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Novartis: Court Of Appeals For Federal Circuit Upholds Validity Of Gilenya Dosage Regimen Patent

Novartis (NVS) said the U.S. Court of Appeals for the Federal Circuit has issued its decision upholding the validity of the US patent covering a dosing regimen for Gilenya. With the decision, Novartis said it expects no generic versions of Gilenya in the US market for at least the next two years.

In August 2020, the U.S. Federal District Court for the District of Delaware issued a permanent injunction against HEC Pharma in the Gilenya patent litigation until the expiration of the '405 patent in December 2027. The CAFC decision confirmed the validity of the patent and allows that injunction to remain in place.

Gilenya is a prescription medicine used to treat relapsing forms of multiple sclerosis.

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