ZURICH (Reuters) – A U.S. district court upheld the validity of a patent for Swiss drugmaker Novartis’ top-selling multiple sclerosis (MS) drug Gilenya, helping Novartis protect its blockbuster MS treatment from U.S. competition.
The U.S. District Court for the district of Delaware said in a ruling dated Aug. 10 and unsealed on Monday that Novartis’ patent was valid, rejecting a lawsuit from generic maker HEC that was backed by other generic drugmakers.
A decade after its U.S. approval, Gilenya remains Novartis’s No. 2 revenue generator at $738 million in the second quarter.
HEC had submitted an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (FDA) seeking approval to make a generic copy of Gilenya prior to the expiration of Novartis’ patent, the court said in the ruling.
The Swiss drugmaker welcomed the decision in a statement, saying it continued the injunction against the marketing and sale of this and other generics that was granted to Novartis in June 2019.
The drugmaker had entered into settlement agreements with other manufacturers which had filed ANDAs for generics and were also active in this litigation, allowing them to launch generic versions of Gilenya at some point before the patent expires in 2027.
However details of the settlement, including when the generics would be allowed, were not given, so the latest court decision gives Novartis an important victory in its quest to retain its U.S. patent on the drug.
The FDA approved three generic versions of the Novartis MS treatment in December.
(Reporting by Silke Koltrowitz; Additional reporting by Jan Wolfe in Washington; Editing by Chizu Nomiyama and David Holmes)