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ARTICLE · 19 MARCH 2018

Undisclosed Routine Details Insufficient To Distinguish Prior Art From Claimed Method

The Federal Circuit affirmed the district court's obviousness opinion.

United StatesIntellectual Property

After reviewing a manufacturing patent related to the antibiotic ertapenem, the US Court of Appeals for the Federal Circuit determined that the claimed manufacturing process was obvious because the prior art disclosed everything except for details that would have been routinely implemented by a person of skill in the art. Merck Sharp & Dohme Corp. v. Hospira Inc., Case No. 874 F.3d 724 (Fed. Cir., Oct. 26, 2017) (Lourie, J) (Newman, J, dissenting).

In May 2014, Hospira filed an abbreviated new drug application (ANDA) seeking approval to market a generic version of Merck's Invanz product—i.e., ertapenem. Merck sued Hospira for infringement of US Patent Nos. 5,952,323 and 6,486,150. Each patent claims a different method relevant to the production of a stable form of ertapenem. Merck created a stable form of ertapenem by forming a carbamate adduct by reacting ertapenem with a carbon dioxide source at a specific pH range of 6.0 to 9.0. The '323 patent describes and

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