Delhi High Court Rejects Novo Nordisk Plea, Dr. Reddy’s Can Continue Manufacturing Semaglutide
Court says Indian firm can produce and export semaglutide despite ongoing patent dispute.
Domestic sales barred until 2026, but ruling boosts India’s pharma industry in global markets.
By Our Legal Reporter
New Delhi: December 06, 2025:
In a major development in India’s pharmaceutical sector, the Delhi High Court has refused to grant Danish drugmaker Novo Nordisk an injunction against Dr. Reddy’s Laboratories in the ongoing patent dispute over semaglutide, the active ingredient in popular diabetes and weight-loss drugs such as Ozempic, Wegovy, and Rybelsus.
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The ruling allows Dr. Reddy’s to continue manufacturing and exporting semaglutide formulations, though sales within India remain restricted until Novo Nordisk’s patent expires in March 2026.
Background of the Case
Novo Nordisk holds Patent No. 262697, covering semaglutide, a GLP-1 receptor agonist used to treat Type 2 diabetes and obesity. The company alleged that Dr. Reddy’s and its associate, OneSource Specialty Pharma, infringed the patent by importing the active pharmaceutical ingredient (API) and producing finished formulations without consent.
Novo Nordisk first raised concerns in 2024, claiming Indian firms were exporting semaglutide in violation of its patent rights. The case was heard across multiple dates in 2025, with Justice Manmeet Pritam Singh Arora eventually rejecting Novo Nordisk’s request for an interim injunction.
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Court’s Observations
The Delhi High Court made several key points:
- No prima facie case of infringement: Novo Nordisk failed to establish a strong case against Dr. Reddy’s.
- Export allowed: Dr. Reddy’s can continue manufacturing semaglutide in India and export it to countries where Novo Nordisk does not hold patents.
- Domestic sales restricted: Indian sales remain barred until March 26, 2026, when Novo Nordisk’s secondary patent expires.
- Balance of convenience: The Court noted that Novo Nordisk does not manufacture semaglutide in India but only imports it, while Dr. Reddy’s contributes to global supply chains.
Why This Matters
The ruling has significant implications:
- For patients: Semaglutide is one of the most sought-after drugs worldwide for diabetes and obesity.
- For Indian pharma: The decision strengthens India’s position as a global supplier of affordable medicines.
- For patent law: It highlights the tension between protecting intellectual property and ensuring access to essential drugs.
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Industry Impact
Dr. Reddy’s can now expand its role in the global semaglutide market, which has seen explosive demand due to its effectiveness in weight management. Analysts believe this ruling could:
- Boost India’s pharma exports.
- Encourage other Indian firms to challenge patents where possible.
- Put pressure on multinational companies to negotiate licensing deals.
Novo Nordisk, meanwhile, faces growing competition as its blockbuster drug becomes a target for generic manufacturers worldwide.
Global Context
Patent disputes over semaglutide are not unique to India. Similar cases have emerged in:
- United States: Generic firms are challenging Novo Nordisk’s patents.
- Europe: Regulators are reviewing patent claims amid rising demand.
- China: Domestic firms are exploring production of GLP-1 drugs.
India’s ruling aligns with global trends where courts balance patent protection with public health needs.
Expert Opinions
Legal experts say the ruling reflects India’s pro-patient and pro-industry stance. According to patent lawyer Ayushi Shukla, Novo Nordisk failed to prove infringement, while Dr. Reddy’s presented a credible challenge.
Pharma analysts argue that while patents are important, excessive control over life-saving drugs can harm patients. The ruling ensures supply continuity without undermining innovation.
Challenges Ahead
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Despite the ruling, challenges remain:
- Domestic access: Indian patients must wait until 2026 for affordable semaglutide generics.
- Global supply chains: Export markets may face legal challenges in countries where Novo Nordisk holds patents.
- Future litigation: Novo Nordisk may pursue further legal action or appeal.
Conclusion
The Delhi High Court’s refusal to grant Novo Nordisk an injunction marks a turning point in India’s pharmaceutical landscape. By allowing Dr. Reddy’s to continue manufacturing and exporting semaglutide, the Court has reinforced India’s role as a global medicine supplier while respecting patent timelines for domestic sales.
As demand for semaglutide surges worldwide, these ruling balances innovation, competition, and patient access—a precedent likely to influence future patent disputes in India and beyond.
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