Delhi HC Permanently Restrains Dr. Reddy’s From Commercially Launching Any Product Consisting Of 'Olaparib'
|The Delhi High Court has permanently restrained Dr. Reddy’s Laboratories Limited from commercially launching any product consisting of ‘Olaparib’, Olaparib API or any other product.
The Court ordered thus in an application filed by Kudos Pharmaceuticals Limited, Astrazeneca AB, and Astrazeneca Pharma India Ltd. against Dr. Reddy’s alleging infringement of patent.
A Single Bench of Justice Prathiba M. Singh directed, “The 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 in terms of paragraph 111 of Bayer Corporation (supra). … Post the expiry of the patent on 12th March, 2024, the above embargo would cease automatically.”
Advocates Pravin Anand, Vaishali R Mittal, and Siddhant Chamola represented the plaintiffs while Advocate J. Sai Deepak represented the defendant.
In this case, the suit was related to the alleged infringement of the plaintiffs’ patent of the product comprising of ‘Olaparib’ sold under the brand name ‘LYNPARZA’ which is used for the treatment of ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer. The plaintiffs claimed to hold a series of patents in respect of the said product Olaparib and other derivatives thereof.
The plaintiffs had conducted independent investigations which revealed that the defendant obtained a Manufacturing License and Specific Export Permission for Olaparib, with operations based in Andhra Pradesh. The said license was valid up to June 30, 2023. The defendant’s website ‘api.drreddys.com’ proclaimed that they were a leading manufacturer and global supplier of Olaparib API.
The High Court after hearing the contentions of the counsel said, “… it is averred that an independent investigator conducted two telephonic investigations, first in June 2023 and then on 12th December 2023. During these calls, Customer Care Executives confirmed that the Defendant could supply bulk quantities of Olaparib API. The Defendant’s representatives provided this information initially, and it was reaffirmed during the second call on 12th December, 2023. It was also clarified that while the Defendant manufactures Olaparib in API form, they do not produce any finished formulation of it. Thus, in view of the above, it is contended that the Plaintiffs’ rights as provided under Section 48 of The Patents Act, 1970 have been violated by the Defendant.”
Furthermore, the Court noted that the life of the patent extends only till March 12, 2024 and that the defendant is willing to give an undertaking that it does not intend to manufacture and sell the product Olaparib on a commercial scale. However, it was also noted by the Court that the defendant was currently manufacturing and exporting Olaparib for the purposes outlined in Section 107A of the Patents Act, 1970.
“On behalf of the Defendant-Mr. Sai Deepak, ld. Counsel submits that the Defendant is willing to give an undertaking that it would not commercially launch the product Olaparib prior to the expiry of the patent until then, it would only undertake activities which are permissible under Section 107 A of The Patents Act, 1970 in terms of the judgment mentioned above”, observed the Court.
The Court said that the plaintiffs have reserved their rights under Order II Rule 2 of the Civil Procedure Code (CPC) in terms of the plaint and hence the rights and remedies, if any, of both parties are left open.
Accordingly, the High Court decreed the suit and disposed of the pending applications.
Cause Title- Kudos Pharmaceuticals Limited & Ors. v. Dr. Reddy’s Laboratories Limited (Neutral Citation: 2023:DHC:9408)