This Federal Circuit opinion analyzes the presumption of obviousness and the obviousness challenge based on prior art that describes a wider range of doses than what is claimed.
Background
Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica NV (collectively, “Janssen”) market and sell Invega Sustenna, an extended-release intramuscular injectable formulation of paliperidone palmitate used to treat schizophrenia. Janssen sued Teva Pharmaceuticals USA, Inc. (“Teva”) under the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2) in the United States District Court for the District of New Jersey alleging patent infringement relating to U.S. Patent No. 9,439,906 (the ’906 Patent), after Teva filed an Abbreviated New Drug Application (“ANDA”) seeking FDA approval to market a generic version of Invega Sustenna. The ’906 Patent covers specific dosing regimens for Invega Sustenna.
Following two bench trials and a prior Federal Circuit review, the only remaining issue was Teva’s obviousness challenge to the ’906 Patent.Continue Reading Claiming A Range, Watch Out For The Presumption Of Obviousness










