6. (1) No person shall apply for any intellectual property right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the previous approval of the National Biodiversity Authority before making such application. Provided that if a person applies for a patent, permission of the National Biodiversity Authority may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned: Provided further that the National Biodiversity Authority shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof.
Several patent applications are based on inventions that relate to material that does not come under the definition of “Biological Resources” under the BDA act. Thus, if patent application is in respect of the following, excluded subject matter, then approval from NBA before filing patent application is not required. Value Added products: Section 2 of BDA explicitly excludes value added products from the purview of “Biological resources”. Value added products are defined as “value added products means products which may contain portions or extract of plants and animals in unrecognizable and physically inseparable form.”. For example, products such as wheat flouri , tobacco dustii, allicin-enriched garlic extractiii, were considered as value added product by the Indian Patent Office. Bio-waste: NBA approval is also not required for, inventions that use/ disclose Bio-waste. Biowaste is generated after the economic use of the biological resource/material is exhausted and is therefore not covered under the definition of “Biological resources”. Synthetically prepared biological material: Inventions that use synthetically prepared biological material, can also be filed without seeking prior approval from NBA. Such material for example includes materials such as enzymes, pigments, gums, sucrose etc. Source: Aparna Kareer
See also WIPO website.