Introduction

The subject of gene patenting has always received wide attention of policy makers worldwide. This article briefly discusses the present stance of Gene Patenting in India and Judicial position of the same. Numerous ethical questions have already been raised regarding the impact of such patents on the entire medical community as well as genetic science research and development. The United States pioneered the idea of gene patenting, but India did not permit it until a few years ago. We have witnessed a tremendous evolution of gene patenting in India over the past few years, and the government of India has produced various regulations to support the demands and international advances in the biotechnology sector. Gene patents are now allowed in India but the law governing gene patenting still demands for more refined clarity on the subject matter and the same has been discussed briefly in this article.

GENE PATENTING & PATENTING OF MICRO-ORGANISMS

With the advancement of the science, gene patenting has become a crucial aspect of Intellectual Property Rights. It is being considered as a major leap in science and everyone is looking to encroach upon the patenting of their gene modifications which are of medical value. Gene patenting is the most debated topic in the field of Intellectual Property Rights because there are many limitations to it. Among the many standards for patentability, one key limitation on patentability is the subject matter limitation. The standards for patenting require the subject matter of a patent to be appropriate. A key component of patent policy , the debate surrounding patenting of nature remain one of the crucial ones surrounding Intellectual Property Rights (IPR) even today. The restriction on patenting under this standard establishes that inter alia a patent shall be invalid if it is a natural phenomenon or a product of nature, i.e., a substance which occurs naturally. The reason the topic remains a dynamic interest is because microorganisms have a wide range of applications in scientific research. It has become very common to use these bacteria to build better medical procedures for lab usage, preserve and modify genes, and do a range of other useful tasks involving modified genes.

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While the idea of patenting microorganisms commenced with the grant of a patent in landmark case of Diamond v. Chakrabarty, India was not quick to grasp to the rapidly changing regime of patenting in the global scenario. Even though the earliest case dates back to 1980, and even after being a signatory to the TRIPS Agreement, India only recognised patenting of natural phenomenon and its matter subject in Dimminaco A.G. v. Controller of Patents and Designs, wherein hon’ble supreme court held that the mere presence of a natural phenomenon in the end product of a patent would not operate as a disqualification for the patent. Later on, the patenting of microorganisms were standardised through various landmark judicial decisions. Other than this, India also adopted a well laid down legal framework in the form of the Patent Manual and the Indian Biotech Guidelines.

Purposively, this article attempts to analyse the law on natural phenomenon, and its respective limitations in light of several landmark judicial pronouncements, and assess whether the construction of a mechanism under this subject transgresses the policy against patenting of nature whether in the form of gene patenting or patenting over naturally occurring substances.

What still remains more interesting from the U.S. jurisprudential development of the subject matter limitations is how Indian law and the Courts in India shall interpret the same, and whether India should dive into questions of patenting nature or not? With India only being in its formative years of development of patent law, it should tread carefully and with a liberal approach towards the issue.

The Supreme Court of India (SC) was briefed with a similar question in the 2019 case of Monsanto v. Nuziveedu . Monsanto Technology had filed for a patent containing the claim scope over Nucleotide Acid Sequence, having application in the farming industry since upon insertion of this particular sequence into cotton seeds, the sequence destroyed and eliminated bollworms from inside the seeds of the farmers produce, thereby reducing the reliance on insecticides and pesticides to a large extent. The patent was rejected by the High Court of Delhi (HC) on grounds that the same was a non-patentable subject matter under Section 3(j) which excludes from the scope of the patent “plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals”. The decision arrived at by the Delhi HC was challenged before the SC, however, due to an inappropriate method of determination of facts, the SC has sent back the case to Delhi HC for re-consideration.

The Delhi HC, before whom the case is presently sub-judice, must take stock of the rules of the TRIPS Agreement. Every signatory is required by Article 27.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to safeguard plant varieties under patent law or any other applicable law. India must have accepted Monsanto’s assertions because it had already integrated the same under the Protection of Plant Variety and Farmers’ Rights Act, 2001 (PPV&FR). However, due to the expiry of Monsanto’s patent in 2019 the case is now a redundant stock of a missed opportunity. Firstly, the SC failed in swiftly deciding the case. A speedy trial in matters pertaining to IPR Law are necessary since the overall life of an IPR would expire even before the case is completely pleaded before the Courts, owing to the tremendous perpetual backlog of cases in the Indian Judiciary. The same was recognised by the SC in Bajaj Auto v. TVS Motor and other cases but failed to receive any due attention from the Courts.

Conclusion

Genetic alteration requires long timelines and is pricey. Whenever a genetically modified species is developed to curb certain illnesses or negative characteristics found in their natural counterparts, the consequences are for the greater good of all. Through enabling such inventions to be patented, Indian law, as well as the judiciary, would consider the efforts involved in these procedures. This entails nothing more than the universal concepts already outlined in India’s patent law to be followed.

Even though the patent of Monsanto has expired, the contents contained therein can still be upheld to formulate any significant policy decision over natural phenomenon subject matter. If and when the SC confronts this question again, it must invoke a decree similar to its U.S. counterpart in Illumina, and must pave the way for a progressive and liberal approach towards patenting in India.

Author : Kaustubh Kumar, 4th Year law student at the National University of Study and Research in Law, Ranchi, in case of any query, contact us at Global Patent Filing or write back us via email at support@globalpatentfiling.com.