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“Consisting Essentially Of” Claims Nixed at Federal Circuit

“Consisting Essentially Of” Claims Nixed at Federal Circuit

Michael Tobin Associate Haynes and Boone, LLP In HZNP Medicines LLC v. Actavis Laboratories UT, Inc. (Fed. Cir. 2019)[1], the Federal Circuit affirmed the district court’s holding that the transitional phrase “consisting essentially of” was indefinite as used in several claims of patents owned by HZNP Medicines LLC and Horizon Pharma USA, Inc. (“Horizon”).[2]  Slip Op. at 2, 33.  Horizon’s patents cover its PENNSAID® 2% product, which is a Non-Steroidal Anti-Inflammatory Drug (NSAID) and the first FDA-approved twice-daily topical diclofenac sodium formulation for the treatment of pain of osteoarthritis of the knees.  Claim 49 of U.S. Patent No. 8,252,838 (the “‘838 patent”) is illustrative of Horizon’s formulation patents and recites: A topical formulation consisting essentially of: 1–2% w/w diclofenac sodium; 40–50% w/w DMSO; 23–29% w/w ethanol; 10–12% w/w propylene glycol; hydroxypropyl cellulose; and water to make 100% w/w, wherein the topical formulation has a viscosity of 500–5000 centipoise. Prior to… Continue Reading

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