Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., No. 21-1070 (Fed. Cir. 2022)Annotate this Case
Novartis markets a 0.5 mg daily dose of fingolimod hydrochloride under the brand name Gilenya. The medication is used to treat relapsing-remitting multiple sclerosis, a debilitating immune-mediated demyelinating disease in which the immune system attacks the myelin coating the nerves in the central nervous system. Most MS patients initially present as RRMS patients, but many eventually develop a secondary progressive form of MS, causing them to experience growing disability. There is currently no cure for MS. The disease is managed by reducing or preventing relapses and thereby slowing disability.
HEC filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Gilenya. Novartis sued, alleging that HEC’s ANDA infringes all claims of the 405 patent. The Federal Circuit affirmed a holding that the patent is not invalid and that HEC’s ANDA infringes. The 405 claims do not fail the written description requirement of 35 U.S.C. 112(a). The district court did not clearly err in finding that a skilled artisan would read the 405 patent’s disclosure to describe the “absent an immediately preceding loading dose” negative limitation.
The court issued a subsequent related opinion or order on January 4, 2022.
The court issued a subsequent related opinion or order on June 21, 2022.