Delhi High Court Rejects Novo Nordisk’s Interim Injunction in Semaglutide Patent Dispute Against Dr. Reddy’s Laboratories

ALO Law Office- IDT Tax I Arbitration I Litigation

Date: 04.12.2025

Delhi High Court Rejects Novo Nordisk’s Interim Injunction in Semaglutide Patent Dispute Against Dr. Reddy’s Laboratories

On December 2, 2025, the Delhi High Court delivered a significant judgment in the case of Novo Nordisk AS vs. Dr. Reddy’s Laboratories Limited & Anr. ​ (CS(COMM) 565/2025), addressing a patent infringement dispute over the pharmaceutical compound Semaglutide. The case revolved around Novo Nordisk’s claim that Dr. Reddy’s Laboratories infringed its patent (Patent No. ​ IN’697) for the drug Semaglutide, marketed under the brand names Ozempic, Wegovy, and Rybelsus. ​

Background of the Case

Novo Nordisk, a global healthcare company specializing in diabetes treatment, filed the suit alleging that Dr. Reddy’s Laboratories and OneSource Specialty Pharma Limited were manufacturing and exporting Semaglutide-based drugs without authorization. ​ Novo Nordisk sought an interim injunction to restrain the defendants from manufacturing and exporting the drug, claiming infringement of its patent.

The defendants argued that the Semaglutide compound was already disclosed in a prior patent, IN’964 (Genus Patent), filed by Novo Nordisk in 2004. They contended that the Semaglutide compound was not novel and lacked an inventive step, making the Suit Patent/IN’697 vulnerable to revocation under Section 64 of the Indian Patents Act, 1970. ​

Key Issues Addressed

The court focused on the following key issues:

1. Anticipation by Prior Claiming (Section 64(1)(a)): The defendants argued that the Semaglutide compound was already claimed in the Genus Patent/IN’964. ​ The court found that the Genus Patent/IN’964 contained specific claims and disclosures that enabled a “person skilled in the art” to arrive at the Semaglutide compound, making the Suit Patent/IN’697 vulnerable to revocation under Section 64(1)(a). ​
2. Anticipation by Prior Publication (Section 64(1)(e)): The court held that the Genus Patent/IN’964, published before the priority date of the Suit Patent/IN’697, disclosed the Semaglutide compound, making the latter patent vulnerable under Section 64(1)(e). ​
3. Obviousness (Section 64(1)(f)): The court determined that the Semaglutide compound was an obvious modification of Example 61 in the Genus Patent/IN’964, given the teachings in the prior arts, including Deacon [1998] and Knudsen [2004]. ​ The court applied the “person in the know” test, considering the common inventors between the Genus Patent/IN’964 and the Suit Patent/IN’697, and concluded that the modifications were within the skillset of the inventors. ​
4. Evergreening: The court noted that Novo Nordisk had invented the Semaglutide compound in 2004, contemporaneous with the filing of the Genus Patent/IN’964. ​ The court found that the filing of the Suit Patent/IN’697 was an attempt to extend the monopoly on the Semaglutide compound, resulting in double patenting and evergreening. ​

Court’s Decision

The court denied Novo Nordisk’s request for an interim injunction, allowing Dr. Reddy’s Laboratories to continue manufacturing the drug in India and exporting it to countries where Novo Nordisk does not hold a patent. ​ However, the court directed the defendants to maintain detailed records of their manufacturing and export activities and prohibited them from selling the drug in India until the expiry of the Suit Patent/IN’697 on March 20, 2026. ​

Key Takeaways

1. No Presumption of Patent Validity: The court reiterated that under Indian patent law, there is no presumption of validity for granted patents, and defendants can challenge the validity of a patent even at the interim stage. ​
2. Evergreening and Double Patenting: The court emphasized that patent law does not permit inventors to extend their monopoly through successive patents for the same invention, as this would be against public interest. ​
3. Importance of Clearing the Way: The court criticized the defendants for failing to challenge the Suit Patent/IN’697 before commencing manufacturing, highlighting the importance of clearing the way in patent disputes. ​

Implications

This judgment is a landmark decision in the realm of patent law, particularly in the pharmaceutical sector. It underscores the importance of assessing patent validity under Indian law and highlights the judiciary’s stance against evergreening practices that could harm public interest. ​ The case also serves as a reminder for companies to clear the way before engaging in activities that may infringe on existing patents.

Source: Delhi High Court

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