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ARTICLE · 01 DECEMBER 2017

Secondary Considerations Transformed Into Rebuttal Evidence

McDermott Will & Emery
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Addressing the issue of prima facie obviousness, the US Court of Appeals for the Federal Circuit affirmed a district court's ruling that evidence of secondary considerations failed to overcome...

United StatesIntellectual Property
Amol Parikh
Amol Parikh
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Addressing the issue of prima facie obviousness, the US Court of Appeals for the Federal Circuit affirmed a district court's ruling that evidence of secondary considerations failed to overcome a strong showing of obviousness. Merck Sharp & Dohme Corp. v. Hospira, Inc., Case No. 17-1115 (Fed. Cir., Oct. 26, 2017) (Lourie, J) (Newman, J, dissenting).

Merck owns a patent directed to a process for preparing a degradation-free formulation of the antibiotic ertapenem. The claimed process involves mixing ertapenem in a carbon dioxide solution having a pH between 6.0 and 9.0 with a temperature between -3°C and 15°C. The combined solution is then lyophilized to obtain the final formulation. Merck sued Hospira for infringement of the patent based on Hospira's filing of an abbreviated new drug application (ANDA).

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