DR.

BABASAHEB AMBEDKAR MARATHWADA UNIVERSITY,

(AURANGABAD), CHHATRAPATI SAMBHAJINAGAR,
MAHARASHTRA

DEPT. OF POST GRADUATE STUDIES IN LAW.

MANIKCHAND PAHADE LAW COLLEGE
AURANGABAD

NON DOCTRINAL RESEARCH

ON
BIOTECHNOLOGICAL PATENT

Under Guidance of

PROF. SIVAKUMAR KOMARAGIRI

Submitted by

Adv. PRATEEK SUBHASH JADHAV

[LLM SECOND YEAR – 3rd SEMESTER]
[Business Law Group]

2023-2024
 ACKNOWLEDGEMENT

This research would not have been possible without the scholarly and timely guidance of my
research guide Prof. Sivakumar Komaragiri and his constructive criticism as well as
encouragement. I owe him my heartfelt gratitude for shaping the character of this study and
for allowing me to research this topic, an Endeavour which could only have been permitted
by an enthusiast of Business law with a sincere desire to promote scholarly research in the
sphere of Biotechnology Patent. Thanks to the teaching and non-teaching staff of the
Department of Post-Graduate Studies in Law for their co-operation and assistance.
DR.BABASAHEB AMBEDKAR MARATHWADA UNIVERSITY, (AURANGABAD),
CHHATRAPATI SAMBHAJINAGAR, MAHARASHTRA

DEPT. OF POST GRADUATE STUDIES IN LAW.

MANIKCHAND PAHADE LAW COLLEGE
(AURANGABAD) CHHATRAPATI SAMBHAJINAGAR

CERTIFICATE

This is to certify that the Non-Doctrinal research entitled “BIOTECHNOLOGICAL

PATENT” has been prepared and submitted by Adv. PRATEEK SUBHASH JADHAV
under my supervision and guidance. In my opinion, the non-doctrinal research is the original
work completed after careful research, survey conducted by him & analysis of the available
literature and relevant data.

Place: Aurangabad
Date: / /
PROF. SIVAKUMAR KOMARAGIRI
 DECLARATION

I hereby declare that the contents of this research report, titled "BIOTECHNOLOGICAL
PATENT” submitted to the Dept. of Post Graduate Studies in Law.Manikchand Pahade
Law College Chhatrapati Sambhajinagar (Aurangabad) is the outcome of my bona fide
research work, carried out under the guidance of Prof. Sivakumar Komaragiri, I have duly
acknowledged all the sources from which the ideas and extracts have been taken. To the best
of my understanding, this research report is free from any copyright and plagiarism issues.

Place – Chhatrapati Sambhajinagar (Aurangabad)

Date:

SUBMITTED BY-
Adv. Prateek Subhash Jadhav
LL.M. – 2nd Year / 3rd Semester
[Business law group]
2023-2024
 INDEX
SR.NO CHAPTER

CHAPTER 1 INTRODUCTION TO IPR

1. Legislation
2. Trademarks
3. Domain names
4. Copyrights
5. Designs
6. Geographical indications
7. Patents
8. Condition for Patenting
i) Novelty of the patent
ii) Inventive Step
iii) InduPstrial Application

CHAPTER 2 TYPES OF PATENTS

1. Utility Patent
2. Design Patent
3. Plant Patent
4. Animal patent

CHAPTER 3 Biotechnological Patents

CHAPTER 4 PATENTING IN BIOTECHNOLOGY

CHAPTER 5 GOVERNMENT POLICIES IN PATENTING

CHAPTER 6 INTERNATIONAL CONVENTIONS

CHAPTER 7 BIOTECHNOLOGICAL INNOVATIONS PATENT

1. Filing a Patent Application in India

CHAPTER 8 QUESTIONNAIRE

CHAPTER 9 DATA ANALYSIS

CHAPTER 10 CONCLUSION AND SUGGESTION

 CRITICAL ANALYSIS ON
BIOTECHNOLOGICAL PATENT

GENERAL INTRODUCTION

• INTRODUCTION:

In the year 1919, an engineer from Hungary introduced the word biotechnology. It is derived
by combining two words biology and technology. Hence in the simple words we can say that
biotechnology is a technology which advances the biology. It gives us the knowledge about
the various products which can be used in the human life. Since last 5 decades the
biotechnology has advanced the other branches also apart from agriculture. It also raises
important policy questions.

We are going to see the biotechnology in India in detail in the further chapters.

• OBJECTIVE OF STUDY:

The object of the study of this research is to know that biotechnology is necessary in day to
day life.
 To analyze the policy factors of biotechnology inventions in India.
 To examine the scope of patenting biotechnology inventions in India.
 To formulate a guideline that will help in patenting biotechnological inventions.

RESEARCH PROBLEM:
Whether the bioinformatics products are patentable under the Indian Patent act?
What is the present position of Patent Law with regard to patenting the biotech inventions?
What is current position in USA, Europe and Japan with regard to the patenting biotech
inventions?
• RESEARCH METHODOLOGY:

In the present analysis, the research of biotechnology information is carried out with the help
of various biotechnology information resources, legal scope of protection to biotech with the
help of patent and bio informatics means.

Definition of Research:
The term ‘research’ is derived from a French word ‘recerch’ meaning to ‘to search’and a
Latin word ‘circare’ meaning ‘to go round in a circle’.
In research
–
‘R’ stands for ‘rational way of thinking’
‘E’ stands for ‘expert and exhaustive treatment’
‘S’ stands for ‘search for solutions’
‘E’ stands for ‘exactness’.
‘A’ stands for ‘analytical analysis of adequate data’
‘R’ stands for ‘relationship between facts and theories’
‘C’ stands for ‘(a) constructive attitude; (b) critical evaluation; (c) condensed and compactly
stated generalization; (d) cautious and careful recording’.
‘H’ stands for ‘honesty and hard work in all aspects of the treatment of data’.

Various definitions as stated by the jurists are as follows:

Manheim, says “research is the careful, diligent and exhaustive investigation of a specific
subject-matter, which has its aim the advancement of mankind’sknowledge.”1

Redman and Mary defines research as “systematized efforts to gain knowledge”.2

Lundberg says “research is a method sufficiently objective and systematic to make possible
classification, generalizations and verification of the data observed”.

1
Dr. S.R. Myneni, “Legal Research Methodology” 2 (Allahabad Law Agency, 5th ed. 2012)
2
ibid
Cook defines “research is a careful enquiry or examination in seeking facts or
Principles and diligent investigation to asserting to something”.

According to Webster’s International Dictionary, “research is a careful, critical

inquiry or explanation in seeking facts or principles; diligent investigation in order toascertain
something”.

According to Encyclopaedia Britannica, “research is an act of searching into a matter

closely and carefully, inquiring directly to the discovery of truth and in particular the trained
scientific investigation of the principles and facts of any subject,based on original and first-
hand study of authorities or experiments. Investigation ofevery kind which have been based
on original source of knowledge may be styledresearch and it may be said that without
‘research’ no authoritative works have beenwritten, no scientific discoveries or inventions
mades, no theories of any valuepropounded...”

Importance of Research:3
The research can be very important for a researcher. Importance of research can belisted
below as:-
 To discover answer to the questions
 To find out the truth which is hidden and yet not discovered.

 To gain familiarity with a phenomenon.

 To portray accurately the characteristics of a particular, individual situations or a group.

 To determine the frequency with which something occurs or with which it is associated
with something else.

 To test the hypothesis of a causal relationship between variables.

3
3 C.R. Kothari and Gaurav Garg, “Research Methodology, Methods and Techniques” 2 (New Age
International Publishers, 3rd ed. 2014)
 HYPOTHESIS:

 Definition of Hypothesis:
 Hypothesis can be divided in to two halves i.e. ‘hypo’ means less than and ‘thesis’ means
idea or general opinion to be defended by a person. Hypothesizes the tentative solution
which is proposed to the research problem by the researcher.

 George A. Lundberg says a hypothesis is a tentative generalization, the validity of

which remains to be tested. In its most elementary stage the hypothesis may be any
hunch, guess, imaginative idea which becomes the basis for action or investigation.

 Werkmeister says the guesses he makes are the hypothesis which either solve the
problems or guide him in further investigation.

 Goode and Hatt says that hypothesis is a proposition which can be put to test to
determine its validity.

 According to Webster’s International Dictionary, hypothesis is a Proposition,

condition or principle which is assumed perhaps without belief, in order to draw out its
logical consequences and by this method to test its accord with facts which are known or
may be defined.

Hypothesis of the Non-Doctrinal:

Biotechnology has become an advanced branch in India in last 10 years. But Indian Patent
practice is still not well settled regarding the biotech patents. Even after completing several
years of TRIPS there are still issues occurring regarding biotech inventions.
The Doctrinal Method
It Includes all international laws, international Conventions, Intellectual Property and study
through reasoning by referring to article, books, journals, case laws, website.

The Non-Doctrinal Method

It includes questionnaire and data collections, articles of several authors on the Judicial
Decision of the Biological Patent.

Sample Questionnaire
The researchers herin have opted to collect data of the people belonging to different units of
age group as indexed.

REVIEW OF LITERATURE:

1) Nikolaus Thumm, Swiss Federal Institute of Intellectual Property, Research and

Patenting in Biotechnology. The report of Thumm presents the result of a survey to
hold a public consultation regarding the preliminary draft of the partial revision of the
patent law.
2) Kima Uche, Biochemistry 118Q: Genomics & Medicine, Genomics & Patents:
Human Heritage At The Cost Of The Innovations. Kima Uche attempted to illuminate
some of the bioethical dilemmas surrounding genetic patents and offered some insight
of the solution proposed by the notable figures and the bioethical dilemmas.
3) Mircea Achiriloaie et.al, originally published in the Suffolk University Law School
Journalof High Technology Law. The authors threw some lights on the necessity of
the critical IP Laws with regard to patenting modern biotechnology inventions.
4) HUGO Intellectual property committee statement on patenting of DNA sequences.
This report is based on the study of patenting development in the area of genomics
and has analyzed its possible impacts specifically on the future of the genomic
research.
5) Sharma, Manju and K.K. Tripathi. 2000b. “Excellent Opportunities in India’s
knowledgebased Biotech Industry”. US-India cooperation in scientific research aiding
entrepreneurs in accelerating velocity of revolution in fast-growing biotech industry.
6) Sharma, Manju and K.K. Tripathi. 2000a. “ 21st Century belongs to Biotechnology”.
Nowadays most of the invents are taking place under the biotechnological system or method
so this century belongs to the biotechnology.

 SCHEME OF CHAPTERISATION:

Chapter I deals with the introduction to the IPR in a wider sense including its legislation,
trademark, copyright, designs, geographical indications, patents and conditions for patenting.

Chapter II deals with the types of patents including plant patent, animal patent and
utilitarian patent along with the topic of biodiversity and biotechnological patents.

Chapter III deals with the biotechnological patents along with its chronology and its IPR
issue and the R&D department in the contribution for the biotechnological inventions and
patents.

Chapter IV deals with PATENTING IN BIOTECHNOLOGY

Chapter V deals with the government policies in patenting it includes some of the policies
regarding the patents which the government has provided.

Chapter VI deals with the international Conventions such as TRIPs, WTO, WIPO and the
biotechnological patents aspects within the ambit of these conventions.

Chapter VII deals with the Biotechnological Innovation Patent

Chapter VIII deals with the Questionnaire

Chapter IX deals with Data Analysis

Chapter X deals with the conclusion and Suggestion regarding the topic

CHAPTER I
 INTRODUCTION TO IPR
Intellectual property rights are the rights given to person over the creation of their minds and
gives the inventor and limited right over the use of his creation for certain period of time.
Intellectual property broadly means the legal rights which results from intellectual activity in
the industrial, scientific, literary and artistic field. Countries have laws to protect intellectual
properties for two main reasons. One is to give legal look to the moral and economic rights to
the creator for his creation and the rights for the public in right to use those creations. The
second is to promote as the deliberate act of the government policy, creativity and
distribution and application of its result and to encourage fair trading which would contribute
to social and economic development.

Intellectual property right in India was imported from west. The Indian Trade and
Merchandise Marks Act, 1884 was the first law concerning IPR. The first Indian Patent Law
was enacted in India in 1856 followed by a series of acts being passed. They are Indian
Patents and Designs Act, 1911 and Indian Copyright Act, 1914. The Indian Trade and
Merchandise Act and Indian Copyrights Act have been replaced by Trade and Merchandise
Act 1958 and Copyright Act 1957 respectively.4

Intellectual properties and its rights attached there to have become the essential supplies and
are being severely protected. In recent years specially in last decade there are being several
numbers of cross border transaction witnessed by the world on large number of scale.
Companies who are carrying on business in several countries by selling and buying the items
or goods by the entities to the multiple locations across the world are called as cross border
transactions. Since IPR are country specific, hence it is necessary to analyze the nature of the
protection given to IPR in each jurisdiction. Well known international trademarks have been
given protection in India in the last few years even after knowing the facts that they are not
registered in India.

In 1948, the Indian government fixed the first committee to review the existing Patents and
Designs legislation. In 1957, Government appointed Justice Rajagobala Ayyangar Committee
4
www.iprlawindia.org 03/03/2021
(RAC) to modify the patent law. Rajagobala Ayyangar Committee submitted its first report
on 1959, the report tried to balance the constitutional guarantee of economics and social
justice enshrined in the preamble of the constitution.

LEGISLATION:
The Trade and Merchandise Act,1958 (TM Act, 1958) has been replaced by the Trademarks
Act, 1999, The Copyrights Act, 1957 has been amended to protect computer programs as
“literary works”. The Patents Act, 1970 has been amended by the Amendments Act of 1999,
2002 and 2005. The Design Act of 1911 was amended by the Designs Act, 2000.

The following acts have been enacted to protect the IPR’s in India:
• • The Geographical Indications of Goods (Registration and Protection) Act,1999.

• • The Semiconductor Integrated Circuits Layout Design Act, 2000.

• • The Protection of Plants and Varieties and Farmers Rights Act, 2001.

• • The Biological Diversity Act, 2002.

These acts are enacted and amended particularly.

TRADEMARKS:
In India, trademarks are protected both under statutory law and common law. The Trade and
Merchandise Act, 1940 was the first law in India which was replaced later by Trademarks Act,
1958. The Trademarks Act,1999 which replaced the Trademarks Act, 1958 came into force on the
September 15, 2003. The TM Act allows for the listing of service marks and three dimensional
marks as well. India follows the nice classification of goods and services which is given in the
schedule to the rules under the TM Act.5

A trademark registry has been established for the purpose of the TM Act, 1940 which has
continued to function under the TM Act,1958 and TM Act. The trademark registry is under

5
Classes of Goods and Services: classes 35-45 covers services and classes 1-34 covers goods.
the charge of the Registrar of Trademark. The head office of the Trademark registry is at
Mumbai, and its branches are at Kolkata, Delhi, Ahmadabad and Madras. The territorial
authority of each office has also been located.

DOMAIN NAMES:
Indian court has been practical in granting orders against the use of infringing domain names.
Some of the cases in which ban against the use of the contradictory domain names has been
approved.

• • www.sifynet.com v. www.siffynet.com6

• • www.yahoo.com v. www.yahooindia.com7

• • www.rediff.com v. www.radiff.com8

These are few domain names which were causing conflict. In www.yahoo.com case it has
been held that the domain name server the same function as the trademark, and is not the
mere address or finding like the numbers on the internet, and therefore it is entitled to the
equal protection as that of trademark.

COPYRIGHTS:

The Copyrights Act, 1957 is supported by the Copyrights rules, 1958 is the governing law for
the copyright protection in India. Substantial amendments were carried out to the Copyright
Act, in early 2012. The Copyright Act provides that a copyright subsists in an original
literary, dramatic, musical, or artistic work, cinematographic films or sound recordings. 9
However, no copyright subsists in a cinematograph film if a large part of a film is an
infringement of the copyright in any other work or in a sound recording, if in making the
sound recording in the literary, dramatic, or music work, copyright in such work is
infringed.10

DESIGNS:
6
Satyam Infoway Ltd v. Sifynet Solutions Pvt. Ltd. AIR 2004 SC, 3540
7
Yahoo India v. Akash Arora (1999) PTC 201 (Del).
8
Rediff Communications Ltd v. Cyberbooth AIR 2000 Bom, 27
9
Section 13 of the Copyrights Act
10
ibid
Industrial designs in India are protected under the Designs Act, 2000 which replaced the
Designs Act, 1911. The Design Act has come in effect on May 11, 2001. The Design rules
are framed under the Design Act. The Design act incorporates the minimum standard for the
protection of the industrial designs, in accordance with the TRIPS agreement. It provides for
the international system of classification as per the Locarno classification. 11

As per the Design Act, “design” means only the feature of shape, configuration, pattern,
ornament or composition of lines or colors applied to any “article” 12 whether in two
dimensional or three dimensional or in both forms, by any industrial process or means,
whether manual, mechanical, or chemical, or separate or combined, which in the finished
article appeal to and are judged solely by the eye. However “design” does not include any
mode or principle of construction or anything which is in substance a mere mechanical device
and does not include any trademark13 or property mark14 or any artistic work15.

To obtain the registration for the design one must apply design to the article. In other way a
mere painting or a natural scene on paper will be not considered as design for registration
under the Design Act, 2000.

GEOGRAPHICAL INDICATIONS:

Geographical indication (GI) means the goods which are identified as an originating where a
given value, status or other uniqueness of the goods are basically attributable to the
geographical origin. Well known examples of GI are ‘Bordeaux’, ‘Champagne’ and
‘Chiante’ the first two indicated the regions in France and the third one indicate the region in
Italy and these all are famous for their wines.

In India, ‘Darjeeling Tea’ was first registered as GI under GI Act, it is registered under the
Tea Board of India which also includes the GI registration for ‘Nilgiri Tea’ and ‘Assam Tea’.
Coffee board has a registration for ‘Malabar Coffee’. ‘Kashmiri Pashmina’, ‘Feni’, ‘Mysore
Silk’, ‘Lucknow Chicken Craft’ etc. are the examples of GI.
11
www.wipo.int
12
Section 2(a), of Design Act:”article” means any article of manufacture and any substance, artificial, partly
artificial and partly natural, and includes any part of an articlecapable of being made and sold separately.
13
Section2(1)v of Trademarks and Merchandise Act,1958
14
Section 479 of IPC
15
Section 2(c) of Copyrights Act, 1957
The GI Act,1999 was on effect on September 15,2003, which was having an aim to protect
the GI of the particular regions which are famous for their products or creativity including
food stuff.

PATENTS
In India law governing for patent is the Patents Act, 1970. Along with India’s continuous
efforts with its commitment under the TRIPS this act has been amended thrice.

• • The Patents (Amendments) Act,1999 (first amendment)

• • The Patents (Amendments) Act,2002 (second amendment)

• • The Patents (Amendments) Act,2005 (third amendment)

The legislation is supported by the Patents Rule, 2003.

Well, not all innovations are invention in the Patents Act. The term ‘invention’ is defined
under section 2(1) (j) of Patents Act as “new product or process involving an inventive step 16
and capable of industrial application” 17. Therefore the aspects of novelty, utility and non-
obviousness are particularly included in the definition of ‘invention’.

Conditions For Patenting:

• Novelty of the patent:

16
Section 2(1) (ja) of the Patents Act
17
Section 2(1) (ac) of the Patents Act
If the invention is known or used by any other person or sold further for its application in
India or outside India then the applicant would not be entitled to the grant of the patent.
Patent application must be filed prior to any public use or publication of the invention. 12
months period is permitted in India for the application of patent. If the invention is being used
by the public in large amount of scale then the inventor or his descendants gets royalty for its
novelty by the particular state in which the invention has taken place. For example the bulb
and electricity is used worldwide therefore its inventor gets the royalty for its novelty.
Section 3 of the Patents Act deals with the innovations that are not inventions and which are
not patentable in the Patents Act.

• Inventive Step:

The invention is not obvious to a person skilled in the art in the light of the prior publication/
knowledge/ document.

• Industrial Application:

Invention should possess utility, so that it can be made or used in industry at the large scale
and which can be beneficial for others too.

CHAPTER II
TYPES OF PATENTS
Types: Patents protects inventions and new discoveries that are new and non obvious. There
are four types of patents: utility patent, design patent, animal patent, and the plant
patent.

Each type of patent has its own eligibility necessities and protects a precise type of invention
or discovery. It’s possible for one invention or discovery to have more than one patent
available for it.

For e.g.if a person invents an object and he wants to patent both the functional characteristic
and the design of the object. The inventor has to apply for two separate patents both the
utility and design patent.

Utility Patent:
It is the most common type of patent that people seek. This types of patents covers processes,
composition of matter, machineries and manufactures that are new and useful. Process
includes the method of doing something or technical process. Composition of matter includes
chemical composition or new mixture ingredients. Machine includes computers or anything
that are manufactured or made with new ideas or techniques.18

Design Patent:
Design Patent includes the surface ornamentation of an object which means shape and
configuration of an object. To get this patent the design must be inseparable from the object.
In order to protect the functional and the structural characteristic of an object one must also
apply for the utility patent.19

Plant Patent:

18
www.findlaw.com 04/03/2020
19
ibid
A plant patent is to protect the new and unique plants. There are few requirements to obtain
this patent i.e., a plant must not be a tuber propagated plant. The plant should not be found in
the unplanted state. And the plant can be asexually reproduced. Asexually reproduced means
instead of being reproduced by seeds it is reproduced by the way of grafting or cutting plant.
Because its proof that the patent applicant can replicate the plant.

Animal patent:
Animal patent is to protect the new species of animals. It includes the animal breeding in two
different species.

For e.g. liger= lion + tiger20

It is the huge species which was developed but the patent was not granted because this
species was dangerous to the human life if it gets aggressive and neither it can kill it because
it is against the right to life. But those animal species which are non dangerous to life can be
granted patent.

Plant Patent:
Although the topic of ‘Plant Variety’ can be an important right in the plant breeder’s right as
a principle subject matter of the protection but this subject matter is barred from the
protection under some of the national patent laws.

Patentability of various plants is not without difficulties. In other words opinions given on
possibility of the transgenic plants protection by plant breeding rights because they meet the
characteristic of the plant variety21, was not completely admitted by the doctrines.

The organization overseeing the protection of new plant varieties is referred to as UPOV (The
International Union for the Protection of New Verities of Plants)

Biodiversity

20
www.findlaw.com 04/03/2020
21
Official Journal of European Patent Office,1995 p-545
Biological diversity (biodiversity) is defined as the diversity of the life of earth, from genetic
diversity to the diversity of the animals and plant species to the diversity of ecosystem.22

Biodiversity management encompass all the activities planned to apply the objectives of the
Convention on Biological Diversity (CBD) including the Cartagena Protocol on Bio-safety
(CPB), and those activities whose in general impact helps to defend the sustainable lifestyles
of exaggerated populations.

The most important target group with regard to biodiversity are those population who are
directly dependent on the biological diversity. The network of possible partners ranges from
international organizations and public administrations to owners and users of administration.
Biodiversity products have obtained a commercial value and increasingly exchanged in
market at a good monetary value, due to which the shares in the national economy can be
judged.

In the Indian context, it is difficult to put a value on diversity as such because the marketable
product are of various kinds both legal and illegal e.g wood and non wood products from
forests which are legally exported as well as illegally exported out of country23.

Biotechnology:
Biotechnology is a gifted technology but also a motivation one. The word biotechnology was
first given in the 20th century by an agricultural engineer from Hungary, named Karl Ereky,
who explained it in such a way that the technology which include all such work by which
products are produced by the raw material with the aid of living organism. In the broad
concept the term “biotechnology” gives the technique applied to living organisms to produce or
design substance to apply it specifically.

CHAPTER III
Biotechnological Patents

22
Art. 2. CBD (Convention on Biological Diversity)
23
Babu, G.V.S; Arora ,S.(1999) Hotspots of biodiversity. New Delhi: Ministry of Environment and Forests.
P-4-5
A set of biological techniques developed through basic research and now applied to research
and product development.24 Biotechnology was based on the traditional knowledge in the first
generation in fermenting food, distillation of medicines, etc. biotechnology of the second
generation was based on the utilization of micro organism at the industrial level which
includes fermentation of antibiotics, production of vaccines for the epidemics like cholera,
typhoid, jaundice, etc. ‘Modern Biotechnology’ can also be known as the third generation of
the biotechnology, where the advanced molecular biology was taking place after the world
war second by including the rDNA techniques, Polymerase chain reaction (PCR), and cloning
method. The fourth generation of the biotechnology includes the information technology and
the nano technology.The rapid growth in the information technology particularly in
bioinformatics has played a huge role in application of modern technology in agriculture and
medicines. ‘Genomic era’ which is made possible by the use of computers to handle the
biological information can also be said as the bioinformatics.
Chronology25.
• 1919: first use of the term biotechnology.

• 1938: commercial use of bio pesticide begins in France.

• 1953: DNA was described as the double helical structure by James Watson and Francis
Crick’s.

• 1965: Harris and Watkins successfully fused mouse and human cells.

• 1981: A mouse first transgenic animal was created.

• 1983: First PCR technique is used.

• 1993: First creation of the Biotechnology Industry Organization.

• 1995: Gene therapy becomes the tool against cancer.

• 2001: The first complete map of genome of rice.

• 2003: Goldfish, the first biotech pet, hits the North American market.

Pharma and agro chemicals:

24
ACGT: Alliance for Cancer Gene Therapy
25
Guide to Biotechnology: Biotech Industry Organization 2005-2006
India is an important manufacturer of globally recognized high quality pharmaceutical
products and has become TRIPS and WTO compliant in GATT period. The trend of patent
grant has increased eventually but the companies who are having patents are very less as
compared to the pharmaceuticals companied in India. Foreign multinationals controls more
than 90% of the pharmaceutical companies. Drugs which were manufactured outside India
were imported for a higher cost in consideration. The Indian pharmaceutical company
remained import dependent till 1972, deeming post of drugs unaffordable.26

In the year 2013, the Indian pharmaceutical industry was the world’s third largest in the terms
of volume which was worth $10 billion.27 Biotechnology is used for pharmaceuticals and
drugs manufacturing through biological processes and this drugs are used to seem as the most
expensive but the best medicine till today. India had a product patent regime for all
inventions under the Patent and Design act,1911. In 1970, the government introduced the new
Patent act which excluded the pharmaceuticals and the agrochemicals products from
patenting.

R&D and IPR issues:

The ownership and utilization of intellectual property rights are the key factors in shaping the
success of any technological innovation introduced in the market that provide the means for
technological progress to continue, to be made and thereby support the competitiveness of
industry of the country. IPRs make it possible to develop strategies for dissemination and
transfer of technologies in such a way, which may provide maximum societal benefits. It is a
well-known fact that a country’s economic and social success is highest when different
members of society have a common understanding, clear division of labor and responsibility
with a common understanding for the shared societal values. The competent management of
IPRs is thus critical in providing the right incentives for continuing technological
innovations. The IPRs are thus helpful for new business opportunities and for value adding
knowledge-based industry. It is high time that India quickly adapts to the challenges posed by
a continuously evolving technological environment of the world.

26
IUP Journal of applied economics 2014; 13(1):47
27
A pre and post TRIPS analysis of India’s Pharmaceutical Industry, New Political Economy 2014;19(3); 384-
406
The regulatory mechanisms in IPRs have their own problems in the coming situation of
budding technologies especially in biotechnology. The regulatory reform-initiatives are
further required to update and sort out the problems in the new frontiers of IPR system. This
would give further competitiveness in other considerable economic sectors involving
copyright, geographical indications, right to information to the society, patenting, etc. The
patenting of new technologies, in the presently highly competitive environment provides the
most robust system in the IP protection. However, the biggest problem, which can be
mentioned, is the copying of technologies that is becoming more and more common with the
coming out of new technologies. For example, 60 per cent of all patented innovations are
imitated on an average within four years; the ratio of imitation time to innovation is on an
average of 70 per cent; the ratio of replication cost to innovation cost is on an average of
about 60 per cent. This is the reason with the advent of new technologies many business
houses decide to protect their product/process by other methods and the most common is
“non-disclosure” or not to protect their IP where the new technologies have a very short span
of life cycle. The most common example of non-disclosure is the case of Coca-Cola and
Pepsi who have never disclosed their formulations to anyone till today. At the same time the
innovative industries try to keep finding better ways to protect their IP.

Ironically, we are in a situation today when the market requirements drive the industry to
focus on short-term results while competitor nations are making significant investments in
science and technological innovations for long-term benefits. There is a strong requirement
for the management of culture, which could stimulate an understanding for research related
IP issues. In the coming situation of new technologies, a number of company bodies have
started their own R&D activities and the competitiveness of the industry is largely
determined by their ability to capture the economic benefits of scientific and technical
innovations through knowledge driven technologies in general and biotechnology in
particular. The arrival of new technologies has not only given huge benefits to society but has
also raised a number of issues in the protection of the intellectual property. Intellectual
Property.
Rights (IPR) on inventions in biotechnology have become a controversial topic of discussion
in present years, as such inventions cut across issues related to science and technology
policies, ethics and economics, etc. These issues are also directly related with the
complexities of international trade. With the use of modern biotechnology many complex
issues have spurred up in the IPR regime in general and patenting in particular. Several issues
are indeed complex. Since the inventions in biotechnology cut across various aspects related
to science & technology polices, polity of international trade, economic and ethical issues, the
business methods in biotechnology have gained more complexity. Why do we have to make
known ourselves with the science and issues surrounding modern biotechnology? There are at
least two reasons. The first has to do with the potential benefits that modern biotechnology
offers to humankind. The second reason why the knowledge of biotechnology is important is
that with more biotechnology-derived products being placed on the market, chances are that
these products will find their way into most countries, even those that do not use
biotechnology for commercial purpose, but have to pay heavily due to strong IPR protection.
A government needs to be familiar with modern biotechnology if it is too well regulate
biotechnological products and ensure the effects, unpleasant if any, on the environment,
human health, and social structures are properly managed, if not avoided. The European
Commission (2002) refers to modern biotechnology as the “next wave of the knowledge-
based economy” after information technology, and the “most promising of the leading edge
technologies.” However, developing countries should remember that the institutional and
economic environment within which modern biotechnology R&D is being conducted differs
significantly from that of Green Revolution technologies. The final was essentially the
prerogative of public research institutions and generous foundations. In contrast, the
application of modern biotechnology to agriculture is a competitive, commercial attempt in
which powerful private sector interests compete. Multinational companies in the seed,
agricultural, chemical, pharmaceutical and food-processing industries play a major role in
biotechnology research. Also, as a result of mergers and acquisitions in the past years, the
development of new biotechnology applications in agriculture has become increasingly
concentrated in the hands of a few companies. The foremost companies that currently operate
within the global markets are Monsanto, Syngenta and Pioneer
Hi-Bred. The Food and Agriculture Organization has pointed out that current transgenic crop
releases are still “very narrow” in terms of crops and traits and thus have yet to address the
special needs of developing countries. While some 200 crops are currently under field testing
in developing countries and other crop-trait combinations are being investigated, focusing
mostly on virus resistance, crop quality, and in some cases, tolerance to a biotic stresses,
many crops (e.g., vegetables) and traits (e.g., drought- and aluminum- resistance) important
to developing countries are still almost entirely neglected. There is a strong public awareness
that privatization of intellectual properties may have negative impact in all developing
countries on their agriculture and healthcare sectors followed by concerns in regional food
security. At present biotechnology is widely used for the manufacture of beneficial
recombinant products, diagnostic devices in animal and human health sector, genetically
modified products in agriculture sector, cleaner methods of fermentation based products for
industrial use, production of microbial consortia for the efficient distillation of environment,
etc. The coming situation would further see many more new and budding products and
processes like gene therapy, creation of artificial organisms, construction of artificial genes,
and many unknown things, etc. The next two years would witness how the developing
countries would deal with the definitions of patentable microorganisms, protection of other
living substances, distinctions between discoveries and invention, ethical issues in biological
inventions, and in the provisions for making deposits for patentable biological materials.
Genetic resources are the properties of the sovereign States to which they are indigenous.
Future accessions of such resources would require consent from the States. The Convention
on Biological Diversity (CBD) promulgates ensuring conservation and sustainable use of
biological diversity, and fair and equitable sharing of benefits from their consumption.
Supply and exchange of biological materials are expected to move across the national
boundaries through the material transfer agreements on the basis of authorized, mutually
agreed terms among States, and subject to authorized prior consent. Consequently, access
legislation and access authority for genetic materials of States would be in the making for all
the CBD member countries.
Under the circumstances, a proper IPR policy thus should be in place, which should strike a
good balance between the knowledge-drive technology products for the 30 country and the
industrial development issues, realizing that both of them could not be independent to each
other. The IPRs are the lifeline of the R&D based knowledge-based technology industry and
they encompass the right of corporate houses to have a chance of recovering their investment
and have a return on capital sufficient to safeguard the interest of the stakeholders. In the
emerging technologies the competitive edge will be a key driver for doing and enhancing
business, whereas the competitiveness is dependent on developing new and advanced
technologies. Thus, the technological innovations are facilitated by the IPRs. In a nutshell,
the innovation will be the main anchor for developing competitive edge in the business with
emerging technologies. The current market size of biotechnology products is reported to be
approximately US $ 1.5 billion and is predictable to grow to US $ 2.5 billion by the year
2005. This guess, however, includes hybrid seeds, tissue culture plants, fermentation derived
products including antibiotics, bakers’ and distillers’ yeast and biological cultures. The
current composition of biotech products is largely composed of therapeutics and diagnostics
products for human health care, industrial enzymes and contract research services. The
introduction of Bt cotton would provide boost for the agri-biotech products further. Thus, in
order to see the opportunities it is important to take cognizance of a number of global trends,
viz. 70 per cent of the products under clinical testing are rDNA products or gene based
products emanating from small and medium size companies; around 25 per cent of R&D is
outsourced by drug majors. The baseline revenues of CROs in 2000 were estimated at US $ 7
billion and are growing at 30 per cent per annum. Outsourced R&D is estimated to account
for 40 per cent of R&D expenditure by the year 2008. Approximately 20 per cent of the drug
revenues are paid out by the drug majors as royalties on licensed products and technologies.
The R&D expenditure of the top 20 Parma majors has more than doubled over the years, i.e.
from US $ 20 billion in 1995 to US $ 40 billion in 2000 and it is expected to increase
exponentially to more than US $ 100 billion by the year 2010. The genomics, proteomics and
other informatics-based research is expected to result in an exposition in the number of these
for drug discovery which will expand both opportunities and challenges for new drugs. This
would dictate the focus of research to disease subsets and differentiate treatments. The big
Parma majors will be forced to 31 cut R&D expenses and speed up R&D programmers
through collaborations and contractual R&D initiatives with smaller biotech companies and
CROs.
 CHAPTER IV
Patenting in Biotechnology

India is among the top 12 biotechnology destinations in the world and has the third-biggest
biotechnology industry in Asia-Pacific. India’s biotechnology industry is evolving rapidly
and growing at a compound annual growth rate of 20%. As per Biospectrum’s 11th annual
Indian biotechnology industry survey, the Indian biotechnology industry grew by 15.1% from
2012 to 2013, increasing its revenues to $3.81 billion. Further, the market size of the sector is
expected to increase to $11.6 billion by 2017. This rapid growth is attributed to a range of
factors, including heightened demand for healthcare services, intensive R&D activities and
strong government initiatives. India is a huge market for biotechnology products and services
due to its billion-plus population and increasing economic prosperity.

The domestic industry is now moving into innovation, with companies focusing on
strengthening their R&D development capabilities. In its 12th five-year plan, the Indian
government aims to spend $3.7 billion on the biotechnology sector, compared to $1.1 billion
in the 11th five-year plan. The Indian biotechnology industry can be divided into five key
segments: bio-pharmaceuticals, bio-services, bio-agriculture, bio-industrial and
bioinformatics. Bio-pharmaceuticals accounts for the largest market share, with over 60% of
the total revenues (see Figure 1).

Patent filing trends

The 2014 Indian Patent Office (IPO) annual report stated that approximately 43,000 patent
applications were filed between April 2013 and March 2014. Over 2,300 of these related to
biotechnology and other related fields (eg, biochemistry, microbiology, biomedical devices
and chemical or biological inventions related to traditional knowledge – see Figure 2).
Although the report indicates no criteria for patent selection in these fields, it gives a
preliminary indication of biotechnology patenting activity in India.
Although patent filing in India in general has increased in the last few years, biotechnology
patent filing has decreased (see Figures 3 and 4). This is consistent with the global trend.
Among other things, it could be attributed to more stringent criteria for patentability and
grant of patents in this domain.

Patentable subject matter

Under the Patent Act 1970, every invention must pass a two-step test in order to be patentable
– namely, it must:
• not fall in any of the categories specifically excluded under Section 3 of the Patent Act; and
• pass the well-known three-pronged test of novelty, inventive step and industrial
applicability.

The following are the excluded biotechnology-related inventions.

Section 3(b) – inventions contrary to public morality

Inventions for which the primary or intended use or commercial exploitation is contrary to
public order or morality or which cause serious prejudice to human, animal or plant life or
health or to the environment are unpatentable. Examples include genetic modification of
animals which results in suffering of the modified animal without any substantial medical or
other benefit, and inventions causing adverse environmental impact.

Section 3(c) – discoveries, things isolated from nature, plants and animals
Discoveries of living things or non-living substances occurring in nature are not patentable
subject matter. Thus, micro-organisms isolated from nature and DNA, RNA or proteins
isolated from living organisms are unpatentable. Although naturally occurring micro-
organisms are unpatentable, genetically modified micro-organisms and vaccines are
patentable, subject to other requirements. Synergistic compositions of new or known micro-
organisms can also be patentable, as can processes for isolating such substances. To remove
any ambiguity, the act was amended in 2002 to include “biochemical, biotechnological and
microbiological processes” within the definition of potentially patentable chemical processes.
In Dimminaco (2012) the court clarified that if the end product is a commercial and vendible
entity, the presence of the living organism in the end product cannot be a bar to the
patentability of the process.

Plants and animals or their parts – including seeds, varieties and species – are un-patentable.
Further, essentially biological processes for the production of plants or animals (eg,
conventional methods of plant breeding and tissue culture techniques) are also un-patentable.

Although the act does not define an ‘essentially biological process’, in Monsanto (2013) the
Intellectual Property Appellate Board (IPAB) provided some guidelines on what constitutes
one. The patent application under consideration claimed a method of producing a transgenic
plant. Although the patent application was rejected on other grounds, the IPAB overturned
the IPO’s objection that it was an essentially biological process. The IPAB agreed with
Monsanto’s submission that the plant cell in the claimed process was transformed as a result
of human intervention in the manner claimed in the application, and was therefore patentable.

Thus, although genetically modified plants or seeds are not patentable in India, processes for
the genetic modification of plants are patentable.

Further, a sui generis system for protection for plant varieties is available under the
Protection of Plant Varieties and Farmers’ Rights Act 2001.

Section 3(d) – new forms or uses of known substance

A new form of a known substance is unpatentable unless it differs significantly in properties
with regard to the known efficacy. This provision essentially prevents the evergreening of
patents through trivial modifications or incremental innovations. However, its interpretation
has been the source of polarising debate among legal professionals, academics, non-
governmental organisations and pharmaceutical companies.
The Supreme Court provided some guidelines for the interpretation of the scope of this
section in its well-known Glivec judgment (2013). The court observed that the provision sets
a higher invention threshold for medicines and drugs and other chemical substances. The
term ‘efficacy’ is not defined in the act. The court held ‘efficacy’ to mean “the ability to
produce a desired or intended result”. The efficacy test depends on the function, utility or
purpose of the product under consideration. Thus, a medicine will undergo a test for
therapeutic efficacy. A mere change of form of a chemical substance with properties inherent
to that form would not qualify as enhancement of efficacy of a known substance. However,
beneficial physico-chemical properties such as better flow-ability, process-ability,
thermodynamic stability and lower hygroscopicity have nothing to do with therapeutic
efficacy. Even increased bioavailability might not pass the test laid down by Section 3(d),
since it does not necessarily lead to an enhancement of therapeutic efficacy; whether it does
so in any given case must be specifically claimed and established by research data.

Under Section 3(d), the mere discovery of any new property or new use of a known substance
is also un-patentable. Therefore, a second therapeutic effect of a known drug is un-patentable.
In Monsanto (2013) a claim for a method of producing heat, salt and drought-tolerant
transgenic plants using cold shock protein was rejected under Section 3(d), since the cold-
tolerant property of cold shock protein was already known in the art.

Table 1. Section 3(i) unpatentable subject matter

Category Unpatentable example

Medicinal methods A process of administering medicines

orally, through injection, topically or
through a dermal patch.

Surgical methods A stitch-free incision for cataract removal.

 Curative methods A method of cleaning plaque from teeth.

Prophylactic methods A method of vaccination.

Diagnostic methods Identification of the nature of a medical

illness by investigating its history and
symptoms and applying tests.

Therapeutic methods Prevention and treatment or cure of diseases.

Methods of treatment to render animals free A method of treating sheep for increasing
of disease or increase their economic value wool yield.
(or that of their products)

Section 3(e) – mere admixture

The mere admixture of two or more previously known substances is un-patentable, unless it
is shown that the combinative effect of such substances is more than the sum of their
individual effects. In other words, such a combination should result in a synergistic effect.
The synergism must be properly demonstrated in the complete specification by providing
appropriate experimental data.

Section 3(i) – methods of treatment and diagnosis

The act does not prevent patenting of pharmaceuticals and medical devices. Thus, medicinal
compounds, drugs, formulations, stents, surgical sutures and staplers are patentable.
However, Section 3(i) precludes from patentability:
• any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or
other treatment of human beings; or
• any treatment of animals which renders them free of disease or increases their economic
value (or that of their products).
The Manual of Patent Office Practice and Procedure 2005 provides examples of subject
matter that falls under this section (see Table 1).

The cosmetic application of substances to the body, methods of operating a medical device
and the manufacture of artificial prostheses and taking measurements thereof are potentially
patentable. Diagnostic methods practised on a living body are unpatentable; however,
diagnostic methods carried out on tissues, cells or biological fluid completely removed from
the body can be patentable.

In 7831/DELNP/2006 the IPO held that fixing of doses for the treatment of a patient is a
method of treatment. It is part of a medical practitioner’s prerogative in deciding the quantum
and frequency of doses based on the patient’s age and condition. Thus, dosage forms, modes
of administering medicine or kits designed for the treatment of a disease that comprise
nothing more than a dosage pattern are un-patentable.

The language of claims is critical in this area. “A method of treating condition X by

administering a composition comprising Y or a pharmaceutically acceptable salt thereof” is
considered a method of treatment. However, “a composition comprising Y or a
pharmaceutically acceptable salt thereof for treatment of condition X” is not considered a
method of treatment.

Section 3(h) – agricultural or horticultural methods

Methods of agriculture or horticulture are un-patentable. In 1785/KOLNP/2009 the IPO
referred to the dictionary definition of both terms and observed that agriculture and
horticulture are processes involving multiple steps, such as preparation of soil, sowing,
applying manure and fertilisers, irrigation, protection from pests and weeds, harvesting and
storage. The application claimed:

A method of combating harmful insects and/or phytopathogenic fungi, which comprises

contacting said harmful insects and/or phytopathogenic fungi, their habit, breeding ground,
food supply, plant, seed, soil, area, material or environment in which the harmful insects
and/or phytopathogenic fungi are growing or may grow, or the materials, plants, seeds, soils,
surfaces or spaces to be protected from attack or infestation by said harmful insects and/or
phytopathogenic fungi with an effective amount of an agrochemical formulation as claimed in
any of claims 1 to 6.

The claim was found to fall under the scope of Section 3(h) and was therefore rejected. In
9827/DELNP/2007 a method of reducing mycotoxin contamination of a plant or harvested
plant material that involved treatment of seeds with the chemicals before sowing or during
sowing in the field for the plant cultivation process was considered un-patentable.

Section 3(p) – traditional knowledge

An invention which is essentially traditional knowledge or which is an aggregation or
duplication of the known properties of a traditionally known component or components is
specifically excluded from patentability. India has developed the Traditional Knowledge
Digital Library (TKDL), providing information on traditional knowledge in the country
related to ayurveda, unani, siddha and yoga. The database is designed to assist the major
patent offices around the world to carry out prior art searches. The information is available in
five languages (English, German, French, Japanese and Spanish). The TKDL enables prompt
cancellation or withdrawal of patent applications relating to India’s traditional knowledge.

Formal requirements for biotechnology patent applications

Deposition of biological material
Under Section 10(4) of the Patent Act, an applicant must deposit the biological material
mentioned in the specification if it is unavailable to the public and cannot be described
adequately as per the provisions of the act. The material must be deposited with an
international depository authority under the Budapest Treaty. The international depository
authorities in India are the Microbial Type Culture Collection and Gene Bank, Chandigarh
and the Microbial Culture Collection, Pune.

The deposit must be made no later than the filing date of the patent application in India. A
reference to the deposit must be made in the specification within the prescribed period (ie,
three months from the filing date). When the biological material is obtained in India,
permission from the competent authority must be submitted before grant of the patent.
The specification must include all available characteristics of the biological material that are
required for its correct identification. These include the name and address of the depository
institution and the date and number of the deposit. The applicant must also disclose the
source and geographical origin of the biological material.

If a plant gene sequence has been claimed which is being used to transform other plant
material, the applicant must disclose the plant from which the gene sequence has been
isolated as well as the plant that is being transformed.

Sequence listing
For genes, nucleotide sequences and polypeptide sequences, the applicant must mention the
sequence listing in the complete specification. The sequence listing must be submitted in
electronic form. A gene accession number must be mentioned for the gene. The fee for filing
a complete specification depends on the total page count. Where sequence listing is provided,
the page count usually runs very high, leading to an increased filing fee. The government of
India has released draft amendments to the Patent Rule 2003 that propose a cap on the
maximum fee payable in case of sequence listing.
 CHAPTER V
GOVERNMENT POLICIES IN PATENTING

Patent Act in India was established in 1856 and has been customized several times. The major
change was done in 1970 which satisfied the international norms of patentability such as
innovation, inventive step and industrial application. The patent act 1970 had nothing specific
about the bio-technology invention and protection. At the sometime a large number of biotech
inventions and patent application were applied in the US and EU patent offices and courts as a
result there was a need for the change of Indian patent act to introduce biotech patentability law.
The change came in 2002 to openly include biochemical, biotechnological and microbiological
processes within the definition of potentially patentable process. 28 The patents and Designs
Protection Act was introduced in 1872 and the Indian Patents and Designs Act in 1911. Later
after independence the Patents bill was ineffectively introduced before the Parliament in 1949 &
1965 and finally the bill was passed into force on 20th April 1970. The Patent system in India is
governed by the Patents Act, 1970 (No. 39 of 1970) and the Patents Rules, 2003. The patents act
has been amended several times in 1974, 1985, 1999, 2002 and in 2005 and the rules have been
amended in 2006.According to the Indian Patent Act 1970 and following Patent (Amendment)
Act, 1999 and2002, patents could be applied mainly for agricultural tools and equipment or the
processes for the development of agricultural chemicals. 29 The Indian patents Act has been hailed
as model legislation for developing countries. It seeks to balance both the need for granting
rewards for inventors while ensuring that India's developmental needs are not ignored. Patent
rights in India ware introduced as early as 1856, and customized in 1859 along the lines of the
English Patent act of 1852 “History of Indian patent system:30.

28
Controller General of Patents, Designs, and Trade Marks report on policy,
29
Patent office history.
30
New Indian Patent (Amendment) Rules, 2014, Gazette of India, extraordinary, Part II,
Section 3, Sub-section (i). 28 February 2014.
The Patents Act provides for private rights for a limited period of time for revelation of
inventions that are new, useful and non-obvious; an art, process, method or manner of
manufacture; machine, equipment or other article or a substance of manufacture. Non-
Patentable inventions under the Patents Act include methods for agriculture or horticulture,
medical, surgical, remedial or prophylactic methods for treatment of human, animals or
plants. For substances that could be used as food, drugs or medicine, only the process for the
manufacturing of the substance could be Patented and not the material itself. Under the
Patents and Designs Act of1911, product Patents were available for all inventions. It was The
Patents Act of 1970 that made product patents unavailable. Recently the Indian Patent Office
has published the Indian Patents (Amendment) Rules, 2014which have come effective from
28th of February 2014. The new amendments rules are ensuing to the previously published
Patents (Amendment) Rules 2005, on 28th December 2004; The Patents (Amendment) Rules
2006, on 5th May 2006; The Patent (Amendment) Rules, 2012 and Gazette Notification of
Patent (Amendments) Rules 201331

The Ministry of Science and Technology has issued the guidelines “Instructions for
Technology Transfer and Intellectual Property Rights”, which would help in enhancing the
motivation of scientists, research institutions and universities in various research and
development projects funded by various departments of the Ministry of Science and
Technology. The salient features of these guidelines are as follows:
 Ownership of Intellectual Property: The institution shall be encouraged to seek protection
of IPR rights in respect of the results of R&D. They may retain the ownership of such
IPRs. Institutions would mean any technical, scientific or academic establishment where
the research is carried through financial support by Central/State Governments.
 Transfer of Technology: The institutions would take necessary steps to commercially
exploit patents on exclusive or non-exclusive basis.

31
Traditional Knowledge Digital Library, Bio-piracy of Traditional Knowledge.
 Royalty to inventors: The owner institutions are acceptable to retain the benefits and
earnings generated out of the IPR. The institution may conclude the share of inventors
and other associated persons from such income. However, such shares shall be limited to
one third of the actual income.

 Norms for the private industry: IPR generated during joint research by institution and
industrial concern through joint research efforts can be owned jointly by them on
mutually agreed terms through a written agreement. The institution and industrial concern
may transfer the technology to a third party for commercialization on exclusive or non-
exclusive basis. The third-party, exclusively licensed to market the innovations in India,
must manufacture the product in India. The joint owners may share the benefits and
earnings arising out of commercial utilization of the IPR. The institution may determine
the share of the inventor and other persons from such actual earnings. Such share shall not
exceed one third of the actual earnings.

 Patent Facilitating Fund: The owner institution shall set apart no less than 25 per cent of
the revenues generated from IPR to create a patent facilitating fund. The fund shall be
utilized by the owner for updating the invention, filing new patents and protecting the IPR
against violation and for building capability in the area of IPR and related issues.

 Information: The institution shall submit information relating to the details of the patents
obtained the benefit and income arising out of the IPR and the yield of the products
occasionally to the Department/Ministry, which has provided the funds.

INTERNATIONAL CONTROVERSY WITH INDIAN PATENTS:

The herbal products have a significant demanding developed and developing countries. The
lead pharmaceutical companies emphasized on indigenous system of medicines acquired
information from traditional healers of indigenous communities. Multi-national
pharmaceutical companies interact with local communities in village level to identify plants
and plant materials at their local and indigenous medicinal use. Biopiracy of Indian
traditional knowledge increases because this traditional information exists in different
regional language in regionally published or unpublished format.
The patent offices are unable to search this information prior to granting patents. The
treatments of human diseases from traditional knowledge are time-tested since they have
been in practice for long ago. The reliability of the application of traditional medicine
coupled with the absence of such information with patent offices provides an opportunity for
the interlopers for getting patents on these therapeutic formulations of traditional medicines.

• Basmati Rice (Oryza sativa Linn.)

Rice Tec. Inc. company had applied for registration of a mark ‘Texmati’ before the UK
Trademark Registry. Agricultural and Processed Food Exports Development Authority
(APEDA) fruitfully opposed it. One of the documents relied upon by Rice Tec as proof in
support of the registration of the said mark was the US Patent 5,663,484 granted by US
Patent Office to Rice Tecon September 2, 1997 and that is how this patent became an issue
for contest. This US utility patent was exclusive in a way to claim a rice plant having
distinctiveness similar to the traditional Indian Basmati Rice lines and with the geological
delimitation covering North, Central or South America or Caribbean Islands. The said patent
covered20 claims covering not only novel rice plant but also various rice lines; resulting
plants and grains, seed deposit claims, method for selecting a rice plant for breeding and
spread. Its claims 15-17 were for a rice grain having distinctiveness similar to those from
Indian Basmati rice lines.

The said claims would have come in the way of Indian exports to US, if lawfully enforced.
Evidence from the IARI (Indian Agricultural Research Institute) announcement was used
against claims 15-17. The evidence was backed up by the germplasm collection of
Directorate of Rice Research, Hyderabad since 1978. CFTRI (Central Food Technological
Research Institute) scientists evaluated the various grain distinctiveness and accordingly the
claims 15-17 were attacked on the basis of the declarations submitted by CFTRI scientists on
grain characteristics. Eventually, a request for re-examination of this patent was filed on
April 28, 2000.
Recently, Indian rice in the foreign markets witnessed hard challenge as a outcome of the
decision of the US Patent and Trademark Office (USPTO) because this office granted
permission on 2nd Sep 1997 under brand name ‘Texmati’ domestic and foreign markets with
a label claiming the product to be greater or at least correspondent to Indian Basmati.
Therefore Government of India filed a petition in the USPTO and subsequently Rice Tec Inc
surrendered four claims in September 2000 and 11 more claims in August 2001. The Rice
Tec Inc is presently selling basmati after developing its novel lines named BAS-867, RT-117,
RT-112. The UK is allowing basmati only from India and Pakistan though it is patented as
Texmati in the USA and as Jasmati in Thailand32.

• • Neem (Azadirachta indica Juss.)

A tree renowned to India has been used as abiopesticide and medicine in India for century’s.
Ancient Indian Ayurvedic texts have described the Neem tree and it’s therapeutic properties
as far backs 5000BC. The leaf extracts of Neem plant can be used for controlling a lots of
pests and fungal diseases. The Neem oil can be used as mixed in soap, flu control, relief from
malaria, cure of skin disease and meningitis. The European patent office approved a patent
(EPO patent No.436257) in 1994 to the US Corporation W.R. Grace Company and US
Department of Agriculture for a method for controlling fungus on plants by the aid of
hydrophobic extracted Neem oil. In 1995, some international NGOs and council of Indian
farmers filed lawful disagreement against the patent of Neem oil. They submitted proof that
the fungicidal effect of extracts of Neem seeds had been known and used for centuries in
Indian agriculture to protect crops, and therefore, it should not be patentable. In the year1999,
the European patent office decided that according to the evidence all features of the present
claim were disclosed to the public prior to the patent submission and the patent was not
considered to involve an inventive step. The patent granted on Neem was revoked by the
European patent office in May 2000. In March 2006 the European patent office rejected the
challenge made by the USDA and the chemicals international, W. R. Grace tothe previous
decision to cancel their patent on the fungicidal properties of the Neem seeds extract 33.

32
Traditional Knowledge Digital Library, Bio-piracy of Traditional Knowledge
33
Traditional Knowledge Digital Library, Bio-piracy of Traditional Knowledge
• • Turmeric (Curcuma longa Linn.)

In India the Turmeric (Haldi) has been traditionally used as medicine for centuries for the
treatment of wound healing and common cold. Itshould not be patented in recent time for
theseproperties of Turmeric. The rhizome of turmerichas the properties that make it an
effective ingredient in medicines, cosmetics and dyes and alsoused as a important spice in
Indian cooking. In1995, two expatriate Indians at the University of Mississippi Medical
Centre were granted a US patent (No.5, 401,504) on use of turmeric in woundhealing. The
Council of Scientific & Industrial Research (CSIR), India, New Delhi filed a complainwith
the US PTO challenging the patent on thegrounds of existing of prior art. The CSIR argued
that the medicinal use of Turmeric for healing wounds and rashes was not a novel invention
as it has been used for thousands of years in India. Their claim was supported by
documentary evidence oftraditional knowledge, including ancient Sanskrittext and a paper
published in 1953 in the Journalof the Indian Medical Association. Despite an appeal by the
patent holders, the US PTO upheld the CSIR objections and cancelled the patent.
Theturmeric case was a landmark judgment as it wasfor the first time that a patent based on
the traditional knowledge of a developing country was successfully challenged. The US
Patent Office revoked this patent in 1997, after ascertaining thatthere was no novelty; the
findings by innovatorshave been known in India for centuries34.

Current and future development of patenting in India:

Recent changes in India’s patent policy have led to some analysis of India’s position on
patents. The recent flow in patent applications in India provides important data for evaluating
the potential for household sector to adjust to the new patent regime. In the last two decades,
most reforms were implemented without any profound knowledge or thorough analysis of the
societal and/or economic impact. The advancements in biotechnology and information
technology have major impact on patenting system. It is difficult to judge whether the patent
system reimbursement to the society. If we did not have a patent system, it would be careless,
on the basis of our present knowledge of its economic penalty, to recommend instituting one.

34
Traditional Knowledge Digital Library, Bio-piracy of Traditional Knowledge
It should be recognized that there is a outstanding connection between wealth, economic
presentation and the scope of the patent system in all rich countries. In recent years, the
patent system has been both strengthened and expanded without any evidence of the benefits
to society. Priority should be given to generation, evaluation, protection and effective
marketable consumption of physical products of intellectual property in agriculture. The
policy related to protection of IPR indifferent sectors of technologies, attention should be
given to further liberalization of its market, promotion of private sector investment and more
efficient technology systems. The R&D in the field of biotechnology should be encouraged
for exploring new tools and improve the biological systems for public interest. To support the
future growth and welfare the development and exchange of knowledge should be properly
evaluated and secured through patent system. By growing the R&D and manufacturing sector
the number of patent filling will grow in future.
 CHAPTER VI
INTERNATIONAL CONVENTIONS

WTO: In Indian context, the intellectual property rights including patents are granted under
the monarch right of the country according to the patent law like in other countries, i.e., they
are effective only in the country. Prima facie the patents are only granted to a processor a
product (as on date, only Exclusive Marketing Rights (EMR) for qualifying products), which
meets the criteria of patentability. As and when the information is received about patents
being granted on certain on-patentable items which affect the Indian interests, the steps are
taken to charge whether the grant of such patents can be challenged under the patent laws of
the country concerned. As we know, there are seven areas of IPR under Agreement on Trade
related Aspects of Intellectual Property(TRIPs) of WTO, viz. trademarks, trade secrets,
industrial designs, copyrights, integrated circuits, geographical indications and patents. In the
first six areas, Indian laws, rules and regulations, administrative procedures and judicial
systems are dependable and are at par with the rest of the world. If we look into the
provisions of the WTO from the Indian Patents System (Indian Patents Act 1970), we see that
they have been different in various ways as follows:

• WTO provides product patents in all branches of technology while the Indian Patents
System provides only process patents and does not provide product patents in drugs, foods
and chemicals, as on date.

• WTO would grant patents for any new inventions with inventive step (non obvious),
capable of industrial applications (useful), whether products or processes, in all fields of
technology but provide elasticity for barring from patentability in areas, like: (i) plants; (ii)
animals; (iii) problem-solving, remedial and surgical methods for the treatment of humans
and animals; and (iv) biological processes for the production of plants or animals. WTO,
however, provides patents on microorganisms, and microbiological processes. In contrast,
Indian patent laws do not allow patenting of any life form; however, patents based on
microbial processes are permitted, as on date.

• WTO provides ambit of patent-life for all patents for a consistent period of 20 years period
while Indian system has brought it at equivalence with WTO only recently, for processes
only (including drugs, food and chemicals, which was only 7 years).
• WTO requires protection of plant varieties either by patents or byan effective “sui generis”
system or by any grouping thereof, Biotechnology and IPR Regime while at present there is
no system for protection of plant varieties in India, despite the Plant Variety Protection (PVP)
Act in place.

The burden of proof in case of violation in WTO insignificantly on the supposed

individual who infringes a patent, while in Indian system it is on the plaintiff

WTO does not permit bias between imported and domestic products while according to the
Indian law, importation does not amount to working of the patent.

WTO requires providing same benefit, goodwill, advantage or immunity granted by “a

Member country” to the nationals of “any other Member country”.

The IPR issues before India and the developing countries include the stand that has to be
taken on the distinctions between discoveries and inventions in biological area, the
definitions and the scope of patentable micro-organisms, the scope of patentability or
protection of other living materials like the plants and the animals, the conditions of
depositions connected with the patentable inventions involving living entities as well as
viruses, bacteria, fungi, plasmids, genes, polynucleotide sequences with useful properties,
plasmids, cosmids ,vectors, gene cassettes, etc. In many of these issues, the stand of theWTO
is also not clear; WTO has not made any exact recommendations in most of these facets, and
the subject matter is left to speculations and conjectures to the member countries.

WIPO: For the past more than three years a new international patent treaty under the one
global patent system has been under negotiation at the World Intellectual Property
Organization (WIPO) in Geneva. The SPLT (Substantive Patent Law Treaty) aims to remove
most of the national flexibility in the patent systems of the member countries and pave the
way for a future world patent granted directly by the WIPO. This seems to be an appealing
proposal especially for the multinational and transnational corporate houses of the developed
countries like the US and EU, who view patents as the primary means to control the
globalized economy.

However, this global patent system does not seem to be a good omen for the developing
countries and their citizens who would loose even the limited freedom left by the WTO,
TRIPs Agreement to adjust patent systems to national developmental goals. The policy
makers in the developing countries should look to the global patent system very cautiously
and can always keep themselves away from the system to stop the negotiation process. This
would provide them free hand and utilization of their national patents for the benefit of the
country.

TRIPS: After more than four years of tie between the developed and developing countries,
there are signs of movement on the TRIPs assessment. The discussions at WTO came out
with two points, viz., one about whether patent applicants have to disclose and make public
the source of the genetic material or lead on inventions involving traditional knowledge, the
other point being whether and how the patent system recognizes traditional knowledge in its
own right. The Africa Group at WTO has added a new dimension to the question by tabling a
proposal to put traditional knowledge formally under TRIPs Rules. The policy makers in
developing countries resisted TRIPs from the very beginning because they saw it as a hazard
to sustainable development on their own terms. In fact this is correct and has now been
increasingly supported by critical evaluation from various UN bodies and other independent
analysts as well as by growing public opinion both in North and South. Several major studies
and analyses have been produced by agencies such as UK-IPR Commission, UK Royal
Society, UNDP and the Human Genome Organization which call for changes in Intellectual
Property Law or limitations on its use to stop itsailing effects on research, innovations and
developments. It has been wide public opinion in the developing countries that TRIPs should
be amended to lessen obligations on them to adopt it in developed form. It has also been
opined that, at a minimum, biodiversity and traditional knowledge should be excluded from
TRIPs.

CHAPTER VII
Filing a Patent Application in India
Filing a Patent Application in India:
Filing a patent application in India is required some important documents, which are
important for granting a patent in India.
a- Application form in duplicate (Form 1 or 1A)
b- Provisional or complete specification in duplicate
c- Abstract of the invention in duplicate

d- Drawing in duplicate (if need)

e- Priority document (if priority date is claimed) in
convention application
f- Declaration of inventor ship
g- Power of attorney (if field through patent agent)
h- Fee (to be paid in cash/by cheque/by demand draft

Patenting trends in biotechnology:

Indian patenting trend: Patents granted to Indian organizations during 1990-2002 in different
sectors easily reveals the fact that chemicals and pharmaceuticals were the major areas in
which Indian organizations had obtained patents. However, it can also be observed that
Indian organizations also got patents in biotechnology. Majority of these were overlapping
patents addressing other sectors (mainly pharmaceuticals). The main technological domains
of patenting activity in biotechnology were in microorganism compositions; macromolecular
compounds; and biocide and plant reproduction techniques.

Steady increase in patenting activities in biotechnology can be observed from the different
data available. Analyses of Indian patenting activity during 2003-04 again shows that in this
period also, pharmaceutical and chemical sectors were the dominant areas of patenting
activity. Pharmaceuticals had 213 patents (46 percent of total patents) during these two years
while chemical sector had 125 patents (27 percent of total patents). Biotechnology sector was
also well addressed with 48 patents granted during this period. Other major sectors
contributed insignificant number of patents.
International Patenting Trend: The US, Japan and the European Patent Office are the three
major patent offices where international firms file patents. However, in the context of
biotechnological inventions, the USPTO has a long tradition of firms filing their patents
therein because of a number of factors such as emergence of firms from the universities,
venture capital investments, and landmark rulings. Thus, by observing patents granted by the
USPTO, a good estimate of patenting activity in biotechnology can be obtained. Patents
granted by the USPTO in biotechnology in comparison to other sectors to some developed
and developing economies have been illustrated in property right dates. It shows that patents
granted to biotechnology inventions are relatively less than other sectors. However, they do
contribute to substantial patents in the overall profile of developed economies. Firms in
developing countries have dominated innovation in biotechnology with extensive patenting,
but the US has clearly dominated patenting covering different application areas of
biotechnology. These innovations have high degree of science linkages and joint partnership
between industry and university.

Patentability of Biotechnological Invention Biotechnology in recent year has created

unprecedented opportunities not only for the humankind but also industrial development. It
has become the world fastest growing technology. Today a number of research institutes
(public and private) are working in the area of modern biotechnology with strong scientific
research system in country12,13. But due to the emergence of modern biotechnology, one of
the most important issues has been raised in legal characterization and Intellectual Property
Protection (IPP). Invention such as genetic engineering, microbiology, medical invention and
biotechnological invention that may be patentable by Indian patent law, 1970 can be
categorized as-

A- The living entities of natural origin such as animal, plant in whole or any part thereof
are not patentable in India.
B- Terminator gene technology and microorganisms are not patentable in India.
C- The biological materials such as organs, tissues, viruses etc and process of preparing
thereof are not patentable in India. But biotechnological materials such as recombinant
DNA, plasmid and process of manufacturing thereof are patentable.
D- Gene sequences, DNA sequences without having disclosed their function are not
patentable. But the process relating to microorganism or producing chemical substances using
such microorganisms are patentable.
E- The process of cloning human being or animals is not patentable
 CHAPTER VIII
QUESTIONNAIRE

1. WHAT IS FAIR USE AND FAIR DEALING IN COPYRIGHT?

2. Why some inventions are are not patentable?

3. Why are patents important to Pharmaceuticals ?

4. What is meant by Bio Patent?

5. Why Bio Patent is necessary?

6. What international conventions protect patent rights?

7. What are Patent Rights?

8. How long does a Patent last?

9. Who grants intellectual property rights for Biotechnology Products?

10. How patents encourage the development of innovation and new technologies in biotech
and genes?

11. How important are patents for your company/institute in the context of:
12. Legal issues related to your company/institute?
 CHAPTER IX
DATA ANALYSIS

INTRODUCTION
The quantitative aspect of this study involved employing data collection methods to draw
conclusions that support the assertions made in the previous chapters, and to test the validity
of the hypotheses made at the start of the study. The following report lays out in detail the
research methodology applied, the data collection techniques used and an analysis drawn
from the results of the survey.

Sampling and Analysis Methods

The survey was conducted by the researcher after preparing a questionnaire in order to find
primary data for this research. Questions were asked to people including Students,
Professionals and Civilians of Aurangabad city. Based on the Questionnaire, a
survey/questionnaire was drawn to be answered by the sample elements. To ensure
uniformity of opinion, an equal number of questionnaires were distributed among Students.
To ensure uniformity of opinion, an equal number of questionnaires were distributed i.e
fifteen questionnaires were distributed among people .
The questionnaires were delivered by the researcher in person and collected the same way.
Upon the return of the questionnaires, a simple analysis was conducted by using basic
arithmetic and drawing suitable inferences.

The findings of the research are as follows;

1. WHAT IS FAIR USE AND FAIR DEALING IN COPYRIGHT?
Fair use supports “Socially Laudable purposes”, typically, if not exclusively, involving the
use of the copyrighted work by second author.

2. Why some inventions are are not patentable?

Inventions which are frivolous or contrary to well established natural laws. Example
inventions that are against the natural laws that are any machine giving 100 % efficiency, or
any machine giving output without an input cannot be consider as obvious and cannot be
patentable.

3. Why are patents important to Pharmaceuticals ?

Pharmaceutical Companies have the ability to develop new drugs that can prolong life and
provide cures to diseases that affect people worldwide. Patents are especially important to
this drug companies because they can guarantee profit and make all the time and cost put into
developing their new drugs worthwhile.

4. What is meant by Bio Patent?

A Bio Patent is a patent granted by the government to the inventor for biological entities and
for products obtain from them. It allows the patent holder to prevent others from making,
using, selling or importing the protected invention for a limited period of time.

5. Why Bio Patent is necessary?

A Patent is important because it can help safeguard your invention. It can protect any
product, design or process that meets certain specification according to its originality,
practicality, sustainability and utility. In most cases a Patent can protect an invention for upto
20 Years.
6. What international conventions protect patent rights?
Paris Convention (The First major international agreement relating to the protection of
industrial property rights, including patents, providing, in particular, national treatment, the
right of priority and a number of common rules in the field substantive patent law. Such as
the independence of patents.

7. What are Patent Rights?

A patent is an exclusive right granted for an invention. In other words, patent protection
means that the invention can not be commercially made, Used, distributed, imported or sold
by others without the patent owners consent.

8. How long does a Patent last?

A U.S utility patent explain above, is generally granted for 20 Year from the date the patent
application is filed, however periodic fees are required to maintain the impossibility patent.

9. Who grants intellectual property rights for Biotechnology Products?

There are Three international Intellectual property treaties which are of particular important
for the protection of Biotechnology: the paris convention for the international recognition of
the deposit of microorganisms for the purposes of patent cooperation treaty.

10. How patents encourage the development of innovation and new technologies in
biotech and genes?
By granting such rights, patents provide incentives for innovators, offering them recognition
for their creativity and enabling them to appropriate the returns of their investment. Patent
protection is usually sought at the research and development (R& D) stage of the technology
life cycle.
 CHAPTER X
CONCLUSION AND SUGGESTION

The application of modern biotechnology for agricultural, ecological and pharmaceutical

sectors has great hopes for the scope to which man can discover and utilize the biological
resources. So it allows for the direct inherited adaptation of the life forms. The
commercialization of genetic modified organisms has led to intense worldwide and
multicultural conflicts and debates. Using the progressed technology to change life forms is
becoming difficult for law and rules to shield property right of biotechnological products.
One of the major developments in the patent laws has been in the Biotechnology sector. The
biotechnology patents are the debating subjects that many countries consider these patents
create future problems to access the patented life forms. Most of the biotechnology processes
have been invented in developed countries Such technologies are yet to help the developing
countries partially due to commercial reasons and also due to the fact that they may not
always be applied in their present form.

Development of suitable biotechnology and their commercialization in developing countries

is delayed by the range of existing patents. Such application will require the use of several
patents with multiple owners. Moreover, such patents are owned by a few companies and
institutions. Negotiating such 'patent thickets' poses serious challenges in development and
application of biotechnology in developing countries. National and worldwide initiatives
should be taken for properly formulation of the intellectual property right law, and
particularly patent law for patenting biotech products with outing gardingly the interest of
common peoples. India’s domestic policy and international negotiations on one feature of
IPRs, patents, provides important lessons for formulating a complete negotiating strategy on
TRIPs. Support from developing countries, disunity among advanced nations and the role of
NGOs were also factors that enabled India to endorse its interests in the discussions. In recent
years a good number of patents are granted for all sorts of biotechnological inventions in
India.

The Research and Development in the field of biotechnology should be encouraged for
exploring new tools and improve the biological systems for the interest of common people.
Precedence should be given to generation, assessment, protection and effective
commercialization of material products of intellectual property in agriculture, environment
and medicine. Researchers in different Institutions must beware of intellectual property issues
in their research topics. The Intellectual property right has an crash on the social and
economic development of a society. The policy related to protection of IPR in different
sectors of technologies, attention should be given to further liberalization of its market,
promotion of more efficient technology systems and private sector investments. The future
growth and development in the sector of biotechnological research and exchange of
knowledge should be encouraged through proper assessment and protected patent system. It
is important that developing countries ensure that their intellectual property legislation and
procedures highlight, to the maximum possible extent, the enforcement of IPRs through
administrative action and through the existing civil justice system.
They should aim to improve the full expenditure of advancement and maintaining all aspects
of the national intellectual property infrastructure through national IPR registration and
administrative charges. Developing countries should seek to develop the maximum possible
benefits in terms of cost decrease and administrative competence from existing regional and
international cooperation mechanisms, through various bilateral agreements in IPR especially
with another developing country in the neighborhood. Like-minded developing countries
should also make determined efforts to support high-level dialogue on new regional and
international co-operation initiatives in IPR management, training and IPR numerical data
collection and management.

Developing countries should encourage policy research and analysis on intellectual property
subjects in the national awareness, especially pertaining to protection of plant varieties;
traditional knowledge; folklore; technology transfer; etc. In order to meet the special needs of
Least Developed Countries (LDCs), in developing the modern intellectual property regime
and wider institutional infrastructure, there is a need for WIPO, EPO and developed countries
to commit some quantity fund for technical and financial assistance. WIPO and EPO should
be formally invited to join as donor agencies of the Integrated Framework alongside the
World Bank, UNDP, UNCTAD, WTO, and ITC, for the purpose.

It is important that WIPO makes funds available to cover the travel, accommodation and
subsistence expenses of representatives from all LDC Member States to participate in all
TRIPs-related ability building projects of WTO, TRIPs Council meetings and in those
meetings at WIPO which such countries are eligible to attend. It is also important that WIPO
strengthen the present systems for monitoring and evaluation of its development cooperation
program esespecially for the developing countries. With these efforts the LDCs and the
developing countries would be able to cope with the fast developing IPR administration
where it is anticipated that the developed world would maximally exploit the resources of
developing countries through various Trade Agreements of WTO.

BIBLOGRAPHY:
• Nikolaus Thumm, Research and Patenting in Biotechnology; Swiss Federal Institute of
Intellectual Property

• Kima Uche, Genomics & Patents: Human Heritage and the Cost of Innovation;
Biochemistry 118Q: Genomics & Medicine

• Report of the Secretary’s Advisory Committee on Genetics, Health and Society; Gene
Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests,

• HUGO Intellectual property committee statement on patenting of DNA sequences

• Issues relating to the Patentability of Biotechnological subject matter in Indian Agriculture

August 2012, Available at:http://www.legalservicesindia.com/article/article/patentability-of-
biotechnological-in-indian-agriculture-1237-1.html

• Mittal R, Singh G. Patenting activities in agriculture from India. JIPR 2005; 10: 315– 320.
• Controller General of Patents, Designs, and Trade Marksreport on policy, Available at:
http://www.ipindia.nic.in/

• Patent office history. Available at:http://www.patentoffice.nic.in/ipr/patent/history.htm.

• New Indian Patent (Amendment) Rules, 2014, Gazette ofIndia, extraordinary, Part II,
Section 3, Sub-section (i). 28 February 2014.

• Traditional Knowledge Digital Library, Bio-piracy of Traditional Knowledge. Available at:

http://www.tkdl.res.in/tkdl/langdefault/Common/Biopiracy. asp?GL=Eng.