Consideration of the issue pertaining to Patents-Decision taken by the RC in the 431st meeting-reg

Slight respite to companies/entities struggling with the confusion whether they could be held liable for patent infringement even when a manufacturing licence is issued in their favour under section 9(4) of the Insecticides Act, 1968 (hereinafter referred to as "follow on" Registrant) ("Insecticides Act"). In a slight respite to companies obtaining licenses under section 9(4) of the Insecticides Act, rather, clarifying the confusion revolving around rights of an original registrant having a registered patent under the Patents Act, 1970 ("Patents Act") and a 'follow on' registrant having a registration under section 9(4) of the Insecticides Act, the recent notification by Central Insecticides Board and Registration Committee ("CIB-RC") dated 21st January, 2022 has clarified: "if any of the applicants do not adhere to the provisions of the Patents Act while applying for Registration of the Insecticides it shall be sole responsibility of the applicants and the RC shall not be responsible in any manner whatsoever." Background: Various 'follow on' entities who were obtaining license to import or manufacture insecticides under section 9(4) of the Insecticides Act not being the original registrant of patent, were facing litigation from patent owners for concerned patents which follow on registrants were obtaining 9(4) licenses. As the law with respect to Insecticides Act, was silent on the point if a follow on registrant obtains a license under section 9(4) and has not obtained any necessary permission to use/license from the original registrant, in such cases, the original registrants were suing the follow on registrants for patent infringement. Clarity from the CIB-RC- The Registration Committee ("RC") has advised entities obtaining 9(4) licenses under Insecticides Act, to adhere to the provisions of the Patents Act before obtaining aforementioned licenses, and the said registration shall be the sole responsibility of the applicant and not CIB-RC. Observation- The above mentioned advise in itself by the RC is contrary to the provisions of the Patent Act, specifically Section 156 of the Patents Act. The statutory intention of the Patents Act, is clear that Drugs authorities are bound by patents, granted under the Patent Act, by virtue of Section 156 and therefore, they cannot, by conferring drug or marketing approval permit violation of patents validly granted. This aspect, still remains a grey area.