Novartis To Petition US Supreme Court To Uphold Patent Validity For Multiple Sclerosis Drug, Gilenya

Swiss drug major Novartis AG NVS plans to petition the U.S. Supreme Court to uphold the validity of the Gilenya (fingolimod) dosing regimen patent.
The decision comes as the U.S. Court of Appeals for the Federal Circuit (CAFC) has denied its petition to rehear the decision regarding the patient validity covering a dosing regimen for 0.5mg Gilenya.
In August 2020, the U.S. District Court for the District of Delaware issued a favorable decision.
A permanent injunction was granted against HEC Pharma until the expiration of the '405 patent in December 2027, including pediatric exclusivity.
After initially upholding the patent in January, the CAFC subsequently ruled in June that it was not valid, opening the door to low-cost competition for Novartis’ third biggest-selling product.
HEC Pharma was the only remaining Abbreviated New Drug Application or ANDA filer challenging this patent.
With the latest decision, HEC and other generic application filers with FDA approval will potentially be able to launch a generic version of 0.5mg Gilenya imminently.
Regarding the financial impact, Novartis said that with the launch of the generic in the U.S., FY22 sales would be negatively impacted by $0.3 billion. However, it is still forecasting “mid-single digit range growth” in sales and core operating income.
Price Action: NVS shares are up 1.45% at $80.73 during the premarket session on the last check Wednesday.