US Supreme Court says it will not rehear Novartis' patent petition
The US Court of Appeals for the Federal Circuit (CAFC) has denied its petition to rehear the negative decision regarding the validity of US Patent No 9,187,405, covering a dosing regimen for 0.5mg of its blockbuster multiple sclerosis drug Gilenya (fingolimod), Swiss pharma giant Novartis (NOVN: VX) announced this morning.
Novartis plans to file a petition seeking further review of the CAFC’s decision with the US Supreme Court. Gilenya, one of Novartis’ top-selling therapies, generated around $2.8 billion sales last year.
In August 2020, the US District Court for the District of Delaware issued a favorable decision and a permanent injunction was granted against Chinese drugmaker HEC Pharma (HKG: 1558) 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.
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