Dr Reddy’s tells Delhi HC it will not launch oral diabetes drug within Novo Nordisk patent range

Dr. Reddy’s Laboratories on Tuesday told the Delhi High Court that it will not commercially manufacture or sell oral tablet Semaglutide falling within the patented range claimed by Novo Nordisk [Novo Nordisk Vs Dr Reddy's].

The assurance was given before Justice Tushar Rao Gedela during the hearing a suit filed by Novo Nordisk alleging patent infringement of its oral semaglutide formulations. The drug is used to manage type 2 diabetes.

"The defendant has agreed not to commercially manufacture, sale, supply/export, offer for sale Semaglutide (Oral Tablet), comprising Semaglutide and salt(s) of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (NAC), wherein the amount of said salt(s) of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is in the range of 0.6 - 2.1 mmol; wherein the amount of the GLP-1 agonist Semaglutide is in the range of 0.01 mg to 100 mg as claimed under Claim 1 of the plaintiffs’ patent no.IN 325669," the Bench recorded in the order.

Novo Nordisk moved the Court claiming that Dr Reddy’s proposed oral semaglutide products infringe its patent covering a specific formulation of the drug.

During the hearing of its plea on Wednesday, counsel for Dr Reddy’s submitted that the company would not commercially manufacture or sell oral semaglutide products that fall within the scope of Novo Nordisk’s patent.

As part of the arrangement, Dr Reddy’s agreed to provide advance samples of its proposed products under the brand names “OBEDA” and “MASHLO”, to Novo Nordisk before any commercial launch.

Novo Nordisk, in turn, assured that any technical data generated from testing these samples will be kept confidential.

"The plaintiffs undertake that the Technical Data/Report arrived at and submitted after the aforesaid samples are tested, shall be kept confidential and not be revealed to any person and would be strictly used for the purpose of this Suit," the Court recorded in the order.

The Court also issued summons in the suit to Dr Reddy’s. The company was been directed to file its written statement within 30 days.

The case will now be heard on April 24.

Novo Nordisk was represented by Senior Advocates Abhishek Manu Singhvi and Amit Sibal with advocates Hemant Singh, Mamta Jha, Rishabh Paliwal, Shreyansh Gupta, Sanchit Sharma, Saksham Dhingra, Smriti Nair, Ankit Handa and Amit Bhandari from Inttl Advocare.

Dr Reddy's was represented by Senior Advocates Dayan Krishnan and J Sai Deepak with advocates Sidhant Goel, Mohit Goel, Aditya Goel, Deepankar Mishra and Kartikeya Tandon from Sim & San.

[Read Order]