The Delhi High Court has delivered a decisive order in the high-stakes battle over semaglutide, the blockbuster diabetes and weight-loss drug. The court refused to grant Novo Nordisk a temporary injunction against Dr Reddy’s Laboratories (DRL), dealing a major blow to the Danish pharmaceutical giant’s attempt to control the Indian market until 2026. The ruling carries far-reaching implications for patent strategy, market competition, and the future of GLP-1 drugs in India.
The court held that DRL had raised a “credible challenge” to Novo Nordisk’s second patent on semaglutide. It found strong indicators of double-patenting, a practice that Indian law treats as an attempt to “evergreen” expired monopolies. The court’s message was clear: companies cannot use secondary patents to prolong control over blockbuster drugs.
Two Patents, One Molecule: How the Dispute Began
Novo Nordisk held two Indian patents related to semaglutide:
- Composition Patent (IN 275964)
This patent covered the semaglutide molecule itself. It expired in September 2024, opening the door for generic manufacturing. - Formulation Patent (IN 262697)
This patent claims a specific formulation and delivery system for the same drug. It remains valid until March 2026.
When the core composition patent lapsed, DRL secured regulatory approval from the Central Drugs Standard Control Organization (CDSCO) to manufacture semaglutide for export. The approval triggered immediate friction. Novo Nordisk rushed to court, claiming that the formulation patent protected not only the delivery mechanism but effectively covered the drug.
It sought an emergency injunction to stop DRL’s manufacturing and export operations. The company argued that any commercial activity—even export—would cause irreparable harm.
The Court’s Ruling: A Firm Stand Against Evergreening
Justice Anish Dayal rejected the injunction request. The court held that DRL’s objections to the formulation patent were strong enough to deny temporary relief to Novo Nordisk.
1. Double-Patenting Concern
The court noted that the formulation patent appeared to reclaim the same invention for which Novo Nordisk’s composition patent had already expired. The claims overlapped heavily.
This amounted to “evergreening”—a tactic where pharmaceutical companies file secondary patents to extend monopoly periods.
Indian patent law, especially after Section 3(d), firmly discourages such strategies.
2. Lack of Inventive Step
The court observed that Novo Nordisk’s claimed improvements in the formulation patent did not appear novel or non-obvious.
The modifications were routine optimizations well known in pharmaceutical science. They did not represent a genuine leap in innovation.
This significantly weakened the validity of the formulation patent.
3. Balance of Convenience Favoured DRL
Since the core patent had expired, the court held that public interest and market competition must be prioritized.
Blocking DRL without conclusive proof of infringement would be unfair, especially when DRL was manufacturing the drug only for export markets.
Exports Allowed, But Indian Market Stays Closed—for Now
The court made a nuanced distinction. DRL may:
- continue manufacturing semaglutide, and
- export it freely to international markets.
However, domestic sales remain prohibited until the formulation patent expires in March 2026, unless the patent is invalidated earlier.
This split ruling reinforces India’s position as the world’s largest exporter of affordable generics, while still respecting valid patent rights inside the country.
A Major Win for Generic Manufacturers
The decision strengthens the confidence of Indian pharmaceutical companies entering high-value therapeutic categories. Semaglutide, widely used for Type-2 diabetes and explosive global demand for weight-loss treatments, represents one of the most lucrative drug classes today.
DRL is not alone. Cipla, Sun Pharma, Biocon, and Mankind Pharma are exploring GLP-1 opportunities. The Delhi HC’s ruling sends a bold signal: secondary patents will face strict scrutiny.
Indian courts have repeatedly warned against evergreening. This judgment continues that legacy, following similar rulings in the cases of imatinib, sofosbuvir, and darunavir.
Why This Case Matters Globally
The global pharmaceutical industry is watching India closely. Semaglutide is one of the world’s most valuable drugs, powering Novo Nordisk’s meteoric rise in recent years.
A single ruling from an Indian court can influence:
- global supply chains,
- generic entry timelines,
- price dynamics across continents.
India produces nearly 40% of the world’s generics. Any shift in the patent landscape here disrupts international markets.
By allowing export manufacturing, the court has opened a potential pipeline of affordable semaglutide to emerging markets struggling with diabetes and obesity crises.
What Happens Next?
Novo Nordisk has several options:
- Appeal before a division bench of the Delhi High Court.
- Initiate a full trial to defend the validity of the formulation patent.
- Seek tighter regulatory restrictions on generic manufacturing.
DRL, meanwhile, may accelerate export production and explore challenging the patent’s validity to unlock the domestic market earlier.
Legal experts expect this case to set an important precedent for future GLP-1 patent disputes, especially as rival companies race to launch their own weight-loss drugs.
Conclusion
The Delhi High Court’s rejection of Novo Nordisk’s interim injunction is a striking affirmation of India’s sharp stance against patent evergreening. The ruling protects open competition, enables affordable access through exports, and reinforces India’s leadership in generic pharmaceuticals.
As demand for semaglutide surges worldwide, the judgment could reshape the global supply chain for one of modern medicine’s most influential drug classes.
