Novartis AG & Anr. Vs. Venkata Narayana Active Ingredients Pvt. Ltd., C.S. No. 282 of 2018, decided on 3 June 2026 by the High Court of Judicature at Madras (Madras High Court), Neutral Citation: 2026:MHC:1874.
The Madras High Court held in favour of Novartis AG in a patent infringement suit concerning the pharmaceutical compound Vildagliptin. The dispute arose after Novartis alleged that the defendant had exported Vildagliptin Active Pharmaceutical Ingredient (API) to entities in Egypt during the subsistence of its patent, despite an earlier consent decree in which the defendant had acknowledged the validity of the patent and undertaken not to deal in the patented product.
The defendant contended that the exports were protected under Section 107A of the Patents Act as they were meant solely for research and development purposes and also challenged the validity of the patent on multiple grounds. The Court rejected these contentions, holding that the defendant was estopped from questioning the validity of the patent because of the earlier consent decree and undertaking. The Court further found no evidence supporting the plea that Vildagliptin was a non-patentable metabolite or that the patent was invalid for non-disclosure under Section 8 of the Patents Act.
After examining the scope of the Bolar exemption under Section 107A and the evidence on record, the Court concluded that the issues relating to patent validity were liable to be decided in favour of the plaintiffs and proceeded to determine the infringement dispute accordingly.
[Disclaimer: Readers are advised not treat this as a substitute for legal advise as it may contain errors in perception,interpretation and presentation of facts and law.]
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Novartis AG v. Venkata Narayana Active Ingredients Pvt. Ltd.: Scope of Section 107A (Bolar Exception) and Patent Validity Challenges in Pharmaceutical Patent Litigation
Alternative SEO-Friendly Titles
Novartis AG v. Venkata Narayana Active Ingredients: Madras High Court Clarifies Scope of Section 107A of the Patents Act
Madras High Court on Vildagliptin Patent Exports and the Bolar Exception
Can Patented Pharmaceutical APIs Be Exported for Research Purposes? Analysis of 2026:MHC:1874
Section 107A of the Patents Act Explained Through the Novartis Vildagliptin Patent Case
Issue Estoppel and Patent Validity Challenges in Pharmaceutical Patent Litigation
Patent Infringement and Regulatory Use Exemption: A Detailed Analysis of Novartis AG v. Venkata Narayana
Introduction
The decision of the Madras High Court in Novartis AG & Anr. v. Venkata Narayana Active Ingredients Pvt. Ltd., Neutral Citation 2026:MHC:1874, is an important judgment concerning pharmaceutical patent protection, the scope of the regulatory-use exemption under Section 107A of the Patents Act, 1970, and the effect of a prior consent decree on subsequent patent validity challenges.
The dispute revolved around the anti-diabetic drug Vildagliptin, covered by Indian Patent No. 212815 owned by Novartis AG. The Court examined whether exports of Vildagliptin Active Pharmaceutical Ingredient (API) by the defendant to entities in Egypt during the subsistence of the patent were protected under Section 107A of the Patents Act or constituted patent infringement. The judgment also considered issues relating to patent term calculation, validity challenges under Section 3(d), disclosure obligations under Section 8 of the Patents Act, and the legal effect of an earlier undertaking furnished by the defendant.The ruling provides important guidance on the extent of the Bolar exemption in India and clarifies the obligations of parties involved in pharmaceutical patent disputes.
Factual and Procedural Background
Novartis AG was the proprietor of Indian Patent No. 212815 relating to Vildagliptin, a pharmaceutical compound used in the treatment of Type 2 Diabetes Mellitus. The patent originated from an international patent application filed under the Patent Cooperation Treaty (PCT) and was granted in India.
Prior to the present proceedings, the parties had been involved in earlier litigation before the Madras High Court. In that suit, the defendant had furnished an undertaking acknowledging the plaintiffs’ patent rights and agreeing not to manufacture, sell, distribute, export, import, or otherwise deal with Vildagliptin in a manner infringing the patent. On the basis of that undertaking, the earlier suit was decreed on 31 July 2015.
The present dispute arose when Novartis alleged that the defendant subsequently exported substantial quantities of Vildagliptin API to purchasers in Egypt during 2016 and 2017 despite the earlier undertaking. According to the plaintiffs, such exports infringed their patent rights because the patent remained in force during the relevant period.
The defendant admitted that exports had taken place but contended that the supplies were exclusively intended for research, development, testing, and regulatory approval purposes and were therefore protected by Section 107A of the Patents Act.
A full trial was conducted and several issues were framed regarding patent validity, patent term, infringement, applicability of Section 107A, and the consequences of the earlier consent decree.
Dispute Before the Court
The principal dispute before the Court was whether the defendant’s manufacture and export of Vildagliptin API fell within the protection of Section 107A of the Patents Act.
The plaintiffs argued that the exports were commercial in nature and therefore constituted infringement of Patent No. 212815.
The defendant contended that the exports were undertaken solely to facilitate research activities and regulatory approval procedures in Egypt and consequently qualified for the statutory exemption provided under Section 107A.
The defendant also sought to challenge the validity of the patent on several grounds. It argued that the patent term had expired earlier than claimed by the plaintiffs, that the invention was not patentable under Section 3(d), and that the patent was vulnerable because of alleged non-disclosure of foreign patent applications under Section 8 of the Patents Act.
Reasoning and Analysis of the Court
One of the first questions considered by the Court concerned the duration of the patent. The defendant argued that the patent term should be calculated from the priority date, which would have resulted in expiry in December 2018. The Court rejected this submission. Referring to Sections 53(1) and 7(1B) of the Patents Act, it held that where an Indian patent application originates from a PCT application designating India, the patent term is calculated from the international filing date and not the priority date. Consequently, the patent remained valid until 9 December 2019.
The Court then examined whether the defendant could challenge the validity of the patent after having previously acknowledged its validity through an undertaking recorded in the earlier suit. The Court analysed the legal principles governing consent decrees and referred to the Supreme Court decisions in Raja Sri Sailendra Narayan Bhanja Deo v. State of Orissa, AIR 1956 SC 346, and Byram Pestonji Gariwala v. Union Bank of India, (1992) 1 SCC 31.
After reviewing these authorities, the Court held that the earlier undertaking and consent decree created an issue estoppel against the defendant. Since the defendant had expressly acknowledged the patent and undertaken not to infringe it, it could not subsequently challenge the patent's validity in later proceedings between the same parties.
The Court also considered the defendant’s argument that Vildagliptin was merely a metabolite and therefore fell within the exclusion contained in Section 3(d) of the Patents Act. The Court found that there was no evidence supporting this contention. On the contrary, the evidence indicated that Vildagliptin was a new chemical entity and had been recognised internationally as such. The Court therefore rejected the Section 3(d) challenge.
Another important issue related to Section 8 of the Patents Act, which requires applicants to disclose details of corresponding foreign patent applications. The defendant alleged that Novartis had failed to comply with this obligation. The Court undertook a detailed examination of Section 8, Rule 12 of the Patent Rules, and Form 3. It concluded that Section 8 requires disclosure of corresponding foreign applications concerning the same or substantially the same invention. It does not impose a general obligation to disclose every piece of prior art.
The Court found that the defendant had failed to establish that the documents relied upon by it constituted foreign applications for the same or substantially the same invention. As a result, the Section 8 defence was rejected.
A substantial portion of the judgment is devoted to the interpretation of Section 107A, commonly known as the Bolar provision. To understand the legislative intent, the Court examined international developments and foreign precedents. It discussed Roche Products Inc. v. Bolar Pharmaceutical Co. Inc., 733 F.2d 858 (Fed. Cir. 1984), which led to legislative reform in the United States. It also referred to Merck KGaA v. Integra Lifesciences Ltd., 545 U.S. 193 (2005), where the United States Supreme Court held that pre-clinical studies reasonably related to regulatory approval could fall within the statutory exemption.
The Court further analysed Article 30 of the TRIPS Agreement and Canada's regulatory review exception, noting that international patent law recognises limited exceptions enabling research and regulatory activities before patent expiry.
The Court then considered the Delhi High Court judgment in Bayer Corporation v. Union of India & Ors., 2019 SCC OnLine Del 11868, which had interpreted Section 107A broadly and recognised that export transactions may fall within the provision if they are genuinely connected with regulatory approval requirements.
Drawing from these authorities, the Court held that Section 107A is an independent statutory provision intended to facilitate scientific research and regulatory preparation. However, the exemption is not automatic. The party invoking it must establish that the acts complained of were undertaken solely for purposes reasonably related to the development and submission of information required under a law regulating the manufacture, sale, use, or import of a product.
The Court emphasised that merely describing supplies as being for research and development purposes does not automatically bring them within the protection of Section 107A. The surrounding facts, quantities involved, nature of transactions, identity of recipients, and overall circumstances must be examined to determine whether the statutory conditions have actually been satisfied.
Final Decision of the Court
The Court held that Patent No. 212815 remained valid and enforceable until 9 December 2019. It further held that the defendant was barred by issue estoppel from challenging the patent's validity because of the earlier consent decree and undertaking.
The Court rejected the defendant’s challenges based on Section 3(d) and Section 8 of the Patents Act. It also reaffirmed that Section 107A is a special statutory provision intended to facilitate regulatory approval activities but can only be invoked where the statutory requirements are strictly satisfied.
The judgment therefore reinforces the principle that pharmaceutical patent rights continue to enjoy protection against commercial exploitation during the patent term while preserving a limited exemption for genuine research and regulatory activities.
Point of Law Settled
The judgment settles several important legal principles. It confirms that the term of a PCT-based Indian patent is calculated from the international filing date under Sections 53(1) and 7(1B) of the Patents Act. It establishes that a party which has acknowledged patent validity through a consent decree may be prevented by issue estoppel from later challenging that validity. It clarifies that Section 8 requires disclosure of corresponding foreign patent applications rather than general prior art references. Most importantly, it confirms that Section 107A protects only those activities that are solely and reasonably related to obtaining regulatory approval and does not provide blanket immunity for all exports of patented pharmaceutical products.
Case Title: Novartis AG & Anr. v. Venkata Narayana Active Ingredients Pvt. Ltd.
Date of Judgment: 3 June 2026
Case Number: C.S. No. 282 of 2018
Neutral Citation: 2026:MHC:1874
Court: High Court of Judicature at Madras
Judge: Hon'ble Mr. Justice Senthilkumar Ramamoorthy
Headnote
The Madras High Court held that the term of a PCT-based Indian patent is computed from the international filing date and not the priority date. The Court further held that a defendant who has acknowledged patent validity in a prior consent decree is barred by issue estoppel from subsequently challenging that validity. The Court clarified that Section 8 of the Patents Act concerns disclosure of corresponding foreign patent applications and not prior art generally. While recognising the broad purpose of Section 107A, the Court held that the exemption applies only where the impugned acts are solely and reasonably related to obtaining regulatory approval and cannot be used as a blanket defence for commercial exports of patented pharmaceutical products.
Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
Disclaimer: Readers are advised not to treat this as substitute for legal advise as it may contain errors in perception, interpretation, and presentation.
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