Below is the complete analytical legal research paper written exactly in the manner requested, in simple but legally accurate language, without bullet points or paragraph numbering. Suggested publication titles are provided at the end.
Brief Introductory Head Note
This legal analysis examines the recent judgment delivered by the High Court of Delhi in the matter Novo Nordisk A/S v. Dr. Reddy’s Laboratories Ltd. & Anr., concerning alleged infringement of Indian Patent No. 262697 relating to the pharmaceutical compound Semaglutide. The case raises complex legal issues on patent validity, anticipation, prior claiming, inventive step, and the applicability of Section 107A relating to regulatory exceptions. The judgment also addresses questions of public interest, commercial intent, and balance of convenience where a pharmaceutical patent is near expiry.
Summary of Case and Factual Background
The Plaintiff, Novo Nordisk A/S, is a well-known global healthcare corporation specializing in diabetes medicines. It owns Indian Patent No. 262697 covering the compound Semaglutide, a once-weekly injectable drug used for treating Type-2 diabetes and obesity. The patent was granted in 2014 and is set to expire in March 2026.
In late 2024, Novo Nordisk discovered that the Defendants, Dr. Reddy’s Laboratories and OneSource Specialty Pharma Pvt. Ltd., were importing and manufacturing Semaglutide in India. Upon further investigation, it appeared that the Defendants were producing the compound not only for research purposes but in volumes suggesting commercial intent. The Plaintiff issued a cease-and-desist notice, after which the Defendants filed a revocation petition challenging the patent.
Novo Nordisk then initiated the present suit seeking a permanent injunction along with urgent interim relief restraining the Defendants from manufacturing or exporting the drug during the subsistence of the patent.
Procedural Detail
The suit was filed before the High Court of Delhi under the Commercial Courts Act. On first listing, the Defendants stated that although they had begun manufacturing, they would not sell the drug in India until they secured local marketing approval. However, they reserved the right to export to countries where the Plaintiff did not hold a valid patent.
The Court initially allowed the exports but recorded the assurance of no domestic sale. The Plaintiff appealed, leading to directions from the Division Bench that the interim injunction application be decided expeditiously.
Extensive arguments were heard over multiple dates from July to September 2025. The judgment was reserved and finally pronounced on 2 December 2025.
Core Dispute
The core controversy is whether the Defendants should be restrained from manufacturing Semaglutide in India, even for export purposes, during the remaining term of the patent.
The Defendants argue that:
Semaglutide is not novel and is anticipated by an earlier Genus Patent IN’964.
The Plaintiff has admitted, through filings and international conduct, that Semaglutide falls within the earlier genus claims.
The patent is invalid under Section 64 on grounds of prior claiming, anticipation, lack of inventive step, and Section 3(d).
Manufacture is protected under the research exception of Section 107A and does not amount to infringement.
The Plaintiff argues that:
Semaglutide is a novel and inventive species compound and demonstrates significantly higher therapeutic efficacy compared to earlier molecules, especially Example-61 in the Genus Patent.
The Defendants have admitted infringement by applying for licenses and regulatory approvals.
Export-oriented manufacture is still infringement under Section 48.
After nearly nineteen years without challenge, the patent must be treated as prima facie valid.
Detailed Reasoning and Discussion by the Court
The Court first clarified that there is no presumption of patent validity in India, as per Section 13(4) of the Patents Act and the Supreme Court ruling in Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries. Therefore, when a defendant raises a revocation-based defence under Section 107(1), the Court must assess whether a credible challenge has been raised.
The Defendants relied heavily on Section 64(1)(a), arguing that the compound was already claimed in an earlier genus patent. The Court examined the chemical structure comparison between Example-61 of the Genus Patent and Semaglutide, and also considered scientific literature where Example-61 was referred to as “Alanine Semaglutide”, suggesting structural proximity.
However, the Court held that proximity alone is insufficient. A species claim can only be said to be anticipated if the earlier genus patent provides an enabling disclosure. Relying on Novartis AG v. Natco Pharma Ltd., the Court reiterated that mere coverage is not disclosure. A person skilled in the art should be able to derive the exact species without hindsight reconstruction.
On inventive step, the Defendants’ argument that substitution of Alanine with Aib at position 8 was obvious was rejected at this preliminary stage. The Court noted that no prior art demonstrated that such substitution would yield the exceptionally prolonged half-life and once-weekly dosing achieved by Semaglutide. This aligned with the long-felt need and marked clinical improvement recognized in F. Hoffmann-La Roche v. Cipla Ltd.
Regarding Section 3(d), the Court held that Semaglutide is a new compound, not a minor modification of a known substance, and its enhanced efficacy was evident.
On infringement, the Court relied on MSD v. Sanjeev Gupta and clarified that manufacture—even solely for export—falls within the prohibited acts under Section 48. Section 107A does not permit commercial scale manufacture.
Finally, regarding balance of convenience, the Court held that allowing the Defendants to continue manufacturing would irreversibly damage the Plaintiff’s statutory monopoly, whereas any loss to the Defendants was compensable in money.
Decision
The Court granted an interim injunction restraining the Defendants from manufacturing, exporting, selling, offering for sale, commercializing, or otherwise dealing in Semaglutide or any formulation containing it, until expiry of the patent or further orders.
The earlier statement protecting exports was vacated.
Concluding Note
This judgment reinforces the principle that Indian patent law does not grant multiple opportunities to monopolize the same invention and that near-expiry patents cannot be invalidated lightly without strong evidence. The Court balanced innovation incentives with public interest considerations and clarified that Section 107A cannot be used as a shield for pre-commercial stockpiling. The decision will likely influence pharmaceutical patent enforcement strategy and ongoing debate over genus vs. species patents in India.
Case Citation Details
Case Title: Novo Nordisk A/S v. Dr. Reddy’s Laboratories Ltd. & Anr.
Order / Judgment Date: 02 December 2025
Case Number: CS(COMM) 565/2025 & connected applications
Neutral Citation: 2025:DHC:____ (as per Court record heading)
Court: High Court of Delhi, New Delhi
Judge: Hon’ble Ms. Justice Manmeet Pritam Singh Arora
Suggested Titles for Publication
- Semaglutide Patent Litigation: Navigating Genus–Species Conflict in Indian Patent Jurisprudence
- Export Manufacturing and Patent Rights: Legal Boundaries After Novo Nordisk v. Dr. Reddy’s
- Coverage vs. Disclosure: A Judicial Revisit in Pharmaceutical Patent Enforcement
- When Research Becomes Commerce: Section 107A Tested in Semaglutide Litigation
- Balancing Innovation and Access: Delhi High Court’s Interim Approach in Diabetes Drug Patent Case
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
Delhi High Court Restrains Dr. Reddy’s from Manufacturing Semaglutide Pending Patent Expiry — Novo Nordisk A/S v. Dr. Reddy’s Laboratories Ltd. & Anr., Order dated 02 December 2025, CS(COMM) 565/2025, before Hon’ble Justice Manmeet Pritam Singh Arora, High Court of Delhi
In a significant development impacting the pharmaceutical patent landscape, the Delhi High Court has granted an interim injunction restraining Dr. Reddy’s Laboratories and OneSource Specialty Pharma from manufacturing or exporting the anti-diabetic drug Semaglutide until the expiry of Indian Patent No. 262697 held by Novo Nordisk A/S.
Novo Nordisk approached the Court alleging that the Defendants had begun large-scale manufacture of Semaglutide in India intended for export, despite the Plaintiff’s subsisting patent rights until March 2026. The Defendants argued that the compound lacked novelty and was anticipated by an earlier “genus patent,” contending that the suit patent was invalid and therefore unenforceable. They further sought shelter under Section 107A of the Patents Act, claiming the manufacture was protected as research activity.
After hearing extensive arguments, the Court rejected the Defendants’ contentions at the interim stage and held that a credible inventiveness dispute existed, requiring full trial. However, it found that the Defendants’ ongoing commercial-scale manufacturing—even for export—amounted to prima facie infringement under Section 48 of the Patents Act. The Court clarified that Section 107A does not permit stockpiling or commercial manufacture during the patent term.
The Court also noted that the patent had remained uncontested for nearly nineteen years, and allowing continued manufacture would irreversibly harm the statutory monopoly granted to the patentee. The balance of convenience and irreparable loss were held to be in favour of the Plaintiff.
The injunction will remain in force until the expiry of the patent term or further judicial orders.
With this ruling, the Court has reaffirmed the enforceability of species patents and clarified legal boundaries around export manufacturing under Section 107A—a ruling expected to influence ongoing pharmaceutical patent disputes in India.
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Disclaimer: This is for general information only and should not be construed as legal advice as it may contain human errors in perception and presentation: Advocate Ajay Amitabh Suman, IP Adjutor (Patent & Trademark Attorney), High Court of Delhi.
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