Swiss pharmaceutical giant Novartis AG (SWX: NOVN) has encountered its latest and potentially final setback in the fight to maintain a key patent covering the multiple sclerosis drug Gilenya (fingolimod) in the United States. The company announced that the US Court of Appeals for the Federal Circuit (CAFC) had denied its petition to rehear the negative decision issued in June regarding the validity of a patent covering a dosing regimen of 0.5mg of Gilenya (US Patent No. 9,187,405).
Novartis’ Response and Future Actions
Novartis stated that it “intends to vigorously defend the validity of the patent and is considering all available options,” including petitioning the US Supreme Court to seek a further review of the CAFC’s decision. However, it may take several months just to determine whether that petition will be granted. Under normal circumstances, Novartis would be considered to have exhausted the standard appeals process.
Background on the Patent Dispute
Novartis has been battling China-based generics firm HEC Pharma over the multiple sclerosis blockbuster drug. HEC 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 at an agreed date prior to the official December 2027 patent expiry. HEC was among the holdouts that took the case all the way through the courts.
Recent Developments and Market Implications
In January 2022, it was reported that the CAFC had thrown out an appeal from HEC against an earlier injunction preventing the Chinese firm 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 sensationally reversed its previous decision to declare the patent invalid on June 21, 2022.
Novartis now warns that the latest CAFC decision means that all previous ANDA filers may now be able to launch to market “imminently.” Gilenya’s global sales reached $2.79 billion during 2021, and Novartis forecasts that if generic launches do take place, FY 2022 sales could be negatively impacted by as much as $300 million. Notably, earlier this month, Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) became the latest firm to win an ANDA approval for its Gilenya generic, and may stand to benefit alongside HEC.-Fineline Info & Tech
