--- title: "Madras High Court Expounds the Scope of the Bolar Exception in Patent Infringement Litigation" date: 2026-07-09 author: "King Stubb & Kasiva" url: https://ksandk.com/newsletter/bolar-exception-section-107a/ --- # Madras High Court Expounds the Scope of the Bolar Exception in Patent Infringement Litigation Posted On - 9 July, 2026 • By - King Stubb & Kasiva In *Novartis AG & Anr. v. Venkata Narayana Active Ingredients Pvt. Ltd.*, the Madras High Court delivered a significant ruling on the scope of the **Bolar exception under Section 107A** of the Patents Act, 1970. The judgment clarifies the evidentiary burden on parties invoking this statutory exception and its narrow application to activities genuinely related to regulatory approvals. ## Summary In *Novartis AG & Anr. v. Venkata Narayana Active Ingredients Pvt. Ltd.*, C.S. No. 282 of 2018, the Madras High Court held that the protection under **Section 107A of the Patents Act, 1970** (the Bolar exception) is available only where the manufacture, use, sale, export or import of a patented invention is solely for purposes reasonably related to obtaining regulatory approval. The Court held that the **burden of proving the applicability of Section 107A** lies upon the party invoking the exception. Mere assertions that exports were for research and development were held to be insufficient in the absence of evidence demonstrating a genuine nexus with regulatory approval. Consequently, the Court held that the Defendant’s manufacture and export of the patented Active Pharmaceutical Ingredient (API) **infringed the Plaintiffs’ patent**. ## Facts of the Case ### Plaintiffs’ Contentions The Plaintiffs, **Novartis AG and Novartis Healthcare Pvt. Ltd.**, instituted a patent infringement suit against Venkata Narayana Active Ingredients Pvt. Ltd. alleging infringement of Indian Patent No. 212815 relating to **Vildagliptin**, an anti-diabetic pharmaceutical compound. The Plaintiffs contended that the Defendant had manufactured and exported Vildagliptin API to purchasers in Egypt without authorisation during the subsistence of the patent, thereby infringing their exclusive rights under **Section 48 of the Patents Act**. ### Defendant’s Defence The Defendant admitted manufacturing and exporting the patented API but relied upon **Section 107A of the Patents Act**, contending that the exports were made solely for research and development purposes to enable regulatory approvals and therefore fell within the statutory Bolar exception. The Defendant also challenged the validity of the patent on several grounds, including alleged non-compliance with **Section 8** of the Patents Act and lack of patentability under **Section 3(d)**. ### Plaintiffs’ Response The Plaintiffs disputed these contentions, arguing that the exports were **commercial in nature** and that the Defendant had produced no evidence demonstrating that the Egyptian purchasers required the API for regulatory approval processes. The Plaintiffs further contended that the Defendant had failed to satisfy the requirements necessary to invoke Section 107A. ## Issue Before the Court Whether the Defendant’s manufacture and export of the patented **Vildagliptin API** fell within the protection afforded by Section 107A of the Patents Act, 1970, or constituted infringement of the Plaintiffs’ patent. ## Findings of the Court ### Legislative History and Purpose of Section 107A The Court undertook an extensive examination of the **legislative history of Section 107A**, its origin in the Bolar exception recognised internationally, the TRIPS Agreement, and the legislative intent underlying its incorporation into the Patents Act. It held that Section 107A was enacted to facilitate the timely availability of generic products immediately upon the expiry of patent protection by permitting **limited use of patented inventions for obtaining regulatory approvals**. ### Distinction Between Section 107A and Section 47 The Court observed that **Section 107A is distinct from the research exemption** contained in Section 47 of the Patents Act. While Section 47 permits experimental and research use, Section 107A is specifically directed towards activities undertaken for obtaining regulatory approval. The Court identified **two essential requirements** for invoking Section 107A: 1. The **sole purpose** of the impugned acts must be compliance with regulatory requirements. 2. Such acts must be **reasonably related** to obtaining regulatory approval. ### Burden of Proof and Evidentiary Requirements Departing from certain observations of the Delhi High Court in *Bayer Corporation v. Union of India*, the Court held that Section 107A operates as an **exception to patent infringement** and, consequently, the burden of establishing its applicability lies on the Defendant invoking the provision. The Court held that a Defendant cannot merely rely upon invoices describing goods as supplied “for research and development purposes”; it must adduce **credible evidence** demonstrating that the manufacture or export was genuinely undertaken to facilitate regulatory approval. Where exports are made to third-party entities abroad, the evidence should ordinarily establish that the overseas recipient required the patented product for obtaining regulatory approval, such as **regulatory requests, documentation, or other supporting material** linking the supply to the approval process. ### Application to the Defendant’s Conduct Applying these principles, the Court found that the Defendant had **failed to prove** that the Egyptian purchasers required the API for regulatory approval or that the exports were reasonably connected with such regulatory purposes. The evidence showed only that the invoices described the supplies as being for research and development, which by itself was **insufficient to satisfy the requirements of Section 107A**. Accordingly, the Defendant failed to discharge the burden necessary to invoke the statutory exception. ### Challenges Under Section 8 and Section 3(d) The Court also rejected the Defendant’s challenge under **Section 8 of the Patents Act**, holding that the statutory obligation extends only to disclosure of corresponding foreign patent applications and not prior art generally. The Defendant failed to establish any actionable violation of Section 8. The Court further rejected the challenge under **Section 3(d)**, holding that the Defendant had failed to establish that the suit patent lacked patentability on that ground. ## Held The Madras High Court held that the Defendant’s manufacture and export of Vildagliptin API **did not fall within the protection of Section 107A** of the Patents Act because the Defendant failed to establish that the impugned activities were solely and reasonably related to obtaining regulatory approvals. The Defendant’s manufacture and export of the patented API therefore constituted **infringement of the Plaintiffs’ patent**. The suit was accordingly decreed in favour of the Plaintiffs. ## Conclusion The judgment is a **significant pronouncement on the scope of the Bolar exception** under Indian patent law. It clarifies that Section 107A is a narrowly construed statutory exception intended exclusively to facilitate regulatory approvals and not a general exemption for research or commercial exports. The decision places the **evidentiary burden upon the party invoking the exception** and requires concrete proof demonstrating a genuine regulatory purpose behind the impugned activities. By distinguishing regulatory approval activities from ordinary research and commercial transactions, the ruling provides important guidance for pharmaceutical manufacturers seeking to rely upon Section 107A while reinforcing the **balance between patent protection and the timely entry of generic medicines** into the market. *Last Updated on 9 July, 2026* --- ## Office Locations - [New Delhi](https://ksandk.com/locations/top-corporate-law-firm-in-delhi/) (HQ): +91-11-41318190 | info@ksandk.com - [Mumbai](https://ksandk.com/locations/top-corporate-law-firm-in-mumbai/): 3 offices (Nariman Point, Lower Parel, Andheri) | mumbai@ksandk.com - [Bangalore](https://ksandk.com/locations/top-corporate-law-firm-in-bangalore/): bangalore@ksandk.com - [Chennai](https://ksandk.com/locations/chennai/): chennai@ksandk.com - [Hyderabad](https://ksandk.com/locations/hyderabad/): hyderabad@ksandk.com - [Pune](https://ksandk.com/locations/pune/): pune@ksandk.com - [Kochi](https://ksandk.com/locations/kochi/): kochi@ksandk.com ## Contact - [Contact Page](https://ksandk.com/contact-us/) - General: info@ksandk.com | +91-11-41318190 - WhatsApp: +91-7428567444 - [Privacy Statement](https://ksandk.com/privacy-statement/) - [Terms of Use](https://ksandk.com/terms-of-use/)