Bolar provision: an experimental use exception to patent monopoly

Abstract

India introduced product patents through the Patents Amendment Act, 2005 (Amendment Act). It was at this time that the Amendment Act also introduced Section 107A, mainly with intent to ensure the availability of the drug (product patent) in the Indian market immediately after the expiry of the term of such a patent. Section 107A of Patent Act deals with Bolar provision, it’s a defence for patent infringement wherein a patented invention (that is due to expire in the next three years) can be exploited by a third party solely for research and development purposes and to obtain the required regulatory approvals, while the patent is still valid. In a recent judgement, the Division Bench of the Delhi High Court (Court), decided on the two appeals filed by Bayer Corporation (Bayer) - one from the decision of the Learned Single Judge in a writ petition, filed by Bayer against the Natco Pharma Limited (Natco) (Bayer Corporation v Union of India & Ors LPA No 359/2017)and the second, in a suit filed by Bayer against Alembic Chemicals Ltd (Alembic) (Bayer Intellectual Property GMBH & Anr v Alembic Pharmaceuticals Ltd, RFA(OS)(Comm)6/2017)), both appeals involved identical issues pertaining to the interpretation of Section 107A of the Patents Act, 1970 (the Act), commonly known as the ‘Bolar’ provision. This research paper through light on how the decision of the Delhi Court and its interpretation of the Section 107A of the Act has clarified certain issues, which there was no clarity previously. Paper also focuses on whether this decision is certainly hailed by local companies who are waiting to enter the market immediately upon the expiry of a patent. ________________________________________________________