MERCK SHARP & DOHME CORP. v. HOSPIRA, INC.

MERCK SHARP & DOHME CORP. v. HOSPIRA, INC., Appeal No. 2017-1115 (Fed. Cir. October 26, 2017).  Before Newman, Lourie and Hughes.  Appealed from D. Del. (Judge Andrews).  (Obviousness)
Background:

Merck owns the 150 Patent directed to a process for preparing a final formulation of a known compound (Ertapenem), the process being considered to increase the stability of the composition.

Merck sued Hospira in response to Hospira’s ANDA filing for a generic version of Merck’s product.  While the court found that one of Merck’s patents covering the compound itself had claims that were nonobvious and infringed, the district court found that the claims of the 150 Patent would have been obvious and thus, invalid.  Notably, the district court found that although some of the steps, as well as the ordering of the steps, were not disclosed in the prior art, the claimed steps leading to the formulation were conventional manufacturing steps that would have been obvious from the prior art as a product of routine experimentation.  The district court considered Merck’s secondary considerations evidence of commercial success and copying, but ultimately found the evidence insufficient to overcome the obviousness finding.

Issue/Holding:

Did the district court err in finding the claims of the 150 Patent would have been obvious?  (continue reading)

Summary by:  Joel Gotkin

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