After fighting for months to protect its Gilenya patent and losing in federal appeals court, Novartis has taken its complaint to the Supreme Court.
In a recent filing (PDF), the company asked the High Court to review a September decision by the U.S. Court of Appeals for the Federal Circuit that went against its favor. That month, a judicial panel overturned a prior win for Novartis and sided with Chinese generics maker HEC Pharm, finding a Gilenya patent invalid and potentially opening the door to competition.
At this juncture, Novartis is taking issue with the sequence of events that led to the decision.
After Novartis appeared set for a win in appeals court, a judge's retirement derailed its case, the company claimed in its Supreme Court filing. Originally, a panel of three judges supported the company's side of the case, but after HEC Pharm filed for a petition for rehearing, one judge retired.
That resulted in the new panel finding the patent invalid, the company said.
The company said the outcome “wrongly deprived Novartis of its patent on a groundbreaking new method for treating multiple sclerosis.”
Gilenya generated $326 million in the U.S. in the third quarter of 2022. The multiple sclerosis drug is already facing an authorized generic from Viatris, according to OptumRx.