Managing the fruits of innovation in India
Plant breeders need to protect their genetically modified (GM) plants to compensate for the high levels of investment in developing plants with desired genotypic and/or phenotypic traits. In India, GM plants enjoy plant variety protection and, to a certain extent, patent protection. However, a recent decision of the Intellectual Property Appellate Board (IPAB) refusing Monsanto’s patent on a method for obtaining shock-resistant plants has made patent protection an unclear issue in India.
Plants or parts of plants and essentially biological methods for propagation of plants are not patentable in India. Similarly, methods of agriculture/horticulture and discovery of isolated genetic sequences from plants or used in plants are not patentable. The guidelines for examination of biotechnology applications for patents specify the relevant provisions relating to non-patentability of genetically modified plants in the Indian Patents Act along with illustrations.
These include:
• A process for preparing seeds or other genetic materials comprising elements which might cause adverse environmental impact—Section 3(b);
• Products such as nucleic acid sequences, proteins, enzymes, compounds, etc, which are directly isolated from nature—Section 3(c);
• Conventional methods performed on actual open fields—Section 3(h); and
• Essential biological processes of growing plants, germination of seeds, of development stages of plants—Section 3(j).
Despite these provisions, numerous patents have been granted to subject matter relating to such plants. In the matter of patent application 2500/KOLNP/2007 by Athenix Corporation directed to transgenic plants with herbicide resistance, claims relating to transgenic plants were rejected under Section 3(j) while claims relating to isolated nucleic acid molecule and isolated polypeptide were rejected under Section 3(c).
During prosecution, the objection under Section 3(c) was overcome by amending the claims relating to the isolated nucleic acid sequence and the isolated polypeptide to ‘recombinant nucleic acid molecule’ and ‘recombinant polypeptide molecule’ along with a reference to the specification supporting the contention that the claimed genetic sequences were free of natural genomic sequences.
The other claims that were allowed by the controller were for: the vector; the bacterial host cell; a method for producing a recombinant polypeptide and a method for conferring herbicide resistance to a plant.
Similarly, in the matter of patent application 1409/KOLNP/2003 by Renessen LLC, USA and Monsanto Company, the application was directed to nucleic acids encoding an anthranaline synthase used to generate transgenic plants. The original claims related to: isolated DNAs; a vector; a seed and a transgenic plant, along with method claims for altering the tryptophan content in plants, producing tryptophan, for making an animal or human feed and for making a plant.
During prosecution, the claims were rejected under Sections 3(c), 3(h) and 3(j). The amended claims related to: isolated DNA; a vector; a method for altering the tryptophan content in plant and a method of making a plant with increased tryptophan content.
