The Indian IP office’s approach to DNA patenting reveals grey area around gene patents
A gene patent is the exclusive right to a specific sequence of DNA (a gene) and is granted to an individual, organisation, 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 (eg, clinical genetic testing) and non-commercial settings (eg, research) for a set term. Gene patents have often led to companies having sole ownership of genetic testing for patented genes.
Gene patenting under the Indian Patents Act
While Section 3(c) of the Indian Patents Act (1970) prohibits patenting a discovery of a living or non-living thing found in nature, DNA patenting remains a matter of conjecture. Critics of genetic patenting rely on Section 3(i) to claim that since plants and animals cannot be patented, similar treatment should 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 only apply if the genetically modified gene is novel, involves an inventive step and has an industrial application. The Indian Patent Office granted protection to Genetically Stable JEV cDNA, which was based on Japanese Encephalitis Virus (Patent 243799). This application was for a recombinant viral construct, aimed at expressing an exogenous polypeptide in a cell. These viral constructs are derived from the Japanese encephalitis virus (JEV). This decision was subject to intense scrutiny as a large section of the medical community believed that the cDNA sequence was not capable of benefitting from protection as it is neither synthesised nor recombinant – it is a mere derivative of the existing natural sequence. Further, IPIndia took a different view with regard to the patent application titled An Expression Vector or Cloning Vector Encoding Filarial Parasite Polypeptide (Patent 246865) and objected to the cDNA sequence. It stated that the sequence was obtained from what already existed in nature. However, these objections were then withdrawn and the patent was granted.
In the recent Monsanto Technology LLC v Nuziveedu Seeds Ltd cade, the Division Bench of the High Court of Delhi held that “genetically modified plants, genetically modified seeds and gene sequences that provide genetic traits to plants are not patentable subject matter in India”. The Division Bench’s decision was subsequently set aside by the Apex Court of India owing to the complexity of issues and the need for a re-examination of evidence. The Supreme Court refrained from making concluding remarks with regard to the patenting of isolated DNA and cDNA, which further obscures the Indian position on the matter.
While gene modification has immense advantages in the development of medicine and other ancillary fields, obtaining patents for such invention remains a contentious issue across the globe. Apart from the ethical issues with regard to ownership of life, legal issues related to breach of privacy and whether DNA can be constituted as a property remain unanswered. Thus, in order to ensure optimum utilisation of the benefits offered by patenting gene sequence, changes are required at the legislative level to ensure statutory clarity in this field.