A U.S. appeals court on Tuesday ruled against Swiss drugmaker Novartis AG in a patent infringement dispute concerning its blockbuster multiple sclerosis drug Gilenya.
The U.S. Court of Appeals for the Federal Circuit, which hears patent appeals, reversed its own earlier ruling in the case.
A divided panel found Novartis’ patent was invalid, reviving Chinese drugmaker HEC Pharm Co’s bid to make a generic version of the medicine.
Novartis reported nearly $2.8 billion in Gilenya sales last year, making it the Swiss company’s third-highest-selling drug.
The companies and their attorneys did not immediately respond to requests for comment on the decision.
The Federal Circuit in January upheld a Delaware court’s ruling that Novartis’ patent was valid and that HEC’s proposed generic infringed it. The patent covers use of a specific dosage of Gilenya, known chemically as fingolimod, to treat relapsing multiple sclerosis.
A split panel with two of the same judges reversed the decision on Tuesday.
Novartis has settled patent cases with several other generic drugmakers, paving the way for some Gilenya generics to be introduced before the patent’s 2027 expiration.
Novartis said after the January decision that it did not expect any Gilenya generics on the U.S. market for at least the next two years.
(Reporting by Jonathan Stempel in New York and Blake Brittain in Washington; Editing by Chizu Nomiyama and Bill Berkrot)
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