DNA PATENTING IN INDIA
Maharashtra National Law University, Mumbai
With numerous advancements being made literally every second, the world is moving forward in every aspect. Be it academics, politics, or general social life, humankind is making a tremendous amount of progress. This progress has been exceptionally fast in the field of science and technology. As individuals and corporations keep achieving newer feats day by day, their accolades bring forth newer sets of problems as regards the protection of the same. In today’s times, the protection of what we call as ‘Intellectual Property’ is of utmost importance. As more unique intellectual properties emerge, so do the questions of their classification and effectively their apparent protection under the current intellectual property laws.
One such case, in the Indian context, is that of DNA patenting. With biotechnology becoming a more and more relevant field of exploration, this has become a matter of pressing concern. A DNA or gene patent is the exclusive right provided with respect to a specific sequence of DNA i.e. a gene, and is granted to an individual, organization or corporation that claims to have identified the gene first. Once a gene patent is granted, the holder can dictate how the gene is used in commercial as well as non-commercial settings. Such gene patents have often led to companies having sole ownership of genetic testing for patented genes.
Like all intellectual property, DNA patents are also subject to infringement. The reason these are treated so importantly is that such patents have the potential capability to alter the entire course of future civilization. Important research in the field could bring about solutions to the most fundamental problems and lacunae in organic life. The day isn’t far away when the concepts of ‘DNA Theft’ and stealing DNA sequences would be commonplace.
The foremost question in such a situation is whether anyone actually holds a primary right to any particular DNA sequence. As such, every person has their own unique genetic sequence. Hence, albeit with some exceptions, they do possess a fundamental right to privacy in terms of DNA sampling and utilization without their knowledge and consent. As for other organisms that are used in experiments and research studies, their DNA sequences have no concretely based ownership criteria, but are generally considered as the property of the entity conducting the experiment or research.
There are hence many reasons why this topic has become a subject of debate. While Section 3(c) of the Indian Patents Act (1970) prohibits patenting the discovery of a living or non-living thing found in nature, DNA patenting itself remains a matter of conjecture. Critics of genetic patenting rely on Section 3(i) to claim that since plants and animals cannot be patented, a similar treatment should naturally be accorded to genes. However, this section applies to plants and animals as a whole, so the patentability of a gene, which is a part of a plant or animal, still remains contentious. The Indian stance on this changed in 2005, when the Draft Manual of Patent Practice and Procedure was released with an annexure specifically dedicated to biotechnical and pharmaceutical inventions. This allowed for recombinant DNA and plasmids to be patented as long as they meet the criterion of “novelty owing to substantial human intervention”. However, for undisclosed reasons, this annexure was missing from the 2008 Draft Manual of Patent Practice and Procedure.
At present, Intellectual Property India’s (IPIndia) Manual of Patent Practice and Procedure, dated March 2011, states in its guidelines on the ‘unity of invention’ that independent claims of different categories may relate to a single inventive concept. With regard to genetically modified gene/amino acid sequences, claims can cover:
- a gene/amino acid sequence;
- a method of expressing the sequence;
- an antibody for the sequence; and
- a kit containing the antibody.
The manual further establishes the fact that these guidelines will apply only if the modified gene fulfills the criteria of novelty, involves an inventive step and has an industrial application.
Along with the same, a lot of academicians and critics are raising concerns over DNA or genetic patenting as a form of breach of individual privacy. On one side, the biotech industry holds its stand that it deserves its patents because the work that they do is not merely a game of chance, but a calculated and sophisticated scheme of meticulous processes to arrive at the most accurate results. On the other, people lobbying against gene patents have a much simpler stand concerning the monopolization of human genetic information by the industry that would lead to apparent infringement of privacy. As per these lobbyists, DNA sequences are a product of nature, and an interference with them amounts to an interference with any bodily part of an organism, and hence such patenting is not credible in any form.
As is, the stand on DNA patenting in India is very conflicted. Even from a purely legal perspective, there is not enough legislation to help arrive at a solid conclusion. There are still contradictions between the form, status and extent of DNA or genetic patenting between India and other countries. It is hence important for us as a developing country to look into the matter in thorough detail, assess all the pros and cons and invest in appropriate legislative reforms to bring forth the best possible outcome in the near as well as far future.