vaccines, proteins, hormones.6 Though India has approved

patenting of microorganisms but the Patent Act is silent about the definition of the term
microorganisms which has resulted many debates concerning patentability of microbes. The
Act bars patenting of plants and animals as such, basically biological processes for the
production of plants and animals and the technique of treatment of humans and animals.
Unlike other developed countries, India has allowed product patent pertaining to inventions
related to microorganisms and other biological materials and it was from 20 May 2003 that
India has started granting patents for invention associated to microorganisms, despite the fact
that India was not indebted to establish laws for patenting microorganisms before 31
December 2004.7
The third amendment was made in 2005 which recognized the Budapest Treaty and also
deposition of the living entity for completion of patent procedure. The grant of patent to
microorganisms relied upon the regulations regarding the requirement of deposition of
microorganisms and also accessibility of that microorganism from the depositories under the
Budapest Treaty of which India is a part of. As per provision (ii) to section 10(d) if the
microorganism is not illustrated completely and is not obtainable to public, it is to be
submitted before the International Depositary Authority under the Budapest Treaty 2002. The
amendment in the Indian Patent Act inserted an explanation to chemical process which says
that the chemical processes consist of biochemical, biotechnological and microbiological
process and areas concerning microorganisms are also patentable in India. For instance, both
a synergistic composition including the microorganism which is either novel or recognized
and a process which uses microorganisms to produce a substance can be patented.
Furthermore, the process of biosynthesis of a new microorganism as well as Microorganisms
that are lyophilized as an end product is patentable.8

6 S Sekar & D Kandeval, Patenting Microorganism: Towards Creating a Policy framework, Journal
of Intellectual Property rights 7 211-12 (2002).
7 Jayshree Vatal, Indian Patent Law on Biotechnological Inventions, APBN 79( 2000).

The term for grant of patents for microbiological inventions is for of 20 years from the date
of filing. The fact that India does not permit patenting of microorganism which already
subsist in nature as it is considered to be a discovery as per section 3(d) distinct it from other
developed. Nevertheless genetically modified versions of the same microorganisms which
lead to enhancement of its known efficacies are patentable. 9\

BIOTECHNOLOGICAL PATENTING IN INDIA

In India biotechnology inventions In India are rather controversial and it has recently
received protection under patents.

DIVERSE NATURE OF BIOTECHNOLOGY

1. Biotechnology as a field is diverse and is further divided into a number of parts. Each
of the sub field consists of characteristics and features which can be differentiated
from the other and therefore it is quiet difficult to lay down a set of general rules
biotechnology as a whole.10 For instance, genomics is dissimilar when compared with
tissue culture in description, functions, processes and products. Similarly, plant tissue
culture has diverse characteristics in relation to animal tissue culture. The diversity
and the varying features of the sub- parts of biotechnology makes framing common
principles of patent for it a tedious task. Hence, the application of patent law to
biotechnology is extremely complex.

DIFFICULTY TO PROVE INVENTIVE STEP

2. The requirements to test the patentability are firstly novelty, inventive step and industrial
application. Hence, microorganisms have to be judged similarly. The prerequisite of inventive
step is extremely difficult to test in case of biotechnology. It is a compulsory condition of the
patent law to supply detailed information of the invention to be protected which is commonly
referred as sufficiency of disclosure. This poses as a problem as these biological materials

8 Suja Senan, M. G. Haridas and J. B. Prajapati, Patenting of microorganisms in India: a point to

ponder, CURRENT SCIENCE, 100 (2011).
9 Office of Controller General of Patents, Designs and Trademarks, Guidelines For Examination Of
Biotechnology Applications For Patent (2013).
10 Ameen Jahuri & Narnaulia, Patenting the Life the Indian European and American Way, Journal of
Intellectual Property rights 15 55-65 (2010).

cannot be easily described in words and sample of living entity has to be deposited fulfil the
sufficiency of disclosure test. 11

DIFFICULTY IN DUPLICATION
3. A patentee is required to reveal the invention entirely in the patent document so that a
person skilled in the art can duplicate the invention and fulfil the claims with the available
information present in the patent document. Repeatability is an issue in case of microbial
inventions. The deposition is recognised to satisfy the procedure of patent procedure in 55
member countries under the Budapest Treaty.

DIMMINACO A.G. V. CONTROLLER12

Dimminaco A.G., a Swiss Company filed an application concerning an invention in relation
to a process for the preparing Bursitis vaccine, which was competent of shielding poultry
against contagious Bursitis infection and with segregation and preparation of novel virus
valuable for preparing such vaccines. the applicant had asked for a patent for the process of
creation of vaccine to guard the poultry from the Bursitis which the Controller of Patents
discarded on the ground that it was not in the ambit of Section 2(1)(j) of the Patent Act, 1970
and cannot be called an invention. However the utility of the invention was not questioned.
The Assistant Controller of patent stated that in India till date, no patent had been granted
for any process of preparing a living organism. As per the Controllers analysis if such a
process happens to be patentable, there will be further problems as foreign sophisticated
technologies will have to be patented in India. It was also argued that the framers of Indias
Patents Act, 1970, had adopted the recommendation of the government laid down in Iyengar
Committee that there should be a narrow definition for invention. The Dimminaco
contented that the Patent Office had not quoted any anticipatory prior art adjacent to the
process which was claimed, nor had they doubted the utility of the end-product vaccine.
Consequently, the process should be patentable as a manner of manufacture bringing it
under the ambit of Patent Acts specific categories of inventions.
11 Tenneti, V. C., Patenting of biotechnology material: Socio-ethical and legal issues, (2010).
12 IPLR 2002 July, (255).

The Calcutta High Court held the span of manner of manufacture under section 2(i) (j) of
the Patents Act, 1970, and observed that the term manufacture had not been defined in the
Patents Act. Thus, the court relied on the dictionary meaning of manufacture or its practice
in the particular trade or business must be acknowledged. Further, the test of vendibility was
established in this case to settle on whether a process of manufacture is to be patented or not.
This test states that if the invention leads to production of some vendible item which can be
transferred from one person to another upon purchase and sale the alleged method will be
patentable. This is because as per the dictionary meaning of manufacture is inclusive of the
process of production a vendible commodity which includes a living substance.
The court said evidence was present to show that the Indian Patent Office had granted a few
biotechnology process patents which produced a living end product before. The Assistant
Controller did not act on correct principles by disallowing the application of Dimminaco on
the view that it was not a manner of manufacture since it had a living virus involved in the
end-product. The Indian Patent Office agreed to the fact that even if an invention is living or
produces a living product cannot be excluded from protection under patent. The MPPP states
that a living entity having an artificial origin for instance micro-organism or vaccines are
patentable. However, higher life forms such as plants or multi-cellular animals, irrespective
of the fact that they have natural or artificial origin are not patentable. In addition, the
processes concerning micro-organisms or production of chemical substances by means of
micro-organisms are patentable.
VANDANA SHIVA AND ORS. V. UNION OF INDIA AND ORS. 13
In this case four petitioners had sought writ of mandamus before the Delhi High Court in
order to prevent India from signing or ratifying GATT Agreement which was indirectly meant
to stop India from incorporating Article 27 3(b) of TRIPs Agreement concerning plant,
animal and microorganism. They also asked for leaving out of patents in relation to life-forms
which included plants, animals, human beings which were created by the means of biological
or microbiological processes on the basis of public order and public morality. Moreover a
direction was also sought against Union of India from infringing the fundamental rights and
guaranteeing their security while signing the Treaty.

13 1995 (32) DRJ 447.

The Court by referred to Article 51 of the Constitution concerning to Directive Principles

which stated that State shall endeavour to
(a) Promote international peace and security;
(b) Maintain just and honourable relations between nations;
(c) Foster respect for international law and treaty obligations in the dealings of organized
peoples with one another; and
(d) Encourage settlement of international disputes by arbitration.14
Therefore the executive authority is empowered to ratify international conventions if it does
not defy nay fundamental right of the citizen. Hence, the appeal was dismissed.

TRIPS REQUIREMENTS IN BIOTECHNOLOGICAL PATENTING

Genetic resources have in the past been declared a common heritage of mankind to be
preserved and to be freely available to all, for use for the benefit of present and future
generations. This philosophy has done well to the country in general and to the society in
particular, in the long run by enabling access to such creations and knowledge to all without
discrimination. But in recent times the industrial countries are busy in the protection and
privatization of inventions in the area of living objects or substances such as patenting of
microorganisms and animals. Such steps were generally not accepted by the developing
countries including India.
However, TRIPs agreement encourages protection of knowledge and it seeks to enforce US
style patent laws around the world. This agreement covers everything from pharmaceuticals
to information technology software and human gene sequences, and is emerging as a major
issue dividing North and South. TRIPs agreement forces all countries to accept a medley of
new biotech patents covering genes, cell lines, organisms and living processes that turn life
into commodities. Governments all over the world have been persuaded into accepting these
patents on life before anyone understood the scientific and ethical implications.
14 The Constitution of India, 1950

The patenting of life-forms and living processes is covered under Article 27.3(b) of TRIPs.
The TRIPS Article 27.3(b) is designed to allow the broadest categories of patents from
genetic engineering and other new biotechnologies. The patenting of lifeforms and living
processes is covered under Article 27.3(b) of TRIPs. This scientific briefing explains why
such patents should be revoked and banned on the following grounds:

All involve biological processes not under the direct control of the scientist. They

cannot be regarded as inventions, but expropriations from life.

The hit or miss technologies do not qualify as inventions, and are inherently

hazardous to health and biodiversity.

There is no scientific basis to support the patenting of genes 15 , genomes16, cells and

microorganisms17, which are discoveries at best.

Many patents are unethical; they destroy livelihoods, contravene basic human rights,
create unnecessary suffering in animals or are otherwise contrary to public order and

morality.
Many patents involve acts of plagiarism of indigenous knowledge and bio-piracy of
plants (and animals) bred and used by local communities for millennia18

In India, as it is mandatory for all the member countries of the WTO to adopt the agreements
of WTO, the Ministry of Science and Technology has issued guidelines Instructions for
Technology transfer and Intellectual Property Rights, which would help in enhancing the
motivation of the scientists, research institutions and universities in various research and
development projects funded by various departments of the Ministry of Science and
Technology. The salient features of these guidelines are as follows:

15 Gene is a stretch of genetic material (DNA or RNA) with a defined function in the organism or
cell. It usually codes for a protein.
16 A genome is the totality of all the genetic material (deoxyribonucleic acid or DNA) in an
organism, which is organised in a precise, though by no means fixed or constant way. In the case of
viruses, most of them will have ribonucleic acid or RNA as the genetic material.
17 microscope, usually, an ordinary light microscope. It includes bacteria, mycoplasm, yeasts, singlecelled algae and protozoa. 12 Cooper, I. P., Biotechnology and the Law, (New York, NY: Clark
Boardman, 1985).
18 Cooper, I. P., Biotechnology and the Law, (New York, NY: Clark Boardman, 1985).

A. Ownership of Intellectual Property: the institution shall be encouraged to seek

protection of IPR rights in respect of the results of R&D. they may retain the
ownership of such IPRs. Institution means any technical, scientific and academic
establishment where the research is carried through funding by central or state
governments.
B. Transfer of Technology: the institutions would take necessary steps to commercially
exploit patents on exclusive or non-exclusive basis.
C. Royalty to inventors: owner institutions are permitted to retain the benefits and
earnings generated out of the IPR. Institutions may determine the share of the
inventors and other associated persons from such earnings. However such sharing is
limited to one third of such earnings.
D. Norms for the private industry: IPR generated through joint research by institutions
and industrial concerns through joint research efforts can be owned jointly by them
on mutually agreed terms through a written agreement. The institution or industrial
concern may transfer the technology to the third party for commercialisation on
exclusive or nonexclusive basis.
E. Patent Facilitating Fund: the owner institution shall set apart not less than 25% of the
revenues generated from IPR to create a patent facilitating fund. The fund shall be
utilised by the owner for updating the inventions, filing applications for new patents
and protecting the IPR against infringement and for building the competency in the
area of IPR and related issues.
F. Information: the institution shall submit the information relating to the details of the
patents obtained the benefits and earnings arising out of the IPR and the turnover of
the products periodically to the Department/ministry, which has provided the funds19.

DO WE NEED BIOTECHNOLOGICAL PATENTS?

The businesses that use biotechnology are persuaded that licensed innovation security ought
to be reachable for the developments that originate from exploration and which have business
potential. Biotechnology research specialists in scholastic foundations progressively share
this perspective in view of their requirement for examination financing which is to a limited
extent contingent on patentability.

19 Tripathi K. K., Biotechnology: Government of India Initiatives, Saketlnd Digest,Feb.2002.pp.4953.

Be that as it may, numerous individuals are not for biotechnology licenses. For some such
gatherings "protecting life" is viewed as dishonest on a basic level. The resistance stretches
out likewise to conceivable basic change in the rural business which may originate from
biotechnology and particularly from the securing by the bigger partnerships of legitimate
rights on the advances that are being made.

A legitimately admissible ground of protest is that qualities are actually happening substances
and that the techniques for exchanging them to plants or creatures are understood and direct.
This is a test to the imagination substance of the specific patent at issue; it is a contention that
modern contenders will now and then use against each others licenses yet so far it has not
made a high progress rate. The contention likewise lies at the ethical's heart protests
numerous with religious convictions need to protecting qualities. They respect cases of
creation, rather than revelation, equivalent to guaranteeing to be God. Some vibe that
licensing living things change the relationship in the middle of mankind and whatever is left
of nature. This is especially touchy as respects creatures, where licenses are seen as giving
"proprietorship", in this way undermining the animals right to freedom of being and
consigning it to the status of a unimportant article. In any case, plants and creatures are
claimed by the ranchers who produce them and use them as agrarian wares. Every single such
proprietor, whether of licensed or unpatented living beings, are sure to regard creature
welfare enactment. The complaint to creature enduring may additionally apply to the
hereditary change of homestead creatures. One early investigation to embed a development
hormone quality into a pig so as to expand development rate succeeded however created
serious unanticipated symptoms including joint pain. Creature welfare gatherings contend
that licenses will empower more research on creature hereditary alteration, which they restrict
on grounds of conceivable enduring and of rule. Planned to anticipate undue enduring,
enactment requires the allowing of creature experimentation licenses and full revelation of
the experimentation.

The patentability of qualities and other nucleic corrosive arrangements is legitimized on the
ground that they have been liable to a microbiological or non-organic procedure, i.e, quality

sequencing, which is itself a standard procedure patentable and protected under existing
patent laws for creation. Along these lines, the real protected element is the nucleic corrosive
grouping itself and its putative capacity. In any case, the DNA or RNA grouping is liable to
change by transformation, cancellation, insertion and reworking. The licensing of genomes
brings up the capacity's issue of the genomes. Once more, the confined genome can do
nothing without anyone else, while its "capacity" in the life form can't be considered
independently from the living being's total

CONCLUSION
At present India grants only process patents for certain biotechnological inventions. However,
Indias adherence to the WTO will entail changes in its patent law by 2000. Although there is
no need for India to go beyond TRIPS and grant patents for plants and animals in the near
future, India will need to patent microorganisms and microbiological processes and products
directly obtained there from. Sui generis plant variety protection can also take advantage of
the flexibility currently allowed to include farmers privilege and breeders exemption.
However, new technological advances may make farmers privilege redundant and local
innovative breeders may themselves demand the limiting of breeders exemption. Some
developing countries have already seen the wisdom of going on to the next stage of granting
patents for plants, genes and animals and many others may do so, once domestic research
capabilities in biotechnology improve. India should also do so once it gains confidence that
IPRs can be used to encourage domestic innovation in this crucial technology

BIBLIOGRAPHY

Articles

N. S. Sreenivasulu, C. B. Raju, Biotechnology and Patent Law: Patenting Living

Beings, 251.
Feroz Ali Khader, The Law Of Patents-With A Special Focus On Pharmaceuticals In
India,

Jayshree Vatal, Indian Patent Law on Biotechnological Inventions, APBN 79( 2000).

Office of Controller General of Patents, Designs and Trademarks, Guidelines For

Examination Of Biotechnology Applications For Patent (2013).
Pillai, M., Kumar, S., Kumar, R. and Agrawal, P., J. Intellect. Property Rights, 5356,
C.B.Raju, Intellectual Property Rights, 1 st Ed., (New Delhi: Serials Publications),
2006.
International Journal of Scientific and Research Publications, Volume 3, Issue 4, April
2013 1

Books

Feroz Ali Khader, The Law Of Patents-With A Special Focus On Pharmaceuticals In India,
99 (2007).
GEORGIOS I. ZEKOS, Patent Law in Cyberspace Era, Electronic Communication, 281-309,
(2002).
N. S. Sreenivasulu, C. B. Raju, Biotechnology and Patent Law: Patenting Living Beings, 251.
Veena, Biotech Patent Law, 49 (1st edn., 2007).
W. R Cornish, Intellectual Property; Sweet & Maxwell, 156 (1996).
Statutes
EPC, Art.53(a) (and correspondingly of Article 6 of the Directive), states if the exploitation
of the invention would be contrary to morality, a patent shall not be granted.
EPC, Convention on the Grant of European Patents, Art.52 (2) (a).
The Constitution of India, 1950
US Constitution Article 1 Section 8.