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, for treating relapsing-remitting multiple sclerosis, a debilitating immune-mediated demyelinating disease. 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 its patent. The Federal Circuit initially affirmed a holding that the patent is not invalid and that HEC’s ANDA infringes that patent.
On rehearing, the Federal Circuit reversed. Because the Novartis patent fails to disclose the absence of a loading dose, the district court clearly erred in finding that the negative claim limitation “absent an immediately preceding loading dose” added during prosecution to overcome prior art satisfied the written description requirement of 35 U.S.C. 112(a). The specification nowhere describes “initially” administering a daily dosage.
This opinion or order relates to an opinion or order originally issued on January 3, 2022.