Delhi High Court: The present suit was filed by plaintiffs, Kudos Pharmaceuticals Ltd., Astrazeneca AB and Astrazeneca Pharma India Ltd. against defendant, Dr. Reddy’s Laboratories Ltd for infringing plaintiffs’ patent IN 228720 (‘suit patent’). Prathiba M. Singh, J.*, held that defendant shall stand permanently restrained from commercially launching any product consisting of Olaparib, Olaparib API or any other product except as permissible under Section 107-A of the Patents Act, 1970 in terms of Bayer Corporation v. Union of India, 2019 SCC OnLine Del 8209 (‘Bayer Corporation Case’). Further, the Court held that post the expiry of plaintiffs’ patent on 12-03-2024, the above embargo would cease automatically.
The suit patent related to plaintiffs’ product comprising of ‘Olaparib’ sold under the brand name ‘LYNPARZA’ was used for the treatment of ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer. In May 2023, plaintiffs conducted independent investigations which revealed that defendant obtained a Manufacturing License and Specific Export Permission for Olaparib, with operations based in Srikakulam District, Andhra Pradesh, India, and the said license was stated to be valid up to 30-06-2023. Further, defendant’s website, ‘api.drreddys.com’, proclaimed that they were a leading manufacturer and global supplier of Olaparib API. The site explained the mechanism of ‘Olaparib’ as an inhibitor of PARP enzymes (PARP1, PARP2, PARP3), detailing its role in cellular processes like DNA transcription, cell cycle regulation, and DNA repair.
The Court noted that an independent investigator conducted two telephonic investigations, first in June 2023 and then on 12-12-2023 and during these calls, Customer Care Executives confirmed that defendant could supply bulk quantities of Olaparib API. Defendant’s representatives reaffirmed this information during the second call on 12-12-2023. It was also clarified that while defendant manufactured Olaparib in API form, they did not produce any finished formulation of it. Thus, it was contended that plaintiffs’ rights as provided under Section 48 of the Patents Act, 1970 were violated by defendant.
The Court noted that the life of the plaintiffs’ patent extended only till 12-03-2024 and defendant was willing to give an undertaking that it did not intend to manufacture and sell the product Olaparib on a commercial scale. The Court further noted defendant’s submission that it was willing to give an undertaking that it would not commercially launch the product ‘Olaparib’ prior to the expiry of the patent until then and it would only undertake activities which were permissible under Section 107-A of the Patents Act, 1970.
Thus, the Court held that defendant shall stand permanently restrained from commercially launching any product consisting of Olaparib, Olaparib API or any other product except as permissible under Section 107-A of the Patents Act, 1970 in terms of Bayer Corporation Case (supra). Further, the Court held that post the expiry of the patent on 12-03-2024, the above embargo would cease automatically.
[Kudos Pharmaceuticals Ltd. v. Dr. Reddy’s Laboratories Ltd., 2023 SCC OnLine Del 8386, decided on 22-12-2023]]
Advocates who appeared in this case:
For the Plaintiffs: Pravin Anand, Vaishali R Mittal, Siddhant Chamola, Pallavi Bhatnagar, Shivang Sharma, Advocates
For the Defendant: J. Sai Deepak, Mohit Goel, Sidhant Goel, Aditya Goel, Deepankar Mishra, Advocates
*Judgment authored by: Justice Prathiba M. Singh
