Dr. Reddy's Laboratories Agrees to Conditions to Avoid Patent Infringement Allegations by Novo Nordisk
In a significant development in the pharmaceutical industry, the Delhi High Court, presided over by Justice Tushar Rao Gedela, has granted an interim injunction in a patent infringement case involving Novo Nordisk A/s and Dr. Reddy's Laboratories Limited. The dispute centers around the alleged infringement of Indian Patent No. IN 325669, which pertains to Semaglutide Oral Tablets.
Novo Nordisk, represented by Senior Advocates Dr. Abhishekh Manu Singhvi and Mr. Amit Sibal, filed the lawsuit seeking urgent relief to prevent Dr. Reddy's from manufacturing or selling products that allegedly infringe on their patent. The court granted an interim injunction based on the urgency of the situation, as per Section 12A of the Commercial Courts Act, 2015, and in consideration of the Supreme Court's judgment in Yamini Manohar v. T.K.D. Keerthi.
Dr. Reddy's Laboratories, represented by Senior Advocates Mr. Dayan Krishnan and Mr. J. Sai Deepak, submitted affidavits affirming that their Semaglutide Oral Tablets do not fall within the patent's claimed range. Specifically, they argued that their product contains 0.398 mmol of SNAC, outside the claimed range of 0.6 to 2.1 mmol, thus not infringing the patent.
Both parties agreed to an interim arrangement, wherein Dr. Reddy's pledged not to commercially manufacture or sell the contested product within the specified range during the patent's subsistence. Additionally, Dr. Reddy's will provide sample strips of their product for testing, ensuring confidentiality of the technical data obtained.
The court's order, while providing temporary relief to Novo Nordisk, allows Dr. Reddy's to pursue activities under Section 107A of the Patents Act, 1970, known as the Bolar exemption, which permits certain uses of a patented invention for research and development.
The case is set for further proceedings, with directions for filing written statements and replies within specified timelines. The outcome of this case could have far-reaching implications for pharmaceutical patent enforcement in India.
Bottom Line:
Patent Law - Interim arrangements and injunction granted in a suit concerning alleged infringement of patent IN 325669 related to Semaglutide Oral Tablets.
Statutory provision(s):
Patents Act, 1970 Section 107A, Commercial Courts Act, 2015 Section 12A, Civil Procedure Code, 1908 Order XXXIX Rules 1 & 2, Bharatiya Sakshya Adhiniyam, 2023 Section 63(4)(C)
Novo Nordisk A/s v. Dr. Reddy's Laboratories Limited, (Delhi) : Law Finder Doc id # 2872569
