Gene Patenting in the 21st Century: The Need for Comprehensive Laws

Symbiosis Law School, Pune

Symbiosis international (deemed university)

ABSTRACT

Recent instances demonstrate that the issuance of patents on humans and/or living organisms'
genetic material is still fraught with uncertainty. Despite more than a decade of heated scholarly
and public debate, the question of whether we should authorize patents on human genetic
material appears to remain unanswered. Even foreign organizations have voiced their worry. The
1997 Universal Declaration on the Human Genome and Human Rights, for instance, stipulates
that "the human genome in its natural condition must not give rise to financial profits." Many
have pushed further to call patenting human genes a sort of "biopiracy." If living organisms and
their components, or something that exists naturally, cannot be patented, how could such a patent
exist? To some degree, we are correct, yet gene patenting does occur, and over 5000 genes have
been patented in the United States. However, whether or not genetic patenting should be lawfully
patented is a contested issue at the moment. This paper explores the term before delving into the
various legal, socio-legal, and ethical controversies surrounding it.

Keywords: Gene Patenting, Myriad, Patents, Organisms.

1. INTRODUCTION
The discussion about whether genetic patents are acceptable has had little impact on the
patent-granting bodies. Since the commencement of human genome research, patent
administrations across the globe have awarded patents for human genetic 'inventions' with no
distinctive or major regulatory impediments. A patent will be awarded as long as patent
seekers meet the practical standards of their region's patent office. Even in France, where the
patentability of human genetic material is still being debated at the topmost levels of
administration, no genetic patent awarded by the European Patent Office (EPO) has really
been overturned.
2. REVIEW OF LITERATURE
a. (Huang, 2005) The paper discusses how the biotechnology sector is mainly associated
with the commercial creation of medicinal, biochemical, and pharmacological goods and
 procedures, some of which are generated from DNA molecule modification and their
encoded proteins. Patents have evolved as an essential, and often contentious, instrument
for safeguarding these biotechnological systems and services during the past thirty years,
and the main conditions for issuing a patent are creativity, non-obviousness, and
usefulness.1
b. (Miller, 2019) The study discusses how native gene and protein structures cannot be
copyrighted in the EU or the US. Even so, biological molecules and gene/protein
sequences exactly equal to those found naturally may be patent shielded under both
regimes in certain situations, and the prerequisites for patentability of gene/protein
patterns differ between both the EU and the US, resulting in a number of problems and
factors that patentees and patent drafters should be cognizant of when attempting to
protect genetic samples in these regions.2
c. (Boyer & Cohen, 2017) The invention of recombinant-DNA (rDNA) technology—the
process by which genetic information from one organism is artificially presented into the
genome of an organism and then reproduced and conveyed by that organism—was
largely credited to Herbert W. Boyer, Stanley N. Cohen, and Paul Berg, though many
other scientists also contributed significantly to the technological advances.3
d. (Boyd & Karen, 1997) To properly flourish, the business requires special treatment; that
is, there is something incorrect with letting the market to choose how much capital
biotechnology gets. Secondly, for egalitarian and financial reasons, society should
promote biotechnology. These ideas aided in the development of the paper's road map.4
e. (Polyakov & Goryunov, 2009) This paper talks about the Myriad Case and how the
isolation of a gene does not make it patentable because it is still a component of the gene
and so occurred naturally. It was believed that Myriad had not generated anything and
had just divided segments of DNA. This does not meet the criteria for an innovative, non-
obvious innovation.
1
Huang, S. (2005). The Nonobviousness Requirement for Biotechnological Inventions - Resolving Uncertainty in
Favor of Innovation. Digital Commons. Retrieved March 9, 2022, from
https://digitalcommons.law.scu.edu/cgi/viewcontent.cgi?article=1386&context=chtlj.
2
Patenting of gene and protein sequences: An EU and US perspective. Taylor Wessing. (2019, October). From
https://www.taylorwessing.com/synapse/ti-patenting-gene-sequences.html
3
Boyer, H. W., & Cohen, S. N. (2017, December 11). Recombinant-DNA (rDNA) technology. Science History
Institute. From https://www.sciencehistory.org/historical-profile/herbert-w-boyer-and-stanley-n-cohen
4
Boyd, K. I. (1997, January 1). Nonobviousness and the Biotechnology Industry: A proposal for a doctrine of
economic nonobviousness. Berkeley Law. From https://lawcat.berkeley.edu/record/1115961

2|Page
3. WHY DOES BIOTECHNOLOGY AND GENE PATENTING NEED TO BE
PERMITTED?
The first theory has been supported by an examination of the sector's culture and economics,
while the second is supported by an examination of the potential advantages the business may
provide to society.

A. Biotechnology Industry’s Cultural Factors

The biotechnology sector is distinguished by a number of interconnected characteristics. The fact

that the business is predominantly made up of tiny, single-product start-up enterprises is perhaps
the most evident of them. This research contends that this critical feature is connected to and
necessitated by two other characteristics of the industry: its college qualified personnel and the
strong interaction between fundamental and applied science in the sector. The development of
the first biotechnology business, Genentech, exemplifies this interdependence. The fundamental
scientific revelation that enables the industry is a method of producing functional chimeric DNA
(recombinant DNA) discovered in 1973 by Stanley Cohen at Stanford University and Herbert
Boyer at the University of California5, San Francisco, whereby a patent was filed in 1974 and
granted in 1980. By 1977, Genentech6, established by venture investor Robert Swanson and
Hebert Boyer, had successfully created genetically modified insulin. It is worth noting that the
potential economic usefulness of the academic study was instantly obvious and remains so. To
accomplish so, the sector must develop an atmosphere comparable to that of a university, and as
a consequence, realistic financial forces must be offered to ensure a high standard of innovation.

B. The Biotechnology Industry's Economic Factors

In addition to cultural characteristics and the associated economic concerns that must be
preserved in order for the biotechnology sector to stay creative, the biotechnology industry has
merely economic reasons that highlight the need for particular regulations. Venture money, for
example, is an essential source of financing for biotechnology firms. Professor Robert Merges'
statement that "extremely costly and highly dangerous discoveries are likely to be pursued at

5
Boyer, H. W., & Cohen, S. N. (2017, December 11). Recombinant-DNA (rDNA) technology. Science History
Institute. From https://www.sciencehistory.org/historical-profile/herbert-w-boyer-and-stanley-n-cohen
6
1976: First Genetic Engineering Company. Genome.gov. (n.d.). From https://www.genome.gov/25520305/online-
education-kit-1976-first-genetic-engineering-company

3|Page
fewer than socially optimal levels" is related to this issue. 7 Biotechnology innovations are usually
both dangerous and costly. Inherently, the first investment seems to be more appealing, owing to
its reduced risk. This perception may be expressed statistically using a metric known as variance.
Variance, as the name indicates, defines how widely varied a collection of possible results is in
this situation. The greater the variation, the greater the danger.

Biotechnology ideas have high variance due to the many challenges that must be overcome
before commercial success.8 Before accessing the market, there must be favorable in vitro data,
animal studies, and three or four phases of clinical trials. Biotechnology goods must also
compete with conventional, and often less costly, alternatives. Finally, when a biotechnology
product is discovered to be effective in a variety of circumstances, there is still the prospect of a
large reward.

4. OBJECTIVES OF THE PAPER

Even though many of the difficulties raised in this piece are a natural result of the use of patents
in an economic system, policymakers must consider whether these are the outcomes they want to
favor. Many of the worries seem to be about licensing, but their true implications and availability
are yet unknown. Although there are occasional instances of exclusive licensing rules, such as
those tried in the BRCA case, they seem to be an anomaly rather than a norm and a serious
danger. Instead, the sheer number of patents related to the application of a specific product or
technique seems to provide a tough quandary. Hence, the main goal of this paper is to push for
more detailed licensing methods to meet the demands and resources at different levels.

5. METHODOLOGY

The necessity for precise gene patenting rules in India is explained in this study report. In order
to better comprehend the history behind it up to now, the report expanded to data acquired via
research papers published in the past. I drew on individual study in the realm of biotechnology,
including its complexity, economic implications, and the scarcity of gene patenting.

6. CONCLUSION

7
Boyd, K. I. (1997, January 1). Nonobviousness and the Biotechnology Industry: A proposal for a doctrine of
economic nonobviousness. Berkeley Law. From https://lawcat.berkeley.edu/record/1115961
8
Boyd, K. I. (1997, January 1). Nonobviousness and the Biotechnology Industry: A proposal for a doctrine of
economic nonobviousness. Berkeley Law. From https://lawcat.berkeley.edu/record/1115961

4|Page
Even though many of the difficulties raised in this piece are a natural result of the use of patents
in an economic system, policymakers must consider whether these are the outcomes they want to
favor. Many of the worries seem to be about licensing, but their true implications and availability
are yet unknown. Although there are occasional instances of exclusive licensing rules, such as
those tried in the BRCA case, they seem to be an anomaly rather than a norm and a serious
danger. Instead, the sheer number of patents related to the application of a specific product or
technique seems to provide a tough quandary. On the other hand, there may be an anti-common
tragedy in which no one or just a few people utilize the invention(s) or patent(s) owing to huge
accrued fees. One practical issue is that doctors, clinical labs, and researchers do not know who
owns the patents or whose procedures are protected by them.

Licensing methods should be developed to meet the demands and resources at different levels.
For example, there may be distinct criteria for fundamental research, therapeutics, and
diagnostics, among other things. Governments should take a more active role in this regard. They
should ensure that hospitals have access to required diagnostic instruments while not infringing
on patent rights. Diagnostic technologies, such equipment, technical instruments, general
software, and so on, might be overseen by specialists in hospitals. License rates should ideally be
modest, since large license payments lead to dissatisfaction and allegations of licensing in
general, even when there is likely no better option. The benefit sharing concept is widely
endorsed by the global policy making community. Concrete proposals for implementing this
concept in the realm of patents are required.

As stated above, other (ancient) cures and creative approaches to the issues and concerns raised
in this background text may exist. The most drastic alternatives offered include abandoning the
patent system and replacing it with fairer sui generis right. Many others believe that the old
patent system works rather well and adequately serves the welfare of stakeholders. In any case,
the active implementation of these policies is important to consider and necessitates actual
actions from the many stakeholders.

5|Page
7. REFERENCES
1. Huang, S. (2005). The Nonobviousness Requirement for Biotechnological Inventions -
Resolving Uncertainty in Favor of Innovation. Digital Commons. Retrieved March 9,
2022, from https://digitalcommons.law.scu.edu/cgi/viewcontent.cgi?
article=1386&context=chtlj.
2. Patenting of gene and protein sequences: An EU and US perspective. Taylor Wessing.
(2019, October). From https://www.taylorwessing.com/synapse/ti-patenting-gene-
sequences.html
3. Boyer, H. W., & Cohen, S. N. (2017, December 11). Recombinant-DNA (rDNA)
technology. Science History Institute. From https://www.sciencehistory.org/historical-
profile/herbert-w-boyer-and-stanley-n-cohen
4. Boyd, K. I. (1997, January 1). Nonobviousness and the Biotechnology Industry: A
proposal for a doctrine of economic nonobviousness. Berkeley Law. From
https://lawcat.berkeley.edu/record/1115961
5. 1976: First Genetic Engineering Company. Genome.gov. (n.d.). From
https://www.genome.gov/25520305/online-education-kit-1976-first-genetic-engineering-
company

6|Page