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01/13/2022

U.S. Court of Appeals for the Federal Circuit upholds validity of Novartis’ Gilenya dosage regimen patent

Novartis said it expects no generic versions of Gilenya in the U.S. market for at least the next two years.
Sandra Levy
Senior Editor
Sandra Levy profile picture

Novartis announced that the U.S. Court of Appeals for the Federal Circuit issued its decision upholding the validity of US Patent No. 9,187,405 covering a dosing regimen for Gilenya.

In August 2020, the U.S. Federal District Court for the District of Delaware issued a favorable decision in the Gilenya patent litigation and a permanent injunction was granted against HEC Pharma until the expiration of the ‘405 patent in December 2027 (including pediatric exclusivity). HEC Pharma was the only remaining ANDA filer challenging this patent. This decision confirms the validity of the patent and allows that injunction to remain in place.

[Read more: Novartis wins patent protection for Gilenya]

Previously, Novartis entered into settlement agreements with a number of ANDA filers. Those ANDA filers will not be able to launch a generic version of Gilenya, if approved by the FDA, before an agreed-upon date that is prior to the expiration of the dosage regimen patent in December 2027.

The potential generic entry date and other terms of the settlement agreement are confidential. With this decision, Novartis confirms that it expects no generic versions of Gilenya in the U.S. market for at least the next two years.

[Read more: Ironwood, Allergan settle patent suit with Teva]

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