China-based generics firm HEC Pharma has managed to overturn a previous final decision in a patent dispute with Swiss pharmaceutical giant Novartis AG (NYSE: NVS) over the multiple sclerosis blockbuster drug Gilenya (fingolimod). In January 2022, the US Court of Appeals for the Federal Circuit (CAFC) had dismissed an appeal from HEC Pharma regarding the validity of the US patent for Gilenya’s dosing regimen (patent no. 9,187,405). This upheld an earlier injunction preventing HEC from launching its generic fingolimod until the ‘405 patent expires in December 2027. However, HEC successfully filed a petition for a rehearing with the CAFC, and a modified panel reversed its previous decision to declare the patent invalid on June 21, 2022.
Novartis’ Response and Legal Strategy
In a statement, Novartis said it “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 the full CAFC, a process which may take several months.” According to Novartis, the modified CAFC panel did not issue a formal mandate closing the appeal process, and therefore “the permanent injunction granted against HEC remains in place and Novartis believes that HEC and other ANDA filers are not permitted to launch a generic version of Gilenya at this time.”
Background on the Generic Approvals and Legal Battle
HEC Pharma’s ANDA filing for fingolimod was among the first three generic versions of Gilenya to be approved by the US FDA (but not permitted to immediately launch to market) back in December 2019, alongside products from Indian firms Biocon Ltd and Sun Pharmaceutical Industries Ltd. Novartis initiated court proceedings against more than a dozen generic developers in 2018 and previously entered into settlement agreements with several other ANDA filers, allowing those companies to launch prior to the official December 2027 patent expiry. HEC was among the holdouts that took the case all the way through the courts.
Market Context and Future Outlook
Gilenya was first approved in the United States in 2010 as the world’s first oral therapy for MS. Novartis reported sales of the drug at $2.79 billion during 2021, with a year-on-year (YOY) decline of 9%. A generic version of the drug has been approved by the European Medicines Agency. In China, where Gilenya only entered the market in 2019, HEC Pharma has also filed a generic version for approval, receiving priority review status two months after filing.-Fineline Info & Tech
