INTRODUCTION
A broad range of methods utilizing living things is referred to as “biotechnology.”[1] Even though biotechnology has a wide range of uses in industries including medicines, food, and agriculture, investment returns could be better. Thus, businesses must preserve their ideas. Innovations in biotechnology are now protected by IP, however, this protection is not guaranteed. Injurious challenges to IP rules and regulations have resulted from the convergence of biotechnology and IPR. Regarding the patentability of living things, which is mainly prohibited, there are a great many different views and disagreements.[2] The ethical debates surrounding biotech inventions are sparked by a variety of issues, such as those raised by the hybridization of human and animal species, the perceived diminution of human dignity, the taking of human life, the exploitation of women for their eggs, and the idea of human ownership. The moral debates surrounding the patenting of biotech ideas are not exclusive to India; organizations in several other nations have commissioned studies and written reports on the ethical and moral concerns surrounding the patenting of certain biotech technologies.[3]
The debate over biotech research that is morally dubious is heated and well-publicized, but the problem of patents on such research is given much less public attention. Nonetheless, due in large part to the connection between patents and research, the issue of patents on the ethically dubious field of biotechnology is crucial. Incentives for the creation of innovative public goods that would otherwise be underproduced are one of the main justifications for giving exclusive patent rights. Nevertheless, conflicting laws work against government support and private ownership of some ethically dubious biotech technologies. It should come as no surprise that determining which inventions should be included in this category is challenging.[4]
THE MORAL ISSUES AND IMPLICATIONS OF BIOTECHNOLOGY PATENTING
While modern new biotechnology has the potential to have significant positive effects on the economy and other spheres, it also carries the risk of having negative effects on human health, the environment, the “natural” biological order, and socioeconomic conditions. The use of such technology usually transgresses established moral, ethical, and religious principles.[5] For the biotechnology business to continue to expand, strong intellectual property rights (IPRS) are crucial. The patenting system, which began to formally permit patents for living things like microbes in 1980 [Diamond vs. Chakrabarty (1980)[6] 26 USPQ 193 altered the course of US patent law by upholding a claim to a bacteria, has been credited with spurring significant investment in biotechnology. In essence, Chakrabarty created a bacteria that was genetically altered to be able to disassemble various elements of crude oil. One of the most significant areas for patenting is now biotechnology. Moreover, it is one of the domains where patenting raises a plethora of moral and ethical problems.[7] A few of the ethical and moral implications of biotechnology patenting are discussed below:
ORGAN TRANSPLANTATION: It is well known that the pig appears to be the best animal for xenotransplanted human organs. Likely, a genetically modified pig will soon be commercially accessible in which the mechanism that causes a pig’s organ to be rejected hyper-acutely when transplanted into a human person, would have been made useless. The transplanting of organs from such a pig to a person would thus be identical to homotransplantation, for which there are already defined and readily available methods. Yet, this raises a significant moral dilemma for those who oppose the biological development that makes organ donation feasible as well as those who, because of their religious convictions, view pigs as an unclean species.[8]
MICRO-ORGANISMS[9]: In the industrial production of biochemicals like ethanol, enzymes, antibiotics, etc., microorganisms have played a significant role. Moreover, they are used in the food processing sector to improve industrial procedures that result in sustainable commercial output (industrial biotechnology).[10] Regarding microorganisms, special emphasis is made on the possibility of genetically engineered microorganisms “escaping” from labs and dispersing across our environment. Some creatures undergo genetic modification with the express intention of being released into the environment.[11] In 2002, Dimminaco A.G. filed a patent application for the method for creating a live vaccination for the contagious chicken illness bursitis. The disease-fighting innovation included a live vaccination. Because the procedure did not qualify as an innovation under the Indian Patent Act of 1970, the Patent Office denied the application. In a decision on appeal, the Calcutta High Court held that there is no legal prohibition to accepting a manufacturing method as patentable if the final product includes a live organism.[12]
GENETICALLY MODIFIED SEEDS: Plant development has benefited significantly from biotechnology. For instance, genetic engineering enables the introduction of novel genes with advantageous properties like insect repellant. Plants, plant types, and seeds cannot be patented under the Patents Act, however, genetically modified seeds may include man-made gene sequences. The creation of a novel plant variety—which may consist of the seeds used for seed propagation—and transgenic variations are both covered by The Protection of Plant Varieties and Farmers Rights Act, 2001. Yet, the Patents Act enables biotechnology firms to patent their genetically modified seeds, which may be produced in a lab and sold. These seeds can be transgenic. An inventor is only permitted to make, use, produce, sell, and distribute their invention if they have a patent, which is an exclusive right. Farmers will be prevented from preserving and trading seeds as a result of a seed patent. According to the Supreme Court’s ruling in the Monsanto & Nuziveedu Seeds case[13], biotechnology crops can be protected under the Indian Patent Act of 1970 as significant advances.
CONCLUSION
To sum up the aforementioned observations, it should be noted that the IP landscape has significantly changed over the past few decades, particularly concerning biotechnological advancements. What was a developing field a few decades ago is now a major player.[14] How, ever still, moral issues continue to arise regarding biotechnology patenting. Strong intellectual property (IP) regulations are required to safeguard the results of inventive activities, including monetary inputs. The best approach for researchers to safeguard any potential financial gain from their produced ideas or technology is through patents. [15]
Within the current IP system, modern biotechnological breakthroughs are faced with significant difficulties.[16] As biotechnology is more or less in a grey area currently regarding legal and moral considerations, it is fair to assume that the moral implications of patenting it would be in turmoil. Yet, emerging nations like India are changing their patent rules to attract foreign investors to compete in the global biotechnology-based industry to establish consistent standards for the patenting life forms, it will be crucial for biotechnology in particular that international policy frameworks are coordinated.[17]
Author(s) Name: Isha Agarwal (College of Law and Legal Studies, Teerthanker Mahaveer University)
Reference(s):
[1] Sterckx and Sigrid, Biotechnology, patents and morality (first published 2000, Routledge 2021) 406
[2] Harikesh Bahadur Singh and Alok Jha and Chetan Keswani (eds), Intellectual Property Issues in Biotechnology (CABI 2016)
[3] Bagley and Margo A, ‘A global controversy: The role of morality in biotechnology patent law’ (2007) University of Virginia Legal Working Paper Series 57 <A Global Controversy: The Role of Morality in Biotechnology Patent Law (bepress.com)> accessed 27 February 2023
[4] Id 3
[5] Dayuan Xue and Clem Tisdell, ‘Safety and socio-economic issues raised by modern biotechnology’ (2000) 27(7-10) International Journal of Social Economics < https://doi.org/10.1108/03068290010335217> accessed 27 February 2023
[6] Diamond v. Chakrabarty [1980] 447 US 303
[7] Sujit Bhattacharya, ‘Patenting in Biotechnology’ (2007) 27(6) DESIDOC Bulletin of Information Technology <Patenting in Biotechnology – ProQuest> accessed 27 February 2023
[8] Bhargava and Pushpa M, ‘The social, moral, ethical, legal and political implications of today’s biological technologies: an Indian point of view’ (2006) 1(1) Biotechnology journal 34-46 <The social, moral, ethical, legal and political implications of today’s …> accessed 27 February 2023
[9] Sterckx and Sigrid, Biotechnology, patents and morality (first published 2000, Routledge 2021) 406
[10] Harikesh Bahadur Singh and Alok Jha and Chetan Keswani (eds), Intellectual Property Issues in Biotechnology (CABI 2016)
[11]Sterckx and Sigrid, Biotechnology, patents and morality (first published 2000, Routledge 2021) 406
[12] Dimminaco A.G. v. Controller of Patents and Designs [2002] IPLR 255 (Cal)
[13] Monsanto Technology LLC Thru the Authorised Representative Ms. Natalia Voruz & Others v Nuziveedu Seeds LTD Thru the Director & Others [2019] (SC)
[14] Angad Singh and Sharanabasava Hallihosur and Latha Rangan, ‘Changing landscape in biotechnology patenting’ (2009) 31(3) World Patent Information 219-225 <Changing landscape in biotechnology patenting – ScienceDirect> accessed 27 February 2023
[15] Id 14
[16] Harikesh Bahadur Singh and Alok Jha and Chetan Keswani (eds), Intellectual Property Issues in Biotechnology (CABI 2016)
[17] Id 16
