Patenting Life: Exploring India's Approach to Genetic Patents and the Stance of the Patent Office with Emphasis on JEV cDNA Virus Patent

A bill[1] was recently introduced in the U.S. Senate that looked forward to bringing back patent eligibility for genetic material and overturning previous U.S. Supreme Court decisions with potentially worrying implications for labs developing tests and public health officials' ability to respond to disease outbreaks. The news sparked the dormant controversy surrounding the patentability of genes and genetic material and gave birth to some generic questions - to what extent do intellectual property rights expand? And what effect would awarding patents to basic building blocks of life have in one's life or on society in general? While there exists a global agreement in the form of TRIPS, the practices across the globe are very different and often vary due to different levels of development in the said field in different nations. This research piece will mainly deal with the Indian perspective regarding genetic patents.

The Indian perspective on Intellectual Property rights has not had a chance to develop much in India due to much ambiguity in this area of law. Gene patenting is one such subject, where the lack of any authoritative precedent makes it subject to the interpretation of laws. The governing legislation of Patents in India is The Patents Act of 1970, where one can find some relevant provisions that affect the patentability of genes in India.

Indian perspective – (An analysis of the Indian Patents Act, 1970)

According to section 3(c) of the Patents Act, mere discovery of a scientific principle, formulation of an abstract theory, or discovery of any living or non-living thing occurring in nature would not be patentable. The entire debate stems from whether genes can be said to be 'naturally occurring.' If naturally occurring were to imply that a substance must be present in the environment in forms that have not been influenced by human activity[2], it would raise a question if a gene is, in fact, naturally occurring.

 While it is true that genes do occur in nature, they are incapable of individual existence. Genes exist as fragments that constitute the DNA and are very function-specific; hence, considerable skill is involved in identifying, locating and isolating a gene. Genes, therefore, can be argued not to be naturally occurring, and hence, gene patenting can be said to be beyond the said restriction. It must also be noted that not all genes are formed in nature. Some genes do not occur naturally and have been lab-grown to facilitate pharmaceutical research. Since they are not naturally occurring in any sense, they are way beyond any restriction put forth by the said section. Another important section that plays an important role in deciding the possibility of gene patenting is section 3(i) of the Indian Patents Act, 1970: which states that plants and animals in whole, or any part thereof, other than microorganisms but including seeds, varieties and species and essentially biological processes for the production of plant and animals- cannot be patented.

Although the Act does not explicitly say anything about gene patenting, an argument would be that genes constitute part of DNA, which is the building block of life. Hence, via deduction, gene is a part of living beings and hence cannot be patented. Exceptions exist in this, too, in the form of modified genomes and artificially produced genes. These genes are planted artificially and hence in their isolated form, do not constitute a 'part' of any living beings. Hence, they can be said to be patentable.

Examination of the manual of patent office practice and procedure

Since many questions in the field have not been answered directly by the Act, the right way to proceed would be to examine the Manual of patent Office Practice and Procedure and the changes in it over time to see their intent and understand its approach. The 2005 draft manual had an annexure dedicated to biotechnology and pharmaceutical inventions.[3]

According to the draft, any living entity, even one of artificial origin and any part thereof, is not patentable. However, it also stated that recombinant DNA is patentable if there is substantial human intervention. While this annexure was not seen in the 2008 draft, under the description of unity of an invention,[4] the manual gives the following illustration:

The following can be claimed when a genetically modified gene sequence/amino acid sequence is novel, involves an inventive step, and has industrial application.

(a) Gene sequence/amino acid sequence

(b) A method of expressing above sequence

(c) An antibody against that protein/sequence

(d) A kit made from the antibody/sequence

The given example implies that a gene is patentable, provided that it exists in sequences and is recombinant in nature, hence strengthening the point involving human alteration. The actual manual released in 2011 does not elaborate much on the topic. The only retained provision was concerning sequence listing that had to be provided by the patentee and the abovementioned bullet list under 'unity of invention.'

The third version of the manual, released in 2019, also continued with the said position regarding the sequence listing. The manual also gave guidelines regarding a detailed description of the invention in the case of biotechnology-related inventions. While the analysis of the manual does help in clarifying the position of the Indian Patent Office (IPO) concerning gene patenting, it is through the individual patents granted that one can understand the scope of gene patenting in India.

Patenting practices by the IPO:

 A Patent granted to a novice Genetically Stable JEV cDNA based on Japanese Encephalitis VirusLee Y, Lee S & Yun S, Genetically stable Jev cDNA based on Japanese Encephalitis Virus (JEV), Indian Patent No. 243799 (8 November 2010[5]). The title of the originally filed invention claimed that it is related to 'the novel genomic RNA' of JEV and a form of cDNA derived from it. However, the final granted patent's title reads: 'Genetically stable JEV cDNA based on Japanese encephalitis viruses.

The RNA is supposed to be the template for the cDNA. This could imply that an objection might have been raised to patenting RNA, but the cDNA claim was entertained. Therefore, it is possible to claim cDNA sequences as a part of a patent in India. However, when the patent is analysed, the claim covers the entire DNA and any further modification made to obtain a vector.

It also claimed the corresponding RNA transcript and the synthetic virus. However, the background of the patent claims the full-length nucleotide sequence of the strain. The patent covers all the nucleotide sequences, including those derived directly without modification. It can be observed that the scope of the patent is not limited to the vector but also the cDNA sequence it contains.

Key finding:

Since the manuals offer little insight into the field of gene patenting, the most reliable source of information to form any viable opinion would be the analysis of the practices of the Indian Patents office. Therefore, it can be concluded that not only are gene sequences created by human intervention patentable, but naturally occurring gene sequences are patentable too if they are an integral part of an artificially created microorganism, a patent of which is not prohibited by the Indian Patents Act.

Conclusion:

The recent pandemic was a lesson on the importance of evolving medicine and the need for accessible patient healthcare. The lethality of the pandemic before and after the vaccines were given to the public were two different stories. It has to be understood that medicine has to be ever-evolving so that the damage that transitioning to the 21st century brings is minimised. The development in the biochemical sector has put genes in the limelight in healthcare and research.

The application of an "invented" gene can vary from diagnostics and comparative analysis to therapy and even sequencing. Patents play a crucial role in determining the path of this field. We need to accept that genes, either directly or indirectly, come under the purview of patent law and are an essential factor as it provides an incentive for further innovation.