Assignment 2

Scope of Protection & Emerging trends in patentability of biotechnological inventions
Assignment-2
Scope of Protection & Emerging trends in

patentability of biotechnological inventions
Prital Desai
ID: PLA477_10
Project Assignment for P.G Diploma in Patents Law
NALSAR PROXIMATE EDUCATION,

NALSAR UNIVERSITY OF LAW, Hyderabad
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Contents:
Serial title Page no.

no.
1 RESEARCH METHODOLOGY 3
2 INTRODUCTION 4
3 HISTORICAL BACKGROUND 5
4 CLASSIFICATION OF 7
BIOTECHNOLOGICAL INVENTIONS
5 PATENTING TRENDS IN 8
BIOTECHNOLOGY
5.1 INDIAN PATENTING TREND 9
5.2 INTERNATIONAL PATENTING TREND 9
6 PATENTABILITY OF 11
BIOTECHNOLOGICAL INVENTION
7 NATURE OF TECHNICAL ADVANCE 12
AND THE QUESTION OF
DETERMINATION OF SCOPE OF
PATENT PROTECTION
8 PATENTING OF BIOTECHNOLOGICAL 13
INVENTIONS
8.1 PATENTABLE SUBJECT MATTERS 14
8.2 NON-PATENTABLE SUBJET MATTERS 16
8.3 EXCEPTION TO EXCLUSION 16
8.4 PATENT FORMS 16
8.5 FILLING A PATENT APPLICATION IN 17
INDIA
8.6 TERM OF PROTECTION 17
8.7 EXCLUSIVE MARKETING RIGHTS 18
(EMRs)
8.8 PRODUCT PATENT FOR INVENTIONS 19
NOT PROTECTABLE
8.9 BURDEN OF PROOF 19
8.10 SUFFICIENT DISCLOSURE AND BEST 19
MODE
8.11 RIGHTS OF PATENTEE 20
9 CONCLUSION 21
10 REFERENCES 22
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LIST OF ADDREVIATIONS/ACRONYMS USED:
CCAP: The Court of Customs and Patents Appeal

EMR: Exclusive Marketing Rights
EPC: European Patent Convention
EST’S: Expressed Sequence Tags
IDA: International Depository Authority
IPP: Intellectual Property Protection
GMO: Genetically Modified Organism
OECD: Organization for Economic Co-operation and Development
TRIPS: Trade Related Aspects of Intellectual Property Rights
UPA: United Progressive Alliance
US: United States
USPTO: United States patent and Trade Mark Office
WIPO: World Intellectual Property Organization
WTO: World Trade Organization
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1) Research methodology:
This document focuses on rationale of making biotechnological inventions

patentable. It details out the issues connected with the scope of patentability of
biotechnological inventions from the standpoint of developing countries which
are likely to lose considerably by expanding and increasing the scope of patent
protection in the case of biotechnological inventions.
It also evaluates patent protection as an:
o Incentive mechanism for biotechnology innovation in India
o Recent enhancements to India's patent laws
o A new acceptance of biotechnology patents.
o It also analyses the international patenting trends.
o It also examines Indian patenting activity and its comparison with

international trends to assess the Indian efforts.
The patentability of products is essential in the biotechnology field, for

limited market exclusivity. The biotechnology field also uniquely faces Federal
Drug Administration (FDA) approval, which includes considerable additional
expense and time issues a biotech company must address.
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2) Introduction:
Patent: A patent is an exclusive right to exploit (make, use, sell, or import) an

invention over a limited period of time (20 years from filing) within the country
where the application is made. Patents are granted for inventions which are
novel, inventive (non-obvious) and have an industrial application (useful).
There are other types of exclusive rights over intangible assets, notably
copyright, design protection and trademarks, but patents provide a broader
protection. In return, the applicant must disclose the invention in the text of the
application, which is published 18 months after application.
As a patent is valid only within the country in which it is granted, it is subject to

national laws and litigation settled in national courts. International agreements
such as the agreement on Trade Related Aspects of Intellectual Property Rights
(TRIPS), signed in 1994 and overseen by the World Trade Organization
(WTO), tend to place restrictions on what national laws and policies can do.
TRIPS introduced intellectual property rules into the multilateral trading system
for the first time, in an attempt to guarantee the same minimum standards of
protection across countries.
Biotechnology: Biotechnology comprises any technology that uses living

entities, in particular animals, plants or microorganisms. According to the
Organization for Economic Cooperation and Development (OECD).
Biotechnology includes any technique that uses living organisms (or parts of
organisms) to make or modify products, to improve plants or animals, or to
develop microorganisms for specific uses the advent of biotechnology
necessitated that patent laws to be suitably modified to match the needs of
science and technology. The traditional notions of adequate disclosure at the
time of applying for a patent had to be altered to cater itself to biotechnological
innovation.
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3) HISTORICAL BACKGROUND:
The story of patenting of biotechnological “inventions” is only twenty

years old. Prior to 1980, it was not clear that the patent law would be so
accommodating. The Court of Customs and Patent Appeals (CCPA) in the
United States (US) suggested as late as 1974 that a new strain of micro-
organisms isolated from a soil sample was an unpatentable natural product and
Congress’s passage of the Plant Variety Protection Act 1970 indicated, at the
very least, that the national legislature worried that the patent law in the United
States did not permit the patenting of living things.
India whose patent act of 1970 was considered by many to be a model law
for the developing world is now already on the way to make its national patent
legislation fully compliant with the World Trade Organization (WTO)
Agreement on Trade Related Intellectual Property Rights (TRIPs).The process
of amendment of national patent legislation has been controversial for the
reason of making pharmaceutical substances and micro-organisms patentable.
In order to implement the new patent regime the government had to even divide
the process of amendment of Indian Patent Act, 1970 into three installments.
Throughout the transition period there was much public debate on the pros and
cons of the possible outcomes of different amendments. The latest installment
of amendments is no exception; these were introduced in the form of an
ordinance by the government because it lacked the requisite majority in the
parliament. The Patents (Amendment) 2004 Ordinance was introduced on
December 24, 2004 to become effective from January 1, 2005. It was criticized
not only by the left parties but also by the sections of Indian pharmaceutical
industry for being expansive on the issue of patentability of pharmaceutical
substance and micro-organisms. Only after agreeing to make some of the key
amendments that the left parties were arguing for inclusion the United
Progressive Alliance (UPA) government could muster strength to press for a
vote on the ordinance in parliament. Although the amended ordinance has been
now adopted in parliament, the controversy continues in respect of the issue of
patenting of biotechnological inventions.
Even today it is not clear that how the controversy surrounding patents for
biotechnological inventions is likely to be resolved in India. The question of
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patentability in relation to the exclusion of micro-organisms and the definition

of pharmaceutical substances has been referred to the expert committee. In
India, controversy has surrounded the field of biotechnological subject matters
from the time the TRIPs Agreement came to be accepted by the government in
April 1994. India had five years to amend its national patent legislation. Legal
provisions were explicitly included with the aim of determining the scope of
patentability of biotechnological subject matter in the Indian Patent Act 1970
when parliament adopted the Second Patent (Amendment) Act 2002. The scope
of patentability of biotechnological subject matter was defined amidst much
controversy.
The issue of from when India has to extend patentability to micro-

organisms was itself raised quite strongly by the critics of the Second Patent
(Amendment) Act 2002. It will not be out of place to also recall here that when
the controversial legislative steps relating to the extension of patentability to
biotechnological subject matters were being taken by the government to provide
for the extension of patents to pharmaceutical and agrochemical products in
1995 through the amendment on exclusive marketing rights (EMR) to become
effective from January 1, 2005, and to micro-organisms from the date of
January 1, 2000 through the Second Patent Amendment Act, 2002, the
concerned governments were even compelled to make promises that they would
be later bringing in 2004 a final installment of amendments to the Indian Patent
Act, 1970 to introduce comprehensive legal provisions with the aim to define
the scope of patentable inventions appropriately for India.
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4) Classification of biotechnological inventions:
(a) Inventions relating to an organism or material such as living entities of

natural or artificial origin (animals, plants, and microorganisms), biological
material (plasmids, viruses and replicas, and parts of organs, tissues, cells, and
organelles), and naturally occurring substances from living entities, biological
material and parts.
(b) Inventions relating to the process for the creation of a living organism or
production of other biological materials.
(c) Inventions relating to the use of such organisms or biological materials.
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5) PATENTING TRENDS IN BIOTECHNOLOGY:
Regarding the current trends in patenting of biological matter including

products, the attempt is to accommodate somehow the biological matter by
bending the patentability requirements. Trends indicate that there is not much
traction retained for the traditional patentability requirements in the case of US
patent law.
The methods and processes of manufacture in biotechnology are the next

most important subject matter of biotechnology. The more commonly known
types of processes, which are included under the rubric of biotechnology, are
fermentation processes, chemical and diagnostic processes as well as methods
of treating human or animal bodies and methods of controlling pests. It also
includes methods and processes for the creation of products of cells such as
hormones, enzymes and the like. The area of methods and processes has raised
a number of issues because the techniques that are available provide the
potential for creation of genetically altered biological matter itself. The methods
and processes of manufacture in biotechnology are distinguishable from other
fields of subject matter in that most of the actual process is carried out by
something other than man. A living organism, e.g. a bacterial cell, or a
biological compound, e.g. an enzyme, does the “work”. The method is really
more of a recipe for success in preparation of product.
Finally, there are inventions which deal with what is done with the
products of biotechnology. In this respect, the exceptions have been developed
in the case of medical treatments involving therapy, surgery and diagnosis for
human beings and animals. Method claims are already excluded in several
jurisdictions. Otherwise, the limitations placed by patenting in biotechnology
are not very different from the problems of absolute monopoly that we are
already encountering in the case of pharmaceutical product patents.
Further, in biotechnology especially many of the results of research are

not merely discoveries of facts but creation of research tools (such as for gene
manipulation, gene mapping and analysis of sequences). A large number of the
research results in the biotechnology field are in effect research tools that are by
their nature of potential use to other researchers.
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5.1) INDIAN PATENTING TREND:
Patents granted to Indian organizations during 1990-2002 in

different sectors easily reveals the fact that chemicals and
pharmaceuticals were the major areas in which Indian organizations had
obtained patents. However, it can also be observed that Indian
organizations also got patents in biotechnology. Majority of these were
overlapping patents addressing other sectors (mainly pharmaceuticals).
The main technological domains of patenting activity in biotechnology
were in microorganism compositions; macromolecular compounds; and
biocide and plant reproduction techniques.
Steady increase in patenting activities in biotechnology can be

observed from the different data available. Analyses of Indian patenting
activity during 2003-04 again shows that I this period also,
pharmaceutical and chemical sectors were the dominant areas of
patenting activity. Pharmaceuticals had 213 patents (46 percent of total
patents) during these two years while chemical sector had 125 patents (27
percent of total patents). Biotechnology sector was also well addressed
with 48 patents granted during this period. Other major sectors
contributed insignificant number of patents.
5.2) INTERNATIONAL PATENTING TREND:
The US, Japan and the European Patent Office are the three major
patent offices where international firms file patents. However, in the
context of biotechnological inventions, the USPTO has a long tradition of
firm filing their patents therein because of a number of factors such as
emergence of firms from the universities, venture capital investments,
and landmark rulings. Thus, by observing patents granted by the USPTO,
a good estimate of patenting activity in biotechnology can be obtained.
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Patent granted by the USPTO in biotechnology in comparison to other

sectors to some developed and developing economies have been
illustrated in property right dates. It shows that patents granted to
biotechnology Inventions are relatively less than other sectors. However,
they do contribute to substantial patents in the overall profile of
developed economies. Firms in developing countries have dominated
innovation in biotechnology with extensive patenting, but the US has
clearly dominated patenting covering different application areas of
biotechnology. These innovations have high degree of science linkages
and joint partnership between industry and university.
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6) PATENTABILITY OF BIOTECHNOLOGICAL INVENTION:
Biotechnology in recent year has created unprecedented

opportunities not only for the humankind but also industrial development.
It has become the world fastest growing technology. Today a number of
research institutes (public and private) are working in the area of modern
biotechnology with strong scientific research system in country. But due
to the emergence of modern biotechnology, one of the most important
issues has been raised in legal characterization and Intellectual Property
Protection (IPP).
Invention such as genetic engineering, microbiology, medical

invention and biotechnological invention that may be patentable by
Indian patent law, 1970 can be categorized as-
• The living entities of natural origin such as animal, plant in whole

or any part thereof are not patentable in India.
• Terminator gene technology and microorganisms are not patentable

in India.
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• The biological materials such as organs, tissues, viruses etc and

process of preparing thereof are not patentable in India. But
biotechnological materials such as recombinant DNA, plasmid and
process of manufacturing thereof are patentable.
• Gene sequences, DNA sequences without having disclosed their

function are not patentable. But the process relating to
microorganism or producing chemical substances using such
microorganisms are patentable.
• The process of cloning human being or animals is not patentable.
7) NATURE OF TECHNICAL ADVANCE AND THE QUESTION OF

DETERMINATION OF SCOPE OF PATENT PROTECTION:
It is also necessary to keep in mind that the fundamental rules of patent

law were set in a world in which inventions were mainly mechanical and
intellectual creations and were not protectable unless good cause was shown.
Patenting was confined to the protection of discrete products. Technical
advance was far less rapid. The scope of protection was not a major issue for
mechanical inventions because it was mostly possible to invent around the
discrete products. In the case of chemical technologies, where to a large extent
chemical product invention tends to fit the ‘discrete’ model, the scope of
protection came to be a controversial matter only because pharmaceutical
product patent leads to the emergence of a monopoly, which cannot be tackled
by inventing around the product.
In the case of pharmaceutical products, since there is a one to one

correspondence between the structure of molecule and the therapeutic effect
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product patent tends to provide absolute monopoly. However, in a number of

technologies, the pattern of technical advance is not discrete. The pattern of
technical advance is mostly cumulative. Evidence indicates that in a number of
technologies where the pattern of technical advance was cumulative the patent
system acted as a drag on the pace of technology development.
In biotechnology, right from the beginning the pattern of technical

advance has been driven by science based technological developments.
However, it appears that due to the intensification of (increased role) of
scientific advances in the innovation process significant changes are today
underway.
The science-based models of biotechnological innovation are today faced

with the task of coping with the systemic nature of technical advance. For
example, in biomedical research the process of technical advance is undergoing
a paradigm shift from gene-centric biology to genome-centric biology that
changes the way we think about biological innovation, genetic information, and
the way biologists do their work. The shift to genomic-centric biology is
creating a hybrid model of discovery and innovation in which the creation of
new ideas and products remains the dominant strand but the supply of new
inputs such as databases and software are becoming increasingly important to
the process of innovation.
8) PATENTING OF BIOTECHNOLOGICAL INVENTIONS:
Strong intellectual property rights (IPRS) in biotechnology are of critical

importance for the continuous growth of the biotechnology industry. Significant
investment in the biotechnology has been attributable to the patenting system
which first officially started to allow patents for living matter such as
microorganisms in 1980 [Diamond vs. Chakrabarty (1980) 26 USPQ 193
changed the direction of patent laws in the US by holding claim to a bacterium
valid. In essence, Chakrabarty developed a genetically engineered bacterium
capable of breaking down multiple components of crude oil].
Biotechnology has emerged as one of the most important domain of

patenting. It is also one of the most important areas of conflict between
developing and developed economies. Some of the biotechnological domains
being patented today are:
 Genetic engineering process
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 Method of producing organisms
 Method of isolation of microorganisms from culture medium
 Method of mutation
 Biologically pure cultures
 Mixed cultures
 Eukaryotic cells
 Tissue or organ cultures
 Mutants
 Transformants
 Plasmids
 Process for making monoclonal antibodies
 Cell lines for making monoclonal antibodies.
However, patenting of biotechnology related inventions has also raised

important issues, For example:
• A number of very basic inventions, fundamental methods, research

techniques and tools significant for product development, have been
made and granted patents.
• In many cases, there were initial doubt about patentability, but the doubts
have regularly been resolved in favor of patentability [at least by the US
Patent and Trademark Office (USPTO)].
• The transgenic research mouse designed as a laboratory model for cancer

studies at Harvard under NIH funding was patented, and licensed to
DuPont, which further sought strong controls over it and other forms of
modified mice.
• Concentrated stem cells, which are undifferentiated or partially

differentiated cells, which can be developed into a number of other cell
types, have been patented in the US.
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• Partial gene sequences including ‘expressed sequence tags’ (EST’s),

which are components of genes being expressed at a particular time, can
now be sequenced.
8.1) PATENTABLE SUBJECT MATTERS:
It provides that patents shall be available for any invention, whether

products or processes in all fields of technology provided that they are new,
involve an inventive step and are capable of industrial applications. The terms
"inventive step" and capable of industrial applications may be deemed to be
synonymous with terms "non-obvious" and "useful" respectively.
It further provides that "patents shall be available and patent rights

enjoyable without discrimination as to the place of invention, the field of
technology and whether products are imported or locally produced".
Thus, under the TRIPS agreement the member country has to grant
patents to any invention in any field of technology without any discrimination,
for products as well as process whether, the products are imported or locally
produced. However, in order to be a patentable invention, following
requirements have to be complied with.
(a)The inventions must be new,

(b)They must involve an inventive step (non-obvious),
(c)The inventions are capable of industrial application (useful).
These provisions do not establish any discrimination to the patentability

of the invention in any field of technology including biotechnological
inventions. However certain exceptions and conditions to patentability are
provided. These provisions are more or less similar to the provisions provided
in the patent laws of various developed countries and also the provisions under
the European Patent Convention (EPC).
8.2) NON-PATENTABLE SUBJET MATTERS:
The TRIPS agreement has excluded certain inventions from the ambit of
patentability. It provides that "members may exclude from patentability any
invention, which is necessary to protect ordre public or morality, including to
protect human, animal or plant life or health or to avoid serious prejudice to the
environment provided that such exclusion is not made merely because the
exploitation is prohibited by domestic law".
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It further provides that "members may also exclude from patentability
(a) Diagnostic, therapeutic and surgical methods for the treatment of human or
animals,
(b) Plants and animal other than microorganism, and essentially biological
processes for the production of plants and animals other than non-biological and
micro-biological processes".
Thus, TRIPS agreement allows discretion to members (Contracting

States) to exclude certain kinds of inventions from patentability in order to
protect public order and morality and also to protect human, animals and plant
life to avoid serious prejudice to the environment.
The notions of ordre public (public order), and morality are not defined in
the Agreement. However it is clear that those inventions that cause injury to
human, animal and plant life as well as the environment are excluded. Member
countries are given flexibility to adjudicate such matters. Patenting of
genetically engineered organisms and life forms is generally possible under
these provisions. Further it is also possible for a state to provide patent
protection to a gene or a whole organism.
8.3) EXCEPTION TO EXCLUSION:
Although certain kinds of inventions have been excluded from the

patentability but patenting of microorganisms and non-biological processes is
allowed. Therefore, in other words, microorganisms, process of their production
and process of their use are made patentable, TRIPS agreement however,
neither defines the term "microorganism" nor does it specify any parameters
concerning the scope of protection to microorganism such as microorganism,
whether found in nature or created artificially such as genetically modified
organism (GMO) etc. However, the EC directives on microorganisms define it
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as "any micro biological entity, cellular or non-cellular, capable of replication or

transferring genetic material. EC directives have also defined "biological
material" as any material containing genetic information and capable of
reproducing itself or being reproduced in a biological system.
8.4) PATENT FORMS:
Form 1- Application for grant of a patent.
Form 1A- Application corresponding to an international application for grant of

a patent.
Form 2- Provisional/ complete specification.
Form 3- Statement and undertaking under Sec- 8.
Form 4- Request for extension of time.
Form 5- Declaration as to inventor-ship.
Form 9- Request for publication.
Form18- Request for examination of application for patent.
8.5) Filing a Patent Application in India:
Filing a patent application in India is required some important documents,

which are important for granting a patent in India.
a- Application form in duplicate (Form 1 or 1A)
b- Provisional or complete specification in duplicate
c- Abstract of the invention in duplicate
d- Drawing in duplicate (if need)
e- Priority document (if priority date is claimed) in convention application
f- Declaration of inventor ship
g- Power of attorney (if field through patent agent)
h- Fee (to be paid in cash/by cheque/by demand draft)
8.6) TERM OF PROTECTION:
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The provisions under TRIPS agreement provide the term of patent

protection for 20 years from the date of filing. Thus, the inventions relating to
biotechnology or to any other fields of technology will have uniform term of
protection without any discrimination or classification as to the field of
technology unlike as was provided in Iranian Patent and Trademark Act, 1931.
8.7) EXCLUSIVE MARKETING RIGHTS (EMRs):
The Patent and Trademark Act, 1931 does not allow the patent protection
for pharmaceutical per se. However, the TRIPS agreement provides that "where
a member does not make available as on the date of entry into force of the
agreement, patent protection for pharmaceutical and agriculture chemical,
products exclusive marketing rights shall be granted, for a period of five years
from the date of such grant after obtaining market approval in that member or
until a product patent is granted or rejected in that member whichever is shorter
provided that a product patent application has been filed and a patent granted
for that product in another member and marketing approval is obtained in such
other member".
Thus, the member country of WTO which does not grant product patent
for the inventions relating to pharmaceuticals and agro-chemicals are required
to provide exclusive marketing rights if the following requirements are fulfilled,
(a) An application for the grant of patent has been filed
(b) Marketing approval has been obtained,
(c) A patent has been granted for that product in another country and
(d) Marketing approval has been obtained in such other country.
Such EMRs will be granted for the period of five years after obtaining
marketing approval or until a product patent is granted or rejected. The EMR
may therefore be available for pharmaceutical produced by using
biotechnological process or methods.
Therefore, in order to implement these provisions, the member country must

accept the filing of applications for patents for pharmaceutical and agrochemical
products from January 1, 1995, even if the member country delays the
application of other provisions of TRIPS agreement, and after expiry of that
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delay, it must take a decision in respect of the application either to reject or

grant a patent. But in doing so, it must apply the criteria of patentability as lays
down in the TRIPS agreement retroactively. If the decision is to grant a patent,
that patent will be available for the remainder period of term of patent.
8.8) PRODUCT PATENT FOR INVENTIONS NOT PROTECTABLE:
The Pharmaceutical, chemical products, agro-chemicals, microorganism,

genetic engineering products etc., are currently excluded from patentability in
many countries including Iran. In 1988 WIPO found that 49 countries, excluded
pharmaceutical products, and 22 countries, chemical products from
patentability. A majority of the countries provided process patents. In some of
the countries, neither was patentable.
Even in some developed and developing countries like India, the life of a
patent is shorter in pharmaceuticals than in other sectors of technology. The
exclusion of product patent for pharmaceuticals and chemicals is motivated by
the concern for public health and availability of these products to the general
public at a reasonable price. The TRIPS agreement allows any developing
country member to delay the application of provisions concerning patents for
products, if the subject matter of invention falls in an area of technology not
patentable in that member country when TRIPS came into effect.
Pharmaceuticals, chemical microorganisms etc., are such areas. Such delay may
be five years, (Art 65.4) added to the four years general delay granted to
developing countries (Art. 65.2) and the one year delay granted to all members,
for total of ten years. A least developed country is entitled to a general
transitional period of 11 years. The TRIPS council shall, upon duly motivated
request by a least developed country member, accord extensions of this period.
8.9) BURDEN OF PROOF:
According to the provisions under TRIPS agreement, the burden of proof

has been shifted to defendant. It provides that "if the patent is granted for a
process for obtaining a product, the judicial authorities shall have the authority
to order the defendant to prove that the process to obtain an identical product is
different from the patented process”.
The burden of proof however shall be subject to following conditions:
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(a) If the product obtained by the patented process is new or
(b) If there is a substantial likelihood that the identical product was made by the
process and the owner of the patent has been unable through reasonable efforts
to determine the process actually used? However, a member country is free to
provide only one of these two conditions for such presumption.
Due to shifting of burden of proof, a manufacturer will be required to

provide the details of the manufacturing process to rebut the infringement of a
process patent. In such a case, the courts are required to take into account the
legitimate interest of the defendant in adducing the evidence to the country.
8.10) SUFFICIENT DISCLOSURE AND BEST MODE:
TRIPS agreement provides that, "the applicant for patents shall disclose the
invention in a manner sufficiently clear and complete for the invention to be
carried by a person skilled in the art and may require the applicant to indicate
the best mode for carrying out the invention known to the inventor at the filing
date or where priority is claimed, at the priority date of the application." For all
practical purposes, the same result is accomplished by the corresponding
provision of Patent Cooperation Treaty(PCT), which includes describing the
nucleotide sequences, deposition of microorganism to supplement the written
description. The provisions as mentioned above, also exist in the patent laws of
almost all countries for the reason that when term of protection (patent) is over,
the public should be able to take benefit of the invention. It is very difficult to
describe the invention relating to biotechnology by written description as it
involves the use of living material such as microorganism. Budapest Treaty,
provides facility to deposit the microorganism in any of the International
Depository Authority (IDA) recognized by WIPO to supplement the written
description to avoid deposition of such microorganism in each country where
the applicant applies for grant of Patent.
8.11) RIGHTS OF PATENTEE:
According to the provisions of Article 28, a patent shall confer on its

owner the following exclusive rights:
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(a) Where the subject matter of patent is a product, to prevent third party
from making, using, offering for sale, selling or importing that product for
these purposes, and
(b) Where the subject matter of patent is a process, to prevent third party
from using the process, offering for sale, selling or importing for these
purposes at least the product obtained directly by that process.
Thus, importation of patented product is allowed as one of the exclusive

rights conferred on patentee under Article 28 of the TRIPS which will be
considered equivalent to commercial working of patents. The provisions
relating to compulsory license, enforcement etc., have been made stricter.
9) Conclusion:
On the one hand it is economic value and on other hand it is public

concern. The major challenge faced during patenting of biotechnology related
inventions is to decide how to weigh positive and negative effects of an
invention. The importance of biotechnological research and patents Is more
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likely to increase in future.
The interest of most people to increase lifetime whatever the costs are,
searches for new sources of nutrition for the expanding world-wide human
population, but also the curiosity and motivation of scientists to find inventions
on one hand and high investments in this field on the other hand, renders this
branch of technology extremely lucrative, but also makes IP protection
necessary.
The TRIPS Agreement makes it mandatory to provide patent protection to

micro-organisms and non-biological and microbiological production of plants
and animals. Plant varieties are to be protected either by patents or by a sui
generis system or a combination of both. This makes it difficult for the
developing countries to exclude inventions within this category altogether.
Hence, the strategy should be how to limit the scope of these provisions. As far
as the patent protection of micro-organism is concerned, TRIPS does not
provide a definition of micro-organism. The national rule-makers should define
micro-organism in such a way as to include the following: bacteria, virus,
fungus and algal space. Another important way to limit the scope of patent
protection to biological materials is to make a difference between the concept of
invention and discovery. Since only inventions are qualified for patenting,
naturally found micro-organisms, DNA structure, genes, blood cells, etc., can be
excluded from patent protection. Developing countries can also exclude certain
inventions in biotechnology by relying on the exclusion provision available
under the TRIPS Agreement which permits the state parties to exclude certain
inventions which are injurious to health and environment of human and animals.
10) REFRENCES:
• Act No 53 of 2001 published in Gazette of India, Part II, section I,

dated 30th October 2001.
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• Coase RH, the Problem of Social Cost, The Journal of Law and
Economics, 1960, 3.
• The Crucible Group Report 1994, p. 53.
• Forsyth M, Biotechnology, patents and public policy: A proposal for

Reform in Australia, Australian intellectual property journal, 2000,
202.
• http://www.uspto.go
• Preamble to TRIPS Agreement. Article 7, Article 8., Article 27(1),

Article 27(2),Article 27(3).
• The Patents (Amendment) Act), The Gazette of India, 15, 2005.
• WIPO publication No. 464(E), 1996, p. 47. Article 66(1), TRIPS

Agreement. Article 34.
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Scope of Protection & Emerging trends in patentability of biotechnological inventions

Scope of Protection & Emerging trends in

NALSAR PROXIMATE EDUCATION,

Serial title Page no.

LIST OF ADDREVIATIONS/ACRONYMS USED:

CCAP: The Court of Customs and Patents Appeal

This document focuses on rationale of making biotechnological inventions

It also evaluates patent protection as an:

o Incentive mechanism for biotechnology innovation in India

o Recent enhancements to India's patent laws

o A new acceptance of biotechnology patents.

o It also analyses the international patenting trends.

o It also examines Indian patenting activity and its comparison with

The patentability of products is essential in the biotechnology field, for

Patent: A patent is an exclusive right to exploit (make, use, sell, or import) an

As a patent is valid only within the country in which it is granted, it is subject to

Biotechnology: Biotechnology comprises any technology that uses living

The story of patenting of biotechnological “inventions” is only twenty

patentability in relation to the exclusion of micro-organisms and the definition

The issue of from when India has to extend patentability to micro-

4) Classification of biotechnological inventions:

(a) Inventions relating to an organism or material such as living entities of

(c) Inventions relating to the use of such organisms or biological materials.

5) PATENTING TRENDS IN BIOTECHNOLOGY:

Regarding the current trends in patenting of biological matter including

The methods and processes of manufacture in biotechnology are the next

Further, in biotechnology especially many of the results of research are

5.1) INDIAN PATENTING TREND:

Patents granted to Indian organizations during 1990-2002 in

Steady increase in patenting activities in biotechnology can be

5.2) INTERNATIONAL PATENTING TREND:

Patent granted by the USPTO in biotechnology in comparison to other

6) PATENTABILITY OF BIOTECHNOLOGICAL INVENTION:

Biotechnology in recent year has created unprecedented

Invention such as genetic engineering, microbiology, medical

• The living entities of natural origin such as animal, plant in whole

• Terminator gene technology and microorganisms are not patentable

• The biological materials such as organs, tissues, viruses etc and

• Gene sequences, DNA sequences without having disclosed their

• The process of cloning human being or animals is not patentable.

7) NATURE OF TECHNICAL ADVANCE AND THE QUESTION OF

It is also necessary to keep in mind that the fundamental rules of patent

In the case of pharmaceutical products, since there is a one to one

product patent tends to provide absolute monopoly. However, in a number of

In biotechnology, right from the beginning the pattern of technical

The science-based models of biotechnological innovation are today faced

8) PATENTING OF BIOTECHNOLOGICAL INVENTIONS:

Strong intellectual property rights (IPRS) in biotechnology are of critical

Biotechnology has emerged as one of the most important domain of

 Genetic engineering process

 Method of producing organisms

 Method of isolation of microorganisms from culture medium

 Biologically pure cultures

 Tissue or organ cultures

 Process for making monoclonal antibodies

 Cell lines for making monoclonal antibodies.

However, patenting of biotechnology related inventions has also raised

• A number of very basic inventions, fundamental methods, research

• The transgenic research mouse designed as a laboratory model for cancer

• Concentrated stem cells, which are undifferentiated or partially

• Partial gene sequences including ‘expressed sequence tags’ (EST’s),

8.1) PATENTABLE SUBJECT MATTERS:

It provides that patents shall be available for any invention, whether