Novartis plans to petition the U.S. Supreme Court to uphold validity of the Gilenya dosing regimen patent.
In August 2020, the U.S. District Court for the District of Delaware issued a favorable decision 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 Abbreviated New Drug Application (ANDA) filer challenging this patent.
In January 2022, a three-judge panel of the CAFC issued a decision upholding the validity of the dosing regimen patent. HEC subsequently filed a petition for rehearing with the CAFC and, in June 2022, a modified panel from the CAFC issued a reversal of its previous decision and found the patent invalid.
Novartis intends to vigorously defend the validity of the patent and is considering all available options, including current plans to seek review of this decision by petition to the US Supreme Court, a process which may take several months to determine if the petition will be granted.
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