Modification in Procedure Regarding Examination of Patent Applications Involving the Use of Biological Material

The Biological Diversity Act (the BD Act) was enacted with the goal to provide for conservation of Biological Diversity, sustainable use of its components and fair and equitable sharing of the benefits arising out of the utilization of biological resources. One of the provisions under the BD Act (section 6) relates to seeking prior permission from National Biodiversity Authority (NBA) before applying for any intellectual property right, if the invention is based on any research or information on a biological resource obtained from India. In the event of an intellectual property right (patent application) being filed without prior NBA permission, NBA permission may be obtained after the acceptance of the patent but before patent grant by the patent authority concerned.

It has been witnessed in a few recent Indian Patent Office (IPO) decisions that patent applications involving use of biological materials, not procured from India and sourced from commercial sources in countries like Switzerland, Spain, Japan and China, were rejected. In light of such IPO decisions, stakeholders at Mumbai and Delhi held meetings to put forward certain issues regularly faced by patent applicants regarding unwarranted objections raised by the IPO concerning requirement of permission from NBA and further delay in obtaining NBA approval.

In view of the submissions made by stakeholders, this issue has been considered by Indian Patent office and instructions/guidelines for NBA permission have been streamlined by way of the following:

S. No.	Issue	Modified procedure to be followed
1	Where the invention does not relate to a biological resource defined under the Biological Diversity Act 2002, such as:(a)    Value-added   product(b)       Bio- wastes (c)        Synthetically prepared biological material	explicitly excludes value added products from the purview of "Biological resources".
2	Where the biological resource/materialused in invention is not obtained /sourced from India.	and,
3.	Marking of applications in the module regarding requirement of NBA approvals.	However, if the Controller is not satisfied with requirement regarding NBA approval, he shall unmark the application by giving reasons thereof.
4	Cases held up for grant of patents only due to non-submission of NBA permission.	Where the applicant has complied with all the objections, except submission of NBA approval, the Controller shall mark the application in the examination module by remark that "NBA approval pending, but in order for grant" and, the System Administrator shall put a tag on such cases so that these applications can be treated as if disposed of the Controller.

IPO 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). Further, as per provisions in section 55(1) of Biological Diversity Act 2002, if the applicant contravenes or attempts to contravene or abets the contravention of the provision of section 6 of the Biological Diversity Act 2002, he shall be liable for penal action under section 55(1) of the Act'.

With the streamlining of instructions/guidelines for NBA permission, the patent applicants can now effectively deal with the unwarranted objections raised by the IPO concerning the requirement of permission from NBA. Henceforth, the patent applicants can question the unjustifiable extension of applicability of Section 6 of the BD Act by IPO to reject patent applications even when the invention is not based on Indian biological resource and/or when the invention is one of a value-added product, bio-waste or a synthetically prepared biological material and hence, does not relate to a biological resource defined under the Biological Diversity Act 2002.

Author: Tanu Goyal, Patent Associate at IIPRD and can be reached at: tanu@khuranaandkhurana.com