PATENT LAW AND ITS IMPORTANCE IN BIOTECHNOLOGY

A DISSERTATION

Submitted by

Harikrishna A J
Class Roll No.34
University Candidate Code; 472 19 551 034
IV Semester Unitary LLB – Evening Batch

As part of the syllabus

requirement of

Unitary LLB – IV Semester – University of Kerala

Kerala Law Academy Law College Peroorkada,

Thiruvananthapuram, Kerala – 695005
July, 2021
 CONTENTS

Chapter - I Introduction 05-09

Chapter – II Origin and growth of Patents 10-18

Chapter - III Efforts to make a uniform level of international 19-26

standard of protection

Chapter - IV Patentability 27-37

Chapter - V Types of Technologies 38-42

Chapter - VI Nuance of Patent Protection with Biotechnology 43-53

Chapter - VII Conclusion 54-61

Bibliography 62-63

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Chapter Page

I Introduction 05-09

1.1 General introduction

1.2 Significance of the problem
1.3 Scope of the study
1.4 Objectives of the study
1.5 Hypotheses
1.6 Research Methodology
1.7 Scheme of the Study
1.8 Review of literature

II Origin and growth of Patents 10-18

2.1 Introduction
2.2 Historical background and worldwide reasons
for the development of patent system
2.3 Modem Individual Property Rights (Patents)
2.4 Development of Patent Law in different countries

III Efforts to make a uniform level of international 19-26

standard of protection

3.1 Introduction
3.2 The Paris Convention
3.3 The European Patent Convention
3.4 Regional Patents
3.5 The Patent Co-opinion Treaty (PCT)
3.6 Other Regional Patent Organizations
3.7 TRIPs regime
3.8 Status in Individual Countries
3.9 Grant and Enforcement of Patents
3.10 Compulsory licensing
3.11 International organizations efforts

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 3.12 Patent Law Treaty (PLT)
3.13 Substantive Patent Law Treaty

IV Patentability 27-37

4.1 Introduction
4.2 National Patent System
4.3 USA
4.4 EUROPE
4.5 INDIA

V Types of Technologies 38-42

5.1 Introduction
5.2 Definition of technology
5.3 Technology and Society
5.4 Broad Classification of Modem
Technologies in view of patents

VI Nuance of Patent Protection with Biotechnology 43-53

6.1 Development of Biotechnology

6.2 Biotechnology in Science
6.3 Biotechnology and the Patents
6.4 Essentials of Patent in Biotechnological
inventions

VII Conclusion 54-61

7.1 Merits of Biotechnology

7.2 Demerits of biotechnology
7.3 Recommendations

Bibliography 62-63

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CHAPTER I

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 INTRODUCTION

"One man should be afraid of improving his possessions, lest they be taken away from
him, or another deterred by high taxes from starting a new business. Rather, the prince
should be ready to reward men who want to do these things and those who endeavour in any
way to increase the prosperity of their city or their state"

- Niccolo Machiavelly
1.1 General introduction
It is a unanimously accepted fact that civilized society is better than uncivilized one. In civilized
society social relations is one of the important factors. In order of social relations, one may find the
basis of different types of institutions and property is one such institution. As all institutions imply
relations between individuals, the institution of property also regulates the relation between individuals
apart from ascertaining their relation with reference to objects as well. Ownership is one such relation
between individuals in respect of use of things. In this setting of the social order, a legal right of
ownership carries with it a legally supported right to use a definite thing for more or less definite
purposes and for definite or indefinite time. The meaning of this right is that, all other persons are
forbidden to interfere with the owner in the exercise of' his right in respect of the thing owned, up to
the point at which the limits of that right are prescribed by law.

1.2 Significance of the problem

The importance of Patent law is steadily increasing in India and as well globally, more
and more legal implications are being increased steadily. The techno-legal approach is new
and has become necessary along with changes and circumstances in the society, which is
essential. Hence I am very much interested in selection of this study which is a significant
problem in the present day context. The problem is much relevant and there is no availability
of literature.

1.3 Scope of the study

This is a problem which is facing by most of the countries (all the developing countries) in
the world. The researcher tried his level best to collect extensive information to analyse the problem
chosen and further confined to study only at country (India) level and limited the problem for socio.
Economic, technical and legal aspects.

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1.4 Objectives of the study
The objectives of the present work are:

1. To study the historical development of Patent LAW in India and in world at large.
2. To study the significance and development of harmonization of patent law in the
International plane.
3. To analyse the fundamental requirements for patent protection and existing legislations
in India and in world at large.
4. To study the growth of biotechnology from existing life Sciences and its importance.
5. To study the importance of patent protection for biotechnology inventions.

1.5 Hypotheses
The following are the plausible hypotheses formulated for the study:

1. Exponential growth of biotechnology created lot of confusion in granting patent

protection.
2. The basic criteria for granting patent protection for biotech inventions which varied
from country to country created a need for drawing a line for harmonization.
3. Whether all the intellectual outcomes in biotechnology era need to be given patent
protection or not if yes, then how to recognize and regulate it, whether the existing
mechanism is sufficient or not and is there any necessity to maintain international
standard of legislations, if yes whether India is maintaining the standards or not.
4. Outcomes of the patent Law while dealing with inventions of Bio-technology and other
modem technologies.

1.6 Research Methodology

The problem is selected with a great interest keeping in mind the significance. Objectives
and impelling need in the society in the present day conditions, circumstances socio-legal and
international binding issues.

Law is a social science and in lieu of this socio scientific methods are applied in the study.
The methods adapted to carry out the research work is in descriptive, structural and
functionally analytical. The relevant material is collected from the primary and secondary
sources and materials horizontally collected from legal and non-legal sources like law books,
journals, Biotechnology journals, publications of interdisciplinary seminars, and other related

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social sciences literature. Newspapers documents and other such sources. Literature also was
horizontally collected by using internet.

1.7 Scheme of the Study

Chapter 1: Introduction

Primarily focuses upon the research objectives, research methodology adopted with reference
to hypothesis and introductory portion of the thesis.

Chapter 2: Origin and Growth of Patents

This chapter covers introduction of Intellectual Property Rights, Historical background and
worldwide reasons for the development of patent system, Development of Patent law in
different countries.

Chapter 3: Efforts to make a uniform level of international standard of protection

Generally points out the role International Organizations, PLT, Paris convention, European
Patent Convention etc.
Chapter 4: Patentability

General understanding of patent protection by a comparative study among USA. EU (UK) and
India.
Chapter 5: Types of Technologies

This chapter gives introduction to technologies, types of technologies and their relevance in
the society.

Chapter 6: Nuance of Patent Protection with Biotechnology

This chapter points out the importance of Patent protection in the field of biotechnology.

Chapter 7: Conclusion

Concludes the thesis by mentioning some of my findings and suggestions

1.8 Review of literature

1. "Intellectual Property: Patents, Copyright, Trademarks and Allied Rights", 2006 -
William.R.Cornish
2. "Patent Law", 2006 - Narayanan.P
3. "International Intellectual Property Law and Policy" - Graeme B Dinwoodie, William
O Hennessey, and Shim Perl mutter

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4. "Law of Patents", 2005 - Elizabeth Verkey
5. "The TRIPS Regime of Patent Rights" - Nuno Pires de Carvalho
6. "Intellectual Property Rights. Trade and Biodiversity: Seeds and Plant Varieties” -
Graham Dutfield.

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CHAPTER II

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 ORIGIN AND GROWTH OF PATENTS

2. 1. Introduction

In law, Intellectual Property is an umbrella term for various legal entitlements, which
attach to certain names, written and recorded media and inventions. The holders of these legal
entitlements are generally entitled to exercise various exclusive rights in relation to the subject
matter of the Intellectual Property, The term intellectual property reflects the idea that this
subject matter is the product of the mind or the intellect, though the term is a matter of some
controversy.1 Intellectual property laws confer a bundle of exclusive rights in relation to the
particular form or manner in which ideas or information are expressed or manifested, and not
in relation to the ideas or concepts themselves, The term "intellectual property" denotes the
specific legal rights, which authors, inventors and other Intellectual Property holders may hold,
and exercise, and not the intellectual work itself.
The basic public policy rationale for the protection of intellectual property is that IP
laws facilitate and encourage the pursuit of innovation and the disclosure of knowledge into
the public domain for the common good, by granting authors and inventors' exclusive rights to
exploit their works and invention for a limited period. From the perspective of economics,
intellectual property is a temporary monopoly on the use or exploitation of that good, supported
by legal, enforcement mechanisms.
Intellectual property protects applications of ideas, expressions and information that are
of commercial value. Intellectual property rights are legal and institutional devices to protect
creations of the mind such as inventions, works of art and literature and designs.2 The subject
of intellectual property rights is growing in importance, to the advanced industrial countries in
particular as the fund of exploitable ideas becomes more sophisticated and as their hopes for a
successful economic future come to depend increasingly upon their superior corpus of new
knowledge and fashionable conceits.3 In other words, IPRs are legal and institutional devices
to protect creations of the mind such as inventions, works of art and literature, and designs.
Prior, intellectual property includes Patents, Trademarks. Copyrights, Unfair competition etc.,
only. Over the years, the rather elastic intellectual property concept has been stretched to
include patents, copyrights, trademarks and industrial designs, but also
1 www.wikipedia.com

2 Graham Dutfield, “Intellectual Property Rights and the Life Science Industries: A
Twentieth Century History”, Ash gate Publishing Company, USA. 2002, p.1.

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Trade secrets, plant breeder's rights, geographical indications and rights to layout designs of
integrated circuits. Of these, patents, copyrights and trademarks are arguably the most
significant in terms of their economic importance, their historical role in the industrialization
of Europe and America, and their current standing as major pillars of the interactional law of
intellectual property. Patents provide inventors with legal rights to prevent others from using,
selling or importing their inventions for a fixed period, nowadays normally 20 years. Applicants
for a patent must satisfy a national patent issuing authority that the invention described in the
application is new, susceptible of industrial application and that its creation involved an
inventive step or would be unobvious to a skilled practitioner. Patent monopolies are extremely
valuable for business.
Copyrights give authors legal protection for various kinds of literary and artistic work.
Copyright law protects authors by granting them exclusive rights to sell copies of their work
in whatever tangible form they fix (printed publication, sound recording, film and so on) is
being used to convey their creative expressions to the public. Legal protection covers the
expression of the ideas contained, not the ideas themselves4. The right lasts for a very long
time indeed, usually the life of the author plus 50-70 years.
Trademarks are marketing tools used to support a company's claim that its products or services
are authentic or distinctive compared with similar products or services of competitors, they
usually consist of a distinctive design, word or series of words placed on a product label.
Normally, trademarks can be renewed indefinitely, though in most jurisdictions this is subject
to continued use, the trademark owner has the exclusive right to prevent third parties or services
where doing so are likely to cause confusion. One of the main benefits of trademarks to the
wider public is that they help to avoid such confusion.
Development of patent systems has a long history. They developed as a way to promote
innovation, originally either by encouraging the importation of new technologies into a country
or by making new inventions. Instead of keeping the invention a secret, countries learned that
one effective way of getting inventors to publicly disclose their intention was to offer them
limited monopoly rights in exchange for doing so.

3. William Cornish and David Llewellyn, “Intellectual Property, patents, Copy write, Trade
Marks, allied rights”, fifth edition, Sweet and Maxwell Limited London, 2003.

4. Graham Dutfield, ”Intellectual Property Rights and the life Science Industries: a 20th
Century History” Ash gate publishing company USA, 2020 P-2

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One way these patent rights were limited was in time. E.g. earlier it is 7, 14 years, after TRIPs
it become minimum 20 years. After this period of time the monopoly rights were lifted and
everybody could use the invention freely.
If the invention were not a success, the applicant would abandon the patent application,
or stop paying the annual fees to patent office to keep the patent alive. So, in theory, the public
learned quickly about a new invention when the patent application describing the invention
was published, and eventually got free access to use it. In the meantime, the patent holder
profited from the patent by selling the new invention at a higher price than would have been
the case without a patent since the patent monopoly prevents competition. In an ideal case,
both parties benefit from its patent bargain. Adopting a patent system is supposed to encourage
investment of resources in making inventions. Research and development (R&D) for new
medicines and in particular the progress in modem medicine, is often given as a good example
as R&D into medicines for some diseases. Negative effect of R&D is neglected diseases such
as sleeping sickness, Chagas disease or leishmaniosis, which only affects poor people, a patent
holder will never be able to make a profit by charging high prices, and so little R&D is
conducted on these diseases. The argument for a patent system encouraging R&D for medical
needs in their countries falls far short.
Whether or not the patent system delivers the right R&D, the patent monopoly means
that a higher price than necessary has to be paid for patented inventions. This is acceptable if
this higher price is merely an inconvenience. However, if the patented invention is essential,
then the price is more of a dilemma. To give a concrete example, the price patent holders charge
for an AIDS drug cocktail remains at around US $10,000 in rich markets. But because generics
companies are able to make their own version where there are no patents to prevent them, these
drugs are now available to patients in some developing countries for less than US $ 300.
Accordingly, it is crucial that a careful decision is made to distinguish between what
should be allowed to be patented and what should not. Before the WTO TRIPs Agreement was
signed, states were free to determine what would or would not be patentable within the country.
States didn't make one-off, long-term decisions on patents. What they allowed to be patented
varied a lot over time depending on the state of development of the country. The scope of
patents has not always been expanded; in fact, states have sometimes decided to deny the
patentability of inventions that were previously patented, or even abandoned their patent
system altogether. The patenting of essential goods such as medicines and foods was for a long
time thought to be self-evidently against the public interest. Indeed, when the Uruguay Round
of WTO trade negotiations were launched in 1986, more than 50 countries were not granting

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patents on pharmaceuticals. However, the general trend in industrialized countries has been
that the 'boundaries of the patent system are re-drawn (almost always by widening) as
industries which are used to working with patented extend their ambit of operation. In their
campaigns for novel patents, they are likely to succeed except where they meet persistent and
implacable opposition from some other interest group'.
In rich countries, extensive pharmaceutical patent protection and the high drug prices
it entails may not produce immediate health crises since the majority of the population can pay
these prices for the new inventions, either privately or though insurance schemes or .other
public health services - although even this model is looking increasingly stretched in Europe
and the United States. In poor countries, where people pay for drugs out of their own pockets
and very seldom have health insurance, excessive prices of medicines become a question of
life and death.
The pro-pharmaceutical patenting lobby argues time and time again that without
patents there will be no new medicines. For example, Africa accounts for some 1% of the
world's medicine market. If there were no patent protection at all in Africa, and even if big
pharmaceutical companies ended up making no sales on the continent, their profits would be
only negligibly impacted. Their ability to generate income to perform more R&D - and produce
enormous returns for their shareholders depends overwhelmingly on OECD markets. Patent
protection in developing countries is not going to make the difference between big
pharmaceutical companies developing new medicines or not. If a developing country chooses
to adopt different rules for its patent system than those used, for example, in the US or Europe,
it doesn't mean that system is of a lower standard or quality than the US or European systems.
Just giving patent protection to whatever the US or Europe does is not by itself a sign of a
quality system. The standard or quality of the system should be judged by how effectively the
patent rules that each country has chosen are used to serve the public interest. For example, if
a developing country like Indian patent law says that patents cannot be granted for new uses,
and that a developing country patent office makes sure that it does not grant any patents for
new uses, this can be considered a high quality system.
Like many other systems of economic regulation, intellectual property rights have a
history going back centuries. The rationale study of law is still to a large extent the study of
history. History must be a part of the study, because without it we cannot know the precise
scope of rules, which it is our business to know. It is a part of the rational study, because it is
the first step toward an enlightened scepticism, that is, toward a deliberate reconsideration of
the worth of those rules. “When you get the dragon out of his cave on to the plain and in the

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daylight, you can count his teeth and claws, and see just what high strength is.5 But the main
IP rights like patents and copyrights took their modern form and functions in the nineteenth
century at a time when Europe and America were in the midst of rapid industrialization, during
this period India is under colonial rule. Over the years, states have granted IPRs for a variety
of public policy purposes such as to encourage the immigration of craftsmen, to reward
importers of foreign technologies, to reward inventors, to create incentives for further inventive
activity, to encourage the dissemination of new knowledge, and to allow corporations to recoup
their investments in R&D
The expansion of trade competition since 1950 has brought ever-increasing advantages
to those in the van of innovation. Intellectual property rights, which help to sustain the lead of
those with technical know-how, with successful marketing schemes, with new fetishes for pop
culture, have come to foster immense commercial returns. The increasing numbers of patents
granted, trademarks registered and copyrighted fixations as publishing, record-producing, film
making and broadcasting stand as some measure of this development majorly happened in
industrial countries. The growth of technology and advancement of research also resulted in
the enhancement of intellectual property.

The growth of international organizations, particularly within the frame of the United
Nations, has provided one forum for the discussion of such claims. International Conventions
such as Paris Convention for the Protection of Industrial Property 1883. Berne Convention for
the Protection of Literary and Artistic Works 1886, the Patent Co-operation Treaty 1970 and
Madrid Agreement on Trademark Registration, 1891 also provided scope in the international
plane for the development of intellectual property to meet the demands for greater protection.
Beyond this there is a separate development, which was the landmark in
the era of intellectual property rights. The General Agreement on Tariffs and Trade (GATT),
in completing its Uruguay Round in April 1994, created a World Trade Organization (WTO),
which, among other things, administers a high significant instrument, the Agreement on Trade-
related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods (TRIPs)

5. Donald. S, Chisum, "Chisum on Patents: A Treatise on the law of Patentability, Validity and
Infringement" Vol. I. Lexis Publishing Preface, 2002. p. XIII

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2.2 Historical background and worldwide reasons for the Development of Patent System

A patent may be defined as a grant by the state of exclusive rights for a limited time in
respect of a new and useful invention. These rights are in general limited to the territory of the
state granting the patent, so that an inventor wishing protection in a number of countries must
obtain separate patents in all of them. The name 'patent' is a contraction of 'letters patent' (Latin
literate. patents, "open letters"), which means a document issued by or in the name of the
sovereign, addressed to all subjects and with the Great Seal pendant at the bottom of the
document so that it can be read without breaking the seal.6

The primary function of patents is to meter inventions in a relatively accurate manner.

Patents have the primary function of serving as metering devices for society to measure an
invention's value, thus allowing patentees to stipulate competitive prices on inventions and,
consequently, on the products and services that embody them. Patents, therefore, are primarily
neutral social mechanisms that contribute to an adequate allocation of private resources to the
creation of technology.
Promotion of invention and innovation is accomplished by allowing inventors to obtain
rents from the results of their activities. That can be done in two different ways. The first is
requiring users of the inventions to pay for them directly. For that to happen, it is necessary to
establish a legal mechanism that allows inventors to put a price on their inventions. That is
precisely the role that patents and trade secrets perform. The second way of obtaining rents is
to provide inventors with public funds or other privileges. In this case, governments allocate
rents to inventors. Users of the inventions will still pay for them, but in an indirect manner,
through taxes. For that matter, so will tax-paying non-users. Social welfare and economic
growth depend, in part on technological innovation, which not only facilitates a more efficient
utilization of available scarce resources, but also provides access to new resources. It is true,
that society needs that a continued flows of inventions be developed and made generally
available. And it is also true that patents are necessary to induce such a flow of inventions.

6 Philip W. Grubb, "Patents for Chemicals, Pharmaceutical and Biotechnology: Fundamentals of

Global law practice and strategy". Fourth Edition, .Oxford University Press, London, 2004.

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 The function of the patent system has thus far been explained in two different ways.
The most common and accepted view is that patents are rewards granted to individuals who
contribute to economic and technological progress by inventing and disclosing the inventions.
This is the reward doctrine in nutshell. A second function of patents is that it operates as titles
of legal scrutiny that permit the inventors to prospect the market for commercial opportunities,
very much like concessions granted to gold prospectors. This is the prospect theory, proposed
by Edmund Ketch.8

2.3 Modem Individual Property Rights (Patents)

The privileges and monopolies were generally granted through letters that the kind or
the lord of the land would address to the introducers of new techniques. Those letters were
made public, or open, or patent, so that third parties were made aware of the right being
granted. Those royal favours were, therefore, called patents. Letters patent are still used in the
UK, for example to confer peerages and to appoint judges, but under the present Patent Act are
no longer used to grant patents for inventions. Prior to 1878, letters patent for inventions were
engrossed on parchment and bore the Great Seal in wax. Subsequently paper was used and a
wafer seal of the Patent Office replaced the Great Seal, but the wording of the letters Patent
document was still very impressive.

2.4 Development of Patent Law in different countries

If we look back into the history we can find incidences here and there at different periods in
different parts of the world, there are incidences at Asia and Europe. In Asia if we look in to
our (Indian) mythology we can find replications in Ramayana, Mahabharata, etc., and later
also if we observe during kingdom rule there also we can find giving awards for the persons
Intellectual works, likewise in Europe also we can find certain incidences way back from 700
B.C. Europe is the first continent started developing specific legislations in protection of
inventions. Even though throughout the world there are incidences in protection of intellectual
developments for example in India we find incidences here and there way back from 5,000
B.C.

7 Arthur R Miller & Michael H Davis, “Intellectual Property – patents, trademark and copy
write in a nutshell” 2nd Edition West Publication, 1990 pp.14-15

8. Edmund W Kitch, “The Nature and Function of the Patent System, 20 J&ECON, 1977,
pp.265, 266

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In our mythology such as Ramayana Mahabharata etc. also we can find, but these incidences
stands in history as such and here we are studying the legislative developments specifically
with regarding to Patents. According to the available history Europe is the first continent who
developed few dare steps and it follows by USA and later it expanded to Asia.

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CHAPTER III

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 Efforts to make a uniform level of international standard of protection

3. 1. Introduction

The US first extended patent protection to foreigners in 1800.9 Under the French patent
law of 1791 as revised in 1844, the printing of a patent in the US or another country
automatically destroyed novelty in France. So by seeking patent protection in one country, an
inventor jeopardized his chances for gaining protection in other countries, such as France, upon
publication of the first filing. European states other than Germany established patent laws in
the middle years of the nineteenth century as a lure to attract foreign technologies: Spain 1826,
Portugal, 1837, Austria 1852, Belgium, 1854 and Italy 1859. Switzerland never had a patent
law in 1817, but abolished it in 1869. Sweden's law of 1859 was limited to nationals. The 1854
Belgian patent act is still in force. Historical events in the 1870s impelled the industrializing
nations of Europe and the US towards harmonization of patent laws.10
The earliest efforts to move beyond purely national protection of intellectual property
involved bilateral agreements between two countries. In response to some of the deficiencies
of bilateral agreements, the late nineteenth century saw the development of multilateral
agreements. These multilateral intellectual property treaties established unions of member
countries that reached agreement on a number of common principles. They did not supplant
national legislation; rather, they imposed upon member countries certain obligations as to how
they will treat each other's products.11 the two most important of these treaties were originally
negotiated in the late nineteenth century. They are Berne Convention for the
Protection of Literary and Artistic Works and the Paris Convention for the Protection of
Industrial Property. Paris Convention covers various industrial properties such patents,
trademarks, unfair competition, industrial designs and indication of source and appellation of
origin. Berne Convention particularly deals with copyrights and related rights.

9. Pennock V. Dialogue, 27 US (1829)

10 Graeme B. Dinwoodie and William O Hennessey and Shiras Perl mutter, "International Intellectual
Property law and Policy", Case Book series, Lexis Nexis, 2001, p.377
11 Graeme B. Dinwoodie, William O. Hennessey, Shiras Perl mutter, "International and
Comparative Patent Law, Lexis Nexis Publications, 2002

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3.2 The Paris Convention

Eleven countries signed the International Convention for the Protection of Industrial
Property in Paris in 1883, originally. The UK acceded in 1884. The Convention is now adhered
to by the majority of the countries of the world, which have any form of patent protection and
since the Convention also deals with trademarks and designs, even by some countries, which
have no patents. The basis of the Paris Convention is one of reciprocal rights, so that an
applicant or patentee from one Convention country shall have the same rights in a second
convention country as a national of that second country has the most important practical result
of the Convention is the possibility of claiming Convention priority for applications made
outside one's home country. The system 12 is such that if an application for a patent is properly
made in one Convention country, corresponding applications may be filed in another
Convention countries within one year from the first filing date, and if certain conditions are
met, these later applications will be entitled to the priority date of the first application. This
means that they will be treated as if they were filed on the same day as the first application, so
that a publication of the invention after the first filing date but before the filing date of the later
application will not invalidate the later filing.

3.3 The European Patent Convention

In 1963, a number of European countries signed the Strasbourg Convention, which

recommended certain common standards for novelty, inventiveness, and the type of invention,
which may be patented. This later formed the basis for the European Patent Convention (EPC)
of 1973, which has led to the establishment of the European Patent Organization, consisting of
the European Patent Office (EPO) which grants European Patents, and the Administrative
Council, which supervises the EPO.13 The Administrative
Council is made up of representatives of all contracting states, and these are usually the heads
of the national patent offices. The EPO must be the only commercial organization in the world,
which is run by a committee of its competitors. The European Patent Convention was originally
negotiated by 19 countries, not all of which ratified the Convention initially, and one of which
(Norway) still has not done so. It started with only seven contracting states but as of 2000 had
been adhered to.

12 Art. 4 of Paris Convention. 188.

13. Art. 4 of European Patent convention

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3.4 Regional Patents

Efforts to provide a single unitary patent for the entire EU covering all member states
just as a US patent covers all the 50 states of the Union began even before the EPC came into
force. The Community Patent Convention (CPC) was signed in 1975, but was never ratified
by a sufficient number of states to allow it to come into force. One major problem with the
CPC was the requirement to provide a translation of the full text-into an official language of
each member state, which meant that the CP would have been as expensive as a normal
European patent covering all EU slates.
The project languished for a long time, various proposals of the EC failing to obtain
the necessary consensus among Member States. Some political leaders had constitutional
objections to the idea that a document such as a patent could have a legal effect in their country
without being translated into the local language; others seemed to think that cultural identity
or national pride were important issues. In March 2003, the Council unanimously agreed upon
a Common Political Approach for the CP. Subsequently a number of drafts for a Regulation
agreed upon some time in 2004. The current draft provides that at some yet to define time,
after the grant of a CP by the European Patent Office, the patentee must tile a translation of the
claims only into an official language of each member state, except for states, which have
renounced their right to receive such translations. Litigation, including both infringement and
validity issues, will be heard at first instance by a special Community Patent Court attached to
the European Court of First Instance in Luxembourg, with appeals to the CFI. Till Community
Patent Court is set up, national courts will have jurisdiction.

3.5 The Patent Co-opinion Treaty (PCT)

An important development in international patenting is the PCT, which entered into

force in January 1978 and as of 1 June 2004, had been ratified by 123 countries including all
EPC states, USA, Japan, China and Russia. The PCT, like the Paris Convention, is
administered by the WIPO, a United Nations organization with its headquarters in Geneva.
Though it is not a supranational patent office, patent applications can be filed there. The tasks
of searching and examination are delegated to other offices, and WIPO does not grant a 'world
patent', but at most provides non- binding opinions on patentability. The main aim of PCT is
to simplify the process of filing patent applications simultaneously in a number of countries.
As per old procedure, it requires a completely separate application in each country, which has
to be translated into the local language before filing, or at best shortly afterwards. Under the

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PCT, a single international application may be filed in one of the official receiving offices, or
at WIPO itself, and potentially gives rights for all PCT contracting states. An initial
International Phase in which a search and possibly also a preliminary examination is carried
out is followed after 18 months by a national phase in which selected national or regional patent
office’s conclude the examination process and grant (or refuse) the patent. The international
application may claim priority from an earlier national, regional, or PCT application is filed
within the normal 12-month period of the Paris Convention.

3.6 Other Regional Patent Organizations

The European Patent Organization is not the only, nor even the first, organization set
up to grant patents covering more than one country. The first the African Intellectual Property
organization, known by its French acronym OAPI, set up by the Libreville Agreement of 1962
as modified by the Bangui Agreement (1977). This grants a single regional patent covering 14
former French colonies in West and Central Africa. The English-speaking counterpart to this
is the African Regional Industrial Property Organization (ARIPO), also covering 14 states, and
dating from 1976. In both cases, the economic levels of the member countries are such that
there is little interest in obtaining patents through these regional offices, although this may
change for ARIPO if South Africa should eventually become a member.
A more recent creation is the Eurasian Patent Convention, by which a single application
filed is Moscow can give protection, for the Russian Federation and for eight of the former
Soviet republics. Its appeal remains limited because a number of the more economically
important of these states, such as Georgia. Ukraine, and an Uzbekistan remains outside the
Convention:

3.7 TRIPs regime

The general Agreement for Tariffs and Trade (GATT) was set up in 1948 to deal with
multilateral trade issues. The latest round of GATT negotiations, the Uruguay Round, was
finally concluded in April 1994, and led to the establishment of the World Trade Organization
(WTO) which became operation on 1 January 1995. The agreement on Trade Related Aspects
of Intellectual Property Rights (somewhat inaccurately rendered by the acronym TRIPs) was
adopted as an integral part of the final ACT of the Uruguay Round, so that all countries, which
become members of WTO, must accept the provisions of TRIPs as part of the deal. The TRIPs
agreement covers a whole muse of intellectual property issues including patents. Trademarks.

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Geographical indications. Industrial designs, integrated circuits. Copyright and trade secret
protection, as well as general provisions about basic principles enforcement and dispute
resolution,
Article 1-8 of TRIPs includes the basic principles of National Treatment and Most-
Favoured Nation (MFN) treatment. That is, each member must give to the nationals of other
members treatment no less favourable than that given to its own nationals, and must give to
the nationals of all members the same privileges as are given to the nationals of any member.
Thus, subject to certain exemptions, bilateral IP agreements between members that restrict the
benefits of the agreement to the two parties should no longer be permitted. These Articles are
of particular importance because their implementation, unlike other provisions of TRIPs, could
not be delayed beyond 1 January 1996 by any member country, whatever its state of
development.

3.8 Status in Individual Countries

India is a country in which there is a serious political conflict between those politicians
and companies who wish to open .up the Indian economy to the outside world and see
membership of WTO as an important part of this goal; and those elements which with
considerable popular support, wish to retain the old protectionism and delay any changes to
the patent law. Accordingly, India ratified GATT on 31 December 1994 by governmental
decree, without seeking the approval of the Indian Parliament, and at the same time amended
the patent law by a Patent Amendment Ordinance so as to allow black box filings.
The ordinance was later allowed to lapse, and the bill which was to replace it failed to
get parliamentary approval, with the result that although black box filings were still accepted,
that were no longer officially recognized, and their legal status was unclear. Dispute
proceedings under GATT were called for by the USA, alleging that India was in breach of its
obligations under TRIPs by not officially providing for black box fillings. The dispute panel
and the appeals body both held against India, but the USA agreed to give India until April 1999
to implement measure which should have been in place in January 1995.

3.9 Grant and Enforcement of Patents

It is of little use to have a strong patent law on paper unless patent applications are
actually processed to grant and the resulting patents can be enforced. Many developing
countries have recently improved their patent laws, mainly as a result of TRIPs, and these laws

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often require substantive examination of the novelty and inventive step of patent applications,
This puts these countries in a difficult position, because of their improved laws their patent
officers receive many more applications than before, but they lack the necessary technical staff
and infrastructure to examine the applications in the way that the laws seem to require. The
problem should not be underestimated; to be able to carry out a proper substantive examination
in all technical fields a patent office must have a large technically qualified staff and enormous
resources of scientific· and patent literature, access to electronic data bases, etc.

3.10 Compulsory licensing

A. General

TRIPs provides that any such licenses must be, Considered on their individual merits;
Granted only if a license on normal terms has been requested and refused; Of limited scope
and duration; Non-assignable other than with the business; Primarily for domestic supply
rather than for export; Capable of being terminated if circumstances change; Subject to
adequate remuneration; and Subject to judicial review;
Compulsory licenses to enable working of a dependent patent may be granted only if
the invention claimed in the later dependent patent involves an important technical advance of
considerable economic significance, and the compulsory license, if granted, shall be non-
assignable except with assignment of the dependent patent. When reviewed by the European
Commission in late 1995, the laws of no single EU member state complied fully with all of
these provisions, so it is hardly surprising that the laws of developing countries were often less
than perfect in this respect. TRIPs clearly mention that discriminatory compulsory licensing of
pharmaceutical patents must be stopped. It is also a concern that certain of the TRIPs provisions
relating to compulsory licenses are not applicable to compulsory licenses granted to remedy
anti-competitive practices.

B. Compulsory Licenses for Export

The entry into force of the TRIPs agreement in 1995 came at a time when the extent of
the AIDS epidemic in Africa was becoming clear. Patented anti-retroviral drugs were being
used in the USA and Europe to control the progression of the disease, but these drugs were
very expensive and unaffordable for the vast majority of patients in developing countries. The
perception arose, fostered by NGOs such as Medicines sans Frontiers (MSF) and Oxfam, that

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patents were the reason why these drugs were not being made available to AIDS sufferers at
an affordable price.

3.11 International organizations efforts

This chapter has set out international developments in patent law, as they have
occurred, without going into the question of how these changes came about. It is of course
clear that such developments, which have generally acted to strengthen patent protection, did
not just happen of their accord, and that political. Diplomatic, and industry lobbying activities
have played a larger role than any objective analysis of the economic and social benefits of the
patent system. In particular industry's ‘forum-switching' from WIPO and UNCTAD to GATT
resulted in the success of the TRIPs agreement. At the same time, however, it brought patent
matters to the attention of a much wider circle of interested parties, including many non-
Governmental organizations, who were opposed to a strong patent system for a variety of
reasons. The result has been a vocal backlash against TRIPs and against patents in general,
which is now increasingly being accepted.as the new reality by the public and politicians alike.

3.12 Patent Law Treaty (PLT)

This treaty, concluded in June 2000, harmonizes the formal requirements for patent
filing in the contracting stales. It simplifies, for example, the requirements for obtaining a filing
date, and allows the specification to be filed in any language, with translation provided later if
necessary. It makes it easier for the applicant to restore his rights if certain time limits are
missed, and should generally reduce costs and increase legal certainty. Although the Treaty
has been signed by 43 states, the necessary ten ratifications, which would enable it to enter into
force, have not been obtained as of the end of 2003.

3.13 Substantive Patent Law Treaty

In contrast to the agreement reached on formal matters in the PLT, little progress has
been made in negotiations on harmonization of substantive patent law. The main stumbling
block is the reluctance of the USA to give up its unique first to invent system.

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CHAPTER IV

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 PATENTABILITY

4.1 Introduction

Almost every country has a patent law that gives an inventor the exclusive right to
something he has invented and consequently rewards him for his industry and creativeness
While rewarding the inventor may be just, the primary purpose of patent laws is to benefits
society by encouraging creativeness, inducing the investment of capital in untested areas, and
providing an incentive to disclose new technology. The substantive requirements of various
patent laws are designed to ensure these ends; thus in every patent law novelty, industrial
usefulness, and non-obviousness are prerequisites to patentability. Novelty, usefulness, and
Non-obviousness are determined by a search of what is known as "prior art". Prior art is the
existing body of knowledge from which patentability is measured and is composed of patents,
publications and prior use. Each country's patent law determines the extent to which prior art
draws upon foreign patents, publications, and prior use. After the body of prior art is
assembled, patentability is determined by examining and comparing the prior art with the
invention to discover whether the invention is truly new, useful, and nonobvious, as defined
by the country's substantive patent law and court decisions. Assuming an accurate search of
the prior art, novelty can be ascertained with some accuracy. Usefulness also is not too difficult
to determine.

Non obviousness, however, requires a highly subjective appraisal If an invention is obvious to

a trained practitioner in the art, issuance of a patent for it fails to promote, and in fact may
hinder, the ends of a patent system. The idea of granting an exclusive right to the direct profits
from an invention is not a recent one. In 1421 the first known patent for invention was granted
by private statute of the Republic of Florence to Filippo Brunelleschi, an architect, for his
invention of “a kind of ship." The grant was for only 3 years and prevented the use of any other
novel means of water transportation in Florentine territory. The Republic of Florence did not
develop the patent notion any further. During the same period, however, the Venetian
Republic, possibly influenced by Brunelleschi's patent, established the first public patent
statute, which rewarded any invention that improved or accelerated the process of silk making.
This was a forerunner of the first known general patent statute, passed in 1474 by the Venetian
Republic. This statute offered protection for a 10-year period to inventors in all fields, required
local novelty and usefulness, and specified the punishment for infringement. Except for its
limited territorial scope, it is Venetian statute contained all the elements of a modern patent

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statute. The patent concept that slowly developed in the rest of Europe was less distinctly
defined than that of the Venetian statute. The European concept was based on the literate
patents', or “letters patent," which were issued by sovereign grace to proclaim a special
privilege, title, or monopoly. In England letters patent were used by the Crown to control trade,
but the system was abused by court favourites who made fortunes from patent-based
monopolies in such industries as salt, tin, starch, and paper. The abuse became so flagrant that
in 1623 Parliament passed the Statute of Monopolies, which declared all monopolies void
except-those granted for new and useful device.

The concept of the patent as an act of grace survived until the advent of the Industrial
Revolution and the idea that individual enterprise should be rewarded by the state as a matter
of course. This modem patent concept appeared United States' in 1790 first patent law, which
provided patent protection after an examination to determine the novelty of the particular
invention. This statute extended patent protection to "any useful art, manufacture, engine,
machine or device or any improvement therein not before known or used. “The requirement of
an examination to determine novelty was abandoned in 1793, only to be added again in 1836
with the passage of a patent act that is the direct antecedent of our present patent law. By the
end of the 19th century most developed countries had begun to adapt their patent systems to
this modem concept.

4.2 National Patent System

At present there is no unified, international patent system. Fundamental differences

regarding the nature and extent of the rights that should be granted by patents have led to wide
dissimilarities among the various national patent systems. At one extreme is the United States,
which grants a property right to the inventor and, in most instances, leaves its exploitation to
his discretion. At the other extreme is the Russia, whose Inventor's Certificate does not
conveyor recognize any exclusive property right, the state simply grants to itself a monopoly
to utilize inventions. Most nations follow a middle course, they grant a property right to the
inventor to exclude other from making use of the invention, but do so only if the invention is
put to commercial use in that country within a reasonable period of time and only if periodically
paid. This tends to decrease the retention of unused or uneconomic patents.

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 Further, many countries have compulsory licensing, which requires-the patentee to
license his invention under stipulated conditions to certain applicants who then can utilize the
invention. Similarly, the protection that a patent offers differs among countries. Most nations,
including the United States, the Scandinavian countries. West Germany, the United Kingdom,
Canada. Australia, and Japan, have examination systems. France and Italy, among others, have
registration systems. An examination system tries to ascertain if the invention meets some
statutory definition of patentability and gives a presumption of validity to a granted patent,
while a registration system leaves the question of validity wholly to the courts. But the
difference between these systems is not as great as one might think. To illustrate, Switzerland
examines with regard to certain areas of technology only. France has started a novelty search
in areas of medical research and is considering a plan 10 extend it, The Netherlands and West
Germany have each enacted a compromised referred-examination system that grants a patent
of limited duration upon application and examines only if the patentee or a third party considers
the validity or scope of the patent of such commercial concern that it justifies his bearing the
cost of the examination required to extend the patient’s life.

Further, even in a country with a pure examination system, such as the United States,
the presumption of validity may be fairly weak. In the United States, for example, almost 60
per cent of all patents considered by the courts are wholly or partially cancelled. Two further
points of difference among patent systems are the first-to-invent criterion and the method of
defining the invention's subject matter. First, if there is any conflict between two inventions in,
for example, the United States, the inventor who can prove he was the first to invent the
discovery will prevail. In most other countries there is no attempt to determine the lust to
invent, for the party who first filed his application will win." Second, patent systems differ
with respects to the specificity required in the inventor's claims his definition of the subject
matter of the invention. A strict definition, such as that required by the United States, involves
a much more detailed description of the invention than is necessary in most European
countries. The differences between the various national patent laws even extend to such minor,
but nevertheless vexing, matters as the size of the paper on which an application is printed.
These various dissimilarities, coupled with the principle of territoriality, which says that the
exclusive right granted by the patent is only good within the state that conferred it and that all
legal dealings in connection with the patent must be determined by the laws of that state, place
a tremendous strain on companies that wish to do business internationally and on the various
countries that search and examine applications. For example, in 1966 approximately 611000

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patent applications were filed worldwide; of these more than half were duplicates and multiple
filings." Since each duplicate application involves a separate application form and (in
examining countries) an independent search and examination, a tremendous waste of
manpower and economic resources is involved. This problem is particularly acute in most
European countries, where the majority of patents granted are filed by foreigners.

4.3 USA
The three basic requirements found common in all patent laws, In US Code 35, the
three consecutive sections 101-103 deal with patentable inventions, Novelty, Non obviousness
and Utility. We look these provisions with the help of case study which is the only way to have
a crystal clear understanding of modem technology patenting.

4.4 EUROPE
4.4.1 European Patent Convention
.
There are three simple requirements for a patentable invention as set out in the European Patent
Convention and in the laws of those countries which have acceded to it; as for example in the
British Patents Act 1977. These are that the invention must be new; that it must involve an
inventive step; and that it must be capable of industrial application. The same three
requirements are met with in one form or another in the USA, Japan, India and indeed in
practically every country, which has a patent system at all. There are in addition certain matters,
which, which arc specifically excluded from protection, which are allowed by the provisions
of TRIPs. These exclusions are not necessarily to be found in the laws of other countries, for
example the USA· and more extensive lists of excluded subject matter may be found in the
laws of countries, which have not yet fully adapted their Jaws to TRIPs.

4.4.2 Novelty
The first and clearest requirement is that nothing can be patentable which is not 'new'.
If a patent were to be granted for something already known, then, on the classical theory of
patent protection in exchange for disclosure, the patentee would be receiving something for
nothing; there would be no consideration for the grant. Quite independently of this theory of
the patent system, if the public at large, or even any part of it, knew of the information and
were free to use it, then the grant of a patent in respect of this information would deprive the
public of rights, which it previously had. Such a patent monopoly would be unjust for the same
reason as Queen Elizabeth I monopolies on salt and playing cards.

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4.4.4 Industrial Application
The third basic requirement of the EPC is that the invention should be capable of
industrial application. Industrial application is broadly defined, and includes making or using
the invention in any kind of industry, including agriculture. Methods of medical treatment or
diagnosis performed on the human or animal bodies are defined as beings incapable of
industrial application, although substances invented for use in such methods are patentable.
This concept of 'industrial applicability' of an invention replaces the old and rather vague
concept of 'manner of manufacture.’

4.5 INDIA
4.5.1 Novelty
The concept of novelty in intellectual property jurisprudence lay's down that only what
is new at the time of the filing of the application for a patent is patentable, patent eligible
subject matter is granted a patent if the subject matter is novel, non-obvious and is capable of
industrial application, Of these requirements, novelties of core value. This is further
emphasized by the definition of 'invention' as set forth in the Indian Patent Act. The Act lay's
down that invention consists of only a new product. The patent Amendment Act of 2005
defines a new invention as any invention or technology, which has not been anticipated by
publication in any document or used in the country or elsewhere in the world before the filing
of the application with the complete specification."

It has been laid down by Their Lordships of the Privy Council that "Invention is finding
out something which has not been found out by other people. There are many instances in
various branches of science of independent investigators making the same discovery. That does
not prevent the one who first applies and gets a patent from having a good patent, for a patent
represents a quid pro quo, the quid to the patentee is the monopoly; the quo is that he presents
to the public the knowledge, which they have not got. That knowledge the other inventor has
kept sealed in his own breast, and he therefore cannot complain that his rival got the patent.
And if this is the case when a person can show that he actually made the discovery surely that
is a much stronger case than the present, when the objector does not say that he did discover,
but only that if he had experimented he would have discovered. The real invention often may
be and is just the last element of the combination.

In Raj Parkash V. Mangat Ram, it was held that 'invention, as is well known, is to find out
something or discover something not found or discovered by anyone before…. It is not

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necessary that the invention should be anything complicated. The essential thins is that the
inventor was the first one to adopt it. The principle, therefore, is that every simple invention
that is claimed, so long as it is something which is novel and new, it would be an invention ...
" A new invention may consist of a new combination of all integers so as to produce a new Dr
important result or may consist of altogether new integers.

Patent system denies the issue of a patent to inventions that were disclosed prior to the
time a patent application was filed at the Patent office. One of the conditions laid down by the
United Kingdom Patent Act. 1977, is that a patent may be granted only for an invention, which
is new. The patent Act, 1977 was enacted to bring the law of UK into conformity with the
corresponding provisions of the European Patent Convention. In USA the concept of novelty
is laid down in Title 35 of United States Code Sec 102. Novelty and anticipation are determined
by reference to the language of the claim of the patent application. The grounds for opposition
of a patent grant are almost the same the tests for revocation of a patent once granted. Under
section 64 of of the Patents Act, a patent shall be revoked "where it is not novel". The Patents
Amendment Act of 2005 state that after an application for patent has been published and before
the grant of a patent, the grant of patent may be opposed on the ground of novelty.

4.5.2 Inventive step

Anticipation is a two-step analysis. The first step involves construction of the claims
of the patent at issue. In the second step, the claims are compared to the prior art. A claim will
be anticipated, and therefore invalid, if every limitation is described in one prior art reference
and the prior art is enabled such that one o ordinary skill in the art could practice the invention.

To be an anticipating reference, an item must disclose each and every element of the
claimed invention. The test is to determine the elements of the claimed invention with that of
the reference in issue. To anticipate a claim for a patent, a single prior source must contain all
its essential elements. An invention said to be anticipated, only if another invention already
known or used is identical in substance. A prior art reference must disclose all the elements of
the claimed invention or their equivalents functioning in essentially the same way. Anticipation
occurs only when some single prior article, patent or publication contain within its four comers
every element of the claim in question. A patent is not anticipated when its elements are
distributed among several prior publications and devices. Anticipation cannot be shown by
combining more than one reference to show the elements of the claimed invention.

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. If the Yprior art reference does not set forth a particular element of the claim that
reference may still anticipate if that element is inherent in its disclosure. To establish inherency
the, extrinsic evidence must make it clear that missing descriptive matter is necessarily present
in the thing described in the reference, and that it would be recognized by persons of ordinary
skill.

The Indian Patent Act refers to prior art as that which was published before the claim
in any claim of a completed specification in

1. Any specification filed for obtaining a patent in India or after 1st day of January, 1912.

2. in India or elsewhere and also in any other documents.

The only exception is where the applicant proves that the matter published was obtained
from him and was published without his consent and that he had applied for the patent as soon
as reasonably practicable after knowing about the publication. But this exception will not be
available where the invention has been commercially worked in India otherwise than for the
purpose of reasonable trial. The Act lay’s down that working of the invention for the purpose
of reasonable trial can be considered as not anticipating the invention. The extent of publication
required to constitute a ground for opposition was discussed in various decisions.

In Press Metal Corpn V. Nosher Sorabji the invention was in relation to improvement
in or relating to mufflers or exhaust silencers for internal combustion engines. The petitioners
argued that the Controller was in error in rejecting the opposition that the invention as claimed
by the inventor in the complete specification has been published before priority date of claim
and that the invention was publicly known or used in India before the date. The controller
overruled the objection of prior publication in "Motor Automotive Encyclopaedia on the
ground that no detail regarding the size of the perforations, which was one of the characterizing
features of the applicant's invention, was given in the books. The petitioners also opposed the
grant of patent on the ground that the publication of the invention can be seen in the letters sent
by Premier Automobiles Ltd, to the representatives of the inventor. The inventor has given 5
different mufflers to Premier Automobiles Ltd, for testing. The argument of the inventor was
that none of the different silencers shown in the motor manuals could give any idea to any
person to manufacture the applicant's muffler. Having regard to the evidence adduced, the
Court found that the claim made by the inventor is no more than a workshop improvement and
the objection that the invention, as is claimed in the claim of the complete specification as,
published before the priority date sustained.

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 Ram Narain V. Ambassador Industries, New Delhi, was a case in which the court found
that the plaintiff had not specified the essentials required in a claim. The plaintiff in the patent-
in-suit sought interim injunction to restrain the defendant from adopting the method and
process for manufacturing, selling or offering for sale air coolers. The defendant claimed prior
art. It was held that the plaintiff had not claimed, that the design proposed by him was an
Improvement on any previously existing coolers, he had also not stated the advantages sought
to be achieved by his invention. The plaintiff contended that the claim made by him read as a
whole does disclose a improvement over the already existing coolers. The court concluded that
the novelty/invention has to be succinctly stated in the claim. The applicant must describe the
advantages sought to be achieved by his invention in the claim.

In Kay Laboratories, Bombay V. Hindustan Lever Ltd the invention was titled as a new
method for making a plant growth nutrient/stimulant. The opponent alleged that it was in fact
discovered in 1977 at Michigan University and the results published prior to the priority date
of claims, and also the compound used in the invention was known much prior to 1977 and its
reference was found in various books and literature, all available in India. The court held that
prior publication was established and .the application was rejected of anticipation.

Anticipation is judged by considering how a person skilled in the art would construe a
prior publication. The issue was decided in Krishore Mahadeo Pole, G.M Walchand Nagar
Industries Lid V. Therax Pvt. Ltd. The invention was entitled “a process for recovery of
potassium sulphate from waste liquids such as distillery spirit wash". The opponents relied on
prior publication and prior public knowledge. It was held that the opponents failed to indicate
all the steps of the invention was held to have a further improvement of incineration technology
and was considered as novel.

In Indian Vacuum Brake Co. Ltd. V. E.S.Luard,0 the petitioners were the holders of
"Hardy Patent" and were importing from the factory in England and selling in British India
vacuum brakes having certain specific features. The designs were published in and known
publicly in British India since 1910. The respondent obtained a patent relating to the pistons
of vacuum brake cylinders identical with the one of the petitioner. On detailed evidence, the
court came to the conclusion that both in the working principle and general character of
construction; the petitioner's design and the respondent's patent are founded on Hardy's patent.
It was also shown that the patented invention of the respondent was in use on Indian Railways
long prior to the grant to the respondent.

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 Reckitt & Colman of India Ltd V Godrej Hi Care Ltd was an opposition to the grant of
a patent to the application of M/s. Reckitt & Colman of India Ltd, for their invention, "A
mosquito/insect repellent device". The opponents challenged the application on the ground of
anticipation by prior claiming, prior public knowledge or public use and obviousness. The
opponents relied on photographs of cordless 'Good Night' and also on patent documents. The
applicants opposed the patent document cited by the opponents that none of the patent
documents were identical to the applicant's alleged invention. The applicants also submitted
that the protection of designs to the mosquito repellent applies only to the feature of shape and
configuration, pattern or ornament as applied to the art.

The tribunal after detailed scrutiny of the cited prior art found that the cited documents
on patents and designs cannot establish anticipation by prior publication by combining the
integers of the mosquito repellent from the cited patent and design article as produced by the
alleged invention. The tribunal also fund that the prior public knowledge or use cannot be
applied as the citations of the designs and the US patent documents will not stop the prior users
from doing what they were doing before.

A person cannot patent what was known or used by others in the country. "All ideas in
general circulation be dedicated to the common good unless they are protected by a valid
patent." The requirement for novelty differs from country to country. The USA Patent Act
considers use and knowledge with the country alone as anticipating an invention. The Indian
Patent Act provides that publication on or after the priority date of the applicant's claim filed
in pursuance of an application for a patent in India, being a claim of which the priority date is
earlier than that of the applicant's claim is a ground for opposition of patent. The UK patent
Act has reflected the difference in the position between the USA and Indian Law. The UK Act
lays down that the state of art can be said to contain everything that has been made available
to the public whether in the UK or elsewhere," The Indian Act states that public knowledge
and use can be a ground of opposition only were it was known or used in India. In the case of
an invention related to a process, importation of the product made by the process to India is
also considered as knowledge and used in India.

4.5.3 Utility

An invention must be useful and capable of industrial application in order to be

patented. There must be some demonstrable utility or specific benefit from an invention. The
invention must have some practical utility in the form of immediate benefit to the public. As
regards the conditions of industrial applicability, no special considerations should apply to

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certain specific type of inventions. The requirement of industrial applicability shall be satisfied
not at the time of filing of parent application but at the time of grant of the patent. It implies
that at the time of filing the patent application if the invention has no practical utility or
industrial application, nevertheless patent shall be granted, if the inventor could establish the
utility before the date of the grant of patent.

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CHAPTER V

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 TYPES OF TECHNOLOGIES

5.1 Introduction
Technology is a broad concept that deals with a species’ usage and knowledge of tools
and crafts and how it affects a species' ability to control and adapt to its environment. It refers
to human activities such, as agriculture or manufacturing and even to processes such as animal
breeding or voting or war that change certain aspects of the world. Further, technology
sometimes refers to the industrial and military institutions dedicated to producing and using
inventions and know-how. In any of these senses, technology has economic, social, ethical,
and aesthetic ramifications that depend on where it is used and on people's attitudes toward its
use.

Technology is a term with origins in the Greek "technologia," i.e., systematic treatment
of an art 2 However ,a strict definition is elusive; 'technology" can refer to material objects of
use to humanity, such as machines, hardware or utensils, but also encompass broader themes,
including systems, method of organization and techniques. The term can either be applied
generally or to specific areas such as construction technology, medical technology, engineering
technology, Nano-technology, biotechnology etc.
Human race recognized the value of technology and began with conversion of natural
resources into simple tools. The pre-historical discovery of the ability to control fire increased
the available sources of food and the invention of the wheel helped humans in traveling in and
controlling their environment. Recent technological developments, including software
technology, biotechnology, engineering technology and Nano-technology have improved the
standards of living of individuals in all respects and at the same time, benefited the society in
overall perspective and made the world as global village. Technology particularly
biotechnology helped the society in a number of ways. It helped in identifying the DNA
structure, genetic engineering, cloning, medicines, gene transplantation etc., which helped to
develop the human health, agricultural sector etc. But various implementations of technology
influenced the values of a society and new technology often raises new ethical questions such
as patenting of gene and living organisms, cloning of animals and human beings, using human
beings in clinical trials.

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 Technology particularly biotechnology helps the mankind in many respects. In the
areas of health sector and agricultural sector due to the inventions made by the Biotechnology
firms, the human life, standard of living particularly in the field of medicine has improved
alarmingly. The other edge of biotechnology is worsening the human life than improving. In
the modem intellectual property era, where it gives exclusive right to inventor to use the
invented technology, it is becoming a cost affair concept and it is not in the hands of a common
middle class man. Before looking in deep about the biotech patents it is required to analyse the
understanding of technology and about biotech patents.

5.2 Definition of technology

In general, technology is the relationship that society has with its tools and crafts, and to
what extent society can control its environment. The Oxford Dictionary offers a definition of
the term, "the scientific study and use of applied sciences"3. The Merriam- Webster dictionary
offers a definition of the term: "the practical application of knowledge especially in a particular
area" and "a capability given by the practical application of knowledge.4 Ursula Franklin, in
her 1989 "Real World of Technology" lecture, gave another definition of the concept; it is
"practice, the way we do things around here"5. ' Bernard Stiegler, in his article 'Technics and
Time,' defines technology in two ways: as "the pursuit of life by means other than life", and as
"organized inorganic matter”.6 the term is mostly used in three different contexts: when
referring to a tool, a technique, the cultural force or a combination of the three.
Technology can be most broadly defined as the entities, both material and immaterial,
created by the application of mental and physical effort in order to achieve some value. In this
usage, technology refers to tools and machines that may be used to solve real-world problems.
Tools and machines need not be material; virtual technologies, such as computer software and
business methods, biotechnology and genetic engineering, etc., fall under this definition of
technology.

5.3 Technology and Society

The relationship of technology with society is generally characterized as synergistic,

symbiotic, co-dependent, co-influential and co-producing, i.e., technology and society depend
heavily one upon the other. It is also generally believed that this synergistic relationship first
occurred at the dawn of humankind with the invention of simple tools, and continues with

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modern technologies today. Today and throughout history, technology influences and is
influenced by such societal issues / factors as economics, values, ethics, institutions, groups,
the environment, government among others. Studying the impacts of science, technology and
society and vice versa is an essential exercise need to be done regularly, then only the balance
can be maintained between nature and technology.

5.4 Broad Classification of Modem Technologies in view of patents

5.4.1 Nano technology

Many describe nanotechnology (Nano-tech) as the science that will usher in the next
industrial revolution. Literally Nano-technology means "technology on the nanometre scale",
nanotechnology has been alternately defined as the application of science at the Nano-scale,
from 1 to 100 nanometers'7, and "the research and development of materials, devices, and
systems that exhibit physical, chemical, and biological properties that are different from those
found at larger scales." One can find myriad other definitions in legal, patent, and scientific
literature.

5.4.2 Information Technology

Information Technology (IT), with regard to the IT sector, there is considerable debate about
the need for exclusive rights to promote development of software and business methods and
whether patent protection is the appropriate regime to use. Unlike copyrights and contractual
rights, patents create claims that are good even against independent inventors. For cumulative
technologies or in instances where inter- operability is an important goal, the need to sift
through prior patents and negotiate rights arguably creates a high tax on innovation and a drag
on development.

5.4.3 Biotechnology

While the term "biotechnology" was coined early in the twentieth century, the use of
biotechnology processes dates back almost as far as the beginning of humankind. Not until the
nineteenth century, however, did scientists begin to understand the chemical and biological
bases for these developments. Specifically, the nineteenth century marked several important
scientific breakthroughs, including Louis Pasteur's discovery of yeast in the fermentation

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process, Gregor Mendel and Charles Darwin's work on heredity, and Schleiden and Schwann's
discovery of the cell, all of which helped open the door for modem biotechnology. Today
biotechnology is a booming industry, generating billions of dollars and producing innovations
ranging from new antibiotics to cloned animals and genetically modified food products.

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CHAPTER VI

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 NUANCES OF PATENT PROTECTION WITH BIOTECHNOLOGY

As long as there have been people, there has been technology. Indeed, the techniques
of shaping tools are taken as the chief evidence of the beginning of human culture. On the
whole, technology has been a powerful force in the development of civilization, all the more
so as its link with science Ms been forged. Technology- like language, ritual, values,
commerce, and the arts-is an intrinsic part of a cultured system and it both shapes and reflects
the system's value. In today’s world, technology is a complex social enterprise that includes
not only research, design, and crafts but also finance, manufacturing, management, labour,
marketing, and maintenance.

In the broadest sense,

(0
technology extends our abilities to change the world: to cut,
shape, or put together materials: to move things from ant place to another: to reach further
with our hands, voices, and senses. We use technology to try to change the world to suit us
better. The changes may relate to survival needs such as food, shelter, or defence, or they may
relate to human aspirations such as knowledge, art, or control. But the results of changing the
world are often complicated and unpredictable. They can include unexpected benefits,
unexpected costs, and unexpected risk-any of which may fall on different social groups at
different times. Anticipating the effects of technology is therefore as important as advancing
its capabilities.

-Science for all Americans

6.1 Development of Biotechnology

Biotechnology has become a new and challenging technique for established industries
and for specialist entrants. Crops may genetically manipulated at every level from the specific
variety to the genus or species, in order to improve their commercial qualities or to make them
resistant to insects or diseases or herbicides which can then be used on surrounding weeds11.
Classical biotechnology may be defined loosely as the production of useful products by
living microorganisms, and as such it has been with us for a long time. The production of
ethanol from yeast cells is as old as history, and over fifty years ago the production of various
industrial chemicals such as acetic acid and acetone by fermentation processes was well,
known. Indeed, even the word biotechnology is not recently coined. In 1920, a Bureau of Bio-

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Technology was established in Leeds, and published a journal dealing with fermentation
technology and related topics. Back in
1873, Louis Pasteur obtained a US patent claiming 'yeast, free from organic germs of disease,
as an article of manufacture', an early case of a patent for living organisms.
More recently, the antibiotics industries were based upon the isolation of products from
selected strains of microorganisms, and although the majority of antibiotics are now produced
synthetically, are, still made from micro-organisms either found in nature or artificially
mutated. Not only antibiotics but also other drugs - for example, the immunosuppressant
cyclosporine - are produced by fermentation of a microorganism.
The modem biotechnology, as distinct from the classical fermentation technology, began
in the 1970s with the two basic techniques of recombinant DNA technology and hybridoma
technology. These are also referred to as gene splicing or genetic engineering, that it causes
the production of a desired protein by the cell; secondly producing monoclonal antibodies.
More recently, the techniques of genetic engineering have been applied to higher organisms to
produce transgenic animals and plants, and even to humans (gene therapy) for example to
replace missing or defective genes coding for a protein required by the body, or to introduce
genes into cancer cells which will render them easier to kill.
The genomic era has started. The concept of Genomics was developed in a high speed by
the sequencing of DNA fragments and has led to the completion ahead of schedule of the
Human Genome Project, and the identification of many human genes, and this science of
genomics can be used to find genes which could make useful protein products, which could be
applicable in gene therapy, and which might be useful in elucidation of disease mechanisms,
in diagnostic kits, and in screening for new drugs. There are also many research tools and
techniques making use of biotechnological processes. 12

6.2 Biotechnology in Science

Biotechnology is all interdisciplinary enterprise, a scientific melting pot whose language
of communication and expression is that of chemistry. It draws, not only upon a wide range of
life sciences, but also on other less obviously related sciences like computer science and
chemical engineering. Biotechnology also brings together a diversity of industrial sectors that
benefit from using it.
For Authur Kornberg, a Nobel laureate for his pioneering research on DNA synthesis,
'the most rational understanding of life' is 'its reduction to the molecular details of chemistry".

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This conceptualization of life as essentially chemical, embodied in and promoted through the
discourse of biotechnology, is undoubtedly appealing to those who esteem modem science for
its progressiveness and rationality.
Modem biotechnology is very much a late twentieth-century phenomenon; it is the result
of scientific advances that go back well over a century. Gregor Mendel, whose findings were
rediscovered in 1900, had worked out the basic rules of heredity in the 1860s. Chromosomes
had been discovered, also in the 1860s, and were found to behave in a systematic manner
during cell division.
The molecular biology emerged in the next decades. The term was actually coined by a
scientists working at the Rockefeller Foundation, an important source of research funding and
scientific guidance in this area between the 1930s and the late 1950s. Linus Pauling, the
renowned American biochemist, working at the California Institute of Technology, Maurice
Wilkins and Rosalind Franklin at King's College, London, and James Watson and Francis
Crick at Cambridge University elucidate the structure of the DNA macromolecule. Watson and
Crick were first to come up with the double helix model, which was announced in 1953 in
Nature.
Unlike DNA and hybridomas, the polymerase chain reaction (PCR) technology came out
of a corporate laboratory. Kary Mullis, a scientist working for the California-based, Cetus
Corporation (like so many of the early Dedicated Biotechnology Firms (DBFs), was credited
with the invention, which is usually dated to 1985.

During the 1980s and 1990s, genetic engineering became increasingly sophisticated, with
genes being transferred not just to microorganisms but also to plants and animals. A cancer-
causing gene was inserted, into a mouse, resulting in the controversial Harvard Onco mouse
that was patented in 1988.

6.3 Biotechnology and the Patents

At global level, the growth and consolidation of the US biotechnology sector is closely
linked to the expansion of patent law into the protection of life forms and their structural and
functional components. The reason behind the regulatory changes taking place in different
countries is the huge importance of patent protection in the biotechnology field. Biotechnology
was and continues to be a high-risk and extremely research-intensive activity, and for DBFs
especially, it has always been crucial to be able to secure large amounts of investment capital
just to stay in business. Patent portfolios are the main magnet for outside investors - which also

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include larger science based firms and the larger the portfolio, the greater the interest from
investors.
Research decision in many companies can depend as much, if not more, on the advice of
patent lawyers as on the opinions of the scientists. Naturally, companies have a strong interest
in securing patents that encompass the broadest possible scope and whose claims are drawn in
ways that seek to anticipate future scientific developments.
At the same time, the strength of competitor's patent positions helps companies to decide
which research not to pursue. The extent of biotechnology patenting has increased
tremendously in the last two decades. If only DNA sequences is taken Giles Stokes of Derwent
Information, a company that provides patent and scientific information, explains that they 'first
began appearing in patents in 1980, just 16 sequences all year. By 1990 that figure had risen
to over 6,000 sequences. Throughout the 1990s the growth in the patenting of sequences
expanded exponentially, and this continued. In 2000 over 3,55,000 sequences were published
in patents, a 5000 percent increase over 1990 -2000.17
It is not just the companies that are doing patenting, the US Department of Health and
Human services was also one of the biggest applicants for patents claiming human gene
sequences. In the agro-biotechnology field, six companies are responsible for three-quarters of
all the US patents granted to the top 30 patent-holding firms. These are Monsanto, Du Pont,
Syngenta, Dow Aventis and Grupo Pulsar.

In Europe, it is estimated that more than 5,000 applications were made to the EPO in
2000, and a 50 percent increase of Biotech application during 2000 to 2005 of which 40 per
cent were for, microorganisms, plants and animals, while 60 per cent were for human and,
animal, DNA sequences or for new gene therapies and medicines, or for both.

6.3.1 Biotechnology patenting in USA

USA pioneered both the commercialization of biotechnology applications and products

and the development of patent law to protect them. Before the 1980s, the patent situation with
respect to biotechnology processes and products was highly uncertain. While clearly non-
biological process technologies such as DNA could be patented in the USA, the product of
nature doctrine was assumed by the Patent and Trademark Office, and by most scientists
entirely to preclude the patenting of life forms and their structural and functional components.
The meaning of the product of nature doctrine is that organisms or substances as they occur in
nature cannot he considered as inventions are therefore not patentable. And, at this time, the

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new DBFs were yet to organize themselves into a single trade association to further their
collective legal and regulatory interests. For better understanding of patenting regulation
development case study is the best way.

6.3.1.1 Vitamin technologies case

A landmark case in early history in US relating to biotechnology is the Vitamin

Technologies' vs. Wisconsin Alumni Research. The suit involves the validity and infringement
of three patents issued to Dr. Harry Steen bock of the University of Wisconsin, who transferred
his interest in them to the plaintiff, Wisconsin Alumni Research Foundation of Madison,
Wisconsin, a non-profit affair, which was organized in 1925 for the purpose of promoting
scientific research at the University in assisting the development of inventions and discoveries
made by the faculty and students of the University. The defendant Vitamin Technologists is a
corporation organized under the laws of the State of California, and the defendant H.F.B.
Roessler is a director and officer of the defendant corporation.
The first patent entitled 'Antirachitic Product & Process 'was issued August 14, 1928,
on an application of Harry Steen bock on June 30, 1924. The second patent entitled
'Antirachitic Product Essence and Process', was issued August 9, 1932, upon an application of
Harry Steen bock, filed December 27, 1926, and is stated therein to be a continuation in part
of the first patent, and the third patent entitled 'Anti-rachitic Product and Process,' was issued
October 13, 1936, on application of Harry Steen bock filed May
14, 1932. The first patent contained claims directed to the process of imparting anti- rachitic
properties to organic substances of dietary value which comprises subjecting the same to the
action of ultra violet rays such as are produced by a quartz mercury vapour lamp for a period
sufficient to effect anti-rachitic activation but seems to be so limited as to avoid subsequent
substantial injury to the anti-rachitic principle.
The second patent contains claims directed to the process of producing a concentrated
anti-rachitically activated substance from substances rich in unsaponifiable Iipoids which
comprises separation and irradiation of unsaponifiable lipoids, such irradiation being effected
by subjecting the Lipoids before or after separation to the action of the ultra violet rays such
as emanate from a quartz mercury vapour lamp for a period sufficient to effect antirachitic
activation and claimed to be limited so as to avoid subsequent substantial injury to the
antirachitic principle. It also contains claims directed to an activated edible compound
comprising an unsaponifiable lipoidol extract activated antirachitically in accordance with the

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process stated in claims, compounded with an inactivated edible substance. The third patent
contains claims directed to a process which comprises antirachitically activating yeast by
subjecting it to the action of artificially produced ultra violet rays for a period sufficient to
render the yeast antirachitically active.
The 9th Circuit Court of Appeals mentioned that it is a general rule that the
last step taken under a claimed discovery, which turns failure into success, is an invention and
is that which is sustained Dr Steen bock's discoveries concerned with the effects of sunlight
followed them up by inventing 'It new method by which to accomplish through artificial means
what sunlight could not do. The court ruled that prior to the Steen bock discoveries and
invention it was not known that ·it was possible to treat edible products with ultra violet rays
so as to make such product a preventive or cure of rickets, and such process was practical
through the use of sunlight, or that the ultra violet rays of the sun could not antirachitically
process medicine or food with any distinction as to selection of substances, or of intensity, or
of time, or that ultra violet rays of the sun could not practically impart the antirachitic principle
to medicine or foods as the only then recognized edible, antirachitic substance was cod liver
oil. It seems clear as the evidence demonstrates that the rays of the sun are not of the intensity
of rays such as are produced by a mercury vapour lamp and that it was man who made use of
artificially produced ultra violet rays which supplied the practical mechanical contrivance that
sunlight had not given, and no product is shown to have been activated by the sun left to itself.
Under most circumstances the scientists seem to realize that the amount of sunshine is
inadequate for the prevention or treatment of rickets and it becomes necessary to supplement
the diet of the infant with some special sources of vitamin D, so that such supplements of one
kind or another must be given in order to be assured of protection against the disease of rickets.
The principle of law is settled that if one has gone beyond the domains of discovery and
laid hold of a new force and connected it with some mechanical contrivance through which it
acts, it is entitled to secure control of it, for the existence in nature of a force that can 'be and
is used by man does not argue against invention unless the invention consists simply in
adopting the type of nature, unaided. It is the use that during patentability, the utilizing of a
law of nature by means of a method. The process covered by the patent is patentable if it is one
where, as said by Judge Lacombe, of the 19 Carnegie Steel Company v. Cambria Iron
Company. C.C., 112 F. 1009.

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 The court also recognized the principle that a natural force is not the product of inventive
skill, but points out the distinction in method for its direction as the patent there did not follow
up the discovery by inventing some new process or method that contrived for its direction, but
recognized the principle urged by plaintiff that 'not until some new instrument or method is
contrived for its direction towards ends which it cannot naturally accomplish does his creative
genius manifest itself’.21 The Court there reached the conclusion that the invention covered a
process of nature, the facts are distinguishable from the present inventions as the present
discoveries which concerned with effects of sunlight were followed up by the use of artificial
means for producing ultra violet rays which sunlight did not and could not perform, patent
protection allowed.

6.4 Essentials of Patent in Biotechnological inventions

6.4.1 Novelty
Novelty is not defined in the patent law of India under section 2(1) (i). But invention is
defined as new product or process involving an, inventive step and capable of industrial
application. The Indian Patent Act, defines inventive step under section 2(1) (I) (a) but it does
not defines the term novelty. Still the understanding of the term can be extracted with the help
of anticipation under chapter VI of Patent Act, 1970 according to section 3 also few subject
matters are not novel or new, such as discoveries and findings of a living or substance occurring
in nature are considered as not new and do not constitute an invention. Further plants, animals,
and essentially biological processes are not considered new and do not constitute an invention.
However micro-organisms are considered, new and can be patented. Human genetic
material in isolated and purified form is also considered new invention. For the first time in
the history of Indian patent law a living process was claimed for patent in Dimminaco A.G. V.
Controller of Patents 53. The process was useful in preparation of a vaccine against infectious
disease in poultry. The applicants contended that the process was new and was patentable. The
patent office ‘initially rejected the patent on the ground that it was a living process, which was
not new and the same did not constitute invention. In appeal the Kolkata high court held that
there is no bar in the patent law to patent a new living process or living product. The High
court accepted the contention of the applicant that the claimed living process is new and
directed the patent office to grant patent on the invention.
In the light of the TRIPs agreement considering biotechnological inventions as new, India
being a signatory to the agreement, amended its patent law to implement the agreement. Now

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with the amendments to the patent law biotechnological inventions, both product and processes
are considered new. There was no strong debate in India unlike in the USA on the novelty of
biotechnological inventions. As the matter is settled in developed countries like USA and EU
that biotechnological inventions are novel over and above the pre-existing biological products
there was no difficulty for India to follow suit.

6.4.2 Inventive step

Patents are granted for inventions involving an inventive step was defined as 'a feature
that makes the invention not obvious to a person skilled in the art'. Any new product or process
that involves an inventive step is patentable in India. The patent law provides that when an
application for patent is made, the patent examiner, will have to conduct an investigation to
find the relevant prior art. If in the investigation it is found that the invention has been
anticipated by publication in India or elsewhere before the date of the applicants filing of the
complete specification, the patent shall not be granted. In such circumstances the invention
falls within the realm of prior art, the knowledge in the public, domain involving no inventive
step. Such knowledge in the public domain being obvious to a person skilled in the relevant
art shall not be 'given patent. The requirement is no different with reference to biotechnology
inventions. However, there is no substantive case law development with regard to inventive
step in the biotechnology inventions in India.
For the first time in India inventive step involved in a biotechnology invention had come
before the courts in Dimminaco A.G. V. Controller of Patents 54. The Kolkata High court was
confronted with a question whether the claimed invention relating to a process for preparation
of infectious bursitis vaccine did involve inventive step and whether the claimed subject matter
constituted invention under the Indian Patent Act, the vaccine was useful for protecting poultry
against contagious bursitis infection. The inventors contended that the process claimed
involved certain chemical steps under specific scientific conditions. The patent office initially
rejected the patent application by stating that living virus or living process did not constitute
invention under the Indian patent Act. However, the Kolkata High Court held that there was
no statutory bar to patent living processes or product that involved inventive step.
In the instant case the process claimed did involve certain inventive step, as it required
certain chemical steps to be taken in the production of the Vaccine. The High court directed
the patent office to grant patent on the claimed process.

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 Therefore as per, the decision of the Kolkata High Court a biotechnology invention
involving a new process or product could be patented if it involved an inventive step. Further,
as per the patent law if the invention was anticipated in the prior art or, is published, used, or
patented, it did not involve an inventive step. In case of biotechnology inventions also the
claimed invention did not constitute an inventive step if it was anticipated or published or used
or patented earlier or in any way formed part of the prior art.
However, in Indian patent law the term 'prior art' is used or defined; the situation is same
in USA also. The EPC used the term 'state of the art' which is Dr.Sreenivasulu N.S and Dr.
Raju.C.B, "Biotechnology, and Patent Law", Manupatra Information Solutions pvt, Ltd,
Noida, First edition 2008 p.94.
Equivalent to prior art and states that state of the art comprises 'everything that is made'
available to the public by means of a written or oral description or by use' in any other way
before the date of filing of the European patent application. The USA patent law, the EPC and
the patent law in India state 'that any invention which is known or published or patented, being
part of the prior art, is obvious and does not involve inventive step. Therefore, an invention,
which is part of the prior-art, does not involve inventive step and is not patentable. The
invention shall be a leap forward from the state of the art or it shall be a step forward from the
already existing knowledge that is prior art. It shall be an advancement of existing knowledge
in the, public domain. It implies that courts while determining the obviousness of any invention
shall have to consider the scope of the prior art. In fact, law courts have taken into consideration
the knowledge in the public domain or the state of the art in deciding the obviousness of an
invention, the presumption is that on the basis of prior art, it an invention becomes obvious to
the person having skill in the relevant art, such' invention does not constitute an inventive step
and must not be patented.

6.4.3 Utility
The patent law states that any new product or process involving inventive step and
capable of industrial application does constitute an invention and is patentable. The expression
'capable of industrial application in relation to an invention' means that the invention is capable
or being made or used in all industry. The requirement of industrial application of inventions
in India is no different from the industrial requirement of Europe or USA or elsewhere of the
globe. However is no substantial case law development with regard to the industrial application
of biotechnology inventions in India as the industry is in' an infant stage.

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 In Dimminaco AG Vs controller of patents for the first time, utility of a biotechnology
invention was demonstrated. The invention related to a process for preparation of infectious
bursitis vaccine. The vaccine was useful for protecting poultry against contagious bursitis
infection. Initially the patent office rejected the patent application on the ground that the claim
did not constitute an invention. But the utility of the invention was not disputed.
The inventions of biotechnology are very much useful in different sectors, specifically
and substantially. Biotechnology is being vastly used in different sectors such as agriculture,
medical, chemical industry, animal husbandry, and many others. Biotechnology has brought
innovative medical treatments and surgical procedures that are useful to the society.
Biotechnology inventions are useful in treating pollution, poultry, fisheries, forestry and others.
The technology is gaining enormous importance in present day life.

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CHAPTER VII

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 CONCLUSION AND SUGGESTIONS

The history of mankind is replete with different revolutions. The progress of society is
influenced by different technologies. Ranging from industrial revolution and electronic
revolution till the information technology revolution, mankind has aptly tackled these
revolutions, In fact, society at largo has been very much influenced by this technological
revolution called biotechnology. This technology is a culmination of human invention and
natural processes. No doubt biotechnology is not new but exists since ancient times. In those
days fermentation technology was used to produce and preserve goods for a long time. With
addition of genetic engineering or recombinant technology the same fermentation technology
is now called biotechnology. In fact, it is genetic engineering which is capable of manipulating
living organisms and of making such organisms to perform and function in a way different
from the natural ones. Because of genetic engineering, biotechnology is called the technology
of modem-day miracles. Perhaps, biotechnology proved itself to be in the field of miracles
when it produced genetically modified or non-natural living organisms.

Ever since a genetically engineered micro-organism was granted patent in 1980 in the
US, the field of biotechnology gained enormous significance. Patent on genetically engineered
micro-organism was followed by patent on genetically engineered plant, animal, and
engineered human genetic material. Today, biotechnology is capable of producing even a
genetically engineered human being. When patent was granted on genetically engineered
microorganisms for the first time, nobody thought that biotechnology could manipulate either
plant or animal or human being. Further, none thought of the need for evolving a
comprehensive law on biotechnology for regulation.
However, the progress and development in the field of biotechnology mandated a
comprehensive legal framework for proper regulation, the result being various
pronouncements of the law courts, legislations at municipal and conventions at international
level. With the coming into being of the Trade Related Intellectual Property Rights (TRIPs)
agreement, protection of various inventions of biotechnology and regulation of biotechnology
has become a complete reality. This thesis gives an idea about the genesis of biotechnology
with its historical developments. Biotechnology has developments. Biotechnology has
developed in various generations at different point of time. Its progress has been expanding in
scope and significance. Today, there is no field where the significance of biotechnology is not

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felt. Biotechnology has become part of modern-day life. Having recognized the significance
of biotechnology and its inventions, there is a need to regulate it with proper means under the
patent regime. The evolution of patent law on biotechnology dates back to the 1960s and the
1970 when patents were claimed on living beings. However, it was the decision of the US
Supreme Court in the Chakrabarty's case which laid the foundation for the patent law on
biotechnology. Now a complete and comprehensive frame work of patent law on
biotechnology, is available thanks to various court decisions followed by international
agreements and municipal legislations. This thesis attempts to probe into the evolution of
biotechnology patent law. There is no doubt that biotechnology inventions could be granted
patent like any other inventions. However, given the complexity of manipulating living beings,
granting of patent on biotech inventions is given much attention. Since an invention that
involves genetically modified living beings may not satisfy the regular requirements of patent,
the issue has become debatable,
It is evident that as compared to USA, the patent law of the United Kingdom and
Europe are conservative when it comes to granting patents regarding biotechnological
inventions. This basically stems from the fact that the United Kingdom along with Europe
preferably would want to stick to the notion of not wanting to grant patents which would invoke
mixed reactions from various sections of the community, the same standpoint is taken by India
which also shares the same feeling. The Indian Patent Law too disallows the patenting of living
subject matter but draws an exception for the patentability of micro- organisms. This also
implies that the Indian patent law is also open to the patenting of genetic material and their
products too, provided they fulfil the criteria of patentability. However, the position of the
Indian law differs from the laws in UK in this respect that India does not allow the patenting
of animals as whole too. Accordingly, inventions relating to transgenic animals will not be
allowed protection in India.
It is quite apparent that the field of biotechnology is ever growing. However with the
increasing innovations in the field it has become quite essential that adequate amount of
protection is made available but at the same time respecting the constraints of the modem
society.
Currently, India regulates only single gear products. So far, the only GM crop
permitted for commercial cultivation in India is the Bt. cotton, which is resistant to the
bold worm. Similarly, countries such as Australia, china, Canada, New Zealand, Russia and
Taiwan regulate products at the single trait level, In the US it is not mandatory to produce
additional safety information on multiple trait products developed by conventional breeding

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if a single trait product is already approved and the traits are unrelated. In contrast, the
European Union considers every stacked trait product as novel or unique, regardless of the
status of the parent trait.
Biotechnology is capable of producing transgenic human beings but the same cannot
be allowed by sacrificing the ethical and moral standards. Producing a transgenic human being
and its patenting is considered highly immoral and unethical. Similarly exploitation of human
embryos and patenting the same is considered unethical. At the same time it is considered
unethical to alter the germ line genetic identity of human' beings. Modifying or sacrificing
the ethical considerations should stop at allowing patents on human genetic material. It should
not proceed further to produce and patent transgenic human being, which would be a gross
violation of ,social order and ethics. Ethics and morality should be used to balance and check
the development of biotechnology, In case of transgenic human beings and human embryos-
ethics overweigh potential benefits. But in the case of transgenic micro- organism, plant,
animal and human genetic material benefits of the invention overweigh ethics. Though
protection is assured to biotechnology inventions through patents, there is a need to
evaluate its merits and demerits. As patenting of biotechnology inventions is too complex
and raises serious questions, it would be pertinent to analyse its potential benefits and
merits on the basis of which patents art being granted undermining ethics. The merits or
advantages of biotechnology can be summarized as follows.

7.1 Merits of Biotechnology

a. Biotechnology is capable of producing high yielding. Pest-resisting and herbicide--
resisting crops
b. Application of biotechnology in animal husbandry resulted in animals with qualities
such as high yield of milk, wool, flesh and fast growth
c. Biotechnology produced innovative medicines, drugs, vaccines, cures, and surgical
methods. It is possible to cure even hereditary diseases through biotechnological
processes.
d. Biotechnologically produced animals could be used for testing new medicines, drugs,
and vaccines prior to the use of the same for human beings.
e. In the field of food and beverages the application of biotechnology resulted in
consumable foods with high nutritional values.
f. For the people who are in need of organs, biotechnology extends great help.

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 Organs produced through biotechnology could be transformed to the needy.
g. In the field of environment, biotechnology is promising to be helpful in combating
pollution and in maintaining ecological balance.
h. Infertile couples can have children through biotechnology-assisted reproduction.

i. Through cloning animals, plants, and other species could be conserved and preserved
in order to maintain biological diversity.

7.2 Demerits of biotechnology

The potential of biotechnology is undoubted but the other force of biotechnology is destructive
in nature. The potential benefits of biotechnology are many but at the same time there could
be some problems due to the misapplication or misuse of biotechnology. Misuse of
biotechnology may give rise to inventing destructive biological weapons. Biological agents
such as bacteria and virus may be misused for the purpose of producing biological weapons
for mass destruction. Micro-organisms with destructive qualities like heightened infection
efficacy may cause danger to the living beings. Using such micro- organisms for mass
.distraction, as biological weapons, will have destructive impact. Release of such micro-
organism, with ·infected diseases may cause 'danger to the health and environment. Further,
biotechnology may be misused to produce artificially created plants and animals to disturb
and destroy ecological balance in any particular locality. Even the irregular release of
transgenic organisms may disturb the safety and balance of the environment. In such
circumstances there may be a threat to the biosafety. Further, gross misuse of biotechnology
may result in procuring transgenic human being, which is a gross violation of public order and
morality. Society has accepted transgenic micro- organisms, plants, and animals. But the same
society is not ready to accept transgenic human beings. The demerits and dangers of
biotechnology could be summarized as follows.

a. One important disadvantage of biotechnology is that it causes sufferings to animals

in manipulating them.
b. The results of many of the biotechnology methods and processes have no
guarantee but are doubtful as the success rate of biotechnological methods like
cloning is only 15 percent
c. The application of biotechnology may result in too much control of living beings

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 and biological processes giving rise to health hazard in plants, animals, and
human beings and also environmental risks.
d. Suppressed or removed genes through biotechnology may result in mutation and
extinction of genes disturbing ecological balance. Further, transferred genes may
jump into other species, giving rise to unforeseen problems.
e. The irregular release of genetically modified organisms into the environment may
result in unforeseen and irreparable consequences.
f. Biotechnology may be misused in producing biological weapons by using micro-
organisms like bacteria and viruses with destructive genes, which may release
harmonious gases when expressed.
g. The ethics and morality of biotechnology inventions are frequently questioned and
vehemently opposed.

After a thorough study of biotechnology and law, particularly focusing on patenting of life, a
few inferences could be drawn by the evaluation of the law relating to patenting of
biotechnology, inventions and the investigation into the patentability of biotechnology
inventions have resulted in a few findings. Further, an inquiry into· the granting and
maintenance of biotechnology patents and the examination of the enforcement of
biotechnology patents resulted in certain findings Similarly the probe into the ethics involved
in patenting biotechnology inventions resulted in specific findings. On the whole the findings
can be summarized as follows

a. The evolution of patent law on biotechnology inventions is not smooth but confusing.
b. There is a need to streamline the same with necessary adjustments in the existing law.
c. The judiciary, which was active in the evolution of biotech patent law, gave liberal
and sometimes unforeseen interpretation of the law.
d. The regular requirements under the existing patent law have been relaxed to extend
patent protection to biotechnology inventions.
e. The patent procedure, especially in India, is cumbersome. In the USA it takes one-
and-a-half year to grant a patent; in Europe it takes three years; but in India it takes
more than five years to grant a patent for which procedure requires to moderate.
f. The enforcement mechanism of biotechnology patents is finding difficulty in
disposing of biotechnology patents infringement suits because of the complexity and
technical nature of the biotechnology inventions.

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 g. The provision for granting compulsory license of biotechnology patents is not
uniform in the states and the TRIPs agreement provisions are not mandatory on the
member states in granting compulsory licenses.
h. There is a possibility of misusing the potential of biotechnology in producing
destructive biological weapons against social order.
i. There is a possibility of producing a transgenic human being by abusing
biotechnology in violation of public order and morality, Doubts exist that given the
potential of the biotechnology transgenic human beings might already have been
produced.
There is always some scope for improvement and there will always be a margin for
developments. Likewise, the law relating to biotechnology and patenting of life could be
strengthened and streamlined by adopting certain modifications. On the basis of the findings
of research work the following suggestions can be made which, if adopted, will bring the
existing law in turn with the latest developments in the field of biotechnology. The suggestions
may be adopted for the proper regulation and management of biotechnology inventions.

7.3 Recommendations

a. The fluctuating approach of the judiciary may be put to a break by removing

ambiguity in laws with reference to the patenting of biotechnology inventions.
b. As patenting of different biotechnology 'inventions is universally accepted except for
transgenic human beings, the local laws may be modified and streamlined by
providing for specific exclusions and prohibitions in the light of the ethical and moral
standards of the society.
c. A universal declaration or convention on the prohibition of transgenic human being
and cloning of human beings for reproductive purposes as a whole may be adopted.
d. The time period for patent grants in India should be reduced. The procedure should
be amended to grant patent at least within three years, by keeping in mind the dynamic
nature of biotechnology where changes take place rapidly. Further, in case of
pendency of any patent application for more than three years before the patent office,
due to the reason of delay in the office of due to the pendency of opposition
proceedings or due to the pendency of appeal proceedings, the domestic laws may be
amended to adjust the patent period accordingly.

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e. Taking the complexities involved in the field of biotechnology and difficulty in
processing and patenting of biotechnology inventions into consideration there
f. Should be an expert committee in the patent offices to assist and advise in assessing
and evaluating the patent applications claiming biotechnology inventions.
g. In the light of technical nature of the biotechnology inventions the enforcement
mechanism may take assistance from expert committees in adjudicating and enforcing
biotechnology inventions.
h. The TRIPs agreement can be "amended to mandate compulsory licensing of
biotechnology inventions on the satisfaction of certain conditions. The word may in
the provision providing for compulsory licensing can be replaced with the word 'shall'
to mandate the granting of compulsory licenses of inventions on the part of the
member states on satisfaction of necessary conditions, such as public emergency or
to meet the public interest.
i. In view of the patent protection to biotechnology inventions and in respect of the
release of genetically engineered organisms into the environment there shall be some
universally applicable biosafety mechanism addressing the dangers posed by the
inventions of biotechnology to ensure safe production, storage, transfer, release, use,
and exploitation. For this purpose necessary amendments can be made to the
convention on Biological Diversity CBD) specifically addressing safety in
biotechnology research.
j. Given the potential of biotechnology in producing biological weapons there can be an
amendment In the CBD to prohibit misuse of biotechnology and production of
biological weapons to guarantee ecological balance and biological diversity.

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BIBLIOGRAPHY

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 1. Bainbridge David I, "Intellectual Property", Person Education (Singapore) Pvt. Ltd,
Singapore 2002
2. Charles E.R.Rickett, Graeme .W. Austin, "International Intellectual Property" and the
Common Law World", Oxford-Portland Oregon, Hart Publishing Ltd, England, 2000.
3. Donald S. Chisum, "Chisum on Patents", Lexis Nexis group Matthew Bender &
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4. Elizabeth Verkey, "Law of Patents", Eastern Book Company, Lucknow, India, 2005,
5. Graham Dutfield, "Intellectual Property Rights, Trade and Biodiversity: Seeds md
Plant Varieties", Earth scan publications Ltd. London UK, 1999.
6. Graeme B Dinwoodie, William O Hennessey, and Shiras Perl mutter. "International,
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New York, USA, 2002,
7. Graham Dutfield, "Intellectual Property Rights and the Life Science Industries A
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8. Graeme B Dinwoodie, William O Hennessey, and Shiras Perl mutter, "International
Intellectual Property Law and Policy", Lexis Nexis group Matthew Bender & company
Inc. New York, USA, 2001.
9. Jennifer Peloso, "Intellectual Property", H. W. Wilson Company, USA 2003.
10. Johanna Gibson, "Patenting Lives-Life Patents, Culture and Development", Journal of
intellectual Property Rights, Vol. 11, March 2006, PP103-112.

Websites
1. http://www.agbioworld.org
2. http://www.indiatogether.org
3. http://www.csdms.org
4. http://www.books.nap.edu
5. http://www.wto.org
6. http://www.wipo.org
7. http://www.westlaw.com
8. http://www.jstor.org
9. http://www.manupatra.com

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