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Merck Sharp & Dohme Corp. v. Hospira, Inc.

United States Court of Appeals, Federal Circuit

October 26, 2017

MERCK SHARP & DOHME CORP., Plaintiff-Appellant
v.
HOSPIRA, INC., Defendant-Appellee

         Appeal from the United States District Court for the District of Delaware in Nos. 1:14-cv-00915-RGA, 1:14-cv-00916-RGA, Judge Richard G. Andrews.

          Jessica Lynn Ellsworth, Hogan Lovells U.S. LLP, Washington, DC, argued for plaintiff-appellant. Also represented by Catherine Emily Stetson; Joseph D. Eng, Tony Valentine Pezzano, Michael P. Dougherty, Nitya Anand, New York, NY; Gerard M. Devlin, Jr., Alysia A. Finnegan, Raynard Yuro, Merck & Co., Inc., Rahway, NJ.

          Thomas J. Meloro, Willkie Farr & Gallagher LLP, New York, NY, argued for defendant-appellee. Also represented by Michael Johnson.

          Before NEWMAN, LOURIE, and HUGHES, Circuit Judges.

          OPINION

          LOURIE, CIRCUIT JUDGE.

         Merck Sharp & Dohme Corp. ("Merck") appeals from the decision of the United States District Court for the District of Delaware concluding, after a bench trial, that claims 21-34 ("the asserted claims") of U.S. Patent 6, 486, 150 ("the '150 patent") are invalid under 35 U.S.C. § 103 (2006). See Merck Sharp & Dohme Corp. v. Hospira Inc., No. CV 14-915-RGA, 2016 WL 5872620, at *21 (D. Del. July 10, 2016) (Decision). Because the district court did not err in its conclusion of obviousness, we affirm.

         Background

         Merck owns the '150 patent, which is directed to a process for preparing a stable formulation of ertapenem, an antibiotic compound, shown below:

         (IMAGE OMITTED)

         Ertapenem is known to be unstable because of two degradation reactions-hydrolysis of the lactam nitrogen (highlighted by a red circle) and dimerization via the pyrrolidine nitrogen (highlighted by a blue square).

         The prior art taught that ertapenem can be stabilized from dimerization by reacting the pyrrolidine nitrogen with carbon dioxide to form a "carbon dioxide adduct." The method of the '150 patent claims a manufacturing process for a final formulation of the antibiotic that purportedly minimizes both dimerization and hydrolysis degradation pathways. See Appellant's Br. 12-14. Claim 21 is representative and reads as follows:

21. A process for preparing a final formulation product of a compound of formula la, (IMAGE OMITTED)
or its pharmaceutically acceptable salt, or hydrates wherein, R4, R5, and R6 are independently:
(a) hydrogen
(b) (C1-C6)-alkyl, or
(c) alkali-metal or alkali earth-metal wherein the alkali-metal or alkali earth-metal is sodium, potassium, lithium, cesium, rubidium, barium, calcium or magnesium;
comprising the steps of:
(1) charging a solution of carbon dioxide source having a pH range of about 6.0 to about 12.0 into a reaction vessel;
(2) adding an effective amount of a mole ratio of a base and an active ingredient into the reaction vessel containing the solution of carbon dioxide source to maintain pH at about 6.0 to about 9.0 and a temperature range of about -3° C. to about 15° C.; [and]
(3) lyophilizing the solution of Step (2) to yield the final formulation product of a compound of formula Ia with less than ...

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