Open Access Research Article
BIOTECHNOLOGY PATENTING, DIFFERENCE BETWEEN USA AND INDIAN PERSPECTIVE BY: MAYURI HANSDA
Published Paper
Article Details
AUTHORED BY: MAYURI HANSDA
Student: 9th Semester B.A.LL. B
Christ Academy Institute of Law (CAIL),
Bengaluru
Abstract
The paper explores the complexities of
biotechnology patents, focusing on the differences between the United States
and India. It addresses the legal, economic, and societal implications of
patenting in these jurisdictions, offering valuable insights for international
collaboration and investment strategies. The study emphasizes the need for a
comprehensive understanding of the global landscape of biotechnology patenting.
The impact of court decisions on biotech patent interpretation is illustrated
through landmark cases in both countries. The Monsanto case in India addressed
patent eligibility for creating transgenic plants, highlighting disagreements
on human intervention. In the US, the Association of Molecular Pathology v
Myriad Genetics Inc decision differentiated between naturally occurring DNA and
engineered elements, influencing patent eligibility.
Keywords
Biotechnology patents, Intellectual
Property Rights, Comparative Analysis, Legal Frameworks, Global Implications
Introduction
One of the most intriguing and
difficult problems facing the patent system is biotechnology. Biotechnology is
the technical application of biological materials, including cells or enzymes,
to produce pharmaceuticals, among other things. Beyond the patent system,
biotechnology unites industry, law, and technology. Legislation is also greatly
influenced by ethics and morality.
Biotechnology items that are eligible
for patents include sequences of nucleotides and amino acids, microbes,
procedures, or techniques for altering these products, applications in the
production of pharmaceuticals, etc. Inventions can be protected in a variety of
ways, as long as they meet the three primary criteria for patentability:
industrial applicability, inventive step, and novelty. A product or procedure
for a particular purpose can be made by biotechnology by using an organism, or
a part of an organism or other biological system.
The United States and India possess
distinct legal frameworks and regulatory landscapes for biotechnology patents.
A comprehensive study of these differences enables professionals to navigate
the complexities of international collaboration, technology transfer, and
investment strategies.
A comparative analysis of the USA and
Indian Perspective is to provide a comprehensive examination of the legal,
economic, and societal implications of biotechnology patents in these two
significant jurisdictions. By achieving these objectives, the research paper
aims to contribute valuable insights to academia, and the broader public,
fostering a deeper understanding of the global implications of biotechnology
patenting and guiding future developments in this critical field.
This research employs an empirical
methodology to investigate biotechnology patenting, specifically comparing the
perspectives in the USA and India. The study relies on survey conducted,
articles, and books to analyse the practical implications of patent laws.
Through this empirical approach, the research aims to provide a data-driven
understanding of how biotechnology patenting differs between the two
jurisdictions and their tangible effects on legal, economic, and societal
aspects.
K. Jeyaprakash (2016) elucidates the
pivotal role if Intellectual Property Rights in the realm of biotechnology. The
author offers an insightful exploration of the legal framework’s impact on
innovation, providing a comprehensive overview of patent laws and their application
within the biotech domain. The article “Biotechnology Patenting” by Jidesh
Kumar (2004) deals with the latest technology to create major intellectual
property problems for courts and legislatures, viz,. biotechnology.
The increasing significance of
biotechnology in addressing global challenge prompts a critical examination of
the Intellectual Property Rights landscape. Despite its acknowledged
importance, a gap exists in understanding how IPR, particularly patents,
functions in biotechnology across diverse jurisdictions such as the United
States and India.
Distinct legal and regulatory
environments in USA & India influence innovation incentives, industry
dynamics, and societal implications differently which ultimately makes the
biotechnology patent differ in two countries.
A.
How
do the patent laws and regulatory frameworks in the united states and india
differ concerning biotechnology?
B.
How
do differences in patent examination processes and criteria contribute to the
disparities in the scope and nature of biotechnology patents granted in the
united states and india?
C.
How
do legal precedents and court decisions in the united states and india shape
the interpretation and enforcement of biotechnology patents?
Regulatory Frameworks for Biotechnology Patents in US
and India
The law which governs patents in
India is Patents Act, 1970 and the Patents Rules, 2003, which includes grant of
patents to biotechnology inventions. As per the Patents Act, 1970, in India not
everything created or invented under the Sun is patented or patentable.
The way the laws are worded
determines the main distinction between the legal systems of the two nations.
The US defines what CAN be patented in a more demonstrative manner. Conversely,
India's patent regulations specify what is NOT eligible for patent protection.
Minor modifications or extensions to
awarded patents are prohibited by Indian Patent Law. That flexibility is,
however, granted by US patent laws.
The Utility patent is a legal concept
in the United States. This permits the patenting of a machine or process
discovery as long as it is new, practical, and obscure. In India, this is not
the case. India's patent rules prohibit patenting the act of discovering a
machine, technique, or product.
The United States permits patents for
the discovery or invention of novel plants under the Plant Patent Act. There is
no similar provision in India. In the United States, new and inventive business
models are patentable. India also prohibits this. It is clear from the
comparison above that US patent laws are more flexible than those in India.
This results from the limitations imposed by the nations on WHAT is patentable.
This depends in part on how "non-obviousness" is defined. In essence,
non-obviousness indicates that no other person with the same competence is
aware of the invention.
Naturally, as people's perceptions
can differ, the definition of such a term needs to adhere to clear guidelines.[1]
For patent practitioners, the United
States Patent and Trademark Office (USPTO) offers examination guidelines and
training materials. The papers offer subject matter eligibility instructions,
examples, training, and guidelines for treating related concerns in patent
applications and for assessing compliance with 35 U.S.C. 112.[2]
Additionally, the USPTO offers a
two-part test for patent practitioners that consists of 100 multiple-choice
questions spread over two three-hour sessions. The exam measures candidates'
familiarity of patent laws, regulations, and procedures as well as their
capacity to apply that information to particular situations.[3]
The MPEP (Manual of Patent Examining
procedure) offers comprehensive information about the review of biotechnology
patent applications, including the conditions that must be met in order for a
patent to be eligible, the kinds of claims that can be made, and the review
processes.[4]
The guidelines for the review of
biotechnology patent applications have been released by the Indian Patent
Office. The purpose of the guidelines is to create standardised and consistent
procedures for the Patents Act of 1970's examination of biotechnology and
related subject patent applications. The instructions offer comprehensive
details about the review process for biotechnology patent applications,
including the kinds of claims that can be made, the conditions that must be met
for patentability, and the methods for examination.[5]
The legal framework in the field of
biotechnology has come across many challenges which has led to certain
amendments done in the Patents Act, 1970 and the Patents Rules, 2003, time to
time. Diamond v. Chakrabarty [6]is
a landmark case in the United States that expanded the application of the U.S.
Patent Act, which had an impact on the biotechnology industry.
In the Monsanto Technology LLC v.
Controller of Patents and Designs [7] case,
the Intellectual Property Appellate Board (IPAB) addressed a patent application
related to creating transgenic plants resistant to environmental challenges.
The disagreement centered on whether the process involved significant human
intervention, as claimed by Monsanto, or if it constituted a non-patentable
biological regeneration and selection process, as argued by the Indian Patent
Office (IPO). While the IPAB disagreed with the IPO regarding the application
of Section 3(j) of the Patents Act, it upheld the IPO's decision on lack of
inventive step and ineligibility under Section 3(d). The IPAB determined that
the claimed method involved human intervention on a plant cell, making it
exempt from Section 3(j).
Additionally, the evolution of
biotech patent doctrine in India was influenced by a 2002 ruling in Dimminaco
AG v. Controller of Patents,[8]
Designs, and Trademarks. In this case, Dimminaco AG sought to patent a method
for producing an infectious bursitis vaccine for poultry. However, the IPO
rejected the application, arguing that creating a vaccination containing a
living virus did not qualify as a manufacturing method under the existing
patent laws, which required inventions to be related to a "new and
useful" method of manufacture. This ruling significantly impacted the
interpretation of patent eligibility in the biotechnology sector.
Regarding living organisms and
patentability, certain provisions exclude the patenting of sequences directly
isolated from nature, unless obtained through substantial human intervention. A
pivotal 2013 US Supreme Court decision, Association of Molecular Pathology v
Myriad Genetics Inc,[9]
declared that isolated, naturally occurring full-length DNA molecules or gene
fragments are not patent-eligible, being deemed "products of nature."
However, complementary DNAs (cDNAs), lacking naturally occurring non-coding
regions (introns), were deemed patent-eligible. The court reasoned that cDNAs,
synthesized in the laboratory from RNA, are not naturally occurring, affirming
the patent eligibility of engineered/recombinant DNAs.[10]
In summary, the regulatory frameworks
for biotechnology patents differ significantly between the United States and
India. The U.S. defines what can be patented more explicitly, while India
specifies what is not eligible for patent protection. The flexibility of U.S.
patent laws contrasts with more restrictive regulations in India. Challenges
and opportunities in biotech patent examination reflect these disparities.
Furthermore, court decisions, such as the Monsanto case, shape patent
interpretation, demonstrating the ongoing evolution of biotech patent doctrine.
Notably, the 2013 U.S. Supreme Court decision on DNA molecules underscores
distinctions in patent eligibility between natural and engineered elements.
Journals
“Biotechnology Patenting” by Jidesh
Kumar (2004)
“Guidelines for Examination of
Biotechnology Applications for Patent”, Office of the Controller General of
Patents, Designs and Trademarks, March 2013
Application and Registration process,
USPTO
Assoc. for Molecular Pathology v.
Myriad Genetics, Inc., 569 U.S. 576 (2013)
Debashish Banerjee and Pankaj
Musyuni, “Biotechnological inventions in India: law, practice and challenges”,
Examination Guidance and Training
Materials, USPTO
K. Jeyaprakash, “Intellectual
Property Rights – Role in Biotechnology, International Journal of Current
Microbiology and Applied Sciences
Manual of Patent Examining Procedure
(MPEP), Ninth Edition
Rahul Dev, “Comparative Study between
Indian & U.S Patent Laws”
Vidhi Birmecha, “Biotechnological
Patenting: Difference between Indian Patent Law and American Patent law”, Bn’W
Journal
Case Laws
Assoc. for Molecular Pathology v.
Myriad Genetics, Inc., 569 U.S. 576 (2013)
Diamond v. Chakrabarty, 447 U.S. 303
(1980)
Dimminaco A.G. v. Controller of
Patents and Designs, (2002) I.P.L.R. 255 (Cal)
Monsanto Technology LLC v. Controller
of Patents and Designs (2022)
Empirical
research report
[1] Rahul Dev, “Comparative Study
between Indian & U.S Patent Laws”, available at https://patentbusinesslawyer.com/comparative-study-between-indian-us-patent-laws/
[2] Examination Guidance and Training
Materials, USPTO, available at https://www.uspto.gov/patents/laws/examination-policy/examination-guidance-and-training-materials
[3] Application and Registration
process, USPTO, available at https://www.uspto.gov/learning-and-resources/patent-and-trademark-practitioners/becoming-patent-practitioner
[4] Manual of Patent Examining
Procedure (MPEP), Ninth Edition, Revision 07.2022, Published February 2023,
available at https://www.uspto.gov/web/offices/pac/mpep/index.html
[5] “Guidelines for Examination of
Biotechnology Applications for Patent”, Office of the Controller General of
Patents, Designs and Trademarks, March 2013
[6] Diamond v. Chakrabarty, 447
U.S. 303 (1980)
[7] Monsanto Technology LLC v.
Controller of Patents and Designs (2022)
[8] Dimminaco A.G. v. Controller of
Patents and Designs, (2002) I.P.L.R. 255 (Cal)
[9] Assoc. for Molecular Pathology
v. Myriad Genetics, Inc., 569 U.S. 576 (2013)
[10] Debashish Banerjee and Pankaj
Musyuni, “Biotechnological inventions in India: law, practice and challenges”,
Published on 23 October 2015, IAM, available at https://www.iam-media.com/global-guide/iam-yearbook/2016/article/biotechnological-inventions-in-india-law-practice-and-challenges
Article Information
BIOTECHNOLOGY PATENTING, DIFFERENCE BETWEEN USA AND INDIAN PERSPECTIVE BY: MAYURI HANSDA
Authors: MAYURI HANSDA
- Journal IJLRA
- ISSN 2582-6433
- Published 2024/02/14
- Issue 7
About Journal
International Journal for Legal Research and Analysis
- Abbreviation IJLRA
- ISSN 2582-6433
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