BIOTECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS: CONCERNING INDIAN SUBCONTINENT

Sanchita Bera

Introduction

Right from the dawn of human civilization, ‘Biotechnology’ has been, if not, extensively, minimally used in agriculture, food production, and medicine. The advancement in science, technology, and research has influenced a revolution in biotechnology, thereby making human life easier and satisfying. The word ‘bio’ has been derived from the Greek word ‘bios’ which means life, while ‘technology’ means the application of scientific knowledge for practical purposes to get desired results[1]. Hence, Biotechnology means the scientific knowledge that uses life or living entities like microorganisms, plants, and animals for practical and commercial purposes to get desired results[2]. The term ‘Biotechnology’ was for the first time coined by Karl Ereky, an agricultural engineer from Hungary. Biotechnology has been used for centuries and is one of the oldest technologies in the world. Biotechnology has been used mainly in customary manufacturing processes, for example, using yeast for making beer, wine, bread, curd, etc. The human race already knew these techniques long back. All these techniques can effortlessly be termed as ‘Biotechnology’. Now, all these biotechnological inventions are well protected by the Intellectual Property Rights, more specifically the ‘Patent Laws’. The development of technological proficiencies has resulted in massive industrialization and pushed countries towards adopting newer international agreements to suit the present needs. This necessity has given rise to the transformation from GATT (General Agreement on Tariffs and Trade) to WTO (World Trade Organization). The WTO has various agreements including TRIPS (Trade-Related Intellectual Property Rights). The main function of TRIPS is the protection and promotion of IPR (Intellectual Property Rights). WTO encourages countries to become a signatory to the TRIPS-plus protection even in the presence of WTO rule-based organization. But the question arises as to whether India has opened its patenting arms towards Biotechnological inventions?

The tussle between Biotechnology and Granting of Patents in India

India has a long history of evolving, drafting, and adjusting according to the international standards. Its Patent legislation finally came out with the Patents Act, 1970. This patent legislation was a beacon into the field of industrial development in India with the main objective of encouraging innovation which will eventually lead to technological development. India is also a signatory to the TRIPS which is one of the sub-agreements of WTO. TRIPS obliged India to amend the seemingly perfect Patent legislation in the years 1999, 2002, and 2005. But even after amendments, the Patenting of Biotechnology in India faces certain issues. The following highlights the same:

  1. Discovery versus Invention: Discovery means to obtain sight or knowledge for the first time[3], which means any kind of living or non-living found in the nature that already existed is known as discovery. Invention means to produce for the first time through the use of imagination or indigenous thinking or experiment[4], which means any kind of living or non-living which is invented/made not found in nature or did not exist. Firstly, the legal criteria for an invention to be protected under the Patent regime requires such ‘thing’ to be an invention and not discovery, now the question arises as to whether ‘Biotechnological innovations’ are inventions or discoveries because they include new forms or modification in the existing forms in genes, DNAs, tissues, cells, micro-organisms, etc. Hence, while considering the patentability of biotechnological innovations, the first question that emerges is the interpretation as to in which category such innovation falls under. Another debatable subject of patenting policies are its tough criteria, that is, novelty, industrial applicability/utility, non-obviousness, and disclosure, because the biotechnological invention’s contemplation for industrial utility stands as a barrier for the grant of patent and the premium standards followed for analyzing novelty and non-obviousness becomes difficult to be applied upon the living creatures.

Secondly, many activists and NGOs argue that changing or modifying genes, cells, DNA is not appropriate because they are a natural boon to the human race and can change made into the same can be approved neither ethically nor morally. Many consider biotechnological inventions immoral or unethical. Therefore, they do not support patenting of biotechnological inventions. Thirdly, as stated above, allowing biotechnological inventions to be patented raises ethical issues, because when patents are granted such new or modified life forms gains ownership, here ownership upon life form surfaces the violation of human rights, and every human must respect the rights of others (as stated in the DPSP). No human can abuse their position and violate the rights of other living creatures, neither can they transgress the dignity, integrity, and rectitude of other living creatures. 

  1. Requirements of depositing biological materials: For obtaining a patent on any microorganism, the applicant is required to deposit the same in the depository under the Budapest Treaty of 1977, because it is difficult to exam the same in a written description without a sample for it. The main problem arises when the sample has to be disclosed or published into the public domain as a part of the patent procedure (18 months from the date of priority). Disclosure or availability of the same means that the competitors of the invention also have access, and there are higher chances of them availing the sample and creating their stain and procuring such stain for grant of patent.
  2. The laissez-faire stances taken by Developed countries: Under the Indian Patent Act, Section 3(j) states that the plants and animals in whole or any part thereof other than microorganisms including seeds, varieties, and species and essentially biological processes for production, propagation of plants and animals as non-patentable inventions[5]. Here, India does not grant patent to any invention of plants and animals, while the patent offices of other developed countries like the European Union, United States, and Japan allow patenting of genetically modified plants and animals. India has taken this step because of two reasons: One, under Article 27(3) (b) of the TRIPS agreement the members can exclude plants, animals, microorganisms, and other biological processes of the same from the category of patent protection. The members are given the option of legislating a separate plant variety protection by way of a sui generis system. India went on with the sui generis system by bringing The Protection of Plant Varieties and Farmers Right Act, 2000. The objective of the PPVFR Act is that the farmers can save, use, sow, re-sow, exchange, or share the seeds of the protected variety, besides offering protection on farmers’ variety, extent variety, and essentially derived variety[6]. If the modified plants were to be categorized under patent legislation, it could have been difficult for the Indian farmers to use the seeds of the patented plants, because when any invention is tagged as a patented product automatically the cost of such invention touches the sky. Also, India being an agrarian country, betterment of the farmers becomes a priority. Therefore, to save the farmers from the costs of the modified plants or seeds, the Indian Government came up with this Act. Two, there are claims that the reason behind farmer’s suicide cases are the genetically modified (GM) seeds or crops, as the farmer pledges loans for buying and sowing GM crops and failing to yield the same, leads to rising debts and consequently, the farmer taking drastic steps. Here, Biotechnology has indeed helped the human race and the industry but not all users of technology can help the poor.

Conclusion

Any legislation in India somewhat follows the Indian tradition adhered to by the Indians. For example, worshipping the plants and animals, patenting genetically modifying plants and animals in India would mean patenting and owning God. Not only does India respect traditions but also has high moral and ethical standards, and allowing biotechnological patenting would signify disrespecting the same. The Patent Act, 1970 states that any invention which is not at par with the ethical and moral standards will not be granted patents. Further, if there are chances that an invention will exploit public health, interest, morals, and order will be put under non-patentable subject matter. But India’s stringent position regarding the patenting system of the biotechnological invention is standing as a barrier in the advancement of the Biotech industries, because the biotech industry is one of the fastest-growing and investment-seeking industries, and if India falls short of attracting the same, India’s pace of development and keeping at par with other nations would be affected.


[1] Sreenivasulu, N.S. and Raju, C.B. (2008). Biotechnology And Patent Law: Patenting Living Beings Noida: Manupatra

[2] Namrata Solanki, “Protecting Biotech Inventions: Are We Ready” III VOR 27 (2014)

[3] Meaning of Discover, https://www.merriam-webster.com/dictionary/discovering, (Last Visited on May 1, 2021)

[4] Meaning of Invention, https://www.merriam-webster.com/dictionary/invented, (Last Visited on May 1, 2021)

[5] Namrata Solanki, “Protecting Biotech Inventions: Are We Ready” III VOR 29 (2014)

[6] Namrata Solanki, “Protecting Biotech Inventions: Are We Ready” III VOR 29 (2014)

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