Project on:

INTELLECTUAL PROPERTY RIGHTS

PATENTING IN BIOLOGICAL INVANSION IN INDIA:

PRACTICE AND PROCIDURE

Submitted by:

PULKIT AGARWAL
BCOM LLB (H) 2015-2020
SECTION B
Semester X
 Table of Contents

RESEARCH METHODOLOGY..........................................................................................2
INTRODUCTION.............................................................................................................3
DEVELOPMENT OF BIOTECHNOLOGICAL PATENT IN INDIA..........................................5
BIOTECHNOLOGICAL PATENTING IN INDIA...................................................................7
DIVERSE NATURE OF BIOTECHNOLOGY.....................................................................7
DIFFICULTY TO PROVE INVENTIVE STEP.....................................................................7
DIFFICULTY IN DUPLICATION.....................................................................................7
TRIPS REQUIREMENTS IN BIOTECHNOLOGICAL PATENTING.......................................10
DO WE NEED BIOTECHNOLOGICAL PATENTS?............................................................12
CONCLUSION...............................................................................................................14
BIBLIOGRAPHY............................................................................................................15
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 BIOTECHNOLOGICAL PATENT IN
INDIA?

2. WHETHER THERE ARE ANY SIGNIFICANT DIFFERENCES IN THE LAWS RELATING TO 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

DEVELOPMENT OF BIOTECHNOLOGICAL PATENT IN INDIA

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).
The Patents Act 1970 which 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 microorganism. 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,
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.
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.
5
S.P. Srivastava, Patenting of Micro-Organism in India: An Overview, SSRN. Published at
www.legalserviceindia.com.
6
S Sekar & D Kandeval, Patenting Microorganism: Towards Creating a Policy framework, Journal of
Intellectual Property rights 7 211-12 (2002).
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

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\

7
Jayshree Vatal, Indian Patent Law on Biotechnological Inventions, APBN 79( 2000).
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).
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 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.

10
Ameen Jahuri & Narnaulia, Patenting the Life the Indian European and American Way, Journal of
Intellectual Property rights 15 55-65 (2010).
11
Tenneti, V. C., Patenting of biotechnology material: Socio-ethical and legal issues, (2010).
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 Controller’s 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 India’s 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 Act’s specific categories of inventions.

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.

12
IPLR 2002 July, (255).
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.

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

13
1995 (32) DRJ 447.
14
The Constitution of India, 1950
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.

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:

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

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, single-celled
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).
 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.

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
19
Tripathi K. K., Biotechnology: Government of India Initiatives, Saketlnd Digest,Feb.2002.pp.49-53.
issue; it is a contention that modern contenders will now and then use against each other‟s
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 animal‟s 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, India’s 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, 53–56,
 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.