{"id":10532,"date":"2025-10-22T07:53:26","date_gmt":"2025-10-22T07:53:26","guid":{"rendered":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/?p=10532"},"modified":"2025-10-22T08:09:55","modified_gmt":"2025-10-22T08:09:55","slug":"copyright-protection-for-pharmaceutical-dossiers","status":"publish","type":"post","link":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/copyright-protection-for-pharmaceutical-dossiers\/","title":{"rendered":"Copyright Protection for Pharmaceutical Dossiers"},"content":{"rendered":"<h2><span class=\"ez-toc-section\" id=\"Jamp_India_Pharmaceuticals_Pvt_Ltd_Vs_Jubilant_Generics_Ltd_and_Others\"><\/span>Jamp India Pharmaceuticals Pvt. Ltd. Vs. Jubilant Generics Ltd. and Others<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3 id=\"factual-background\"><span class=\"ez-toc-section\" id=\"Factual_Background\"><\/span>Factual Background<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Jubilant Generics Ltd., a pharmaceutical company based in Noida, India, is engaged in developing and manufacturing drug formulations for global markets. It had created detailed Product Dossiers for drugs such as Losartan, Amlodipine, and Citalopram. These dossiers, developed through years of research, contain technical, clinical, and manufacturing data required for obtaining marketing authorizations from global regulatory bodies. Jubilant claimed copyright and confidentiality protection over these dossiers as \u201cliterary works\u201d under Section 2(o) of the Copyright Act, 1957.<\/p><div id=\"ez-toc-container\" class=\"ez-toc-v2_0_83 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\/copyright-protection-for-pharmaceutical-dossiers\/#Jamp_India_Pharmaceuticals_Pvt_Ltd_Vs_Jubilant_Generics_Ltd_and_Others\" >Jamp India Pharmaceuticals Pvt. Ltd. Vs. Jubilant Generics Ltd. and Others<\/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\/copyright-protection-for-pharmaceutical-dossiers\/#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\/copyright-protection-for-pharmaceutical-dossiers\/#Procedural_History\" >Procedural History<\/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\/copyright-protection-for-pharmaceutical-dossiers\/#Nature_of_Dispute\" >Nature of 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\/copyright-protection-for-pharmaceutical-dossiers\/#Arguments_by_Appellants\" >Arguments by Appellants<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/copyright-protection-for-pharmaceutical-dossiers\/#Non-Compliance_with_Section_12-A_of_the_Commercial_Courts_Act_2015\" >Non-Compliance with Section 12-A of the Commercial Courts Act, 2015<\/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\/copyright-protection-for-pharmaceutical-dossiers\/#Composite_Suit_and_Lack_of_Jurisdiction\" >Composite Suit and Lack of Jurisdiction<\/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\/copyright-protection-for-pharmaceutical-dossiers\/#Absence_of_Copyrightable_Subject_Matter\" >Absence of Copyrightable Subject Matter<\/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\/copyright-protection-for-pharmaceutical-dossiers\/#No_Infringement_Established\" >No Infringement Established<\/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\/copyright-protection-for-pharmaceutical-dossiers\/#Parallel_Arbitration_Proceedings\" >Parallel Arbitration Proceedings<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/copyright-protection-for-pharmaceutical-dossiers\/#Arguments_by_Respondent\" >Arguments by Respondent<\/a><\/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\/copyright-protection-for-pharmaceutical-dossiers\/#Reasoning_of_Court\" >Reasoning of Court<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/copyright-protection-for-pharmaceutical-dossiers\/#Decision\" >Decision<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/copyright-protection-for-pharmaceutical-dossiers\/#Legal_Significance\" >Legal Significance<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/copyright-protection-for-pharmaceutical-dossiers\/#Disclaimer\" >Disclaimer<\/a><\/li><\/ul><\/nav><\/div>\n\n<p>To market these drugs in Canada, Jubilant entered into a series of non-exclusive license and supply agreements with Jamp Pharma Corporation (a Canadian company) between 2010 and 2014. These agreements permitted Jamp Pharma to use Jubilant\u2019s Product Dossiers exclusively for regulatory and manufacturing purposes within Canada. The license was defined as \u201cfully paid-up, perpetual, royalty-free and non-exclusive\u201d, but territorially limited to Canada.<\/p>\n<p>In 2024, Jubilant alleged that Jamp Pharma had violated these agreements by transferring the Product Dossiers to its Indian subsidiary, Jamp India Pharmaceuticals Pvt. Ltd., and further to Indian manufacturers \u2014 Medreich Ltd., VS International Pvt. Ltd., and Gracure Pharmaceuticals Ltd. \u2014 for commercial manufacturing and distribution in India. Jubilant claimed this was an unlawful reproduction and use of its copyrighted and confidential materials.<\/p>\n<p>Upon discovery of this alleged misuse, Jubilant filed Original Suit No. 370 of 2024 before the Commercial Court at Gautam Budh Nagar seeking permanent injunction, damages, and ancillary reliefs under the Copyright Act and for breach of confidentiality. An ex parte ad-interim injunction was granted on 23 August 2024, restraining the defendants from using or sharing the disputed dossiers.<\/p>\n<h2 id=\"procedural-history\"><span class=\"ez-toc-section\" id=\"Procedural_History\"><\/span>Procedural History<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The defendants filed applications under Order XXXIX Rule 4 CPC to vacate the injunction, arguing lack of urgency, absence of copyright infringement, and existence of parallel arbitration proceedings in Canada between Jubilant and Jamp Pharma.<\/p>\n<p>The Commercial Court, by order dated 07 November 2024, continued the injunction. However, upon appeal (FAFOD No. 21 of 2025), the Allahabad High Court set aside this order, directing the Commercial Court to reconsider the injunction application after addressing the three essential elements \u2014 prima facie case, balance of convenience, and irreparable injury. On remand, the Commercial Court again upheld the injunction by order dated 25 February 2025, prompting Jamp India Pharmaceuticals and VS International Pvt. Ltd. to file Commercial Appeals No. 13 and 14 of 2025 before the High Court.<\/p>\n<h2 id=\"nature-of-dispute\"><span class=\"ez-toc-section\" id=\"Nature_of_Dispute\"><\/span>Nature of Dispute<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>At the core of this dispute lies the question of whether Product Dossiers qualify for copyright protection as \u201cliterary works\u201d under the Copyright Act, and whether their use by Indian affiliates amounts to copyright infringement or merely a breach of contractual confidentiality.<\/p>\n<p>The defendants argued that the suit was contractual in nature, arising from alleged breach of license agreements, and therefore could not be maintained as a copyright infringement action. They further asserted that the agreements\u2019 arbitration clause required the dispute to be settled before the International Chamber of Commerce (ICC), where parallel proceedings were already underway.<\/p>\n<p>Conversely, Jubilant claimed the action was one for infringement of statutory copyright rights \u2014 a right in rem, enforceable against the world at large \u2014 and not merely a contractual right in personam, thus placing it outside the scope of arbitration.<\/p>\n<h2 id=\"arguments-by-appellants\"><span class=\"ez-toc-section\" id=\"Arguments_by_Appellants\"><\/span>Arguments by Appellants<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3 id=\"non-compliance-section12A\"><span class=\"ez-toc-section\" id=\"Non-Compliance_with_Section_12-A_of_the_Commercial_Courts_Act_2015\"><\/span>Non-Compliance with Section 12-A of the Commercial Courts Act, 2015<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>Jubilant failed to undertake mandatory pre-institution mediation as required under Section 12-A.<\/li>\n<li>The alleged cause of action arose as early as 2021 through internal emails, and therefore there was no \u201curgency\u201d justifying exemption.<\/li>\n<li>Reliance placed on: <i>Patil Automation Pvt. Ltd. v. Rakheja Engineers Pvt. Ltd. (2022) 10 SCC 1<\/i> and <i>Yamini Manohar v. TKD Keerthi (2024) 5 SCC 815<\/i>.<\/li>\n<\/ul>\n<h3 id=\"composite-suit\"><span class=\"ez-toc-section\" id=\"Composite_Suit_and_Lack_of_Jurisdiction\"><\/span>Composite Suit and Lack of Jurisdiction<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>The claim combined two independent causes \u2014 breach of confidentiality and copyright infringement.<\/li>\n<li>The Commercial Court had jurisdiction only over the latter under Section 62 of the Copyright Act.<\/li>\n<li>Cases cited: <i>Dhodha House v. S.K. Maingi (2006) 9 SCC 41<\/i> and <i>Paragon Rubber Industries v. Pragathi Rubber Mills (2014) 14 SCC 762<\/i>.<\/li>\n<\/ul>\n<h3 id=\"absence-of-copyright\"><span class=\"ez-toc-section\" id=\"Absence_of_Copyrightable_Subject_Matter\"><\/span>Absence of Copyrightable Subject Matter<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>The Product Dossiers were compilations of scientific data and chemical processes lacking originality or creativity.<\/li>\n<li>They were technical documents rather than literary works, hence not protectable under Section 13.<\/li>\n<li>Relied on: <i>Eastern Book Company v. D.B. Modak (2008) 1 SCC 1<\/i> and <i>Dr. Reckeweg &amp; Co. GmbH v. Aven Biotech Pvt. Ltd. (2008 SCC OnLine Del 1741)<\/i>.<\/li>\n<\/ul>\n<h3 id=\"no-infringement\"><span class=\"ez-toc-section\" id=\"No_Infringement_Established\"><\/span>No Infringement Established<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Merely using the technology or information within the dossiers for manufacturing does not constitute reproduction or adaptation as per Section 14 of the Copyright Act.<\/p>\n<h3 id=\"parallel-arbitration\"><span class=\"ez-toc-section\" id=\"Parallel_Arbitration_Proceedings\"><\/span>Parallel Arbitration Proceedings<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Since an ICC arbitration between Jubilant and Jamp Pharma was already pending, the present suit amounted to forum shopping and risked conflicting findings. Reliance placed on <i>Bharat Aluminum Co. v. Kaiser Aluminum Technical Services Inc. (2012) 9 SCC 552 (BALCO)<\/i>.<\/p>\n<h2 id=\"arguments-by-respondent\"><span class=\"ez-toc-section\" id=\"Arguments_by_Respondent\"><\/span>Arguments by Respondent<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li><b>Section 12-A Inapplicable:<\/b> The suit sought urgent interim injunction against ongoing copyright infringement, falling within the exception under Section 12-A. Cited: <i>Y-Not Films LLP v. Ultra Media (2024 SCC OnLine Bom 3085)<\/i>.<\/li>\n<li><b>Product Dossiers as \u201cLiterary Works\u201d:<\/b> The dossiers involved significant intellectual skill, judgment, and discretion \u2014 satisfying the minimal creativity threshold under <i>Eastern Book Company v. D.B. Modak<\/i>.<\/li>\n<li><b>Copyright vs Contractual Rights:<\/b> Copyright infringement is a statutory right in rem. Such disputes cannot be referred to arbitration (<i>Booz Allen &amp; Hamilton Inc. v. SBI Home Finance Ltd.<\/i>; <i>Vidya Drolia v. Durga Trading Corporation<\/i>).<\/li>\n<li><b>Jurisdiction:<\/b> The plaintiff carried on business in Noida (Section 62(2)), and part of the cause of action arose at the iPHEX 2024 Exhibition in Greater Noida.<\/li>\n<\/ul>\n<h2 id=\"reasoning-of-court\"><span class=\"ez-toc-section\" id=\"Reasoning_of_Court\"><\/span>Reasoning of Court<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<table>\n<tbody>\n<tr>\n<th>Issue<\/th>\n<th>Finding<\/th>\n<\/tr>\n<tr>\n<td>Composite Suit and Jurisdiction<\/td>\n<td>The dominant purpose was to protect copyright; confidentiality was incidental. Commercial Court at Noida had jurisdiction.<\/td>\n<\/tr>\n<tr>\n<td>Copyrightability<\/td>\n<td>Product Dossiers qualified as \u201cliterary works\u201d as they involved skill and judgment. Originality does not require novelty.<\/td>\n<\/tr>\n<tr>\n<td>Section 12-A Compliance<\/td>\n<td>Urgent interim relief justified exemption under Section 12-A; cause of action arose in April 2024.<\/td>\n<\/tr>\n<tr>\n<td>Arbitration<\/td>\n<td>Contractual disputes were arbitrable, but statutory copyright infringement was not.<\/td>\n<\/tr>\n<tr>\n<td>Interim Injunction<\/td>\n<td>Prima facie case established; balance of convenience and irreparable harm favored Jubilant.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2 id=\"decision\"><span class=\"ez-toc-section\" id=\"Decision\"><\/span>Decision<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The High Court dismissed both appeals, affirming the injunction order dated 25 February 2025 of the Commercial Court, Gautam Budh Nagar. Jubilant established a strong prima facie case of copyright infringement and breach of confidentiality. Section 12-A did not bar the proceedings, and Product Dossiers were recognized as protectable literary works under the Copyright Act.<\/p>\n<h2 id=\"legal-significance\"><span class=\"ez-toc-section\" id=\"Legal_Significance\"><\/span>Legal Significance<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li>Product Dossiers and regulatory compilations may qualify as \u201cliterary works.\u201d<\/li>\n<li>Statutory copyright claims can proceed independently of arbitral disputes.<\/li>\n<li>Urgent IP injunctions can bypass pre-institution mediation under Section 12-A.<\/li>\n<li>Confidential information incorporated in a literary work may receive copyright protection.<\/li>\n<\/ul>\n<div class=\"case-details\">\n<p><strong>Case Title:<\/strong> Jamp India Pharmaceuticals Pvt. Ltd. Vs. Jubilant Generics Ltd. and Others<\/p>\n<p><strong>Neutral Citation:<\/strong> 2025:ALLHC:1015<\/p>\n<p><strong>Case Number:<\/strong> Commercial Appeal No. 14 of 2025<\/p>\n<p><strong>Order Date:<\/strong> 15 October 2025<\/p>\n<p><strong>Court:<\/strong> High Court of Judicature at Allahabad<\/p>\n<p><strong>Coram:<\/strong> Hon\u2019ble Mr. Justice Arun Bhansali, Chief Justice, and Hon\u2019ble Mr. Justice Kshitij Shailendra<\/p>\n<\/div>\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 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><strong>Written By:<\/strong> Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jamp India Pharmaceuticals Pvt. Ltd. Vs. Jubilant Generics Ltd. and Others Factual Background Jubilant Generics Ltd., a pharmaceutical company based in Noida, India, is engaged in developing and manufacturing drug formulations for global markets. It had created detailed Product Dossiers for drugs such as Losartan, Amlodipine, and Citalopram. These dossiers, developed through years of research,<\/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":[1199,28],"class_list":{"0":"post-10532","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-intellectual-property","7":"tag-intellectual-property-law","8":"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\/10532","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=10532"}],"version-history":[{"count":0,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts\/10532\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/media?parent=10532"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/categories?post=10532"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/tags?post=10532"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}