THE LEGAL AND ETHICAL ISSUES FOUND IN PATENTING OF THE BIOTECHNOLOGY

INTRODUCTION

We’ve recently seen a trend in scientific advances at the intersection of biology and technology in fields like biotechnology, bioinformatics, and synthetic biology. As a result, a uniquely biological perspective has been implemented in newly established technologies in fields as diverse as design, architecture, material science, health care, and agriculture. The pillars of modern science, as taught to us by thinkers such as Rene Descartes, have taught us to place humans outside the natural sphere. We also distinguished between the cultural, or man-made, and the natural.

Scientific and technological progress has separated us from our natural environment. The ostensibly rational, modern man disconnected himself from the natural world, seeking to regulate and exploit it with his own resources for his own ends. Biotechnology is a broad field of biology that involves the use of living systems and organisms to create or manufacture goods[1]. It also overlaps with related scientific areas in terms of methods and applications. Biotechnology inventions are important for human development. It is the broad area of biology involving living systems and organisms to develop or make products or any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific uses. [2]

A patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem. To get a patent, technical information about the invention must be disclosed to the public in a patent application.[3] The biotechnology sector is being heralded as the Republic of India’s “rising star.” It has made steady progress in recent years and has the potential to become a global leader in the biotech industry. Furthermore, patents are a critical means of disclosing biotechnology inventions.

LEGAL ISSUES

Due to the technical and ethical issues involved, legal protection remains very sensitive and sophisticated in the case of biotechnology in general, and agricultural biotechnology in particular. The emerging Trade-Related Aspects of Property Rights (TRIPS) compliant legal system in India, which went into effect on January 1, 2005, is posing significant challenges to the Indian biotech industry. TRIPS Article 27.3 (b) excludes biological processes for the assembly of plants or animals as patentable materials, but patents are frequently granted to microorganisms, non-biological, and microbiological processes used in plant and animal assembly. This includes gene sequences, which can be for a specific character, a promoter, genetic markers, or something similar.

With the rise of transgenic research, both publicly and privately funded research organisations must understand the issues of royalty payments, material transfer agreements (MTA), and legal obligations and bindings. Many governments refuse to recognise the patentability of new biological forms and processes because IPR protection of new life forms raises a slew of unfavourable technical and ethical concerns. Because IPR protection is only granted for inventions and not discoveries, it’s difficult to say whether a new body in the form of a gene, DNA, cell, etc. is a scientific discovery or a technological invention in the case of biotechnology innovations. Discovery is simply making available what nature already has. A substance found or discovered in nature that is freely occurring is not patentable. However, if the substance found in nature must first be isolated from its surroundings and a method for obtaining it is developed, that method is considered an invention and thus patentable.

ETHICAL ISSUES

It can be seen that biotechnology and life form patentability are being researched in India. Every innovation is indeed motivated by a need. Our needs are growing in this modern age, fueling inventions, but it is also our duty to defend our rights. While the patent system was designed primarily to determine the patentability of an invention, it has developed over time to consider moral issues. In the age of biotechnology, where patents are being obtained for innovations originating from tainted sources, issues of the morality of an invention have become more important.

Requiring patent applicants to provide information about the ethical sourcing of human biological content does not inherently deviate from the patent law’s primary goal. The patent law’s morality clause serves as a filter, discouraging patents for innovations originating from tainted sources. Biotechnology is a significant advancement in science, but socio-cultural issues must be addressed because India has ancient basic ethics and religious practices. New research in these areas is encouraged, and the public should be kept up to date on biotechnological developments. Existing information and emerging technology systems can be used in tandem to improve production through a decentralized and participatory method. Despite the numerous laws and acts in place in the country, there are still many gaps that are impeding the growth of the biotechnology field. Ethics and morality have always been relevant in the country.

CONCLUSION

New research in these fields should be promoted, and the public should be kept informed about biotechnological advancements. The morality clause of patent law acts as a filter, preventing patents for inventions arising from tainted sources. Despite the numerous laws and acts in place in the country, there are still many gaps that are impeding the growth of the biotechnology field. Ethics and morality have always been relevant in the country.

In India, the regulation of access to biological resources seeks to prevent bio piracy while also protecting the rights of the holders of these resources and the traditional expertise associated with them, by imposing preferential treatment for study, survey, and commercial use made by firms and individuals, foreigners and Indians. It can be concluded from the study that little simple and precise guidelines, as well as some new laws in accordance with the latest trend in biotechnology, will assist India in achieving its full potential. Making any strategic decisions on patenting in India, Innovators, buyers, and patent practitioners ought to examine their inventions in mild of Indian patent regulation.

The large opportunities present in the country should be utilized. Given that biotech is still in its early stages, the methodologies used in the industry have a lot of potential for development, new techniques should be used, and novel innovations should be given more priority and chances to show its potential. The missing link that is seen between the research and commercialization should be minimized. There is also a very vast lack of venture capital seen in the companies dealing with biotechnology. The relatively low R&D expenditure by industry is also seen as one of the major problems. The means of gaining capital should be made more. More opportunities should be given.

Author(s) Name: Shreya Patel (The Maharaja Sayajirao University of Baroda)

References:

[1] Ashwin Rajan, ‘What is the main purpose of Biotecgnology ?(paid for articles –  March 16 (2022)  <‘What Is The Main Purpose Of Biotechnology? (paidforarticles.com) > accessed on 3 June 2022.

[2] Monika Shailesh, ‘India: Biotechnology Patent and Related Moral Issues’ (Manupatrafast.com) < INTELLECTUAL PROPERTY AND TECHNOLOGY LAW UPDATES (manupatrafast.com) > Accessed on 2 June 2022.

[3] World Intellectual Property Rights Oragnisation , <https://www.wipo.int/patent/en/>