Patents – Bolar provision – Defendant in infringement suit must discharge a heavier burden to establish supply under Section 107A providing exception

The Madras High Court has observed that a defendant in an action for infringement is required to discharge a far heavier burden to establish that the supply falls within the scope of Section 107A of the Patents Act, 1970 which according to the Court provides for exception which if not satisfied would constitute infringing use. The High Court here disagreed with the Delhi High Court decision in Bayer Corporation v. Union of India that Section 107A is a special provision and not an exception. [See an article on the Delhi High Court decision here.]

Section 107A allows certain acts involving patented inventions, such as making, constructing, using, selling or importing for regulatory purposes or authorized parallel imports, without constituting patent infringement. Thus, authorizing use so as to comply with statutory regulations in order to launch generic drugs as soon as the patent lapses. 

However, concurring with the Delhi High Court decision on non-exhaustive aspects to be taken note of to evaluate whether the sale, use, etc., falls within the scope of Section 107A, the Madras HC in Novartis AG v. Venkata Narayana Active Ingredients Pvt. Ltd. [Judgement dated 3 June 2026] also specified the following 4 categories of documents necessary to be provided by a person relying on Section 107A:

• Evidence that regulatory approval was sought in India or abroad for the patented product.
• Evidence that the regulator sought product-related data, including pre-clinical or clinical trial data.
• If the applicant is not the API/formulation manufacturer, evidence of its supply request to the manufacturer or seller, with supporting documents.
• Evidence that the impugned use was reasonably related to regulatory approval.