Delhi High Court Permits Dr. Reddy’s To Manufacture Semaglutide Drug & Export To Other Countries Where Novo Nordisk Doesn’t Have Patent

The Delhi High Court has permitted Dr. Reddy’s Laboratories Limited to manufacture Semaglutide drug and export the same to other countries where Novo Nordisk AS. does not have patent registration.

The Court was hearing an Application filed by Novo Nordisk under Order XXXIX, Rules 1 and 2 of the Code of Civil Procedure, 1908 (CPC).

A Single Bench of Justice Manmeet Pritam Singh Arora observed, “Since the Plaintiff is not manufacturing in India and only importing to India, this Court accepts the undertaking by the Defendants and permits them to manufacture the impugned drug in India and export it to countries where the Plaintiff does not have a Patent registration.”

The Bench said that Novo Nordisk failed to make out a prima facie case for the grant of an interim injunction and any damages suffered by it can be adequately compensated, if deemed appropriate, after the trial has been concluded in accordance with law.

Advocate Hemant Singh appeared on behalf of the Plaintiff, while Senior Advocates Gopal Subramanium and J. Sai Deepak appeared on behalf of the Defendants.

Brief Facts

A Suit was filed alleging infringement of Patent by the Plaintiff-Novo Nordisk, a global healthcare company with more than a hundred years of innovation and leadership in treatment for diabetes and other rare diseases. By way of the Application, the Plaintiff sought an interim injunction to restrain the infringement of Patent “ACYLATED GLP-1 ANALOGS COMPRISING NO PROTEOGENIC AMINO ACID RESIDUE”. The suit was related to the filed of therapeutic peptides i.e., new protracted GLP-1 analogues for the treatment of diseases such as Type 2 Diabetes and Obesity. The Suit Patent claimed a compound with an International Non-Proprietary Name (INN), i.e., ‘Semaglutide’, as assigned by the World Health Organisation (WHO). Semaglutide is a breakthrough drug, as it is the only GLP-1 analogue administered subcutaneously once a week, compared to earlier known GLP-1 analogues such as Exenatide and Liraglutide, which are administered twice a day and once a day, respectively.

Semaglutide was the Active Pharmaceutical Ingredient (API) in the Plaintiff’s commercial product (Semaglutide compound), which is marketed under the brand names Ozempic, Wegovy, and Rybelsus worldwide and under the brand names Wegovy and Rybelsus in India. An independent investigator’s report in December 2024 confirmed that the Defendant-Dr. Reddy’s Laboratories Limited, an Indian Pharmaceutical company has been importing and exporting Semaglutide compound (impugned drug) in significant quantities, suggesting commercial rather than research use. The High Court in May 2025 bound the Defendants to the statement that they will not sell the impugned drug in India; however, the Defendants were not restrained from carrying on exports of the said drug to other countries from India. This was under challenge.

Reasoning

The High Court in the above regard, noted, “The problems identified in the Suit Patent/IN’697 are similar or identical to the problem addressed in the relevant prior arts, which is to offer less frequent Type 2 Diabetes injections with an increased half-life period. … All prior arts suggest use of GLP-1 analogues for addressing the problem of the Suit Patent/IN’697.”

The Court remarked that the rapidity of the inventions in this case is such that the Suit Patent has been filed within less than two years of the closest prior art, i.e., Genus Patent/IN’964.

“The technology involved in the present case, which encompasses drug discovery and testing, is highly sophisticated. … The educational background of scientists working in this field typically includes a high degree in medicinal chemistry. … The inventors in both the Genus Patent/IN’964 and the Suit Patent/IN’697 are the same”, it added.

The Court was of the view that for the assessment of inventive step or obviousness in the case, the “person skilled in the art” will be a “person in the know” who is aware of all the prior arts, having a skill matching with the inventors of the Genus Patent/IN’964, i.e., a person skilled in medicinal chemistry and this person will also be capable of working the Genus Patent/IN’964, along with all the examples, revealing its full scope as per the prior art disclosures.

“Thus, this Court is satisfied that the single substitution made to the GLP-1 analogue of Example 61 compound of the Genus Patent/IN’964 to arrive at the Semaglutide compound in the Suit Patent/IN’697 were obvious to try for a ‘person skilled in the art’, or in this case, the ‘person in the know’ with a reasonable expectation of success, i.e. to obtain GLP-1(7-37) analogue with increased half-life for effective treatment of Type 2 Diabetes. 130. Therefore, this Court is of the prima facie opinion that the Suit Patent/IN’697 is vulnerable on the ground of obviousness on account of the claims and compounds disclosed in the Genus Patent/IN’964 as well as the teaching in the prior art in Deacon [1998] and Knudsen [2004]”, it held.

The Court further observed that the Plaintiff invented the Semaglutide compound in 2004, which is contemporaneous to the time of filing the Genus Patent IN’964, but wilfully withheld the Semaglutide compound from the Patent Office and artificially created a second patent [Suit Patent/IN’697] that were filed at a later filing date after the Genus Patent/IN’964, to extend the monopoly already granted with the acceptance of the Genus Patent/IN’964.

“Therefore, it can be concluded that the Genus Patent/IN’964, which discloses the Semaglutide compound has enjoyed protection for a period of twenty [20] years; however, the protection for the same remains extended due to the Suit Patent/IN’697, resulting in double patenting and, thereby, evergreening. These facts, at this prima facie stage, further strengthen the credible challenge raised by the Defendants to the Suit Patent/IN’697 on the ground of Section 64(1)(a) and 64(1)(f) of the Patent Act”, it also said.

The Court directed that the Defendants will not sell the impugned drugs in India until the Suit Patent/IN’697 has expired; however, the Defendants shall maintain an account of the drugs manufactured and exports carried out by them for the entire period from the commencement of manufacture until the expiry of the Suit Patent/IN’697 for the purposes of the trial.

“In view of the undertaking of the Defendants that they will not sell the impugned drugs in India as well as the direction of the Court to the Defendants to not sell the impugned drugs in India until the expiry of the Suit Patent/IN’697, this Court is of the considered opinion that the interest of both parties stands balanced. The Defendants have been further bound down to their statement and restricted to exporting the impugned drugs only to countries in which Plaintiff does not hold a patent. There will be no loss of revenue to the Plaintiff within India. The Defendants have been directed to maintain accounts of the stock manufactured and exported, therefore in case the Plaintiff succeeds, the Plaintiff will be compensated by damages”, it added.

Conclusion

Moreover, the Court noted that the Defendants are regular litigants and have been parties to several patent infringement actions in the Court, whether as a Plaintiff or a Defendant and are therefore well versed with the legal reasoning behind the principle of clearing the way.

“The Defendants, therefore, by proceeding to commence setting up of manufacturing facilities and manufacture without challenging the Suit Patent/IN’697 did so at its own peril and therefore there is no balance of convenience in their favour so as to entitle them to sell the impugned drugs in India until the expiry of Suit Patent/IN’697, which is imminent being 20th March, 2026”, it concluded.

Accordingly, the High Court dismissed the Application.

Cause Title- Novo Nordisk AS. v. Dr. Reddy’s Laboratories Limited & Anr. (Neutral Citation: 2025:DHC:10820)

Appearance:

Plaintiff: Advocates Hemant Singh, Mamta Jha, Siddhant Sharma, Rishabh Paliwal, Abhay Tandon, and Shreyansh Gupta.

Defendants: Senior Advocates Gopal Subramanium, J. Sai Deepak, Advocates Mohit Goel, Sidhant Goel, Aditya Goel, Deepankar Mishra, Kartikeya Tandon, Pavan Bhushan, and Avinash K. Sharma.

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