Cadence Pharma, Inc. v. Exela Pharma Sciences, LLC, No. 14-1184 (Fed. Cir. 2015)
Annotate this CaseCadence’s patents are directed to aqueous phenol formulations— particularly acetaminophen (sometimes referred to as “paracetamol”). The 222 patent, issued in 2000, explains that in aqueous solutions, acetaminophen decomposes into potentially toxic products and is directed at avoiding this decomposition by adding a free-radical capturing agent and a buffer. The 218 patent claims priority to a 2000 French application and discloses a method for obtaining stable acetaminophen formulations by deoxygenating solutions with an inert gas to achieve oxygen concentrations below 2 parts-per-million. Cadence’s FDA-approved injectable acetaminophen product is distributed under the name Ofirmev®. The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) lists the patents in connection with Ofirmev®. Exela filed an FDA Abbreviated New Drug Application, seeking approval of a generic equivalent of Ofirmev®. The ANDA included a certification under 21 U.S.C. 355(j)(2)(A)(vii)(IV) (Paragraph IV certification) stating that the 222 and 218 patents were invalid and not infringed. Cadence sued Exela for infringement under 35 U.S.C. 271(e)(2)). The district court found the 222 patent not invalid and literally infringed and the 218 patent not invalid and infringed under the doctrine of equivalents. The Federal Circuit affirmed, upholding the constructions of “buffering agent” and “vacuum stoppering step.”
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