Manufacturing and Selling of Olaparib by Natco Constitutes Infringement: Delhi HC Grants Injunction Upholding Kudos Pharmaceuticals’ Patent Rights

The Delhi High Court, in a landmark judgment, has upheld the patent rights of Kudos Pharmaceuticals Limited, restraining Natco Pharma Limited from the manufacture and sale of the cancer drug Olaparib. The court’s decision addresses vital aspects of patent law, reinforcing the protection granted to patented innovations in the pharmaceutical sector.

1. Patent Infringement Established: The judgment pronounced that Natco’s activities related to Olaparib constituted a clear infringement of Kudos’ suit patent IN’720, emphasizing the patent’s long-standing validity without opposition for 19 years.
2. Examination of Validity Challenge: The court meticulously examined Natco’s arguments against the patent’s validity, focusing on inventive step and anticipation arguments. The ruling articulated that these challenges lacked the necessary credibility.
3. Court’s Decision: The Delhi High Court awarded an interlocutory injunction favoring Kudos, thereby preventing Natco from engaging in activities involving Olaparib. Concurrently, Natco’s counterclaim seeking an injunction against Kudos was dismissed.
4. Legal Precedents and Principles: The decision elaborated on critical principles under Sections 64, 3(d), and 8 of the Patents Act. It highlighted the stringent criteria for mounting a credible challenge to the validity of a patent, distinguishing between patent coverage and actual disclosure.

Observations from the Court: Justice C. Hari Shankar noted, “The lack of opposition through the patent’s life span and the failure of the defendant to initiate any proceedings challenging the patent illustrate the strength and legitimacy of the patent holder’s rights.”

This ruling is a significant triumph for Kudos Pharmaceuticals, reinforcing the company’s patent on Olaparib. It sets a crucial precedent regarding the requirements for successfully challenging the validity of a patent.

Date of Decision: March 1, 2024

Kudos Pharmaceuticals Limited & Ors. Vs. Natco Pharma Limited