ABSTRACT This article evaluates patent protection as an incentive mechanism for biotechnology innovation in India, Recent enhancements to India&apos;s patent laws, a new acceptance of biotechnology patents. It analyses the international patenting trends, patents that have significant impact and countries active in patenting. It also examines Indian patenting activity and its comparison with international trends to assess the Indian efforts. The patentability of products is essential in the biotechnology field, for limited market exclusivity compensates biotech companies&apos; investments in research and development. The biotechnology field also uniquely faces Federal Drug Administration (FDA) approval, which includes considerable additional expense and time issues a biotech company must address

Kumar Sharma

Pramod Mayank Bansal

Pranati Srivastava

Rishabha Malviya

Vineet Bhardwaj

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Volume 3, Issue 2, July – August 2010; Article 024                                                                                    ISSN 0976 – 044X 
International Journal of Pharmaceutical Sciences Review and Research                                                               Page 131 
Available online at www.globalresearchonline.net 
 
BIOTECHNOLOGICAL INNOVATIONS PATENT: A REVIEW 
 
 
Rishabha Malviya*, Vineet Bhardwaj, Pranati Srivastava, Mayank Bansal, Pramod Kumar Sharma 
Department of Pharmaceutical Technology, Meerut Institute of Engineering and Technology, Baghpat By-Pass, Delhi -
Roorki Highway, Meerut-250005, U.P., India. 
*Email: rishabhamalviya19@gmail.com 
 
 
ABSTRACT 
This article evaluates patent protection as an incentive mechanism for biotechnology   innovation in India, Recent enhancements to 
India's patent laws, a new acceptance of biotechnology patents. It analyses the international patenting trends, patents that have significant 
impact and countries active in patenting. It also examines Indian patenting activity and its comparison with international trends to assess 
the Indian efforts. The patentability of products is essential in the biotechnology field, for limited market exclusivity compensates 
biotech companies’ investments in research and development. The biotechnology field also uniquely faces Federal Drug Administration 
(FDA) approval, which includes considerable additional expense and time issues a biotech company must address.  
Keywords: Biotechnology, patents, proprietary right, patenting trends. 
 
INTRODUCTION 
Many Indian biotechnology companies have developed 
proprietary processes for manufacturing "bio-generics" or 
"bio-similar," i.e., copies or derivative forms of first-
generation biologics such as recombinant human insulin 
and erythropoietin now coming off patent in the U.S. and 
elsewhere. Despite their success in process development, 
the Indian firms are not yet filing a significant number of 
patent applications in India. Data gathered for this article, 
limited to companies generating significant biotechnology 
revenues in India; reveal that they filed only a handful of 
Indian patent applications during that period. The anomaly 
in patenting biotechnological products arises because 
patent law was intended to satisfy the requirements of 
industrial technology1. The advent of biotechnology 
necessitated that patent laws to be suitably modified to 
match the needs of science and technology. The traditional 
notions of adequate disclosure at the time of applying for a 
patent had to be altered to cater itself to biotechnological 
innovation. 
The TRIPS-mandated term extension of Indian chemical 
(including biotechnological) process patents from seven to 
twenty years from filing, coupled with a shifted burden of 
proof for alleged infringements of process patents, will 
work in concert with the Indian biotechnology industry's 
desire to lead the world in supplying generic biologics. As 
multiple Indian companies compete to sell the same 
biotechnology product, each firm's need to distinguish 
itself by process development increases. Stronger process 
patent protection will facilitate competitive advantage 
among Indian biotechnology companies. 
Patent: A patent is an exclusive right granted by the 
government to the patentee in respect of a new invention, 
which may be product or process. A patent is granted by 
the patent office in which you wish to protect your voluble 
invention. A patent cover every area of technology as 
pencil to helicopter1. 
Biotechnology: Biotechnology comprises any technology 
that uses living entities, in particular animals, plants or 
microorganisms. According to the Organization for 
Economic Cooperation and Development (OECD) 
biotechnology includes any technique that uses living 
organisms (or parts of organisms) to make or modify 
products, to improve plants or animals, or to develop 
microorganisms for specific uses. 
Biotechnology Inventions Classification:  
(a) Inventions relating to an organism or material such as 
living entities of natural or artificial origin (animals, 
plants, and microorganisms), biological material 
(plasmids, viruses and replicas, and parts of organs, 
tissues, cells, and organelles), and naturally occurring 
substances from living entities, biological material and 
parts. 
(b) Inventions relating to the process for the creation of a 
living organism or production of other biological 
materials.  
(c) Inventions relating to the use of such organisms or 
biological materials2. 
 Innovation: Innovation is a new way of doing something 
or "new stuff that is made useful". It may refer to 
incremental and emergent or    radical and revolutionary 
changes in thinking, products, processes, or organizations. 
Following Schumpeter (1934), contributors to the 
scholarly literature on innovation typically distinguish 
between invention, an idea made manifest, and innovation, 
ideas applied successfully in practice. In many fields, 
something new must be substantially different to be 
innovative, not an insignificant change, e.g., in the arts, 
economics, business and government policy. In economics 
the change must increase value, customer value, or 
producer value. The goal of innovation is positive change, 
to make someone or something better. Innovation leading 
to increased productivity is the fundamental source of 
increasing wealth in an economy. 
Patent Forms3: 
Form 1- Application for grant of a patent. 
Volume 3, Issue 2, July – August 2010; Article 024                                                                                    ISSN 0976 – 044X 
International Journal of Pharmaceutical Sciences Review and Research                                                               Page 132 
Available online at www.globalresearchonline.net 
Form 1A- Application corresponding to an international 
application for grant of a patent. 
Form 2- Provisional/ complete specification. 
Form 3- Statement and undertaking under Sec- 8. 
Form 4- Request for extension of time. 
Form 5- Declaration as to inventor-ship. 
Form 9- Request for publication. 
Form18- Request for examination of application for 
patent. 
Filing a Patent Application in India4: 
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 patents5. 
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 university6, 7. 
Patentability of Biotechnological Invention7-11: 
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 patentable14, 15. 
E- The process of cloning human being or animals is not 
patentable15. 
 
CONCLUSION 
The study examined the field of biotechnology and 
identified some of the important areas in the context of 
patentability in this field. The article underscores the fact 
that patenting in biotechnology gives rise to complex 
issues as it involves patenting of living organisms, and 
how Indian patent provisions address the issue of 
patentability in this subject domain without violating the 
TRIPS Agreement. The study shows that Indian firms 
have been able to obtain a number of patents in 
Volume 3, Issue 2, July – August 2010; Article 024                                                                                    ISSN 0976 – 044X 
International Journal of Pharmaceutical Sciences Review and Research                                                               Page 133 
Available online at www.globalresearchonline.net 
biotechnology during 1990-2004 by the US and Indian 
patent offices, particularly in the later period.  
   
REFERENCES 
1. Coase RH, The Problem of Social Cost, The Journal 
of Law and Economics, 1960, 3. 
2. Eisenberg R, Proprietary Rights and the Norms of 
Science in Biotechnology Research, Yale Law 
Journal, 97, 1987, 177. 
3. Howlett MJ, Christie AJ, An analysis of the 
approach of the European, Japanese and United 
States Patent Offices to partial DNA sequences 
(ESTs), International Review of Industrial Property 
and Copyright Law, 34, 2003, 581-710. 
4. The Patents (Amendment) Act), The Gazette of 
India, 15, 2005. 
5. Bhattacharya S, Garg KC, Sharma SC, Bharvi D, 
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BIOTECHNOLOGICAL INNOVATIONS PATENT: A REVIEW

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BIOTECHNOLOGICAL INNOVATIONS PATENT: A REVIEW

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