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