{"id":25548,"date":"2026-06-06T05:31:49","date_gmt":"2026-06-06T05:31:49","guid":{"rendered":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/?p=25548"},"modified":"2026-06-06T05:35:02","modified_gmt":"2026-06-06T05:35:02","slug":"novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026","status":"publish","type":"post","link":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/","title":{"rendered":"Novartis v. Venkata Narayana Active Ingredients: Madras High Court Clarifies Section 107A: Bolar Exemption and Patent Infringement in Vildagliptin Case"},"content":{"rendered":"\n<h2 id=\"h-introduction\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Introduction\"><\/span>Introduction<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The decision of the Madras High Court in <em>Novartis AG &amp; Anr. v. Venkata Narayana Active Ingredients Pvt. <\/em>Ltd, Neutral Citation 2026:MHC:1874, is an important judgement 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.<\/p><div id=\"ez-toc-container\" class=\"ez-toc-v2_0_84 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #0c0c0c;color:#0c0c0c\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #0c0c0c;color:#0c0c0c\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Introduction\" >Introduction<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Factual_and_Procedural_Background\" >Factual and Procedural Background<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Key_Issues_Before_the_Court\" >Key Issues Before the Court<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Important_Legal_Questions_Considered\" >Important Legal Questions Considered<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Dispute_Before_The_Court\" >Dispute Before The Court<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Reasoning_And_Analysis_Of_The_Court\" >Reasoning And Analysis Of The Court<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Patent_Term_And_Duration_Of_Protection\" >Patent Term And Duration Of Protection<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Issue_Estoppel_And_Consent_Decree\" >Issue Estoppel And Consent Decree<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Section_3d_Challenge_To_Vildagliptin_Patent\" >Section 3(d): Challenge To Vildagliptin Patent<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Section_8_Disclosure_Of_Foreign_Patent_Applications\" >Section 8: Disclosure Of Foreign Patent Applications<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Interpretation_Of_Section_107A_Bolar_Provision\" >Interpretation Of Section 107A (Bolar Provision)<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#International_Authorities_Considered\" >International Authorities Considered<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Reliance_On_Bayer_Corporation_v_Union_Of_India_Ors\" >Reliance On Bayer Corporation v. Union Of India &amp; Ors.<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Scope_And_Limitations_Of_Section_107A\" >Scope And Limitations Of Section 107A<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Requirements_For_Availing_Section_107A_Protection\" >Requirements For Availing Section 107A Protection<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Court_On_Research_And_Development_Claims\" >Court On Research And Development Claims<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Final_Decision_of_the_Court\" >Final Decision of the Court<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Key_Findings_of_the_Court\" >Key Findings of the Court<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Point_of_Law_Settled\" >Point of Law Settled<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Legal_Principles_Confirmed_by_the_Judgment\" >Legal Principles Confirmed by the Judgment<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-21\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Case_Details\" >Case Details<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-22\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#Quick_Case_Summary\" >Quick Case Summary<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n\n\n\n\n<p class=\"wp-block-paragraph\">The dispute revolved around the antidiabetic 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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The judgement 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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<h2 id=\"h-factual-and-procedural-background\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Factual_and_Procedural_Background\"><\/span>Factual and Procedural Background<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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\u2019 patent rights and agreeing not to manufacture, sell, distribute, export, import, or otherwise deal with Vildagliptin in a manner infringing the patent.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">On the basis of that undertaking, the earlier suit was decreed on 31 July 2015.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">According to the plaintiffs, such exports infringed their patent rights because the patent remained in force during the relevant period.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<h2 id=\"h-key-issues-before-the-court\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Key_Issues_Before_the_Court\"><\/span>Key Issues Before the Court<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Issue<\/th><th>Subject Matter<\/th><\/tr><\/thead><tbody><tr><td>Patent Validity<\/td><td>Challenges under Sections 3(d) and 8 of the Patents Act<\/td><\/tr><tr><td>Patent Term<\/td><td>Whether Patent No. 212815 remained valid during the export period<\/td><\/tr><tr><td>Patent Infringement<\/td><td>Whether exports of Vildagliptin API infringed Novartis&#8217; patent rights<\/td><\/tr><tr><td>Section 107A Defence<\/td><td>Whether the exports qualified for the Bolar exemption<\/td><\/tr><tr><td>Prior Undertaking<\/td><td>Effect of the earlier consent decree and undertaking given by the defendant<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-important-legal-questions-considered\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Important_Legal_Questions_Considered\"><\/span>Important Legal Questions Considered<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Whether exports of Vildagliptin API to Egypt were protected under Section 107A of the Patents Act.<\/li>\n\n\n\n<li>Whether such exports constituted patent infringement during the subsistence of Patent No. 212815.<\/li>\n\n\n\n<li>Whether the patent suffered from defects under Section 3(d) of the Patents Act.<\/li>\n\n\n\n<li>Whether there was non-compliance with disclosure requirements under Section 8.<\/li>\n\n\n\n<li>Whether the defendant could challenge the patent after furnishing an earlier undertaking acknowledging the patent rights of Novartis.<\/li>\n\n\n\n<li>Whether the prior consent decree had a binding effect on the parties.<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-dispute-before-the-court\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Dispute_Before_The_Court\"><\/span>Dispute Before The Court<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The principal dispute before the Court was whether the defendant\u2019s manufacture and export of Vildagliptin API fell within the protection of Section 107A of the Patents Act.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The plaintiffs argued that the exports were commercial in nature and therefore constituted infringement of Patent No. 212815.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<h2 id=\"h-reasoning-and-analysis-of-the-court\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Reasoning_And_Analysis_Of_The_Court\"><\/span>Reasoning And Analysis Of The Court<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 id=\"h-patent-term-and-duration-of-protection\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Patent_Term_And_Duration_Of_Protection\"><\/span>Patent Term And Duration Of Protection<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">One of the first questions considered by the Court concerned the duration of the patent.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The defendant argued that the patent term should be calculated from the priority date, which would have resulted in expiry in December 2018.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Court rejected this submission.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Consequently, the patent remained valid until 9 December 2019.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Issue<\/th><th>Defendant&#8217;s Argument<\/th><th>Court&#8217;s Finding<\/th><\/tr><\/thead><tbody><tr><td>Patent Term Calculation<\/td><td>The term should be calculated from the priority date.<\/td><td>The term must be calculated from the international filing date under Sections 53(1) and 7(1B).<\/td><\/tr><tr><td>Patent Expiry<\/td><td>Patent expired in December 2018.<\/td><td>The patent remained valid until 9 December 2019.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 id=\"h-issue-estoppel-and-consent-decree\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Issue_Estoppel_And_Consent_Decree\"><\/span>Issue Estoppel And Consent Decree<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Court analysed the legal principles governing consent decrees and referred to the Supreme Court decisions in <em>Raja Sri Sailendra Narayan Bhanja Deo v. State of Orissa, AIR 1956 SC 346<\/em>, and <em>Byram Pestonji Gariwala v. Union Bank of India, (1992) 1 SCC 31<\/em>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">After reviewing these authorities, the Court held that the earlier undertaking and consent decree created an issue estoppel against the defendant.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Since the defendant had expressly acknowledged the patent and undertaken not to infringe it, it could not subsequently challenge the patent&#8217;s validity in later proceedings between the same parties.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Earlier undertaking acknowledged patent validity.<\/li>\n\n\n\n<li>Consent decree operated as issue estoppel.<\/li>\n\n\n\n<li>Subsequent challenge to validity was barred.<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-section-3-d-challenge-to-vildagliptin-patent\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Section_3d_Challenge_To_Vildagliptin_Patent\"><\/span>Section 3(d): Challenge To Vildagliptin Patent<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The court also considered the defendant\u2019s argument that vildagliptin was merely a metabolite and therefore fell within the exclusion contained in Section 3(d) of the Patents Act.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Court found that there was no evidence supporting this contention.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">On the contrary, the evidence indicated that Vildagliptin was a new chemical entity and had been recognised internationally as such.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Court therefore rejected the Section 3(d) challenge.<\/p>\n\n\n\n<h3 id=\"h-section-8-disclosure-of-foreign-patent-applications\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Section_8_Disclosure_Of_Foreign_Patent_Applications\"><\/span>Section 8: Disclosure Of Foreign Patent Applications<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Another important issue related to Section 8 of the Patents Act, which requires applicants to disclose details of corresponding foreign patent applications.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The defendant alleged that Novartis had failed to comply with this obligation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Court undertook a detailed examination of Section 8, Rule 12 of the Patent Rules, and Form 3.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It concluded that Section 8 requires disclosure of corresponding foreign applications concerning the same or substantially the same invention.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It does not impose a general obligation to disclose every piece of prior art.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As a result, the Section 8 defence was rejected.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Section 8 Issue<\/th><th>Court&#8217;s Interpretation<\/th><\/tr><\/thead><tbody><tr><td>Scope of Disclosure<\/td><td>Limited to corresponding foreign applications involving the same or substantially the same invention.<\/td><\/tr><tr><td>Prior Art Disclosure<\/td><td>No obligation to disclose every item of prior art.<\/td><\/tr><tr><td>Defence Outcome<\/td><td>Rejected due to lack of supporting evidence.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 id=\"h-interpretation-of-section-107a-bolar-provision\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Interpretation_Of_Section_107A_Bolar_Provision\"><\/span>Interpretation Of Section 107A (Bolar Provision)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A substantial portion of the judgement is devoted to the interpretation of Section 107A, commonly known as the Bolar provision.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">To understand the legislative intent, the Court examined international developments and foreign precedents.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It discussed <em>Roche Products Inc. v. Bolar Pharmaceutical Co. Inc., 733 F.2d 858 (Fed. Cir. 1984)<\/em>, which led to legislative reform in the United States.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It also referred to <em>Merck KGaA v. Integra Lifesciences Ltd, 545 U.S. 193 (2005)<\/em>, where the United States Supreme Court held that pre-clinical studies reasonably related to regulatory approval could fall within the statutory exemption.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Court further analysed Article 30 of the TRIPS Agreement and Canada&#8217;s regulatory review exception, noting that international patent law recognises limited exceptions enabling research and regulatory activities before patent expiry.<\/p>\n\n\n\n<h4 id=\"h-international-authorities-considered\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"International_Authorities_Considered\"><\/span>International Authorities Considered<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Authority<\/th><th>Principle Considered By The Court<\/th><\/tr><\/thead><tbody><tr><td>Roche Products Inc. v. Bolar Pharmaceutical Co. Inc.<\/td><td>Background leading to legislative reform regarding regulatory-use exceptions.<\/td><\/tr><tr><td>Merck KGaA v. Integra Lifesciences Ltd.<\/td><td>Pre-clinical studies related to regulatory approval may qualify for statutory exemption.<\/td><\/tr><tr><td>TRIPS Agreement, Article 30<\/td><td>Recognition of limited patent exceptions.<\/td><\/tr><tr><td>Canada&#8217;s Regulatory Review Exception<\/td><td>Permits regulatory preparation before patent expiry.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 id=\"h-reliance-on-bayer-corporation-v-union-of-india-amp-ors\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Reliance_On_Bayer_Corporation_v_Union_Of_India_Ors\"><\/span>Reliance On Bayer Corporation v. Union Of India &amp; Ors.<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The Court then considered the Delhi High Court judgement in <em>Bayer Corporation v. Union of India &amp; Ors., 2019 SCC OnLine Del 11868<\/em>, 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.<\/p>\n\n\n\n<h3 id=\"h-scope-and-limitations-of-section-107a\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Scope_And_Limitations_Of_Section_107A\"><\/span>Scope And Limitations Of Section 107A<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Drawing from these authorities, the Court held that Section 107A is an independent statutory provision intended to facilitate scientific research and regulatory preparation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">However, the exemption is not automatic.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<h4 id=\"h-requirements-for-availing-section-107a-protection\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Requirements_For_Availing_Section_107A_Protection\"><\/span>Requirements For Availing Section 107A Protection<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The activity must be reasonably related to regulatory approval.<\/li>\n\n\n\n<li>The purpose must be research, testing, or information generation required by law.<\/li>\n\n\n\n<li>The exemption must be supported by evidence.<\/li>\n\n\n\n<li>The protection is not available merely because a party labels an activity as research and development.<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-court-on-research-and-development-claims\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Court_On_Research_And_Development_Claims\"><\/span>Court On Research And Development Claims<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Factors To Be Examined<\/th><\/tr><\/thead><tbody><tr><td>Quantities involved in the transaction<\/td><\/tr><tr><td>Nature of the supplies<\/td><\/tr><tr><td>Identity of the recipients<\/td><\/tr><tr><td>Purpose of the transaction<\/td><\/tr><tr><td>Overall surrounding circumstances<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-final-decision-of-the-court\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Final_Decision_of_the_Court\"><\/span>Final Decision of the Court<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">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&#8217;s validity because of the earlier consent decree and undertaking.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Court rejected the defendant\u2019s 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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The judgement 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.<\/p>\n\n\n\n<h3 id=\"h-key-findings-of-the-court\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Key_Findings_of_the_Court\"><\/span>Key Findings of the Court<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Patent No. 212815 remained valid and enforceable until 9 December 2019.<\/li>\n\n\n\n<li>The defendant was barred by issue estoppel from challenging patent validity.<\/li>\n\n\n\n<li>Challenges under Section 3(d) and Section 8 of the Patents Act were rejected.<\/li>\n\n\n\n<li>Section 107A was recognised as a special statutory provision for regulatory approval activities.<\/li>\n\n\n\n<li>The exemption under Section 107A applies only when statutory requirements are strictly satisfied.<\/li>\n\n\n\n<li>Pharmaceutical patent rights remain protected against commercial exploitation during the patent term.<\/li>\n\n\n\n<li>A limited exemption continues for genuine research and regulatory activities.<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-point-of-law-settled\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Point_of_Law_Settled\"><\/span>Point of Law Settled<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The judgement settles several important legal principles.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It clarifies that Section 8 requires disclosure of corresponding foreign patent applications rather than general prior art references.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n\n\n\n<h3 id=\"h-legal-principles-confirmed-by-the-judgment\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Legal_Principles_Confirmed_by_the_Judgment\"><\/span>Legal Principles Confirmed by the Judgment<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Legal Issue<\/th><th>Principle Confirmed by the Court<\/th><\/tr><\/thead><tbody><tr><td>PCT-Based Patent Term<\/td><td>The term of an Indian patent filed through the PCT route is calculated from the international filing date under Sections 53(1) and 7(1B) of the Patents Act.<\/td><\/tr><tr><td>Issue Estoppel<\/td><td>A party that has acknowledged patent validity through a consent decree may be barred from subsequently challenging that validity.<\/td><\/tr><tr><td>Section 8 Compliance<\/td><td>Disclosure obligations relate to corresponding foreign patent applications and not to general prior art references.<\/td><\/tr><tr><td>Section 107A (Bolar Exemption)<\/td><td>Protection is limited to activities solely and reasonably connected with obtaining regulatory approval.<\/td><\/tr><tr><td>Export of Patented Products<\/td><td>Section 107A does not provide blanket immunity for all exports of patented pharmaceutical products.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-case-details\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Case_Details\"><\/span>Case Details<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>Case Title<\/th><td>Novartis AG &amp; AG Vs Venkata Narayana Active Ingredients Pvt. Ltd.<\/td><\/tr><tr><th>Date of Judgment<\/th><td>3 June 2026<\/td><\/tr><tr><th>Case Number<\/th><td>C.S. No. 282 of 2018<\/td><\/tr><tr><th>Neutral Citation<\/th><td>2026: MHC: 1874<\/td><\/tr><tr><th>Court<\/th><td>High Court of Judicature at Madras<\/td><\/tr><tr><th>Judge<\/th><td>Hon&#8217;ble Mr Justice Senthilkumar Ramamoorthy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 id=\"h-quick-case-summary\" class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Quick_Case_Summary\"><\/span>Quick Case Summary<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Patent Number:<\/strong> 212815<\/li>\n\n\n\n<li><strong>Core Issue:<\/strong> Patent validity, issue estoppel, Section 3(d), Section 8, and Section 107A of the Patents Act.<\/li>\n\n\n\n<li><strong>Outcome:<\/strong> Patent upheld and challenges rejected.<\/li>\n\n\n\n<li><strong>Significance:<\/strong> Clarifies the scope of the Bolar exemption under Section 107A and strengthens protection of pharmaceutical patent rights.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Introduction The decision of the Madras High Court in Novartis AG &amp; Anr. v. Venkata Narayana Active Ingredients Pvt. Ltd, Neutral Citation 2026:MHC:1874, is an important judgement 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<\/p>\n","protected":false},"author":56,"featured_media":25547,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"two_page_speed":[],"_jetpack_memberships_contains_paid_content":false,"_joinchat":[],"footnotes":""},"categories":[21],"tags":[5149],"class_list":["post-25548","post","type-post","status-publish","format-standard","has-post-thumbnail","category-intellectual-property","tag-intellectual-property"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.7 (Yoast SEO v27.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Novartis v. Venkata Narayana Active Ingredients: Madras High Court Clarifies Section 107A: Bolar Exemption and Patent Infringement in Vildagliptin Case - Legal Service India - Articles<\/title>\n<meta name=\"description\" content=\"Madras High Court clarifies Section 107A Bolar exemption, upholds Novartis&#039; Vildagliptin patent, and strengthens pharma patent rights.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Novartis v. Venkata Narayana Active Ingredients: Madras High Court Clarifies Section 107A: Bolar Exemption and Patent Infringement in Vildagliptin Case\" \/>\n<meta property=\"og:description\" content=\"Madras High Court clarifies Section 107A Bolar exemption, upholds Novartis&#039; Vildagliptin patent, and strengthens pharma patent rights.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/\" \/>\n<meta property=\"og:site_name\" content=\"Legal Service India - Articles\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/legalservicesind\" \/>\n<meta property=\"article:published_time\" content=\"2026-06-06T05:31:49+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-06-06T05:35:02+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-content\/uploads\/2026\/06\/92e25ef9-0501-4ba3-8cc3-48ca65dc425a-1024x576.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\n\t<meta property=\"og:image:height\" content=\"576\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"ADVOCATE AJAY AMITABH SUMAN\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@legalserviceind\" \/>\n<meta name=\"twitter:site\" content=\"@legalserviceind\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"ADVOCATE AJAY AMITABH SUMAN\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"10 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\\\/\"},\"author\":{\"name\":\"ADVOCATE AJAY AMITABH SUMAN\",\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/#\\\/schema\\\/person\\\/96ae33c2330691e5b3ccd88cf127a305\"},\"headline\":\"Novartis v. Venkata Narayana Active Ingredients: Madras High Court Clarifies Section 107A: Bolar Exemption and Patent Infringement in Vildagliptin Case\",\"datePublished\":\"2026-06-06T05:31:49+00:00\",\"dateModified\":\"2026-06-06T05:35:02+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\\\/\"},\"wordCount\":2188,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/92e25ef9-0501-4ba3-8cc3-48ca65dc425a.png\",\"keywords\":[\"Intellectual Property\"],\"articleSection\":[\"Intellectual Property\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\\\/\",\"url\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\\\/\",\"name\":\"Novartis v. Venkata Narayana Active Ingredients: Madras High Court Clarifies Section 107A: Bolar Exemption and Patent Infringement in Vildagliptin Case - Legal Service India - Articles\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/92e25ef9-0501-4ba3-8cc3-48ca65dc425a.png\",\"datePublished\":\"2026-06-06T05:31:49+00:00\",\"dateModified\":\"2026-06-06T05:35:02+00:00\",\"description\":\"Madras High Court clarifies Section 107A Bolar exemption, upholds Novartis' Vildagliptin patent, and strengthens pharma patent rights.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/92e25ef9-0501-4ba3-8cc3-48ca65dc425a.png\",\"contentUrl\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/92e25ef9-0501-4ba3-8cc3-48ca65dc425a.png\",\"width\":1672,\"height\":941,\"caption\":\"Novartis Vildagliptin Patent\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Intellectual Property > Madras High Court upholds Novartis' Vildagliptin patent, rejects Section 3(d) and Section 8 challenges, and defines the limits of the Section 107A Bolar exemption in pharmaceutical patent law.\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/#website\",\"url\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/\",\"name\":\"Legal Service India - Law Articles\",\"description\":\"Legal Service India - Law Article Directory is the oldest in India since 2000, with thousands of article written by lawyers, law Students and Scholars on all branches of law\",\"publisher\":{\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/#organization\",\"name\":\"Legal Service India\",\"url\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/logo-circle-1.png\",\"contentUrl\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/logo-circle-1.png\",\"width\":105,\"height\":95,\"caption\":\"Legal Service India\"},\"image\":{\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/legalservicesind\",\"https:\\\/\\\/x.com\\\/legalserviceind\",\"https:\\\/\\\/www.youtube.com\\\/@LegalServiceIndia-lsi\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/#\\\/schema\\\/person\\\/96ae33c2330691e5b3ccd88cf127a305\",\"name\":\"ADVOCATE AJAY AMITABH SUMAN\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"\\\/\\\/www.gravatar.com\\\/avatar\\\/b894b0814afe1239db393e20da4b2e76?s=96&#038;r=g&#038;d=mm\",\"url\":\"\\\/\\\/www.gravatar.com\\\/avatar\\\/b894b0814afe1239db393e20da4b2e76?s=96&#038;r=g&#038;d=mm\",\"contentUrl\":\"\\\/\\\/www.gravatar.com\\\/avatar\\\/b894b0814afe1239db393e20da4b2e76?s=96&#038;r=g&#038;d=mm\",\"caption\":\"ADVOCATE AJAY AMITABH SUMAN\"},\"description\":\"Professional and Literary Profile Mr. Ajay Amitabh Suman, Advocate, is an alumnus of the Campus Law Centre, University of Delhi, with over 20 years of experience in IP litigation before the Delhi High Court. He currently serves as a Patent and Trademark Attorney at United &amp; United, a leading intellectual property law firm. Deeply committed to legal scholarship, he has authored more than 900 articles on intellectual property law, published on major platforms including Legal Service India, Bar &amp; Bench, Live Law, SCC Online Blog, Legal Desire, SpicyIP, among others. Beyond his legal practice, he is also an accomplished writer and poet, with over 1,500 literary works and more than 20 books published in Hindi and English. His journey reflects a unique blend of legal advocacy and creative expression, inspired by a passion for justice, knowledge, and reform.\",\"url\":\"https:\\\/\\\/www.legalserviceindia.com\\\/Legal-Articles\\\/author\\\/ajayamitabhsuman\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Novartis v. Venkata Narayana Active Ingredients: Madras High Court Clarifies Section 107A: Bolar Exemption and Patent Infringement in Vildagliptin Case - Legal Service India - Articles","description":"Madras High Court clarifies Section 107A Bolar exemption, upholds Novartis' Vildagliptin patent, and strengthens pharma patent rights.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/","og_locale":"en_US","og_type":"article","og_title":"Novartis v. Venkata Narayana Active Ingredients: Madras High Court Clarifies Section 107A: Bolar Exemption and Patent Infringement in Vildagliptin Case","og_description":"Madras High Court clarifies Section 107A Bolar exemption, upholds Novartis' Vildagliptin patent, and strengthens pharma patent rights.","og_url":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/","og_site_name":"Legal Service India - Articles","article_publisher":"https:\/\/www.facebook.com\/legalservicesind","article_published_time":"2026-06-06T05:31:49+00:00","article_modified_time":"2026-06-06T05:35:02+00:00","og_image":[{"width":1024,"height":576,"url":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-content\/uploads\/2026\/06\/92e25ef9-0501-4ba3-8cc3-48ca65dc425a-1024x576.png","type":"image\/png"}],"author":"ADVOCATE AJAY AMITABH SUMAN","twitter_card":"summary_large_image","twitter_creator":"@legalserviceind","twitter_site":"@legalserviceind","twitter_misc":{"Written by":"ADVOCATE AJAY AMITABH SUMAN","Est. reading time":"10 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#article","isPartOf":{"@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/"},"author":{"name":"ADVOCATE AJAY AMITABH SUMAN","@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/#\/schema\/person\/96ae33c2330691e5b3ccd88cf127a305"},"headline":"Novartis v. Venkata Narayana Active Ingredients: Madras High Court Clarifies Section 107A: Bolar Exemption and Patent Infringement in Vildagliptin Case","datePublished":"2026-06-06T05:31:49+00:00","dateModified":"2026-06-06T05:35:02+00:00","mainEntityOfPage":{"@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/"},"wordCount":2188,"commentCount":0,"publisher":{"@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/#organization"},"image":{"@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#primaryimage"},"thumbnailUrl":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-content\/uploads\/2026\/06\/92e25ef9-0501-4ba3-8cc3-48ca65dc425a.png","keywords":["Intellectual Property"],"articleSection":["Intellectual Property"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/","url":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/","name":"Novartis v. Venkata Narayana Active Ingredients: Madras High Court Clarifies Section 107A: Bolar Exemption and Patent Infringement in Vildagliptin Case - Legal Service India - Articles","isPartOf":{"@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#primaryimage"},"image":{"@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#primaryimage"},"thumbnailUrl":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-content\/uploads\/2026\/06\/92e25ef9-0501-4ba3-8cc3-48ca65dc425a.png","datePublished":"2026-06-06T05:31:49+00:00","dateModified":"2026-06-06T05:35:02+00:00","description":"Madras High Court clarifies Section 107A Bolar exemption, upholds Novartis' Vildagliptin patent, and strengthens pharma patent rights.","breadcrumb":{"@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#primaryimage","url":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-content\/uploads\/2026\/06\/92e25ef9-0501-4ba3-8cc3-48ca65dc425a.png","contentUrl":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-content\/uploads\/2026\/06\/92e25ef9-0501-4ba3-8cc3-48ca65dc425a.png","width":1672,"height":941,"caption":"Novartis Vildagliptin Patent"},{"@type":"BreadcrumbList","@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/novartis-vs-venkata-narayana-section-107a-bolar-exemption-vildagliptin-patent-madras-high-court-2026\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/"},{"@type":"ListItem","position":2,"name":"Intellectual Property > Madras High Court upholds Novartis' Vildagliptin patent, rejects Section 3(d) and Section 8 challenges, and defines the limits of the Section 107A Bolar exemption in pharmaceutical patent law."}]},{"@type":"WebSite","@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/#website","url":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/","name":"Legal Service India - Law Articles","description":"Legal Service India - Law Article Directory is the oldest in India since 2000, with thousands of article written by lawyers, law Students and Scholars on all branches of law","publisher":{"@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/#organization","name":"Legal Service India","url":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/#\/schema\/logo\/image\/","url":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-content\/uploads\/2025\/06\/logo-circle-1.png","contentUrl":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-content\/uploads\/2025\/06\/logo-circle-1.png","width":105,"height":95,"caption":"Legal Service India"},"image":{"@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/legalservicesind","https:\/\/x.com\/legalserviceind","https:\/\/www.youtube.com\/@LegalServiceIndia-lsi"]},{"@type":"Person","@id":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/#\/schema\/person\/96ae33c2330691e5b3ccd88cf127a305","name":"ADVOCATE AJAY AMITABH SUMAN","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"\/\/www.gravatar.com\/avatar\/b894b0814afe1239db393e20da4b2e76?s=96&#038;r=g&#038;d=mm","url":"\/\/www.gravatar.com\/avatar\/b894b0814afe1239db393e20da4b2e76?s=96&#038;r=g&#038;d=mm","contentUrl":"\/\/www.gravatar.com\/avatar\/b894b0814afe1239db393e20da4b2e76?s=96&#038;r=g&#038;d=mm","caption":"ADVOCATE AJAY AMITABH SUMAN"},"description":"Professional and Literary Profile Mr. Ajay Amitabh Suman, Advocate, is an alumnus of the Campus Law Centre, University of Delhi, with over 20 years of experience in IP litigation before the Delhi High Court. He currently serves as a Patent and Trademark Attorney at United &amp; United, a leading intellectual property law firm. Deeply committed to legal scholarship, he has authored more than 900 articles on intellectual property law, published on major platforms including Legal Service India, Bar &amp; Bench, Live Law, SCC Online Blog, Legal Desire, SpicyIP, among others. Beyond his legal practice, he is also an accomplished writer and poet, with over 1,500 literary works and more than 20 books published in Hindi and English. His journey reflects a unique blend of legal advocacy and creative expression, inspired by a passion for justice, knowledge, and reform.","url":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/author\/ajayamitabhsuman\/"}]}},"jetpack_featured_media_url":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-content\/uploads\/2026\/06\/92e25ef9-0501-4ba3-8cc3-48ca65dc425a.png","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts\/25548","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/users\/56"}],"replies":[{"embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/comments?post=25548"}],"version-history":[{"count":2,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts\/25548\/revisions"}],"predecessor-version":[{"id":25618,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts\/25548\/revisions\/25618"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/media\/25547"}],"wp:attachment":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/media?parent=25548"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/categories?post=25548"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/tags?post=25548"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}