By Ms. Kiran Sharma, Copyright Examiner at Copyright Office, DPIIT

The Biological Diversity Act, 2002 (BDA) is an outcome of United Nations Convention on Biological Diversity held in 1992, wherein the sovereign rights of the states over their biological resources were reaffirmed. India being signatory to the said Convention found it necessary to give effect to the said Convention. This Act is to provide for conservation of Biological Diversity[1], sustainable use of its components and fair and equitable sharing of the benefits arising out of the use of biological resources, knowledge and for the matters connected therewith or incidental thereto and also the fair and equitable sharing of the benefits arising out of utilisation of genetic resources.

Genetic resources is not defined under this Act but biological resources as defined under the Act[2] means plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value added products[3]) with actual or potential use or value but does not include human genetic material.

It has been reported that the Indian Patent Office is granting patents on inventions related to biological resources obtained from India without taking adequate care to observe the mandate of law[4]. Patent as defined under The Patents Act, 1970 means a patent for any inventions granted under this Act[5]. The Patents Act does not mentions the inventions which are patentable but has mentioned under Section 3, inventions which are not patentable, where it has mentioned that micro-organisms are subject matter of patents[6].

The legal interface between The Patents Act and The Biological Diversity Act can be seen under Section 6 of BDA which states that without prior approval of the National Biodiversity Authority (NBA) no person can apply for any intellectual property right in or outside India, for any invention based on any research or information on biological resources obtained from India. In case the person applies for patent then permission of the NBA may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned and that the NBA shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof.

BDA also has a penal provision in this regard which states that “whoever contravenes or attempts to contravene or abets the contravention of the provisions of the section 6 shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to ten lakh rupees and where the damage caused exceeds ten lakh rupees such fine may commensurate with the damage caused, or with both”.[7]

The Indian Patent Law complements this provision of the BDA by making it mandatory for the applicant of a patent to submit a declaration[8]to the effect that “the invention as disclosed in the specification uses the biological material from India and the necessary permission from the Competent Authority shall be submitted before the grant of patent.”[9]This provision of declaration and every application submitted thereafter should mandatorily have either the affirmative or cancelled out declaration. Where the applicant leaves the declaration unattended and such omission is noted during any stage of processing of the application, the Examiner/Controller should raise an objection in this regard[10].

If the above declaration regarding the use of biological material from India is affirmative, the Examiner/Controller should raise the objection about the requirement of permission from NBA in the matter, if already not submitted. In any case, the patent should not be granted unless the NBA permission is submitted by the applicant. On the other hand, if the declaration regarding the use of biological material from India is cancelled out by the applicant and the specification also states that the source and geographical origin of the biological material is not from India, the specification should be amended by way of incorporation of a separate heading/paragraph at the beginning of the description that the biological material used in the invention is not from India and should clearly specify the country of source and geographical origin of the same. Where the declaration is cancelled out but the disclosure in the specification is that the source and/or the origin of the biological material are from India, then NBA permission is required[11].

Therefore, no patent shall be granted without the necessary permission from the National Biodiversity Authority in cases where the invention uses biological material from India or the source and/or the origin of the biological material is from India as per the disclosure in the specification.

The conflict between the BDA and the Patents Act arises because of the reason that both the authorities i.e. NBA and Patent office are independent of each other and they are not bound to follow directions of each other. So where the applicant has obtained the acceptance of patent from the Patent Office, the seal of patent can’t be obtained before obtaining the permission of NBA. This shift from one authority to another which does not have any connection in between affects the patent rights of the applicant. Even though the time limit has been mentioned in the Act for granting the permission by NBA but the time taken in reality is much more than that. This led the applicant to wait just for permission and delaying the right to use the patent. Supposedly, NBA refuses to grant the permission after all this process, the time, money, energy spend from the very beginning in obtaining the patent will all get wasted and the patent will get revoked.

The solution to this conflict is that, both these Acts need to harmonize with each other in order to facilitate the grant of patent applications based on research or information on a biological resource obtained from India. One of the suggestions could be that permission from NBA can be obtained at much earlier stage, may be at the time when it is disclosed in specifications that there is invention regarding biological resource so that further time could be saved or NBA grant permission according to the statutory limit without any delay.

[1] As defined under Sec 2(b) of The Biological Diversity Act, “biological diversity” means the variability among living organisms from all sources and the ecological complexes of which they are part and includes diversity within species or between species and of eco systems.

[2] Sec 2(c) the Biological Diversity Act, 2002.

[3] Sec 2(p) the Biological Diversity Act, 2002.

[4]Office of the Controller General of Patents, Designs and Trademarks, Guidelines for processing of Patent applications relating to Traditional Knowledge and biological material (Para 1 Pg. 1).

[5] Sec 2(1) (m) the Patents Act, 1970.

[6] Sec 3(j) of The Patents Act, 1970 states that plants and animals in whole or any part thereof other than micro-organisms are not patentable.

[7] Sec 55(1) the Biological Diversity Act, 2002.

[8] Form-1 (Application for Grant of Patent) of the Patent Rules 2003.

[9] Supra Note 4 (Para 4 Pg. 3)

[10] Ibid (Para 18 Pg. 9).

[11] Supra Note 4 (Para 19, 20, 21 Pg. 9).

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