Mumbai-based Sun Pharma has received a favourable ruling from the US Court of Appeals for the Federal Circuit, paving way for the launch of Leqselvi in the USA, according to a company filing to the stock exchange.
“While the litigation between Incyte Corporation and the company continues, the preliminary injunction is no longer in effect,” the statement by Sun Pharma said.
Advertisement
Earlier, Sun Pharma had appealed against the District of New Jersey’s decision that had previously granted a preliminary injunction delaying its launch of Leqselvi (deuruxolitinib) in the United States. The pharma company said it will disclose its launch plans in due course of time, and it is no longer under the court order that delays or restricts Leqselvi in the USA.
In February, Dilip Shanghvi of Sun Pharma had stated in February that the judgment was crucial for Sun Pharma’s future course of action on this drug launch. “The judgment is to validate the existing judgment, and we can’t launch till the time we get a more favourable judgment,” Shanghvi stated.
Last year, Sun Pharma had acquired the drug Leqselvi through its 576 million US dollar Concert Pharma buyout in March 2023, and had positioned the drug as a key product in its specialty portfolio. The deal gave Sun Pharma rights to its lead candidate deuruxolitinib, a drug supposed to be a “potential best-in-class” drug.
However, Incyte Corporation had filed a patent infringement suit against Sun Pharma, which claimed that the drug is an infringement on one of its patents for ruxolitinib, a similar drug, and valid until December 2026. Later, the US District Court of New Jersey granted Incyte a preliminary injunction, in November 2024, which prevented Sun Pharma from rolling out Leqselvi in the US until a favourable hearing, or the expiry of the patent, as per the statement.