The document discusses biotechnology patents in India. It provides background on intellectual property rights in biotechnology and how India's patent law was amended in 2002 to explicitly include biotechnology. Key points covered include what is and isn't patentable under Indian law for biotechnology, such as discoveries in nature not being patentable but purified biological materials produced through technical means can be. The legislative framework and policies governing biotechnology in India are also outlined.

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BIOTECHNOLOGY PATENTS – STATUS OF PROTECTION
 ABSTRACT
The main objective of this review is to highlight and explore the inter-relationship and the
functioning of the intellectual property right in the pharmaceutical and biotechnology industry.
The rising tide of patent applications can be witnessed globally in this industry as the need for
such protection and licensing has become imperative so as to safeguard the rights of the inventor
and also to encourage and promote new talents, inventions and innovations which can be a boon
for the economy. The field of biotechnology is an upcoming science which is still at the initial
stage of establishing a foundation but it promises a revolution in the fields of medicine,
agriculture, pharmaceuticals and industrial sector amongst other sectors of the economy along
with contribution to the GDP growth.

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 INTRODUCTION
Patents in the life sciences :-
To comply with requirements under the TRIPS Agreement of the World Trade Organization,
most countries allow for the patenting of microorganisms and, as explained above, often require
the deposit of a sample of the microorganism at a recognized depositary institution when
necessary to comply with the enabling disclosure requirement. Some countries exclude plants
and animals (other than microorganisms) from patentability. Biological materials that have been
purified and isolated from their natural environment or produced by means of a technical process
are patentable in many jurisdictions. National patent law in many countries may also list some
specific types of inventions that are excluded from patentable subject matter, such as processes
for cloning human beings or processes for modifying the germ line genetic identity of human
beings.

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 WHAT ARE BIOTECHNOLOGY PATENTS IN INDIA?
Biotechnology inventions are a broad area of biology involving living organisms and systems to
make or develop products, or any other technological application that uses living organisms,
biological systems, or derivatives thereof, to modify or make products or processes for specific
uses.
The man behind the first Patent Act Thomas Jefferson does not have any idea that life forms can
also become a subject matter for protection under Patent. In the case of Diamond v Anand
Chakrabarty, a biochemist at General Electric (GE) developed a genetically modified organism
that had the capability to decompose crude oil. Initially, the Patent application of the inventor
was rejected. But later on, a further appeal was made which and the Patent was granted by the
court to the inventor with an order stating that the claim of the inventor is not to a hitherto
unknown natural phenomenon, but a non-naturally occurring composition or manufacture of
matter-a product of human inventiveness”
 WHAT IS THE HISTORY OF THE BIOTECHNOLOGY PATENTS
IN INDIA ?
In India, the Patent Act was enacted in the year 1856. Since then, the Patent Act was modified
and amended several times. In the year 1970, one major amendment came into being which
satisfied the international norms of patentability of an invention covering novelty, industrial
application, and inventive step. But the amended version of the Patent Act, 1970[1], does not
include anything specific concerning the invention related to Biotechnology and the protection of
such Biotechnology inventions.
At the same time, the US and the EU Patent offices and courts were observing an increase in the
number of Biotechnology inventions and Patent applications for the same. Hence, a high demand
for an amendment in the Patent Act, 1970, was done to introduce Biotechnology Patents in India.
The amendment related to Biotechnology Patents in India came in the year 2002, to explicitly
include biochemical, microbiological, and biotechnological processes within the definition of
potentially patentable methods.

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 WHAT ARE THE PROVISIONS RELATED TO BIOTECHNOLOGY
PATENTS IN INDIA ?
 Section 2 (1) (j) of the Act, in which the provisions are related to novelty, inventive step
& industrial applicability of products or processes.
 Section 3 (b) of the Act, in which the provisions are related to Inventions contrary to
morality or which cause serious prejudice to human, animal or plant life or health or
environment.
 Section 3 (c) of the Act, in which the provisions are related to the discovery of any living
thing or non-living substance occurring in nature.
 Section 3 (d) of the Act, in which the provisions are related to Mere discovery of a new
form of a known substance which does not result in enhancement of known efficacy or
mere discovery of any new property or new use for a known substance.
 Section 3 (e) of the Act, in which the provisions are related to Mere admixture resulting
only in the aggregation of the properties.
 Section 3 (h) of the Act, in which the provisions are related to the method of agriculture
and horticulture.

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 WHAT IS NOT PATENTABLE UNDER BIOTECHNOLOGY
PATENTS IN INDIA ?
The followings things are not patentable under Biotechnology Patents in India:
 The invention of the inventor is against public order or immoral, harmful to the animal,
human or plant life or harmful to the environment as per Section 3 (b) of the Patents
Act, 1970;
 The invention is related to the discovery of living things or non- living substances or
materials in nature as per Section 3 (c) of the Patents Act, 1970;
 The invention is related to plants and animals in whole or any parts thereof other than the
micro-organisms but including varieties, seeds, and species as per Section 3 (j) of the
Patents Act, 1970;
 The invention is related to any essentially biological processes for the production or
propagation of plants and animals as per Section 3 (j) of the Patent Act, 1970;
 The invention is related to any Process for the medicinal, curative, surgical, prophylactic,
diagnostic or therapeutic or other treatment of human beings or animals to render them
free from a disease or to increase their economic value or that of their products as
per Section 3 (i) of the Patent Acts, 1970;
 The invention is related to specific methods of agriculture or horticulture as per Section 3
(h) of the Patents Act, 1970;

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 LEGISLATIVE FRAMEWORK AND POLICIES FOR THE
PROTECTION OF BIOTECHNOLOGY.
 Environment Protection Act, 1986- The Environment Protection Act, 1986- The
Rules for the Manufacture, Use, Import, Export and Storage of Hazardous
Microorganisms/ Genetically Engineered Organisms or Cells 1989 (Rules, 1989) were
first notified under the Environment (Protection) Act, 1986.
 EXIM Policy- Units undertaking to export their entire production of goods and services
may be set up under Bio-Technology Park (BTP) scheme for manufacture of goods.
 Seeds Act, 1966- This Act provides for compulsory registration of seed on the basis of
their performance, deregulation/ decontrol of seed industry/ processing units and
imposition of more stringent penalties to check the sale o the spurious seeds.
 Drugs & Cosmetic Act 1940- An Act to regulate the import, manufacture, distribution
and sale of drugs and cosmetics.

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a. To lay down general principles for stem cell research and therapy keeping in view
the ethical issues;
b. To formulate specific guidelines for derivation, propagation, differentiation,
characterization, banking, and use of human stem cells for research and therapy;
These guidelines provide a mechanism to ensure that research with human stem cells is
conducted in a responsible and ethically sensitive manner and complies with all
regulatory requirements pertaining to biomedical research in general and stem cell
research in Particular;
 India is one of the first Asian countries to invest in agricultural biotechnology research
and to set up a bio-safety system to regulate the approval of genetically modified
(GM) crops. This provides the base for Agri-biotech companies;
 The Indo-Australian Biotechnology Fund- to develop and support collaborative
research activities and workshops;
 APIDC Venture Capital launched India's first biotechnology focused VC Fund of 37
million UDS with investors Like IFC, Washington, APIDC, LIC, Andhra bank,
Technology Development Board.

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 REFERENCES CASES
[1] Tripathi K. K., Biotechnology and IPR Regime: In the Context of India and Developing
Countries, “Biotech Patent Law”,1st Ed.( the Icfai University Press,2007) p.,187
[2] Philip W. Grubb, Patents for Chemical, Pharmaceuticals and Biotechnology, 4th
Ed,(New Delhi: Oxford University Press) 2006. P. 245- 246
[3] C.B.Raju, Intellectual Property Rights, 1 st Ed., (New Delhi: Serials Publications), 2006.
CONCIUSION
In the modern period, patenting of Biotechnology inventions is a significant aspect because of its
investment and research-intensive nature. The recent case laws nowadays, clearly infer that the
biological materials or substances which are designed in labs and were earlier not available in the
natural environment have earned some right of patentability. Hence, for the protection of the
inventor’s interest and rights of patentability, the Biotechnology Patents in India was introduced.
The process for filing for the grant of the Biotechnology Patents in India is lengthy and long-
lasting. We at Corpbiz have skillful experts to guide you with the process of filing for Patent
Registration in India. Our experts will help and assist you throughout the Patent registration
process. Our experts will ensure the timely and successful completion of your work.