ZURICH (Reuters) – A U.S. district court upheld the validity of the dosage regimen patent for Swiss drugmaker Novartis’ top-selling multiple sclerosis (MS) drug Gilenya, dealing a blow to generic maker HEC Pharm Co.
The U.S. District Court for the district of Delaware said in a ruling dated Aug. 10 and unsealed on Monday that Novartis’s dosage regimen patent was valid and HEC was infringing it.
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’s 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 FDA approved three generic versions of the Novartis MS treatment in December.
HEC could not immediately be reached for comment.
(Reporting by Silke Koltrowitz, additional reporting by Jan Wolfe in Washington, editing by Chris Reese and Chizu Nomiyama)
