{"id":9969,"date":"2025-10-12T10:57:42","date_gmt":"2025-10-12T10:57:42","guid":{"rendered":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/?p=9969"},"modified":"2025-10-12T11:06:06","modified_gmt":"2025-10-12T11:06:06","slug":"patent-infringement-and-person-in-the-know","status":"publish","type":"post","link":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/patent-infringement-and-person-in-the-know\/","title":{"rendered":"Patent Infringement and Person in the Know"},"content":{"rendered":"<h2 id=\"the-appeal\"><span class=\"ez-toc-section\" id=\"The_Appeal\"><\/span>The Appeal<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>In this matter, the High Court of Delhi was called upon to decide an appeal by <strong>F. Hoffmann-La Roche AG<\/strong> against <strong>Natco Pharma Limited<\/strong> regarding the manufacture and sale of the drug \u201cRisdiplam.\u201d The appellants, holders of Indian Patent IN 3343971 concerning compounds for treating spinal muscular atrophy, sought an injunction to prevent Natco from producing and selling Risdiplam.<\/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\/patent-infringement-and-person-in-the-know\/#The_Appeal\" >The Appeal<\/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\/patent-infringement-and-person-in-the-know\/#Facts_of_the_Case\" >Facts of the Case<\/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\/patent-infringement-and-person-in-the-know\/#The_Procedural_Background\" >The Procedural Background<\/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\/patent-infringement-and-person-in-the-know\/#Courts_Reasoning_on_Appellate_Review\" >Court\u2019s Reasoning on Appellate Review<\/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\/patent-infringement-and-person-in-the-know\/#The_Legal_Provision\" >The Legal Provision<\/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\/patent-infringement-and-person-in-the-know\/#Coverage_vs_Disclosure\" >Coverage vs Disclosure<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/patent-infringement-and-person-in-the-know\/#The_Obviousness\" >The Obviousness<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/patent-infringement-and-person-in-the-know\/#Person_Skilled_in_the_Art\" >Person Skilled in the Art<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/patent-infringement-and-person-in-the-know\/#Public_Interest_and_Policy\" >Public Interest and Policy<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/patent-infringement-and-person-in-the-know\/#Conclusion_and_Decision\" >Conclusion and Decision<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/patent-infringement-and-person-in-the-know\/#Case_Summary\" >Case Summary<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/patent-infringement-and-person-in-the-know\/#Disclaimer\" >Disclaimer<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/patent-infringement-and-person-in-the-know\/#Written_By\" >Written By<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n\n<h2 id=\"facts-of-the-case\"><span class=\"ez-toc-section\" id=\"Facts_of_the_Case\"><\/span>Facts of the Case<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The facts of the case are straightforward. F. Hoffmann-La Roche AG is the patentee for Risdiplam, marketed under the brand name <strong>EVRYSDI<\/strong>, used for spinal muscular atrophy. Natco Pharma began manufacturing and marketing Risdiplam, which the appellants argued amounted to patent infringement under <strong>Section 48 of the Indian Patents Act<\/strong>.<\/p>\n<ul>\n<li><strong>Key Question:<\/strong> Whether Natco\u2019s actions amounted to patent infringement.<\/li>\n<li><strong>Defense:<\/strong> Whether Natco could invoke statutory defenses to avoid liability.<\/li>\n<\/ul>\n<h2 id=\"procedural-background\"><span class=\"ez-toc-section\" id=\"The_Procedural_Background\"><\/span>The Procedural Background<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The dispute arose after a single judge of the High Court declined the injunction against Natco, leading the appellants to file the present appeal. Natco admitted making and selling Risdiplam but asserted a defense under <strong>Section 107<\/strong> of the Patents Act, relying on <strong>Section 64(e)<\/strong> and <strong>Section 64(f)<\/strong>, which allow revocation if the invention lacks novelty or inventive step.<\/p>\n<h2 id=\"court-reasoning\"><span class=\"ez-toc-section\" id=\"Courts_Reasoning_on_Appellate_Review\"><\/span>Court\u2019s Reasoning on Appellate Review<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The Court clarified the law on appellate review, citing <em>Wander Ltd. v. Antox India P Ltd.<\/em> (Supreme Court: 1990 Supp SCC 727). It emphasized that appeals against discretionary reliefs like injunctions are not appeals on facts but on principles. The appellate court would intervene only if the lower court\u2019s discretion was arbitrary or legally unsound.<\/p>\n<h2 id=\"legal-provisions\"><span class=\"ez-toc-section\" id=\"The_Legal_Provision\"><\/span>The Legal Provision<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Legal provisions examined included:<\/p>\n<table border=\"1\" cellspacing=\"0\" cellpadding=\"6\">\n<thead>\n<tr>\n<th>Section<\/th>\n<th>Provision<\/th>\n<th>Purpose<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Section 48<\/td>\n<td>Patentee\u2019s Rights<\/td>\n<td>Exclusive right to make, use, sell, or import the patented product.<\/td>\n<\/tr>\n<tr>\n<td>Section 64(e)<\/td>\n<td>Lack of Novelty<\/td>\n<td>Allows revocation if the invention is already disclosed in prior art.<\/td>\n<\/tr>\n<tr>\n<td>Section 64(f)<\/td>\n<td>Obviousness<\/td>\n<td>Allows revocation if the invention is obvious to a skilled person.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2 id=\"coverage-vs-disclosure\"><span class=\"ez-toc-section\" id=\"Coverage_vs_Disclosure\"><\/span>Coverage vs Disclosure<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The Single Judge focused on whether Risdiplam, though covered by earlier patents (WO916, US955), was disclosed sufficiently to destroy novelty. The Court discussed the difference between:<\/p>\n<ul>\n<li><strong>Coverage:<\/strong> Compound encompassed within a broad claim.<\/li>\n<li><strong>Disclosure:<\/strong> Compound specifically taught or enabled in prior art.<\/li>\n<\/ul>\n<p>Key precedents included:<\/p>\n<ul>\n<li><em>Novartis AG v Union of India<\/em> (2013 6 SCC 1)<\/li>\n<li><em>Astrazeneca AB v Intas Pharmaceutical Ltd<\/em> (2020 84 PTC 326 Del)<\/li>\n<\/ul>\n<p>The Division Bench clarified that disclosure must be enabling\u2014it should guide a skilled person to create the compound. Mere theoretical coverage is insufficient.<\/p>\n<h2 id=\"obviousness\"><span class=\"ez-toc-section\" id=\"The_Obviousness\"><\/span>The Obviousness<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Under <strong>Section 64(f)<\/strong>, the Court examined whether a skilled person could derive Risdiplam from earlier patents. The difference between Risdiplam and \u201cCompound 809\u201d was only a nitrogen atom replacing a CH group. The Court noted that such substitutions were routine in chemical synthesis and supported by chemical principles like the <strong>Grimm\u2019s Hydride Displacement Law<\/strong>.<\/p>\n<h2 id=\"person-skilled-in-art\"><span class=\"ez-toc-section\" id=\"Person_Skilled_in_the_Art\"><\/span>Person Skilled in the Art<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The Court highlighted that when inventors of both patents are the same, they are \u201cpersons in the know.\u201d Therefore, minor modifications by such inventors cannot justify new patents, as it risks <strong>evergreening<\/strong> \u2014 obtaining extended monopolies for trivial changes.<\/p>\n<h2 id=\"public-interest\"><span class=\"ez-toc-section\" id=\"Public_Interest_and_Policy\"><\/span>Public Interest and Policy<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The Court emphasized that patent protection is for true inventions. Extending monopolies through obvious changes undermines public access to affordable, life-saving drugs. Hence, public interest must guide judicial interpretation in pharmaceutical patents.<\/p>\n<h2 id=\"conclusion\"><span class=\"ez-toc-section\" id=\"Conclusion_and_Decision\"><\/span>Conclusion and Decision<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The Division Bench found no fault in the Single Judge\u2019s reasoning. Since the lower court applied correct legal principles and exercised discretion properly, the appeal was dismissed. The finding of a credible defense of obviousness justified denying the injunction.<\/p>\n<h3 id=\"case-summary\"><span class=\"ez-toc-section\" id=\"Case_Summary\"><\/span>Case Summary<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<table border=\"1\" cellspacing=\"0\" cellpadding=\"6\">\n<thead>\n<tr>\n<th>Details<\/th>\n<th>Information<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>Case Title<\/strong><\/td>\n<td>F. Hoffmann-La Roche AG &amp; Another Vs. Natco Pharma Limited<\/td>\n<\/tr>\n<tr>\n<td><strong>Order Date<\/strong><\/td>\n<td>9th October 2025<\/td>\n<\/tr>\n<tr>\n<td><strong>Case Number<\/strong><\/td>\n<td>FAO(OS)(COMM) 43\/2025<\/td>\n<\/tr>\n<tr>\n<td><strong>Neutral Citation<\/strong><\/td>\n<td>2025:DHC:8943-DB<\/td>\n<\/tr>\n<tr>\n<td><strong>Court<\/strong><\/td>\n<td>High Court of Delhi at New Delhi<\/td>\n<\/tr>\n<tr>\n<td><strong>Judges<\/strong><\/td>\n<td>Hon\u2019ble Mr. Justice C. Hari Shankar and Mr. Justice Ajay Digpaul<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2 id=\"disclaimer\"><span class=\"ez-toc-section\" id=\"Disclaimer\"><\/span>Disclaimer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The information shared here serves the public interest by offering legal insights. Readers are advised to exercise discretion when interpreting this content. It may include subjective analysis and errors in perception or presentation.<\/p>\n<h3 id=\"author\"><span class=\"ez-toc-section\" id=\"Written_By\"><\/span>Written By<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>Advocate Ajay Amitabh Suman<\/strong><br \/>\nIP Adjutor [Patent and Trademark Attorney]<br \/>\nHigh Court of Delhi<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Appeal In this matter, the High Court of Delhi was called upon to decide an appeal by F. Hoffmann-La Roche AG against Natco Pharma Limited regarding the manufacture and sale of the drug \u201cRisdiplam.\u201d The appellants, holders of Indian Patent IN 3343971 concerning compounds for treating spinal muscular atrophy, sought an injunction to prevent<\/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":[1199],"class_list":{"0":"post-9969","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-intellectual-property","7":"tag-intellectual-property-law"},"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts\/9969","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=9969"}],"version-history":[{"count":0,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts\/9969\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/media?parent=9969"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/categories?post=9969"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/tags?post=9969"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}