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Hospira, Inc. v. Fresenius Kabi USA LLC

Post-Priority Date Evidence May Be Considered When Evaluating Inherency

Hospira, Inc. v. Fresenius Kabi USA LLC, __ F.3d __, 2020 WL 97521 (Fed. Cir. Jan. 9, 2020) (LOURIE, Dyk, Moore) (N.D. Ill.: Pallmeyer) (2 of 5 stars)

Fed Cir affirms Hatch-Waxman judgment of invalidity. Hospira’s patent relates to pharmaceutical compositions comprising dexmedetomidine, formulated as a liquid for parenteral administration. It covers Hospira’s Precedex Premix product, a sedative. In finding one limitation inherently present in the prior art, the district court did not err by relying on data obtained after the patent’s priority date. “Extrinsic evidence can be used to demonstrate what is ‘necessarily present‘ in a prior art embodiment even if the extrinsic evidence is not itself prior art.” Op. at 11. Further there is no proscription against using an inventor or patentee’s own work as evidence of inherency. Reviewing the record, the opinion finds no clear error in the district court’s fact finding on inherency. The district court did harmlessly err by including an unnecessary determination that a person of ordinary skill would have had a reasonable expectation of success in practicing a certain limitation, as the district court had elsewhere held that limitation necessarily present in the prior art. The opinion also describes how the district court’s findings support an obviousness conclusion. “It is well-settled that the inclusion of an inherent, but undisclosed, property of a composition does not render a claim to the composition nonobvious.” Op. at 15 (citing Atlas Powder, 190 F.3d 1342 (Fed. Cir. 1999)).

KEYWORDS: HATCH-WAXMAN; INHERENCY; OBVIOUSNESS