Basel, January 4, 2022 — Today, Novartis announced that the US Court of Appeals for the Federal Circuit (CAFC) has issued a ruling to maintain the validity of US Patent No. 9,187,405, which covers Gilenya’s dosing regimen. In August 2020, the Federal District Court of Delaware made a favorable ruling in Gilenya’s patent litigation and granted HEC Pharma a permanent injunction until the expiration of the ‘405 patent (including pediatric exclusivity) in December 2027. HEC Pharma is the only abbreviated new drug application (ANDA) applicant to challenge this patent. The decision confirmed the validity of the patent and allowed the ban to continue in effect.
Previously, Novartis had signed settlement agreements with multiple ANDA applicants. If approved by the FDA, those ANDA applicants will not be able to launch Gilenya’s generic drug before the agreed date before the expiration of the dosage regimen patent in December 2027. The settlement agreement is confidential. With this decision, Novartis confirmed that no imitation version of Gilenya will appear in the US market for at least the next two years.
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