Hanmi Pharmaceutical said it has completed preparations for product release, as it has become the first Korean company to win all four patent suits concerning the use patent of Entresto, Novartis’ chronic heart failure treatment.

Hanmi, also the first in Korea to meet requirements for priority sales permission, plans to release the product as soon as it receives approval.

The company said it recently received an invalidation decision from the Intellectual Property Trial and Appeal Board in a patent invalidation trial filed against Novartis over the most difficult and broad-ranging use patent among Entresto's follow-up patents.

Accordingly, Hanmi has won all four follow-up Entresto patents, including the decision patent, which expires in September 2027, and two composite patents, which run out in November 2028 and January 2029, respectively. Then, it will become the first Korean company to overcome all Entresto-related patents among domestic pharmaceuticals trying to invalidate Entresto patents.

“The Entresto patent was the most broad-ranging and difficult among registered patents, but the Intellectual Property Trial and Appeal Board accepted our arguments that the patent lacks description requirements and pharmaceutical efficacy and judged that it is invalid,” said Kim Yun-ho, a Hanmi executive leading its patent team.

Kim added that it is an achievement based on Hanmi’s active patent challenge and firm management principles.