{"id":5588,"date":"2025-07-01T10:33:41","date_gmt":"2025-07-01T10:33:41","guid":{"rendered":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/?p=5588"},"modified":"2025-07-01T10:33:50","modified_gmt":"2025-07-01T10:33:50","slug":"section-83-of-patent-act-is-not-a-defense-to-infringement-remedy-lies-via-section-84-compulsory-licensing","status":"publish","type":"post","link":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/section-83-of-patent-act-is-not-a-defense-to-infringement-remedy-lies-via-section-84-compulsory-licensing\/","title":{"rendered":"Section 83 of Patent Act is not a Defense to Infringement; Remedy Lies via Section 84 Compulsory Licensing"},"content":{"rendered":"<h2><span class=\"ez-toc-section\" id=\"Novartis_AG_Anr_v_Cipla_Ltd_2015\"><\/span>Novartis AG &amp; Anr. v. Cipla Ltd. (2015)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>In the intricate tapestry of intellectual property law<\/strong>, few cases exemplify the tension between patent rights and public health as vividly as <em>Novartis AG &amp; Anr. v. Cipla Ltd.<\/em>, decided by the Delhi High Court on January 9, 2015. This legal skirmish revolved around the enforcement of a patent for INDACATEROL, a groundbreaking bronchodilator for chronic obstructive pulmonary disease (COPD), against the backdrop of India\u2019s burgeoning public health crisis. The plaintiffs, Novartis AG and its Indian subsidiary, sought to protect their statutory monopoly, while the defendant, Cipla Ltd., challenged the exclusivity by invoking the dire needs of COPD patients.<\/p><div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 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\/section-83-of-patent-act-is-not-a-defense-to-infringement-remedy-lies-via-section-84-compulsory-licensing\/#Novartis_AG_Anr_v_Cipla_Ltd_2015\" >Novartis AG &amp; Anr. v. Cipla Ltd. (2015)<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/section-83-of-patent-act-is-not-a-defense-to-infringement-remedy-lies-via-section-84-compulsory-licensing\/#Detailed_Factual_Background\" >Detailed Factual Background<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/section-83-of-patent-act-is-not-a-defense-to-infringement-remedy-lies-via-section-84-compulsory-licensing\/#Detailed_Procedural_Background\" >Detailed Procedural Background<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/section-83-of-patent-act-is-not-a-defense-to-infringement-remedy-lies-via-section-84-compulsory-licensing\/#Issues_Involved_in_the_Case\" >Issues Involved in the Case<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/section-83-of-patent-act-is-not-a-defense-to-infringement-remedy-lies-via-section-84-compulsory-licensing\/#Detailed_Submission_of_Parties\" >Detailed Submission of Parties<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/section-83-of-patent-act-is-not-a-defense-to-infringement-remedy-lies-via-section-84-compulsory-licensing\/#Judgments_and_Precedents_Cited\" >Judgments and Precedents Cited<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/section-83-of-patent-act-is-not-a-defense-to-infringement-remedy-lies-via-section-84-compulsory-licensing\/#Judicial_Reasoning_and_Analysis\" >Judicial Reasoning and Analysis<\/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\/section-83-of-patent-act-is-not-a-defense-to-infringement-remedy-lies-via-section-84-compulsory-licensing\/#Final_Decision\" >Final Decision<\/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\/section-83-of-patent-act-is-not-a-defense-to-infringement-remedy-lies-via-section-84-compulsory-licensing\/#Law_Settled_in_This_Case\" >Law Settled in This Case<\/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\/section-83-of-patent-act-is-not-a-defense-to-infringement-remedy-lies-via-section-84-compulsory-licensing\/#Case_Details\" >Case Details<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n\n<h3><span class=\"ez-toc-section\" id=\"Detailed_Factual_Background\"><\/span>Detailed Factual Background<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The dispute centered on Indian Patent No. 222346, granted to Novartis AG, a Swiss pharmaceutical giant, on August 5, 2008, covering INDACATEROL and its maleate salt, INDACATEROL Maleate. Novartis AG is renowned for its pharmaceutical R&amp;D, investing USD 7.2 billion in 2013 alone. Its Indian arm, Novartis Healthcare Pvt. Ltd., partnered with Lupin Ltd. under a 2012 agreement to market INDACATEROL Maleate in India as ONBREZ.<\/p>\n<p>INDACATEROL, a novel ultra-long-acting \u03b22-agonist, offered 24-hour bronchodilation\u2014an advance over 12-hour therapies\u2014approved globally by the EMA (2009) and the U.S. FDA (2011).<\/p>\n<p>Cipla Ltd., an Indian pharmaceutical powerhouse, launched its own INDACATEROL-based product in October 2014, citing Novartis\u2019s failure to meet India\u2019s COPD demand\u2014estimated at 1.5 crore patients annually\u2014with imports covering only 0.03% of the need. Cipla argued that Novartis\u2019s high-priced imports exacerbated the plight of India\u2019s COPD population, which faces challenges like smoking, biomass fuel exposure, and limited healthcare access.<\/p>\n<p>Novartis countered that INDACATEROL was a New Chemical Entity (NCE) developed through extensive R&amp;D and centrally manufactured in Switzerland. Global sales hit USD 192.2 million in 2013; Indian sales rose from INR 4.2 million in 2010 to INR 23.6 million by September 2014. Cipla claimed this was still insufficient, citing studies predicting a rise in COPD cases to 2.2 crore.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Detailed_Procedural_Background\"><\/span>Detailed Procedural Background<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Novartis filed suit (CS(OS) 3812\/2014) in the Delhi High Court, seeking a permanent injunction against Cipla for infringing Patent No. 222346, along with claims for damages and delivery-up. Novartis also moved an interim injunction application (I.A. No. 24863\/2014) under Order XXXIX Rules 1 and 2 of the CPC.<\/p>\n<p>Cipla, yet to file its written statement, replied on December 11, 2014. Earlier, on October 22, 2014, it had petitioned the Central Government under Sections 66 and 92(3) of the Patents Act, 1970, to revoke the patent. Novartis filed a rejoinder affirming its patent\u2019s validity. Cipla also applied to implead the government\u2014notice was issued but unresolved at judgment.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Issues_Involved_in_the_Case\"><\/span>Issues Involved in the Case<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ol>\n<li>Whether Novartis established a prima facie case of patent infringement warranting an interim injunction?<\/li>\n<li>Whether public interest, i.e., INDACATEROL\u2019s limited availability and affordability, could override Novartis\u2019s statutory rights under Section 48 of the Patents Act?<\/li>\n<\/ol>\n<h3><span class=\"ez-toc-section\" id=\"Detailed_Submission_of_Parties\"><\/span>Detailed Submission of Parties<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>Novartis:<\/strong> Asserted that Patent No. 222346, unchallenged since 2008, conferred an exclusive right under Section 48. Cited global approvals and claimed Cipla\u2019s launch infringed the patent. Denied inadequate supply allegations, citing sales data and readiness to meet demand. Rejected Cipla\u2019s public interest argument, proposing licensing (which Cipla refused). Emphasized that compulsory licensing belongs before the Controller.<\/p>\n<p><strong>Cipla:<\/strong> Challenged patent validity under Section 64 (obviousness, lack of novelty). Main argument was public interest under Sections 83 and 84, claiming Novartis failed to meet India\u2019s COPD crisis. Positioned itself as offering a life-saving, affordable alternative. Cited TRIPS Agreement (Article 7) and Indian Constitution (Article 21). Proposed royalty deposit instead of injunction.<\/p>\n<p><strong>Novartis (Rejoinder):<\/strong> Dismissed revocation plea as implicit admission of patent validity. Contested Cipla\u2019s COPD demand estimates. Argued that INDACATEROL suits only mild-to-moderate COPD. Claimed no mandate exists for local manufacturing.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Judgments_and_Precedents_Cited\"><\/span>Judgments and Precedents Cited<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><strong>American Cyanamid Co. v. Ethicon Ltd.<\/strong>, [1975] RPC 513 (UK): Established prima facie case, balance of convenience, and irreparable harm for interim relief.<\/li>\n<li><strong>eBay Inc. v. MercExchange, L.L.C.<\/strong>, 547 U.S. 388 (2006): Introduced a four-factor test for injunctive relief in patent cases\u2014referenced for public interest considerations.<\/li>\n<li><strong>Bard Peripheral Vascular, Inc. v. W.L. Gore &amp; Associates, Inc.<\/strong>, 670 F.3d 1171 (2012): Denied permanent injunction on public access grounds\u2014relevant for alternatives like royalties.<\/li>\n<li><strong>F. Hoffmann-La Roche Ltd. v. Cipla Ltd.<\/strong>, 148 (2008) DLT 598: Denied injunction due to validity concerns and public interest\u2014distinguished but endorsed the public interest principle.<\/li>\n<li><strong>Bayer Corporation v. Union of India &amp; Ors.<\/strong>, W.P. No. 1323 of 2013: Addressed what constitutes \u201cworking\u201d a patent\u2014Cipla\u2019s argument; court deferred to the Controller.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Judicial_Reasoning_and_Analysis\"><\/span>Judicial Reasoning and Analysis<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The Court interpreted Section 48 of the Patents Act to grant exclusive rights, but noted that public interest arguments (e.g., under Section 83) must be pursued before the Controller, not in infringement suits. The Court acknowledged public interest as relevant to balance of convenience in equitable relief, especially for life-saving drugs.<\/p>\n<p>The court found Cipla\u2019s demand estimates vague and unsupported, while Novartis\u2019s affidavit indicated surplus stock and willingness to meet demand. Cipla\u2019s proposal of royalty deposit was rejected due to lack of financial clarity and inequity to Novartis.<\/p>\n<p>A conditional injunction was granted, allowing Cipla to pursue compulsory licensing within two weeks. Otherwise, Cipla was restrained from manufacturing or selling INDACATEROL Maleate until trial or licensing outcome.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Final_Decision\"><\/span>Final Decision<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>On January 9, 2015, the Court granted an <strong>interim injunction<\/strong> restraining Cipla from manufacturing or selling INDACATEROL Maleate. However, it permitted Cipla to seek a compulsory license within two weeks, with the Controller required to decide within six months.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Law_Settled_in_This_Case\"><\/span>Law Settled in This Case<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The judgment clarified that public interest arguments like non-working or affordability (under Section 83) are not valid defenses in infringement proceedings. These must be addressed via <strong>compulsory licensing under Section 84<\/strong>. However, courts may consider public interest within the balance of convenience for interim relief, provided strong evidence exists.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Case_Details\"><\/span>Case Details<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><strong>Case Title:<\/strong> Novartis AG &amp; Anr. Vs. Cipla Ltd.<\/li>\n<li><strong>Date of Order:<\/strong> January 9, 2015<\/li>\n<li><strong>Case No.:<\/strong> CS(OS) 3812\/2014<\/li>\n<li><strong>Court:<\/strong> High Court of Delhi at New Delhi<\/li>\n<li><strong>Judge:<\/strong> Hon&#8217;ble Justice Shree Manmohan Singh<\/li>\n<\/ul>\n<p><b>Disclaimer: <\/b>The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.<\/p>\n<p><b>Written By: Advocate Ajay Amitabh Suman<\/b>, IP Adjutor &#8211; Patent and Trademark Attorney<br \/>\nEmail: ajayamitabhsuman@gmail.com, Ph no: 9990389539<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Novartis AG &amp; Anr. v. Cipla Ltd. (2015) In the intricate tapestry of intellectual property law, few cases exemplify the tension between patent rights and public health as vividly as Novartis AG &amp; Anr. v. Cipla Ltd., decided by the Delhi High Court on January 9, 2015. This legal skirmish revolved around the enforcement of<\/p>\n","protected":false},"author":56,"featured_media":0,"comment_status":"open","ping_status":"open","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":[24],"class_list":{"0":"post-5588","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-intellectual-property","7":"tag-just-in"},"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts\/5588","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=5588"}],"version-history":[{"count":0,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts\/5588\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/media?parent=5588"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/categories?post=5588"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/tags?post=5588"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}