Semaglutide is a significant GLP-1 analogue marketed globally under the brand names Ozempic, Rybelsus, and Wegovy for the treatment of Type-2 diabetes and chronic weight management. In India, the active pharmaceutical ingredient is protected under Indian Patent No. IN 262697 (hereafter \u201csuit patent\u201d), titled \u201cAcylated GLP-1 Analogs Comprising Non-Proteogenic Amino Acid Residue\u201d, which expires on 20 March 2026.<\/p>\n
Novo Nordisk does not manufacture Semaglutide in India and supplies the market through imports of finished formulations. Its earlier genus patent, IN 275964 (hereafter \u201cgenus patent\u201d), filed in 2003 and covering a broad class of acylated GLP-1 analogues, expired on 17 September 2024.<\/p>\n
Following the expiry of the genus patent, DRL obtained a manufacturing licence and commenced production of Semaglutide in April 2025. Upon learning that DRL, along with OneSource Specialty Pharma Ltd., was exporting Semaglutide in significant quantities, Novo Nordisk issued a cease-and-desist notice.<\/p>\n
In response, DRL filed a revocation petition under Section 64 of the Patents Act, 1970, challenging the validity of the suit patent on grounds of prior claiming, lack of novelty, and obviousness. DRL contended that Semaglutide was already disclosed, claimed, and enabled in the expired genus patent IN\u2019964.<\/p>\n
On 29 May 2025, DRL undertook before the Delhi High Court not to sell Semaglutide in India and to restrict its activities to exports to jurisdictions where Novo Nordisk did not enjoy patent protection. The Court recorded this undertaking and allowed exports to continue. Novo Nordisk appealed this order, seeking to restrain all manufacture and export pending trial.<\/p>\n
Novo Nordisk asserted that Semaglutide, as claimed in the suit patent, was novel and inventive. It argued that the compound\u2019s enhanced pharmacokinetic profile, particularly its extended half-life and once-weekly dosing regimen represented a significant therapeutic advancement over earlier GLP-1 analogues.<\/p>\n
Novo Nordisk submitted that DRL\u2019s reliance on Example 61 of the genus patent to derive Semaglutide, by replacing Alanine with Aib (2-methyl alanine), was a classic case of impermissible hindsight reconstruction. It contended that the genus patent neither specifically disclosed nor claimed Semaglutide, and that none of the compounds described in the genus patent were ever developed into approved drugs. It also maintained that the genus patent was not a relevant prior art, as it was published after the priority date of the suit patent.<\/p>\n
Novo Nordisk argued that DRL\u2019s admitted manufacture of Semaglutide, even solely for export, violated its exclusive rights under Section 48 of the Patents Act. It contended that damages would not be an adequate remedy and asserted that DRL had failed to \u201cclear the way\u201d by challenging the suit patent before commencing commercial manufacture.<\/p>\n
DRL submitted that Semaglutide was merely a derivative of Example 61 in the genus patent, differing only by the substitution of Aib (2-methyl Alanine) for Alanine at position 8, a modification well known in the art and expressly taught in the genus patent.<\/p>\n
DRL further contended that Novo Nordisk\u2019s conduct in obtaining patent term extensions for both the genus and species patent across multiple jurisdictions amounted to an admission that Semaglutide fell within the scope of the claims of the genus patent.<\/p>\n
Relying on \u00a0the decision of the European Opposition Division, which shifted the effective priority date of the corresponding European patent application, from which the suit patent claimed priority, 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 also pointed out that WIPO\u2019s International Search Report had classified the genus patent as a category \u201cX\u201d document, capable of independently destroying novelty or inventive step.<\/p>\n
DRL further argued that Novo Nordisk\u2019s own conduct, particularly the filing of single Form 27 statements covering both patents, constituted a clear admission that Semaglutide fell within the scope of the genus patent. Invoking the Gillette defence, DRL argued that a product covered by an expired genus patent could not infringe the later species patent.<\/p>\n
Further, DRL submitted that the balance of convenience decisively favoured it, highlighting its investment of over \u20b91,000 crores in manufacturing infrastructure and reiterating its court-recorded undertaking not to sell the product in India. With barely seven months remaining before the suit patent\u2019s expiry, DRL argued that any restraint at this stage would cause it disproportionate and irreparable harm, while any alleged injury to Novo Nordisk could be adequately compensated by damages.<\/p>\n
The Court reiterated that the grant of an interim injunction required Novo Nordisk to establish a strong prima facie<\/em> case, particularly in light of the revocation challenge. Accepting the findings of the European Opposition Division, the Court found that the effective priority date of the suit patent was 20 March 2006, rendering the genus patent relevant prior art.<\/p>\n The Court also found substantial structural overlap between Example 61 of the genus patent and Semaglutide and noted that the classification of the genus patent as an \u201cX\u201d document in the International Search Report reinforced the prima facie<\/em> challenge to novelty and inventive step.<\/p>\n The Court further noted inconsistencies in Novo Nordisk\u2019s conduct, including its treatment of Semaglutide as covered by the genus patent in regulatory and statutory filings, as well as non-disclosure of material facts and misrepresentations regarding local manufacturing capabilities. Such conduct, the Court observed, undermined its claim to equitable relief.<\/p>\n The Court also observed that DRL, a frequent litigant in patent disputes, was well aware of the \u201cclearing the way\u201d principle, but began manufacturing without first challenging the suit patent. As a result, there was no balance of convenience in their favour to permit domestic sales in India until the expiry of the patent. However, the Court noted that, given the patent\u2019s imminent expiry, this did not justify restraining manufacturing for export.<\/p>\n On the overall balance of convenience, the Court noted that Novo Nordisk\u2019s exclusive reliance on imports, DRL\u2019s undertaking not to sell the product in India, and the short remaining life of the suit patent all weighed against the grant of an injunction. Any potential loss to Novo Nordisk, the Court observed, could be adequately compensated by damages.<\/p>\n The Delhi High Court concluded that Novo Nordisk failed to establish a prima facie<\/em> case for interim relief and that the suit patent was subject to serious and credible challenges based on anticipation and lack of inventive step. The application for interim injunction was accordingly dismissed.<\/p>\n DRL was permitted to continue manufacturing Semaglutide in India solely for export to non-patent jurisdictions, subject to its undertaking and disclosure obligations. The Court clarified that all findings were prima facie<\/em> and would not prejudice the final adjudication at trial.<\/p>\nConclusion<\/h4>\n