Merck Sharp & Dohme Corp. v. Hospira, Inc., No. 17-1115 (Fed. Cir. 2017)
Annotate this CaseMerck owns the 150 patent, which is directed to a process for preparing a stable formulation of ertapenem, an antibiotic compound, and claims a manufacturing process for a final formulation of the antibiotic that purportedly minimizes both dimerization and hydrolysis degradation pathways. Hospira notified Merck that it had filed an abbreviated new drug application, seeking FDA approval to engage in the commercial manufacture, use, or sale of generic versions of Merck’s Invanz® product, the principal component of which is the carbon dioxide adduct of ertapenem. Merck sued Hospira for infringement of two patents—the 150 patent and the 323 patent. The Federal Circuit affirmed a holding that certain claims of the 150 patent are invalid under 35 U.S.C. 103, for obviousness. It was reasonable for the district court to deduce from the evidence that the order and detail of the steps, if not already known, would have been discovered by routine experimentation while implementing known principles.
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