US court upholds Gilenya dosage regimen patent

The US District Court for the District of Delaware has upheld the validity of the Gilenya (fingolimod) dosage regimen patent, said Swiss pharma giant Novartis (NOVN: VX), noting “our intellectual property reflects the innovation and investment needed to invent and develop treatments that improve and extend people’s lives.”

The decision also holds that the generic fingolimod product proposed by HEC Pharm (HKG: 1558) and HEC Pharm USA Inc (HEC) in its Abbreviated New Drug Application (ANDA) will infringe the dosage regimen patent (US Patent No 9,187,405). The decision is appealable to the US Court of Appeals for the Federal Circuit.

This decision continues the injunction against the marketing and sale of this and other generics that was granted to Novartis in June 2019. The dosage regimen patent with the associated pediatric exclusivity expires on December 25, 2027; however, Novartis has previously entered into settlement agreements with a number of manufacturers which had filed ANDAs to market a generic version of Gilenya and who were active in this litigation.