For inventions with an affirmative declaration in column 12(III) of form 1, i.e. application for patent in India, applicants are to pledge a certain percentage of their revenue to the National Biodiversity Authority (NBA), one that is decided by the authority itself. Upon this execution, NBA sends an approval for patent filing, which is essential for the application process.
However, there is lack of information virtually at all levels on issues such as the need of NBA and the provisions of criminal prosecution upon failure to honour the agreement. This leads to an avoidable delay in the processing of patent applications developed through Indian resources, as evidenced by a sizeable number of applications pending with the status “NBA approval pending, but in order for grant (under section 43)”.
In order to clear this logjam, the Indian Patent Office (IPO) issued circular CG/office circular (P)/2017/ 451, dated 23 May 2017, where it declared that value added products defined under section 2(p), along with bio waste and synthetically prepared biological material would not come under the definition of biological resources as defined under section 2(c) of the Biological Diversity Act, 2002 (BD Act).
In order to waive any formal requirement under the BD Act, the product/composition/formulation must be synthetic and may only be performed with direct human/ intelligent intervention, where the ingredients in formulation/composition are unrecognizable and physically inseparable. Therefore, no biological material may get a waiver from the BD Act per se, even if only the process of preparation is claimed. However, this is yet to fetch any directive under administrative orders.
In a recent effort by LS Davar & Co, while pursuing DBT/NCDC patent application No. 833/DEL/2001 pending for NBA approval since 2014, the NBA made communication to the firm, which has been communicated to the IPO as a circular, rendering all applications prior to enactment of the BD Act, 2002, out of the purview of BD Act. This circular might pave the clearance of hundreds of pending applications, which are in order for grant under section 43, pending NBA approval. This indeed presents a silver lining for the prevailing patent regime in India.
Joshita Davar Khemani
Managing partner, LS Davar & Co
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