Copyright Protection for Pharmaceutical Dossiers
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, 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 “literary works” under Section 2(o) of the Copyright Act, 1957.
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’s Product Dossiers exclusively for regulatory and manufacturing purposes within Canada. The license was defined as “fully paid-up, perpetual, royalty-free and non-exclusive”, but territorially limited to Canada.
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 — Medreich Ltd., VS International Pvt. Ltd., and Gracure Pharmaceuticals Ltd. — for commercial manufacturing and distribution in India. Jubilant claimed this was an unlawful reproduction and use of its copyrighted and confidential materials.
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.
Procedural Histroy: 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.
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 — 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.
Nature of Dispute: At the core of this dispute lies the question of whether Product Dossiers qualify for copyright protection as “literary works” under the Copyright Act, and whether their use by Indian affiliates amounts to copyright infringement or merely a breach of contractual confidentiality.
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’ arbitration clause required the dispute to be settled before the International Chamber of Commerce (ICC), where parallel proceedings were already underway.
Conversely, Jubilant claimed the action was one for infringement of statutory copyright rights — a right in rem, enforceable against the world at large — and not merely a contractual right in personam, thus placing it outside the scope of arbitration.
Arguments by Appellants: The appellants contended that:
Non-Compliance with Section 12-A of the Commercial Courts Act, 2015:Jubilant failed to undertake mandatory pre-institution mediation, as required under Section 12-A. The alleged cause of action arose as early as 2021 through internal emails, and therefore there was no “urgency” justifying exemption.They relied on Patil Automation Pvt. Ltd. v. Rakheja Engineers Pvt. Ltd. (2022) 10 SCC 1 and Yamini Manohar v. TKD Keerthi (2024) 5 SCC 815.
Composite Suit and Lack of Jurisdiction: The claim combined two independent causes — breach of confidentiality and copyright infringement. The Commercial Court, relying on Section 62 of the Copyright Act, had jurisdiction only over the latter. Citing Dhodha House v. S.K. Maingi (2006) 9 SCC 41 and Paragon Rubber Industries v. Pragathi Rubber Mills (2014) 14 SCC 762, the appellants argued that a court cannot assume jurisdiction over an entire composite suit when it lacks territorial competence for one of the causes.
Absence of Copyrightable Subject Matter:The Product Dossiers, being compilations of scientific data and chemical processes, lacked originality or creativity. They were technical documents rather than literary works, hence not protectable under Section 13 of the Act.They relied on Eastern Book Company v. D.B. Modak (2008) 1 SCC 1 and Dr. Reckeweg & Co. GmbH v. Aven Biotech Pvt. Ltd. (2008 SCC OnLine Del 1741).
No Infringement Established: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.
Parallel Arbitration Proceedings:Since an ICC arbitration between Jubilant and Jamp Pharma was already pending, the present suit amounted to forum shopping and risked conflicting findings.Reliance was placed on Bharat Aluminum Co. v. Kaiser Aluminum Technical Services Inc. (2012) 9 SCC 552 (BALCO).
Argument by Respondent: Jubilant countered that:
Section 12-A Inapplicable:The suit sought urgent interim injunction against ongoing copyright infringement, falling within the exception under Section 12-A. Reliance was placed on Y-Not Films LLP v. Ultra Media (2024 SCC OnLine Bom 3085).
Product Dossiers as “Literary Works”:The Dossiers involved significant intellectual skill, judgment, and discretion — thus satisfying the minimal creativity threshold under Eastern Book Company v. D.B. Modak (2008) 1 SCC 1.
Copyright vs Contractual Rights: Copyright infringement is a statutory right in rem, enforceable independently of contractual obligations. Disputes relating to rights in rem cannot be referred to arbitration (Booz Allen & Hamilton Inc. v. SBI Home Finance Ltd., (2011) 5 SCC 532; Vidya Drolia v. Durga Trading Corporation, (2021) 2 SCC 1).
Jurisdiction of the Commercial Court:Under Section 62(2) of the Copyright Act, the plaintiff may institute the suit where it carries on business — in this case, Noida. Furthermore, part of the cause of action arose within its jurisdiction as the defendants promoted and advertised infringing products at the iPHEX 2024 Exhibition in Greater Noida.
Reasoning of court:
Composite Suit and Jurisdiction: The Court examined Sections 62 of the Copyright Act and 20 of the CPC and reiterated the principle from Dhodha House and Paragon Rubber that a court cannot assume jurisdiction for an entire composite suit if one part lies beyond its territorial reach. However, the Bench found that the dominant purpose of the plaint was to protect copyright, and the confidentiality aspect was incidental and ancillary. Therefore, the Commercial Court at Noida rightly exercised jurisdiction.
On Copyrightability of Product Dossiers: The Court held that Product Dossiers, being compilations of scientific and regulatory data developed through skill and judgment, qualified as “literary works” under Section 2(o). The reasoning drew from Eastern Book Company v. D.B. Modak (2008) 1 SCC 1, clarifying that originality does not require novelty — only the exercise of creative judgment.
On Section 12-A Compliance: The Court acknowledged Patil Automation but emphasized that exemption under Section 12-A applies where urgent interim relief is sought. The cause of action arose on 2 April 2024, when Jamp Pharma’s senior vice president admitted transferring the dossiers in his affidavit. The Court held that the plaintiff could not have initiated pre-mediation without risking continued infringement.
On Arbitration: The Bench agreed that the arbitration proceedings related to contractual issues between Jubilant and Jamp Pharma, not statutory rights under the Copyright Act. Hence, the present suit was maintainable before the Indian Commercial Court.
On Grant of Interim Injunction:Applying principles from Anand Prasad Agarwalla v. Tarkeshwar Prasad (AIR 2001 SC 2367) and Pernod Ricard India Pvt. Ltd. v. Karanveer Singh Chhabra (2025 SCC OnLine SC 1701), the Court held that: Jubilant had established a prima facie case of ownership and unauthorized use of its Dossiers. Balance of convenience favored protection of intellectual property over commercial convenience.Continued misuse would cause irreparable harm to Jubilant’s proprietary rights. The injunction was thus upheld.
Decision: The High Court dismissed both appeals, affirming the injunction order dated 25 February 2025 of the Commercial Court, Gautam Budh Nagar. It concluded that Jubilant had made out a strong prima facie case of copyright infringement and breach of confidentiality, and that Section 12-A did not bar the proceedings. The Product Dossiers were recognized as protectable literary works under the Copyright Act.
Legal Significance: This judgment is a landmark for the pharmaceutical and intellectual property industries. It establishes that: Product Dossiers and regulatory compilations may qualify as “literary works” under the Copyright Act. Statutory copyright claims can proceed independently of contractual or arbitral disputes. Urgent injunctions in IP cases can bypass pre-institution mediation under Section 12-A of the Commercial Courts Act. Confidential information, though contractual in nature, may be protected under the broader ambit of copyright law when incorporated in literary work.
Case Title: Jamp India Pharmaceuticals Pvt. Ltd. Vs. Jubilant Generics Ltd. and Others
Neutral Citation: 2025:ALLHC:1015
Case Number: Commercial Appeal No. 14 of 2025
Order Date: 15 October 2025
Court: High Court of Judicature at Allahabad
Coram: Hon’ble Mr. Justice Arun Bhansali, Chief Justice, and Hon’ble Mr. Justice Kshitij Shailendra
Disclaimer: 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.
Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi