{"id":6626,"date":"2025-07-27T11:05:52","date_gmt":"2025-07-27T11:05:52","guid":{"rendered":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/?p=6626"},"modified":"2025-07-27T11:07:34","modified_gmt":"2025-07-27T11:07:34","slug":"section-104a-of-patent-act-1970-and-disclosure-challenges-in-biologic-patent-litigation","status":"publish","type":"post","link":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/section-104a-of-patent-act-1970-and-disclosure-challenges-in-biologic-patent-litigation\/","title":{"rendered":"Section 104A of Patent Act 1970 and Disclosure Challenges in Biologic Patent Litigation"},"content":{"rendered":"<h2><span class=\"ez-toc-section\" id=\"F_Hoffmann-La_Roche_AG_Anr_versus_Zydus_Lifesciences_Limited\"><\/span>F. Hoffmann-La Roche AG &amp; Anr. versus Zydus Lifesciences Limited<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>Introduction:<\/strong> The case of <em>F. Hoffmann-La Roche AG &amp; Anr. versus Zydus Lifesciences Limited<\/em> represents a significant patent infringement dispute in the realm of biological drugs, specifically concerning the monoclonal antibody Pertuzumab, used in treating breast cancer.<\/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-104a-of-patent-act-1970-and-disclosure-challenges-in-biologic-patent-litigation\/#F_Hoffmann-La_Roche_AG_Anr_versus_Zydus_Lifesciences_Limited\" >F. Hoffmann-La Roche AG &amp; Anr. versus Zydus Lifesciences Limited<\/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-104a-of-patent-act-1970-and-disclosure-challenges-in-biologic-patent-litigation\/#Factual_Background\" >Factual Background<\/a><\/li><\/ul><\/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\/section-104a-of-patent-act-1970-and-disclosure-challenges-in-biologic-patent-litigation\/#Procedural_Background\" >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\/section-104a-of-patent-act-1970-and-disclosure-challenges-in-biologic-patent-litigation\/#Core_Dispute\" >Core Dispute<\/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\/section-104a-of-patent-act-1970-and-disclosure-challenges-in-biologic-patent-litigation\/#Discussion_on_Judgments\" >Discussion on Judgments<\/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\/section-104a-of-patent-act-1970-and-disclosure-challenges-in-biologic-patent-litigation\/#Reasoning_and_Analysis\" >Reasoning and Analysis<\/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\/section-104a-of-patent-act-1970-and-disclosure-challenges-in-biologic-patent-litigation\/#Final_Decision\" >Final Decision<\/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\/section-104a-of-patent-act-1970-and-disclosure-challenges-in-biologic-patent-litigation\/#Law_Settled_in_This_Case\" >Law Settled in This Case<\/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\/section-104a-of-patent-act-1970-and-disclosure-challenges-in-biologic-patent-litigation\/#Case_Information\" >Case Information<\/a><\/li><\/ul><\/nav><\/div>\n\n<h3><span class=\"ez-toc-section\" id=\"Factual_Background\"><\/span>Factual Background<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The plaintiffs, F. Hoffmann-La Roche AG and its affiliate, hold two Indian patents relevant to this dispute:<\/p>\n<ul>\n<li><strong>Indian Patent No. IN 268632<\/strong>: \u201cPharmaceutical Formulation Comprising HER2 Antibody\u201d \u2013 a product patent covering an aqueous pharmaceutical formulation of Pertuzumab with specific excipients.<\/li>\n<li><strong>Indian Patent No. IN 464646<\/strong>: \u201cPertuzumab Variants and Evaluation Thereof\u201d \u2013 a process patent detailing a method for producing Pertuzumab and its variants.<\/li>\n<\/ul>\n<p>The defendant, Zydus Lifesciences Limited, sought regulatory approval to manufacture and sell a similar biologic, ZRC-3277, referencing Perjeta in its clinical trial application. The plaintiffs filed a <em>quia timet<\/em> suit alleging potential infringement.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Procedural_Background\"><\/span>Procedural Background<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The suit, CS(COMM) 159\/2024, included applications for:<\/p>\n<ul>\n<li>Interim injunctions (I.A. 4196\/2024 and I.A. 33509\/2024)<\/li>\n<li>Confidentiality club constitution (I.A. 5827\/2024)<\/li>\n<\/ul>\n<p>Summons were issued on February 23, 2024. The plaintiffs were directed to conduct claim mapping. The defendant filed its manufacturing process under sealed cover on March 22, 2024. After a series of legal developments and appeals, the plaintiffs chose to focus solely on I.A. 5827\/2024.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Core_Dispute\"><\/span>Core Dispute<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The central issue: Were the plaintiffs entitled to access the defendant\u2019s manufacturing process through a confidentiality club to verify infringement of their process patent (IN 646)?<\/p>\n<p>The plaintiffs invoked Section 104A of the Patents Act and discovery provisions under the Commercial Courts Act. The defendant argued that prerequisites for applying Section 104A were unmet, and that their product and process differed materially.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Discussion_on_Judgments\"><\/span>Discussion on Judgments<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>Plaintiffs relied on:<\/strong><\/p>\n<ul>\n<li><em>F. Hoffmann-La Roche v. Drugs Controller General of India (2025 SCC OnLine Del 934)<\/em> \u2013 argued for discovery under Commercial Courts Act.<\/li>\n<li><em>Roche Products v. DCGI (2016 SCC OnLine Del 2358)<\/em> \u2013 biologics cannot be identical, Section 104A impractical for biologics.<\/li>\n<\/ul>\n<p><strong>Court&#8217;s response:<\/strong> Distinguished the above, affirming IN 646\u2019s validity and requiring strict compliance with Section 104A.<\/p>\n<p><strong>Defendant relied on:<\/strong><\/p>\n<ul>\n<li><em>Natural Remedies Pvt. Ltd. v. Indian Herbs Research (Karnataka HC, 2011)<\/em> \u2013 identicality must be proven before disclosure.<\/li>\n<li><em>Bristol-Myers<\/em> \u2013 supports Section 104A at interlocutory stages.<\/li>\n<li><em>Ericsson v. CCI<\/em> \u2013 Patents Act prevails over Commercial Courts Act.<\/li>\n<li><em>Pfizer v. Samsung Bioepis (Australia, 2017)<\/em> \u2013 similarity \u2260 process infringement.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Reasoning_and_Analysis\"><\/span>Reasoning and Analysis<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The court focused on Section 104A&#8217;s scope, clarifying that it permits burden-shifting only when:<\/p>\n<ol>\n<li>The plaintiff proves that the defendant\u2019s product is identical to the patented product.<\/li>\n<li>The patented process is novel or substantially likely used.<\/li>\n<\/ol>\n<p>The court held that Section 104A applies even at interlocutory stages. The plaintiffs\u2019 discovery request under the Commercial Courts Act was dismissed due to the special nature of the Patents Act. The court emphasized that &#8220;identical product&#8221; is a legislative threshold that cannot be diluted for biologics.<\/p>\n<p>Claim mapping showed formulation differences (arginine citrate vs. histidine acetate). The defendant\u2019s use of Perjeta as a reference did not imply process infringement. Thus, the plaintiffs failed to meet Section 104A conditions.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Final_Decision\"><\/span>Final Decision<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The court dismissed I.A. 5827\/2024, denying constitution of a confidentiality club. It clarified that the ruling was limited to the application and would not affect the suit\u2019s final outcome.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Law_Settled_in_This_Case\"><\/span>Law Settled in This Case<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li>Section 104A governs disclosure in process patent cases and applies at all stages.<\/li>\n<li>Plaintiffs must prove product identity before invoking Section 104A.<\/li>\n<li>The Patents Act prevails over general laws like the Commercial Courts Act.<\/li>\n<li>\u201cSimilar biologic\u201d is not equivalent to \u201cidentical product.\u201d<\/li>\n<li>Reference to a branded biologic in regulatory filings does not imply process infringement.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Case_Information\"><\/span>Case Information<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li><strong>Case Title:<\/strong> F. Hoffmann-La Roche AG &amp; Anr. versus Zydus Lifesciences Limited<\/li>\n<li><strong>Date of Order:<\/strong> July 23, 2025<\/li>\n<li><strong>Case Number:<\/strong> CS(COMM) 159\/2024<\/li>\n<li><strong>Neutral Citation:<\/strong> 2025:DHC:5927:<\/li>\n<li><strong>Name of Court:<\/strong> High Court of Delhi at New Delhi<\/li>\n<li><strong>Judge:<\/strong> Honourable Mr. Justice Amit Bansal<\/li>\n<\/ul>\n<p><b><br \/>\nDisclaimer:<\/b>\u00a0The 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.<b><\/p>\n<p>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>F. Hoffmann-La Roche AG &amp; Anr. versus Zydus Lifesciences Limited Introduction: The case of F. Hoffmann-La Roche AG &amp; Anr. versus Zydus Lifesciences Limited represents a significant patent infringement dispute in the realm of biological drugs, specifically concerning the monoclonal antibody Pertuzumab, used in treating breast cancer. Factual Background The plaintiffs, F. Hoffmann-La Roche AG<\/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":[28],"class_list":{"0":"post-6626","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-intellectual-property","7":"tag-top-news"},"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts\/6626","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=6626"}],"version-history":[{"count":0,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts\/6626\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/media?parent=6626"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/categories?post=6626"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/tags?post=6626"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}