Regulatory Authorities Governing The Biological Resources Used in Invention in India

Patent documents are techno-legal documents which contain scientific and technical details of the invention and more specifically claims to identify the scope of the invention sought for protection. According to the Patents Act, a patent application must disclose detailed information with regards to the invention so that a person of ordinary skill in the field related to the invention is able to perform the invention. Patent Applications relating to biological material under the (Indian) Patents Act, 1970, are subject to the provisions set out in Section 10(4) (ii) of the Patents Act, 1970, and Rule 13(8) of the Patents Rules, 2003 which states that- if the applicant mentions a biological material in the specification which may not be described in such a way as to satisfy clauses (a) and (b), and if such material is not available to the public, the application shall be completed by depositing 42 [the material to an international depositary authority under the Budapest Treaty] and by fulfilling the following conditions, namely:-

• the deposit of the material shall be made not later than the date of filing the patent application in India and a reference thereof shall be made in the specification within the prescribed period;
• all the available characteristics of the material required for it to be correctly identified or indicated are included in the specification including the name, address of the depository institution and the date and number of the deposit of the material at the institution;
• access to the material is available in the depository institution only after the date of the application of the patent in India or if a priority is claimed after the date of the priority;
• disclose the source and geographical origin of the biological material in the specification, when used in an invention.

Further references with regard to deposit of biological material are required to be mentioned in Form 1 (The second Schedule of The Patent Rules, 2003) and Section 6 of the National Biodiversity Act, 2002.

If the invention uses biological material and it is not already known, then it has to be submitted to the International Depository Authority not later than the date of making the patent application in India and a reference thereof shall be made in the specification within the period of three months from the date of filing of the application. The material is deposited so that every complete specification shall fully and particularly describe the invention and its operation or use and the method by which it is to be performed and shall also disclose the best method of performing the invention. The applicant shall also disclose in the specification the source and geographical origin of the biological material. After the deposit has been made, the applicant shall in the specification include name, the address of the depository institution and the date and number of the deposit of the material at the institution.

The applicant also needs to fulfill the requirement of section 6 of the National Biodiversity Act, 2002, which makes it mandatory for the applicant to take permission of the National Biodiversity Authority before sealing of the patent if the invention of the patent application uses the biological material.