Overview of Delhi High Court Ruling on Semaglutide Patent Dispute

The Delhi High Court has denied an interim injunction sought by Novo Nordisk against Dr Reddy’s Laboratories (DRL), allowing the latter to continue producing and exporting semaglutide, a drug used to treat Type 2 diabetes and obesity.

Background and Context

• Semaglutide: An active pharmaceutical ingredient (API) marketed by Novo Nordisk as Ozempic for diabetes and Wegovy for weight loss.
• Novo Nordisk's Legal Action: Sought to restrain DRL from using, manufacturing, and exporting semaglutide, citing patent infringement.

Legal Proceedings

• Novo Nordisk's patents on semaglutide: 
  • Indian Patent No. 275964: Composition patent, filed in March 2006, granted in September 2016, expired in September 2024.
  • Indian Patent No. 262697: Formulation patent, filed in March 2007, granted in March 2014, expiring in March 2026.
• DRL challenged the formulation patent, arguing it lacked novelty and inventive step.

Court's Findings and Decision

• The court sided with DRL, allowing it to continue with manufacturing and export activities.
• DRL's challenge to the patent was considered prima facie valid but awaits final adjudication.
• The court noted that Novo Nordisk's second patent involved evergreening, prohibited under Section 3(d) of the Indian Patents Act, 1970.

Impact and Implications

• DRL and other companies like Mankind Pharma, Cipla, and Sun Pharma see potential to enter the GLP-1 product market in India.
• With the expiry of semaglutide patents in major markets, opportunities for generic manufacturers could increase, potentially lowering prices.
• According to an IQVIA report, a lower-cost off-patent semaglutide could significantly increase patient access, particularly in countries with high obesity rates.

Market Prospects

• Semaglutide and similar GLP-1 drugs are emerging as lucrative markets globally, leading to contention over manufacturing and selling rights.
• Over ten companies have filed submissions for Phase III studies in India, indicating growing interest and competition.