{"id":144833,"date":"2025-07-25T08:00:07","date_gmt":"2025-07-25T02:30:07","guid":{"rendered":"https:\/\/www.bananaip.com\/intellepedia\/?p=144833"},"modified":"2025-07-24T18:06:31","modified_gmt":"2025-07-24T12:36:31","slug":"patented-biologics-and-section-104a-no-process-disclosure-without-proving-product-identity","status":"publish","type":"post","link":"https:\/\/www.bananaip.com\/intellepedia\/patented-biologics-and-section-104a-no-process-disclosure-without-proving-product-identity\/","title":{"rendered":"Patented Biologics and Section 104A: No Process Disclosure Without Proving Product Identity"},"content":{"rendered":"<h2>Background &amp; Facts<\/h2>\n<p>Roche holds two Indian patents covering its breast cancer drug Pertuzumab, sold under the brand name Perjeta. IN 268632 claims a formulation. IN 464646 claims a process for making Pertuzumab with specific variants.<\/p>\n<p>In January 2024, Roche discovered that Zydus had applied to the drug regulator to market Sigrima, a biosimilar of Pertuzumab. It filed suit for patent infringement as a quia timet action and sought an interim direction to compel Zydus to disclose its manufacturing process, invoking Section 104A.<\/p>\n<p>Zydus had earlier described Perjeta as the reference biologic in its filings, which Roche argued showed that the products were identical.<\/p>\n<h2>Issues for the Court<\/h2>\n<ol>\n<li style=\"list-style-type: none;\">\n<ol>\n<li style=\"list-style-type: none;\">\n<ol>\n<li>Can Roche compel Zydus to disclose its process under Section 104A without first showing the two products are identical?<\/li>\n<li>Does a biosimilar qualify as an &#8220;identical product&#8221; under Section 104A?<\/li>\n<li>Should Zydus\u2019s sealed disclosure be shared with Roche\u2019s representatives in a confidentiality club?<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<h2>Key Arguments<\/h2>\n<p>Roche argued that:<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Section 104A does not require proof of identity at the interim stage; it only shifts the burden of proof during trial.<\/li>\n<li>Zydus\u2019s use of Perjeta as a reference biologic in regulatory filings supports a strong presumption of identity.<\/li>\n<li>Similar biologics are, by definition, close enough to be treated as functionally equivalent.<\/li>\n<li>Disclosure is needed for claim mapping, and confidentiality measures can safeguard Zydus\u2019s trade secrets.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>Zydus argued that:<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Its product is a similar biologic, not identical to Perjeta.<\/li>\n<li>Section 104A applies only if the two products are identical, as per statutory language and case law.<\/li>\n<li>Roche cannot invoke Section 104A unless it proves identity first.<\/li>\n<li>Process disclosure at this stage would unfairly reveal proprietary information.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2>Court\u2019s Analysis<\/h2>\n<p>The Court held that Section 104A creates a limited exception to the normal rule that the plaintiff must prove infringement. It shifts the burden of proof only if:<\/p>\n<p>a) the patent covers a process for making a product, and<br \/>\nb) the plaintiff first proves that the defendant\u2019s product is identical to the one made by the patented process.<\/p>\n<p>The Court distinguished \u201cidentical\u201d from \u201csimilar,\u201d citing dictionaries and precedent:<br \/>\n\u201cThe word used is \u2018identical\u2019 and not \u2018similar\u2019&#8230; \u2018Similar\u2019 means having a resemblance&#8230; but not identical.\u201d [\u00b625]<\/p>\n<p>As per the Court, Roche\u2019s patent IN 646 covered not just Pertuzumab but also specific variants. Sigrima, according to the Court, did not contain those variants. So the two products were not identical.<\/p>\n<p>The Court also rejected Roche\u2019s argument that biologics should be treated differently due to their complex nature. It stated that even biosimilars must satisfy the legal threshold of identity under Section 104A before the burden of proof can shift.<br \/>\nBecause Roche had not shown identity, the Court refused to order Zydus to share its process details with the confidentiality club.<\/p>\n<h2>Findings &amp; Order<\/h2>\n<p>The Court held:<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Section 104A does not apply unless the plaintiff proves product identity.<\/li>\n<li>A similar biologic is not the same as an identical product.<\/li>\n<li>Roche had not shown that Sigrima and Perjeta were identical.<\/li>\n<li>Therefore, the Court would not compel Zydus to disclose its manufacturing process.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2>Relevant Paragraphs<\/h2>\n<p><em>\u201cThe word used is \u2018identical\u2019 and not \u2018similar\u2019&#8230; The meaning of the word \u2018identical\u2019 means being the same, exactly equal and alike&#8230; \u2018Similar\u2019 means having a resemblance&#8230; but not identical.\u201d [\u00b625]<\/em><\/p>\n<p><em>\u201cUnless the two products are identical, Section 104A is not attracted. The products being identical is sine qua non for applicability of Section 104A.\u201d [\u00b670]<\/em><\/p>\n<p><em>\u201cA similar biologic can never be an exact replica&#8230; Nonetheless, a similar biologic is nearly identical to its reference biologic\u2026 Therefore, the requirement of identity is not satisfied.\u201d [\u00b616.4]<\/em><\/p>\n<h2>Disclaimer<\/h2>\n<p>This case note has been prepared based on the author\u2019s understanding, views, and conclusions. Opinions of others may differ.<\/p>\n<p><strong>Citation:<\/strong> F-Hoffmann-La Roche AG &amp; Anr. v. Zydus Lifesciences Ltd., CS(COMM) 159\/2024, 2025 SCC OnLine Del 2347,<a id=\"LPlnk533521\" title=\"https:\/\/indiankanoon.org\/doc\/103228643\/\" href=\"https:\/\/indiankanoon.org\/doc\/103228643\/\" target=\"_blank\" rel=\"noopener noreferrer\" data-auth=\"NotApplicable\" data-linkindex=\"0\"> https:\/\/indiankanoon.org\/doc\/103228643\/<\/a>\u00a0(last visited July 24, 2025).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Roche sued Zydus for infringing its process patent on Pertuzumab. The Delhi High Court held that Roche had not shown Zydus\u2019s biosimilar was identical to its product. Without identity, Section 104A did not apply, and the Court refused to compel Zydus to disclose its manufacturing process.<\/p>\n","protected":false},"author":12,"featured_media":144834,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"iawp_total_views":143,"footnotes":""},"categories":[5495,6,14],"tags":[12176,486,163,753,12178,12180,6626,12177,12179,615],"class_list":["post-144833","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-reviews","category-intellectual-property","category-patents","tag-biosimilars","tag-delhi-high-court","tag-indian-patent-law","tag-patent-law-india","tag-perjeta","tag-pharma-litigation","tag-roche","tag-section-104a","tag-sigrima","tag-zydus"],"_links":{"self":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/144833","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/comments?post=144833"}],"version-history":[{"count":1,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/144833\/revisions"}],"predecessor-version":[{"id":144835,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/144833\/revisions\/144835"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/media\/144834"}],"wp:attachment":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/media?parent=144833"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/categories?post=144833"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/tags?post=144833"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}