Delhi High Court Rules in Favor of Kudos Pharmaceuticals in Patent Infringement Case

In a significant development in the pharmaceutical industry, Kudos Pharmaceuticals Ltd. ("Kudos") secured a victory in a legal battle against Natco Pharma Limited ("Natco") over the patent rights of Olaparib, with the court granting a permanent injunction in favour of Kudos.

Kudos is the registered proprietor of Indian Patent IN 228720 (IN'720), issued on March 12, 2004, for 20 years, covering the innovation of "Phthalazinone derivative." The patent certificate was awarded by the Indian Patent Office (IPO) on February 10, 2009, after an application was filed in India on August 31, 2005, with a priority date of March 12, 2003.

Natco's challenge to the suit patent came only after Kudos filed a complaint against Natco for manufacturing and selling its generic version of Olaparib under the brand name BRACANAT, claiming infringement of the suit patent. Kudos sought a permanent injunction prohibiting Natco from manufacturing, distributing, or dealing with any Olaparib product.

The court examined Natco's contention that the suit patent lacked an inventive step, arguing that Olaparib did not demonstrate a technical advance over prior art. However, the court ruled against Natco, stating that technical advancement over prior art is not necessary for an inventive step to be included in a patent claim.

While various technical arguments were presented, the court primarily focused on establishing a prima facie case favouring Kudos. It was acknowledged that Natco exploited the suit patent to manufacture and sell Olaparib in the nineteenth year of the patent's life. Despite Natco's attempts to challenge the validity of the suit patent under Section 64 of the Patent Act, the court found no credible basis for invalidating the patent.

As a result, the court granted a permanent injunction prohibiting Natco from manufacturing, selling, or dealing with Olaparib under the brand name BRACANAT or any other brand name until the matter is fully resolved, as long as the suit patent remains valid.

This ruling marks a significant victory for Kudos Pharmaceuticals in protecting its intellectual property rights and sets a precedent in the pharmaceutical industry regarding patent infringement disputes.