Biotechnological inventions are, extensively, the result of excessive research and use of intellect and creation of the human mind. Though the technology is advancing dramatically yet returns on such innovations are too slow and therefore, are required to be protected before disclosing the creativity to the world. Such protection is provided by the emerging field of intellectual property law.

The field of Intellectual Property Law is aimed at fostering human ingenuity and accords the owner or the creator of a work a legal right to reap the fruits of his labour put into that work, without any fear of his work being misappropriated by another. It guarantees exclusive protection for a certain period to the intangible creations of the owner or creator, or the intellect and ideas of the human mind incorporated into a tangible product.

International Standards of TRIPS Agreement

 The Indian Patent Act, 1970, was amended three times, in 1999, 2002^[1] and 2005, to comply with the mandate of WTO’s TRIPS Agreement, 1995, which is the most comprehensive multilateral instrument on Intellectual Property, covering all aspects of IPRs on a global level.

Having seen various biotechnological inventions and products at the time of drafting, signing and adopting TRIPS, Article 27.1^[2] was introduced in the TRIPS Agreement, which explicitly recognises the advancement in all fields of technology, including biotechnology, and stresses the member nations to provide patent protection to all inventions, including biotechnological inventions, without any discrimination, once they fulfil the required criteria of novelty, inventiveness and industrial usefulness, and do not fall into the exclusions mentioned under Article 27.2 and 27.3.

Article 27.2 and Article 27.3 of TRIPS Agreement^[3] are marked as relevant when it comes to biotechnological inventions. Article 27.2 restricts from providing patent protection to inventions contrary to public order and morality, and the commercial exploitation of which is seriously prejudicial to human beings, animals, plant life, health or environment. Article 27.3(a) prohibits patenting of treatment and diagnostic methods for humans and animals. Further, Article 27.3(b), often called the “Biotechnology Clause”, addresses the most controversial and debatable issue till the present time, the drafting of which is subject to an early review, for it represents, on one hand, an intense desire of developed nations like the USA favouring protection of biotechnological inventions, and on the other hand, the concerns of other developed nations like EU towards the scope of patent protection, and other issues of developing nations about patenting life forms^[4]. Article 27.3(b), though currently under review, prohibits patenting of plants and animals as a whole and essentially biological processes, all of which are of paramount importance in the field of biotechnology.

Analysis of Article 27.3(b) clarifies that although member nations are free to exclude “plants” from the patentable subject-matter, but it obliges them to protect plant varieties either, under a patent regime, or under an effective sui generis system, if such plants cannot be patented by any reason under the national patent legislation, or by a combination of both. However, it has not yet given any due consideration to animal patenting or in fact, the patenting of a gene or genomic DNA, another developing field of biotechnology research. Also, important terms such as essentially biological processes are not defined in the TRIPS Agreement, as such member nations are free to adopt any interpretation of their own, subject to their relevant national legislation and international commitments.

It is also important to note that the TRIPS agreement does not define the term “inventions” and has left it on member nations to define it as per standards generally applied by them, taking into account the economical, ethical, and legal aspects involved in patenting living materials or certain types thereof. There is no obligation on member nations to adopt an expansive concept of “invention”.Further, the TRIPS Agreement does not provide any uniform definition to draw a line between “invention” and “discovery”.

This implies that with respect to biotechnological inventions, member nations are free to exclude the pre-existing natural biological matter, both products and processes, from the definition of invention, but can include the human intervened or manipulated living matter, both products or processes, within the definition of the same, subject to the patentability criteria and the list of exceptions they deem fit to cover in their national patent laws.

Indian Patent Law: The Patent Act, 1970: Patentability of Biotechnological Inventions: Statutory Criterion

Generally, for an invention to be patented, the invention must satisfy the universal three-pronged test:

1. Novelty- The invention must be new and original^[5]

The invention must be a new and original product or process, without any prior disclosure of the claimed subject-matter in the patent application. The requirement of novelty prevents the prior art from being patented again.

As regards biotechnological inventions, the earlier issue was that it deals with “substance existing in nature”, which implied that the substance is not novel. However, with time, it was understood that a “natural substance” can be considered “novel” if it had no previously recognised existence, i.e., the substance found in nature must be isolated from its surroundings and made available to public, and must be defined either by its structure or by the process used to obtain it^[6].The same approach was adopted by EU in Relaxin case^[7].For instance, the Howard Florey Institute claimed the patent for a synthetic form of human relaxin hormone which they developed by cloning the second form of a human relaxin gene by way of Recombinant DNA technology. The opponent challenged the claimed invention on the ground of novelty and said that the gene encoding relaxin had always been present in the female body.

However, shutting down the objection, EPO granted the patent and clarified that the claimed gene sequence was novel, as it was developed and claimed in the form of complementary DNA which does not exist in nature. Also, the form of relaxin that it coded for was unknown until the inventor isolated it for the first time.

The modus operandi of a relaxin case is applicable only in protein for gene cases, and not protein to protein case. In such cases, if a protein, similar to naturally occurring protein, is isolated, purified and made known to the public, it shall be regarded as a novel. However, the inventor may obtain only “product patent” and not “process patent”, until the method used by him to isolate and purify the biotech protein is new and non-obvious.

2. Inventiveness (Non-obviousness)^[8]

The invention must be significantly advanced as compared to existing technology and must be economically efficient.

Technical advancement, having regard to the prior art, implies that the invention or the feature of the invention, or the combination, substitution or modification of the prior art must not be obvious in the eyes of the person skilled in the same field on the relevant date and time with respect to the knowledge he possessed.

The crucial point to determine non-obviousness of an invention is to determine prior art. Prior art is not what is known to nature, but what is known to man^[9]. For instance, If a protein is what is known to a man, but a gene, which he has isolated and purified, is what is claimed by him, then such a gene shall be regarded as novel. However, the test of non-obviousness would be satisfied once it is clear that even though a person skilled in the art knew about the existence of the particular sequence of that gene, it would be non-obvious until he would have been able to identify and isolate that particular sequence of the gene.

3. Utility (Industrial Application)

For an invention to be patented, the final requirement is that the invention must be capable of being made or used in an industry^[10], i.e., it is capable of being reproduced on a large scale with the same characteristics and as many times as necessary.

Lack of industrial utility in an invention is a ground of revocation of the patent under section 64 of Indian Patent Act, 1970.

Author: Adv. Sakshi Kothari

^[1] The Indian Patent Act, 1970 was amended in 2002 to include biochemical, biotechnological and microbiological processes within the definition of potentially patentable process

^[2] TRIPS Agreement art. 27.1.

^[3] Id. at art. 27.2 and art. 27.3

^[4] Martin Khor and Cecilia Oh, Joint NGO Statement on Review of Article 27.3(b) of The TRIPS Agreement, THIRD WORLD NETWORK , https://www.twn.my/title/joint2.htm.

^[5] supra note 4, at §2, cl. 1(l)

^[6] Minh Chau Dao, Novelty and Nonobviousness of Biotechnological Inventions under EU and US Law, IIPS IPOST, 92 (2010).

^[7] Bioethics and Patent Law: The Relaxin Case, WIPO MAGAZINE, https://www.wipo.int/wipo_magazine/en/2006/02/article_0009.html.

^[8] supra note 4, at § 2, cl. 1(ja)

^[9] Rahul Deo, Biotechnology Patents and Problem of Non-Obviousness, LAW OCTOPUS ,https://www.lawctopus.com/academike/biotechnology-patents-problem-non-obviousness/.

^[10] supra note 4, at § 2, cl. 1(ac)