Janssen markets Invega Sustenna, an extended-release intramuscular formulation of paliperidone palmitate used to treat schizophrenia. Janssen sued Teva under the Hatch-Waxman Act after Teva filed an ANDA seeking approval to market a generic version. The '906 Patent claims specific dosing regimens, including representative claims reciting loading doses of about 150 mg-eq and about 100 mg-eq followed by monthly maintenance doses of 25–150 mg-eq, with injection-site distinctions and renal-adjusted dosing claims. The only remaining issue on appeal was Teva's obviousness challenge, which primarily relied on three Janssen-generated prior-art references, including a clinical protocol NCT00210548.
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 parties agreed that claims 2, 10, 13, 20, and 21 are representative. Claim 2 recites a regimen involving a first dose of about 150 mg-eq and, about a week later, a second dose of about 100 mg-eq-collectively, "loading doses"-followed by monthly maintenance doses of 25-150 mg-eq. The loading doses are injected into the deltoid muscle, while the maintenance doses may be injected into either the deltoid or gluteal muscle.
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