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Requirements to be Fulfilled If Invention Uses Biological Material

You might find this article useful if you have questions like what is Budapest treaty, is India also member to the treaty, if my invention uses biological material, what obligations I have to fulfil under this treaty, what are the timelines to comply with those.

Budapest treaty is the international treaty on the recognition of the deposit of micro-organisms for the purposes of patent procedure signed at Budapest (capital of Hungary). It was signed on 28th day of April, 1977 and has been amended and modified since then. India is member of this treaty with effect from December 17, 2001. If the invention uses biological material and it is not already known, then it has to be submitted at 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. Applicant shall also disclose in the specification the source and geographical origin of the biological material. After the deposit has been made, applicant shall in the specification include name, address of the depository institution and the date and number of the deposit of the material at the institution. In India, there is one International Depository Authority at Chandigarh which is known as Institute of Microbial Technology (IMTECH) and other is at Microbial Culture Collection (MCC), Pune. Access to the material is available in the depository institution only after the date of the application of patent in India or if a priority is claimed after the date of the priority. One can also refer to the Public Notice dated July 02, 2014, made available by Indian Patent Office (IPO) regarding the same. If the invention is related to biological material obtained from India, applicant needs to add one declaration in form 1. The declaration is ‘The invention as disclosed in the specification uses the biological material from India and the necessary permission from the competent authority shall be submitted by me before the grant of the patent to me.’ Applicant also needs to fulfil 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 invention of the patent application uses biological material.

Legal basis: Section 10 (4) (ii) (A), (B), (C) and (D) of the Patents Act, 1970 and Rule 13 (8) of the Patents Rules, 2003, form 1 under Indian Patents Act, 1970 and Section 6 of the National Biodiversity Act, 2002.

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: [email protected].

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