Hospira, Inc. v. Fresenius Kabi USA, LLC, No. 19-1329 (Fed. Cir. 2020)Annotate this Case
Farmos developed and patented Dexmedetomidine, a compound that is effective as a sedative, in the 1980s, and conducted human studies using intravenous administration of 20 µg/mL dexmedetomidine hydrochloride. Farmos abandoned its testing based on adverse effects. In 1994, Farmos’s successor granted Abbott an exclusive license to make, use, and sell dexmedetomidine in the U.S. In 1999, Abbott received FDA approval for “Precedex Concentrate,” a 100 µg/mL concentration too strong to be directly administered to patients; the label provides dilution instructions. In 2002, the European Medicines Evaluation Agency authorized the use of Dexdomitor, a ready-to-use 500 µg/mL formulation of dexmedetomidine hydrochloride. Hospira’s 106 patent, entitled “Dexmedetomidine Premix Formulation,” is directed to a liquid for parenteral administration, “wherein the composition is disposed within a sealed container as a premixture.” Fresenius sought FDA approval for a generic ready-to-use dexmedetomidine product. Hospira sued for infringement. Fresenius stipulated to infringement of the 106 patent. The Federal Circuit upheld a finding that a claim in that patent is invalid as obvious over prior art. The patent states that the invention was based on “the discovery that dexmedetomidine prepared in a premixed formulation . . . remains stable and active after prolonged storage.” It does not recite any manufacturing limitations related to stability or an added component that enhances stability; it recites a composition, with a “wherein” clause that describes the stability of that recited composition, a result that was inherent in prior art.