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Date: 04.12.2025
Delhi High Court Rejects Novo Nordisk’s Interim Injunction in Semaglutide Patent Dispute Against Dr. Reddyβs Laboratories
This Article has been written by Shri Ravi Shekhar Jha, Advocate based in New Delhi. The views expressed are based on his interpretation of the law. He can be reached at his email id intelconsul@gmail.comor on his Mobile +91-9999005379. Β β
On December 2, 2025, the Delhi High Court delivered a significant judgment in the case of Novo Nordisk AS vs. Dr. Reddyβs Laboratories Limited & Anr. β (CS(COMM) 565/2025), addressing a patent infringement dispute over the pharmaceutical compound Semaglutide. The case revolved around Novo Nordiskβs claim that Dr. Reddyβs Laboratories infringed its patent (Patent No. β INβ697) for the drug Semaglutide, marketed under the brand names Ozempic, Wegovy, and Rybelsus. β
Background of the Case
Novo Nordisk, a global healthcare company specializing in diabetes treatment, filed the suit alleging that Dr. Reddyβs Laboratories and OneSource Specialty Pharma Limited were manufacturing and exporting Semaglutide-based drugs without authorization. β 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, INβ964 (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/INβ697 vulnerable to revocation under Section 64 of the Indian Patents Act, 1970. β
Key Issues Addressed
The court focused on the following key issues:
- Anticipation by Prior Claiming (Section 64(1)(a)): The defendants argued that the Semaglutide compound was already claimed in the Genus Patent/INβ964. β The court found that the Genus Patent/INβ964 contained specific claims and disclosures that enabled a “person skilled in the art” to arrive at the Semaglutide compound, making the Suit Patent/INβ697 vulnerable to revocation under Section 64(1)(a). β
- Anticipation by Prior Publication (Section 64(1)(e)): The court held that the Genus Patent/INβ964, published before the priority date of the Suit Patent/INβ697, disclosed the Semaglutide compound, making the latter patent vulnerable under Section 64(1)(e). β
- Obviousness (Section 64(1)(f)): The court determined that the Semaglutide compound was an obvious modification of Example 61 in the Genus Patent/INβ964, given the teachings in the prior arts, including Deacon [1998] and Knudsen [2004]. β The court applied the “person in the know” test, considering the common inventors between the Genus Patent/INβ964 and the Suit Patent/INβ697, and concluded that the modifications were within the skillset of the inventors. β
- Evergreening: The court noted that Novo Nordisk had invented the Semaglutide compound in 2004, contemporaneous with the filing of the Genus Patent/INβ964. β The court found that the filing of the Suit Patent/INβ697 was an attempt to extend the monopoly on the Semaglutide compound, resulting in double patenting and evergreening. β
Courtβs Decision
The court denied Novo Nordiskβs request for an interim injunction, allowing Dr. Reddyβs Laboratories to continue manufacturing the drug in India and exporting it to countries where Novo Nordisk does not hold a patent. β 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/INβ697 on March 20, 2026. β
Key Takeaways
- 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. β
- 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. β
- Importance of Clearing the Way: The court criticized the defendants for failing to challenge the Suit Patent/INβ697 before commencing manufacturing, highlighting the importance of clearing the way in patent disputes. β
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 judiciaryβs stance against evergreening practices that could harm public interest. β 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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