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Hospira, Inc. v. Fresenius Kabi USA, LLC

United States Court of Appeals for the Federal Circuit

January 9, 2020, Decided

2019-1329, 2019-1367

Opinion

 [*1324]  Lourie, Circuit Judge.

Hospira Inc. ("Hospira") appeals from the judgment of the United States District Court for the Northern District of Illinois that claim 6 of U.S. Patent 8,648,106 ("the '106 patent") is invalid as obvious. Hospira, Inc. v. Fresenius Kabi USA, LLC, 343 F. Supp. 3d 823 (N.D. Ill. 2018) ("Opinion"). Because we find that the district court's factual findings were not clearly erroneous and that those findings support a conclusion of obviousness, we affirm.

Background

Hospira makes and sells dexmedetomidine products under the brand name Precedex, including a ready-to-use product known as Precedex Premix. Hospira owns  [*1325]  a number of patents that cover its Precedex Premix product. Fresenius Kabi USA LLC ("Fresenius") filed [**2]  an Abbreviated New Drug Application ("ANDA") seeking approval to enter the market with a generic ready-to-use dexmedetomidine product. Hospira sued for infringement of five patents and eventually dropped all but two claims, one of which was claim 6 of the '106 patent.1 Fresenius stipulated to infringement of claim 6, and the district court held a bench trial on its validity.

I. Prior Art Dexmedetomidine

Dexmedetomidine is a chemical compound that is effective as a sedative. '106 patent col. 1 ll. 36-37. Dexmedetomidine was first developed and patented by Farmos Yhtyma Oy ("Farmos") in the 1980s. Farmos was issued U.S. Patent 4,910,214, which disclosed the dexmedetomidine compound and its use as a sedative.

In 1989, Farmos submitted an Investigational New Drug application ("the Farmos IND") to the U.S. Food and Drug Administration ("FDA") seeking approval to begin safety testing dexmedetomidine formulations in humans. Farmos conducted at least two human safety studies using intravenous administration of 20 µg/mL dexmedetomidine hydrochloride but subsequently abandoned its safety testing after the studies showed adverse effects.

In 1994, Farmos's successor granted Abbott Laboratories (Hospira's predecessor-in-interest) an exclusive [**3]  license to make, use, and sell dexmedetomidine for human use in the United States. In 1999, Abbott Laboratories received FDA approval to market a 100 µg/mL dexmedetomidine hydrochloride formulation known as "Precedex Concentrate." Precedex Concentrate is supplied in 2 mL clear glass vials and 2 mL clear glass ampoules made from Type IA sulfur-treated glass sealed with coated rubber stoppers. The 100 µg/mL concentration of Precedex Concentrate is too strong to be directly administered to patients, and thus the label provides instructions for diluting the drug to a concentration of 4 µg/mL before intravenous administration.

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946 F.3d 1322 *; 2020 U.S. App. LEXIS 545 **; 2020 U.S.P.Q.2D (BNA) 6227; 2020 WL 97521

HOSPIRA, INC., Plaintiff-Appellant v. FRESENIUS KABI USA, LLC, Defendant-Appellee

Prior History:  [**1] Appeals from the United States District Court for the Northern District of Illinois in Nos. 1:16-cv-00651, 1:17-cv-07903, Judge Rebecca R. Pallmeyer.

Hospira, Inc. v. Fresenius Kabi USA, LLC, 343 F. Supp. 3d 823, 2018 U.S. Dist. LEXIS 212916 (N.D. Ill., Dec. 17, 2018)

Disposition: AFFIRMED.

CORE TERMS

dexmedetomidine, district court, prior art, concentration, stability, composition, embodiment, samples, patent, necessarily present, glass, pharmaceutical, tested, reasonable expectation, premixed, skill, manufacturing process, factual findings, formulations, sealed, invention, dilution, invalid, stable, stored, clearly erroneous, ordinary person, hydrochloride, container, describes

Civil Procedure, Appeals, Standards of Review, Clearly Erroneous Review, Patent Law, Anticipation & Novelty, Accidental Anticipation & Inherency, Nonobviousness, Evidence, Fact & Law Issues, Evidence, Elements & Tests, Prior Art, Elements & Tests