The aim of India's Biodiversity Act 2002 (herein referred to as 'the BD Act') is to conserve the rich biodiversity of the country. The act was implemented in 2003 under the auspices of the National Biodiversity Authority (NBA). As per the BD Act, NBA is responsible for access and benefit sharing (ABS), approval for access to and transfer of biological resources, results or technology of scientific research to foreign citizens, companies or non-resident Indians and several other matters related to conservation of India's biodiversity. The Act insists upon appropriate benefit sharing under mutually agreed terms related to access and transfer of biological resources or knowledge occurring in or obtained from India for various purposes.
The BD Act and What it says
Section 6 (1) of the Biological Diversity Act, 20021 "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 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."
Biodiversity related provisions from The Indian Patents Act 1970 and Rules 2003:
According to Section 10 (4) (d) (ii)2 of the Patents Act, 1970, the patent applicant should disclose the source and geographical origin of the biological material when used in an invention. Such a disclosure can be included in the beginning of the specification.
Form 1 Declaration Requirement The Indian Patent Rules 2003, in order to complement with the BD Act 2002, requires the applicant of a patent to submit a declaration under Form-1 titled Application for Grant of Patent of the Patent Rules 2003 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 by me/us before the grant of patent to me/us".
NBA may, while granting approval, impose benefit sharing fee or royalty for commercialization of any rights arising out of the biological resources obtained from India.
Therefore, the guidelines make it mandatory for the applicant to obtain permission from NBA for a patent to be granted. Hence, a controller can raise an objection in the examination report if the permission from NBA is not obtained/ submitted. Even if the objection was not raised during the examination stage, the same could be raised in a later stage.
In case the patent application mentions a biological resource which is not originated in India, then an approval from NBA is not required. In such cases, even if an objection is raised during examination, the applicant can overcome the same by stating that the biological resource mentioned in the invention is not of Indian origin and shall submit a declaration as well supporting the same. It is to be noted that in such cases the specification of the patent application 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 source country and geographical origin of the same.
Penalties for Contravention of the BD Act
Under Section 55(1) of the BD Act 20023, "whoever contravenes or attempts to contravene or abets the contravention of the provisions of the section 3 or section 4 or 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."
Consequences of Contravention of Biodiversity
Provisions under Indian Patents Act 1970 Contravention of provisions related to biodiversity provisions under Indian Patents Act 1970, shall lead to refusal of patent under Section 15. In case of pregrant opposition under clauses (d), (f) and (k) of section 25(1) and in case of post-grant opposition granted patents shall still be revoked under clauses (d), (f) and (k) of section 25(2) of the Patents Act 1970.
If the complete specification does not disclose or wrongly mentions the source and geographical origin of biological material used for the invention, then as per clause (j) of Sections 25(1) and 25(2) respectively of the Patents Act, 1970, such scenario forms a ground for both pre-grant and post-grant opposition, respectively.
Post-Grant Opposition of NBA Vs Sunev Pharma Solutions Ltd4
On August 27, 2019, the secretary of NBA, filed post-grant opposition against Sunev Pharma Solutions for having obtained patent on invention bio-resources viz. Azadirachta indica, Berberis aristata or Berberis vulgaris, Glycyrrhiza glabra, Jasminum officinale, Picrorhiza kurroa, Pongamia pinnata, Rubia cordiflia, Saussurea lappa, Terminalia chebula, Capsicum abbreviata, Nymphea lotus, Curcuma longa; Tricosanthes diocia, Symplocos racemose, Ichnocarpus frutescens, Sesamum indicum oil, Ricinus communis oil, Cocos nucifera oil, Brassica juncea oil.
Violation of Section 6 of the BD Act 2002
"On scrutiny it was identified by NBA that patents for the same invention were granted in places like Europe, South Africa, United States of America, South Korea, and Mexico without prior approval of the NBA. Subsequently a patent was granted by the Indian Patent Office on October 10, 2018, with the patent number 302105. The objection was raised in the FER regarding the submission of approval from NBA, for which the applicant on October 10, 2015 replied that they have applied for NBA approval. Subsequently the applicant amended their reply on January 14, 2018, stating that all the biological resources were imported from China except Sesamum indicum oil, Ricinus communis oil, Cocos nucifera oil, Brassica juncea oil which were sourced from India and are exempted from permission of NBA as they are notified as Normally Traded Commodities in the NBA notification dated April 07, 2016. Based on the information provided by the applicant, patent was granted on October 10, 2018 with the patent number 302105."
The above stated case is a classic example of wrongful disclosure of the geographical source and origin of biological resource. It will be interesting to the see the move of the Indian Patent Office in this case as it has further clearly stated that any false declaration on behalf of the applicant makes him liable for revocation of patent under section 64 (1) (j)/ 64(1) (p) of the Patents Act 1970 (as amended).
Inventions that do not relate to 'Biological Resource' defined under the BD Act, 2002
In view of the recent submissions made by the stakeholders with regards to the IPO decisions for the patent applications involving the use of biological materials not sourced/originated in India as well as the inventions that relate to material that does not come under the definition of 'Biological Resources' under the BD Act, 2002, the IPO has issued guidelines which have streamlined the following:
Value Added Product
Section 2 of Biological Diversity Act 2002 explicitly excludes value added products from the purview of "Biological resources". Section 2 (p) - "value added products" means products which may contain portions or extracts of plants and animals in unrecognizable and physically inseparable form.
For example, if an invention is based on Tulsi plant itself, the patent applicant would require approval from NBA; whereas if an invention is based on the extract obtained from Tulsi plant, then no approval from NBA is required.
Bio-wastes are usually generated after the economic use of the biological resource is exhausted. In case of inventions that utilize bio-wastes no approval from NBA is required.
Synthetically prepared biological material
NBA approval is not required for inventions which are based on synthetically prepared material like enzymes, pigments, gums, sucrose etc., which may be produced from a biological resource.
Form the above, it is obvious that for inventions using 'biological resource' of Indian origin, it is mandatory to obtain timely approvals under the BD Act, 2002, while prosecution of patent applications in order to ensure a hassle-free patent grant process.