Setback to Sun Pharma: Delhi HC Puts Semaglutide Launch on Hold

New Delhi: The Delhi High Court has placed Sun Pharma's proposed launch of semaglutide tablets under judicial scrutiny, directing the company to seek the court's prior approval before taking further steps towards commercial launch, amid a patent infringement dispute raised by Danish pharmaceutical major Novo Nordisk over the oral formulation of the diabetes and weight-management drug.

According to the news reported by ET, Justice Anup Jairam Bhambhani directed that if Sun Pharma receives a licence for the commercial manufacture of semaglutide tablets, the company must inform the court and seek its approval before taking any further steps towards launching the product in the market.

The court has also sought a response from Sun Pharmaceutical Industries Limited, the parent company of Sun Pharma Laboratories, on Novo Nordisk’s patent infringement petition. Novo Nordisk has alleged that Sun Pharma has obtained approval from the subject expert committee to manufacture semaglutide tablets in 3 mg, 7 mg and 14 mg strengths, and that the proposed products infringe its patent covering semaglutide tablets.

Seeking interim protection, Novo Nordisk argued that Sun Pharma could be ready to enter the market as soon as it obtains the necessary marketing approval. The Danish company submitted that once the product is launched commercially, withdrawing it from the market at a later stage could be difficult.

Novo Nordisk further contended that its new patent relates specifically to semaglutide tablets, while its earlier patent covered semaglutide in an injectable formulation. The company has therefore maintained that the patent covering the tablet formulation provides a separate basis for seeking protection against Sun Pharma’s proposed product.

Sun Pharma, meanwhile, challenged the Delhi High Court’s territorial jurisdiction to hear the matter, arguing that the Indian company is headquartered in Maharashtra. The company also contended that Novo Nordisk would need to establish similarity between the products and questioned the reliance on its earlier patent, which had already expired, reports ET.

Responding to the jurisdiction objection, Novo Nordisk submitted that Sun Pharma Laboratories has a Delhi address and conducts business within the National Capital Territory. The company claimed that Sun Pharma sells its products in Delhi through both online and offline channels and would also market its semaglutide tablets in the city after obtaining the required regulatory approval.