Delhi High Court Allows Dr. Reddy’s to Continue Exporting Semaglutide Amid Patent Dispute with Novo Nordisk

The Delhi High Court has declined Novo Nordisk’s request for an interim injunction against Dr. Reddy’s Laboratories (DRL) concerning alleged infringement of Indian Patent No. 262697, which covers the active pharmaceutical ingredient Semaglutide. The Court’s decision permits DRL to continue manufacturing Semaglutide in India exclusively for export to jurisdictions where no corresponding patent protection exists, provided DRL undertakes not to sell the product domestically.

Semaglutide, a glucagon-like peptide-1 (GLP-1) analogue, is marketed globally under brand names such as Ozempic, Rybelsus, and Wegovy. It is used primarily for treating Type-2 diabetes and chronic weight management. In India, the active ingredient is protected under the suit patent titled “Acylated GLP-1 Analogs Comprising Non-Proteogenic Amino Acid Residue,” which is set to expire on 20 March 2026.

Novo Nordisk does not manufacture Semaglutide in India but supplies the Indian market through imports of finished formulations. Its earlier genus patent, IN 275964, filed in 2003 and covering a broad class of acylated GLP-1 analogues, expired on 17 September 2024.

Following the expiry of the genus patent, DRL obtained a manufacturing license and commenced production of Semaglutide in April 2025. Upon discovering that DRL and OneSource Specialty Pharma Ltd. were exporting significant quantities of Semaglutide, Novo Nordisk issued a cease-and-desist notice alleging patent infringement.

In response, DRL filed a revocation petition under Section 64 of the Patents Act, 1970, challenging the validity of the suit patent on grounds including prior claiming, lack of novelty, and obviousness. DRL argued that Semaglutide was already disclosed, claimed, and enabled in the expired genus patent IN 275964.

On 29 May 2025, DRL gave an undertaking before the Delhi High Court not to sell Semaglutide in India and to restrict its activities to exports where Novo Nordisk held no patent rights. The Court recorded this undertaking and allowed DRL to continue exports. Novo Nordisk appealed, seeking to restrain all manufacture and export pending trial.

Novo Nordisk contended that the suit patent claimed a novel and inventive compound with an improved pharmacokinetic profile, including an extended half-life enabling once-weekly dosing. It argued that DRL’s reliance on Example 61 of the genus patent to derive Semaglutide by substituting Alanine with Aib (2-methyl alanine) was impermissible hindsight reconstruction.

Novo Nordisk maintained that the genus patent neither specifically disclosed nor claimed Semaglutide, and that none of the compounds described therein had been developed into approved drugs. It also asserted that the genus patent was not relevant prior art as it was published after the priority date of the suit patent.

Further, Novo Nordisk argued that DRL’s manufacture of Semaglutide, even solely for export, violated its exclusive rights under Section 48 of the Patents Act. It claimed damages would be inadequate and criticized DRL for failing to “clear the way” by challenging the suit patent before commencing commercial manufacture.

DRL countered that Semaglutide was a derivative of Example 61 in the genus patent, differing only by the substitution of Aib for Alanine at position 8—a modification well known and expressly taught in the genus patent. DRL also highlighted Novo Nordisk’s patent term extensions for both genus and species patents across multiple jurisdictions as an implicit admission that Semaglutide fell within the genus patent’s scope.

Relying on a European Opposition Division decision, which shifted the effective priority date of the corresponding European patent application to 20 March 2006, DRL argued that the genus patent, published on 31 March 2005, constituted relevant prior art for assessing anticipation and inventive step. DRL noted that the WIPO International Search Report classified the genus patent as a category “X” document capable of independently destroying novelty or inventive step.

DRL further pointed to Novo Nordisk’s own conduct, including filing single Form 27 statements covering both patents, as a clear admission that Semaglutide fell within the genus patent’s scope. Invoking the Gillette defence, DRL argued that a product covered by an expired genus patent could not infringe a later species patent.

DRL emphasized the balance of convenience favored it, citing over ₹1,000 crores invested in manufacturing infrastructure and reiterating its undertaking not to sell Semaglutide in India. With less than seven months remaining before the suit patent’s expiry, DRL argued that restraining manufacturing would cause disproportionate and irreparable harm, while any injury to Novo Nordisk could be compensated by damages.

The Court reiterated that an interim injunction requires a strong prima facie case, especially given the revocation challenge. Accepting the European Opposition Division’s findings, the Court held that the effective priority date of the suit patent was 20 March 2006, making the genus patent relevant prior art.

The Court found substantial structural overlap between Example 61 of the genus patent and Semaglutide, noting the genus patent’s classification as an “X” document reinforced the prima facie challenge to novelty and inventive step.

The Court also observed inconsistencies in Novo Nordisk’s conduct, including treating Semaglutide as covered by the genus patent in regulatory filings and non-disclosure of material facts regarding local manufacturing capabilities. Such conduct undermined Novo Nordisk’s claim to equitable relief.