Semaglutide Patent Clash: Delhi HC Denies Novo Nordisk Injunction, Manufacturing by Dr Reddy's to Continue

Justice Manmeet Pritam Singh Arora heard the matter across several dates — July 31, August 1, August 8, August 22, August 27, September 8 and September 9 — and reserved the order on September 15, 2025. Novo Nordisk had first received indications in 2024 that Indian firms were exporting Semaglutide in violation of its patent, and later confirmed that Dr Reddy’s began commercial-scale manufacture in April 2025, despite not holding marketing authorisation for India.

On May 29, 2025, Dr Reddy’s gave an undertaking that it would not sell Semaglutide in India and would export the drug only to countries where Novo Nordisk did not hold a patent. This undertaking was formally recorded and later reaffirmed by affidavit.

Novo Nordisk’s Arguments

Senior advocate Hemant Singh argued that Semaglutide was a novel and inventive compound featuring a superior half-life of 165 hours and once-weekly dosing. He asserted that the defendants had effectively admitted infringement by seeking a voluntary licence in December 2024 after expiry of the earlier genus patent. He also highlighted that Dr Reddy’s had filed a process patent referencing Novo’s U.S. patent and had withdrawn challenges to the U.S. counterpart during Delaware litigation.

Novo Nordisk maintained that manufacture in India constitutes infringement regardless of export destination, stating: “manufacturing the impugned drug in India for exporting itself amounts to infringement.”

The company also relied on the patent’s unchallenged 19-year survival to claim prima facie validity.

Dr Reddy’s Arguments

Senior advocates Gopal Subramanium and J. Sai Deepak argued that Semaglutide was already disclosed, claimed, and enabled in the earlier genus patent IN’964, rendering the suit patent vulnerable under Section 64(1)(a). They pointed to Example 61 of the genus patent — which they described as “Alanine Semaglutide” — differing only by one amino-acid substitution.

They said the shift of priority date to 2006 made the genus patent prior art and cast doubt on the novelty and inventive step of IN’697. Dr Reddy’s also highlighted that manufacturing began only after the genus patent expired on September 17, 2024, and that over ₹1,000 crore had already been invested in production facilities. They further argued that Novo Nordisk does not manufacture Semaglutide in India but imports it at premium prices.

They submitted that the credible validity challenge under Section 107 defeated the request for an interim injunction.

Court’s Observations and Technical Findings

The Delhi High Court held that Dr Reddy’s had raised a substantial, credible challenge to the validity of Novo Nordisk’s species patent. The court stated:

“This Court finds merit in the submissions of the Defendants… the Court has to examine whether the defendant has raised a credible challenge of vulnerability of the suit patent.”

Emphasising that Indian law does not presume patent validity, the court observed:

“There is no presumption in favour of the validity of the patent.”

The court also relied on the defendants’ undertaking that “They will not sell the impugned drug in India,” noting this adequately protected Novo Nordisk’s market within the country.

The High Court then conducted a detailed assessment of the scientific and technical issues. It held:

“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.”

Discussing the timeline, the court remarked:

“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.”

On the level of expertise required, the court stated:

“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.”

In its prima facie finding of obviousness, the court held:

“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].”

On evergreening, the court found:

“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.”

Manufacture Allowed; Sale in India Prohibited

The High Court permitted Dr Reddy’s to continue manufacturing Semaglutide in India but barred domestic sale until the patent expires. It directed:

“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.”

Balancing both sides’ interests, the court further stated:

“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.”

Subsequently, the court noted the defendants’ awareness of the risk they undertook by beginning manufacture without 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.”

Accordingly, the High Court dismissed Novo Nordisk’s interim injunction application.

To view the original judgement, click on the link below: