{"id":6503,"date":"2025-07-20T05:03:46","date_gmt":"2025-07-20T05:03:46","guid":{"rendered":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/?p=6503"},"modified":"2025-07-20T05:07:48","modified_gmt":"2025-07-20T05:07:48","slug":"quia-timet-action-and-patent-protection-in-the-biologics-sector","status":"publish","type":"post","link":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/quia-timet-action-and-patent-protection-in-the-biologics-sector\/","title":{"rendered":"Quia Timet Action and Patent Protection in the Biologics Sector"},"content":{"rendered":"<h2><span class=\"ez-toc-section\" id=\"E_R_Squibb_and_Sons_LLC_Ors_Vs_Zydus_Lifesciences_Limited_%E2%80%93_Delhi_High_Court_Judgment_Analysis\"><\/span>E. R. Squibb and Sons, LLC &amp; Ors. Vs. Zydus Lifesciences Limited &#8211; Delhi High Court Judgment Analysis<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"Intersection_of_Biopharma_Innovation_and_Patent_Law\"><\/span>Intersection of Biopharma Innovation and Patent Law<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The intersection of biopharmaceutical innovation and patent law stands at the heart of the recent judgment delivered by the Hon&#8217;ble High Court of Delhi in <strong>E. R. Squibb and Sons, LLC &amp; Ors. v. Zydus Lifesciences Limited<\/strong>. This decision is significant for its detailed analysis of patent claim construction, the scope of patent infringement in biosimilar development, and the jurisprudence surrounding interim relief in quia timet actions. The matter concerns Indian Patent No. IN 340060 (hereinafter &#8220;suit patent&#8221;) which claims the monoclonal antibody Nivolumab, an anti-PD-1 antibody used in cancer immunotherapy.<\/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\/quia-timet-action-and-patent-protection-in-the-biologics-sector\/#E_R_Squibb_and_Sons_LLC_Ors_Vs_Zydus_Lifesciences_Limited_%E2%80%93_Delhi_High_Court_Judgment_Analysis\" >E. R. Squibb and Sons, LLC &amp; Ors. Vs. Zydus Lifesciences Limited &#8211; Delhi High Court Judgment Analysis<\/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\/quia-timet-action-and-patent-protection-in-the-biologics-sector\/#Intersection_of_Biopharma_Innovation_and_Patent_Law\" >Intersection of Biopharma Innovation and Patent Law<\/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\/quia-timet-action-and-patent-protection-in-the-biologics-sector\/#Factual_Background\" >Factual 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\/quia-timet-action-and-patent-protection-in-the-biologics-sector\/#Procedural_Background\" >Procedural Background<\/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\/quia-timet-action-and-patent-protection-in-the-biologics-sector\/#Core_Dispute\" >Core Dispute<\/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\/quia-timet-action-and-patent-protection-in-the-biologics-sector\/#Discussion_on_Judgments\" >Discussion on Judgments<\/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\/quia-timet-action-and-patent-protection-in-the-biologics-sector\/#Reasoning_and_Analysis_of_the_Judge\" >Reasoning and Analysis of the Judge<\/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\/quia-timet-action-and-patent-protection-in-the-biologics-sector\/#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\/quia-timet-action-and-patent-protection-in-the-biologics-sector\/#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\/quia-timet-action-and-patent-protection-in-the-biologics-sector\/#Case_Details\" >Case Details<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n\n<p>With the defendants poised to launch a biosimilar product allegedly infringing the suit patent, the plaintiffs sought a pre-emptive injunction, prompting a thorough judicial evaluation of patent validity, claim construction, prior art, and the credibility of apprehended infringement.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Factual_Background\"><\/span>Factual Background<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The suit patent IN 340060 titled \u201cHuman Monoclonal Antibodies to Programmed Death 1 (PD-1) for use in treating Cancer\u201d was filed as a national phase application from PCT\/JP2006\/309606, claiming priority from U.S. provisional applications dating back to 2005. Granted in India on 1 July 2020, the patent claims a 20-year term expiring on 2 May 2026. The invention relates to the monoclonal antibody known as Nivolumab (also referred to as 5C4), which binds to the PD-1 receptor on T-cells, thereby modulating immune responses against cancer cells.<\/p>\n<p>Nivolumab is marketed globally under the brand name Opdivo\u00ae and is sold in India as Opdyta\u00ae. The patent was granted after rejection of four pre-grant oppositions, and a post-grant opposition filed by Zydus Healthcare Limited, a sister concern of the defendant, is currently pending. An Opposition Board Recommendation (OBR) dated 31 January 2023 opined that the suit patent lacked novelty and inventive step, which was subsequently set aside by the High Court of Madras. The matter was remanded to the Single Judge for fresh adjudication.<\/p>\n<p>Plaintiffs became aware in April 2022 that the defendant had sought regulatory approval for clinical trials of a biosimilar to Nivolumab. Although the defendant responded by claiming protection under the Bolar exemption (Section 107A, Patents Act, 1970), further investigation revealed registration of clinical trials under the name ZRC-3276, with Opdivo\u00ae listed as the reference product.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Procedural_Background\"><\/span>Procedural Background<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The plaintiffs issued a cease-and-desist letter in May 2022, to which the defendant responded by asserting that it was only conducting clinical trials and had not yet launched the product. Based on this assurance and the clinical trial stage of development, the plaintiffs did not pursue legal action at the time.<\/p>\n<p>In April 2024, the plaintiffs received inquiries from medical professionals and distribution networks indicating that the defendant may be preparing for a commercial launch. Upon discovering that the defendant had applied for marketing authorisation for ZRC-3276, the plaintiffs initiated a quia timet suit for permanent injunction and filed I.A. 10533\/2024 under Order XXXIX Rules 1 and 2 CPC seeking interim relief. On 8 May 2024, the Delhi High Court granted an ad interim injunction restraining the defendant from launching the biosimilar without court approval. The order remained in force till final adjudication of the interim application, which was decided vide judgment dated 18 July 2025.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Core_Dispute\"><\/span>Core Dispute<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The central issue was whether the plaintiffs were entitled to an interim injunction against the defendant\u2019s potential commercial launch of its biosimilar version of Nivolumab on grounds of patent infringement. The dispute also involved determining whether the plaintiffs had made out a prima facie case of infringement, whether the suit patent was prima facie valid despite the post-grant opposition and prior art cited, and whether the plaintiffs had approached the Court with delay, thereby disentitling them to interim relief.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Discussion_on_Judgments\"><\/span>Discussion on Judgments<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The plaintiffs relied on <em>Jay Switches India Pvt. Ltd. v. Sandhar Technologies Ltd.<\/em>, 2024 SCC OnLine Del 8434, to underscore the importance of claim construction in determining patent infringement. The Court in Jay Switches emphasised that interpreting the scope of the claims is the primary step in adjudicating infringement actions, particularly in complex technologies like antibodies.<\/p>\n<p>The plaintiffs also cited <em>Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries<\/em>, (1979) 2 SCC 511, where the Supreme Court stressed that the claims in a patent must be read with the complete specification, and that claim construction must be rooted in the technical disclosures of the patent.<\/p>\n<p>Further, reliance was placed on <em>Novonordisk v. Union of India<\/em>, 2022 SCC OnLine Del 1944, which held that the Opposition Board Recommendation under Section 25(3) of the Patents Act is not binding on the Controller and is merely recommendatory. This case was cited to negate the defendant&#8217;s reliance on the OBR recommending revocation of the patent.<\/p>\n<p>The defendants countered by citing prior art documents including WO 2001\/014557, WO 2002\/079499, and EP 1537878 B1 (WO 2004\/004771), arguing that the suit patent lacked novelty and inventive step. They further contended that the plaintiffs had admitted in foreign patent filings that Nivolumab was developed under an earlier patent family, thereby invalidating the suit patent.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Reasoning_and_Analysis_of_the_Judge\"><\/span>Reasoning and Analysis of the Judge<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The Court, on the issue of delay, accepted the plaintiffs\u2019 explanation that they initially refrained from filing the suit in 2022 due to the defendant\u2019s reliance on the Bolar exemption. The Court observed that a fresh cause of action arose only in 2024 when credible information regarding imminent commercial launch surfaced.<\/p>\n<p>Regarding the question of infringement, the Court held that Nivolumab (also known as 5C4 antibody) was clearly claimed in Claims 1, 3, and 7 of the suit patent, which were defined by specific amino acid sequences in the CDR regions and variable chains. Since the defendant was developing a biosimilar using the plaintiffs\u2019 product as a reference, it was prima facie covered by the scope of the claims.<\/p>\n<p>On validity, the Court found that the prior art documents relied on by the defendant did not disclose the specific amino acid sequences claimed in the suit patent. D3 (EP &#8216;878) was held to pertain only to the use of anti-PD-1 antibodies in general, not to the precise structure of Nivolumab. Further, D1 and D2 were dismissed for failing to disclose any antibody sequences. The Court relied on the Guidelines for Examination of Biotechnology Applications for Patent, 2013, which state that unless the prior art matches the claimed sequence exactly, it cannot be deemed anticipatory.<\/p>\n<p>The Court also dismissed the defendant\u2019s reliance on the Opposition Board\u2019s adverse recommendation, noting its recommendatory nature and the pending adjudication in the Madras High Court.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Final_Decision\"><\/span>Final Decision<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The High Court of Delhi granted interim relief in favour of the plaintiffs, continuing the injunction against the defendant from launching or commercially exploiting its biosimilar product ZRC-3276 without court approval until the expiry of the patent or final adjudication of the suit. The Court held that the plaintiffs had made out a strong prima facie case of infringement, that the balance of convenience lay in their favour, and that irreparable harm would be caused if the injunction was denied.<\/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>This judgment reinforces the jurisprudence on quia timet actions in patent infringement suits, particularly in the biopharmaceutical context. It clarifies that the apprehension of infringement, if supported by credible evidence, can sustain an injunction even before actual launch. The case also reaffirms that prior art must disclose specific elements of the claimed invention\u2014such as amino acid sequences in the case of biologics\u2014for a credible challenge to novelty or inventive step. Furthermore, the judgment affirms that the recommendation of an Opposition Board is not binding and cannot by itself undermine a patent\u2019s validity. Lastly, it underlines that reference to a patented product in biosimilar development may constitute prima facie infringement if claim mapping is established.<\/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> E. R. Squibb and Sons, LLC &amp; Ors. Vs. Zydus Lifesciences Limited<\/li>\n<li><strong>Date of Order:<\/strong> 18 July 2025<\/li>\n<li><strong>Case Number:<\/strong> CS(COMM) 376\/2024<\/li>\n<li><strong>Neutral Citation:<\/strong> 2025:DHC:5802<\/li>\n<li><strong>Name of Court:<\/strong> High Court of Delhi<\/li>\n<li><strong>Name of Judge:<\/strong> Hon\u2019ble Ms. Justice Mini Pushkarna<\/li>\n<\/ul>\n<p><b>Disclaimer:\u00a0<\/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>E. R. Squibb and Sons, LLC &amp; Ors. Vs. Zydus Lifesciences Limited &#8211; Delhi High Court Judgment Analysis Intersection of Biopharma Innovation and Patent Law The intersection of biopharmaceutical innovation and patent law stands at the heart of the recent judgment delivered by the Hon&#8217;ble High Court of Delhi in E. R. Squibb and Sons,<\/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-6503","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\/6503","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=6503"}],"version-history":[{"count":0,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts\/6503\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/media?parent=6503"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/categories?post=6503"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/tags?post=6503"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}