Novartis: plans petition for Gilenya
(CercleFinance.com) - Novartis plans to petition the US Supreme Court to uphold the validity of the Gilenya (fingolimod) dosage regimen patent.
Novartis plans to file a petition for further review of the CAFC decision with the US Supreme Court.
In August 2020, the US District Court for the District of Delaware ruled in favour and a permanent injunction was granted against HEC Pharma until the expiry of the '405 patent in December 2027 (including paediatric exclusivity).
In January 2022, a three-judge panel of the CAFC issued a decision upholding the validity of the dosage schedule patent. HEC then filed a petition for rehearing with the CAFC and, in June 2022, an amended CAFC panel overturned its earlier decision and declared the patent invalid.
"Should generics launch in the US, we expect FY 2022 sales to be negatively impacted by USD 0.3b," Novartis says.
"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".
Copyright (c) 2022 CercleFinance.com. All rights reserved.
Novartis plans to file a petition for further review of the CAFC decision with the US Supreme Court.
In August 2020, the US District Court for the District of Delaware ruled in favour and a permanent injunction was granted against HEC Pharma until the expiry of the '405 patent in December 2027 (including paediatric exclusivity).
In January 2022, a three-judge panel of the CAFC issued a decision upholding the validity of the dosage schedule patent. HEC then filed a petition for rehearing with the CAFC and, in June 2022, an amended CAFC panel overturned its earlier decision and declared the patent invalid.
"Should generics launch in the US, we expect FY 2022 sales to be negatively impacted by USD 0.3b," Novartis says.
"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".
Copyright (c) 2022 CercleFinance.com. All rights reserved.