MERCK SHARP & DOHME CORP. V. HOSPIRA, INC: October 26, 2017. Before Newman (dissent), Lourie (majority), and Hughes

Takeaways:

• A process is obvious if it differs from a previously patented process only in routine details that, even though not disclosed in the prior art, could be achieved by a person with ordinary skill in the art via routine experimentation.

• Evidence of secondary considerations, including evidence of commercial success and evidence of copying, is balanced against and must overcome competing evidence of obviousness.

• Commercial success is a fact-specific inquiry that may be relevant to an inference of non-obviousness, even given the existence of other relevant patents, including those owned by the same patentee.

Procedural Posture: Merck sued Hospira, Inc. for infringement of two patents after Hospira, Inc. filed an ANDA seeking approval relating to generic versions of Merck’s Invanz® product, the principal component of which is the carbon dioxide adduct of ertapenem. D. Del. concluded the asserted claims of one of the patents would be infringed, but were invalid as obvious over Merck’s other patent and another reference (“Almarsson”). Merck appealed. CAFC affirmed invalidity of the patent for obviousness.

Synopsis:

Obviousness: On appeal, Merck argued the process was only obvious to try with the benefit of hindsight, and that there were very specific differences between the asserted patent and the invalidating patent, including problems in the earlier technology that the subsequent patent solved, such as with degradation over time. The CAFC disagreed, affirming the district court’s finding that the process was obvious. The only elements of the claimed process that were not expressly disclosed in the prior art—namely, the order of the steps, the simultaneous addition of base, the specific temperature range, and the final moisture content—were all experimental details that only required implementing known principles via routine experimentation. Neither evidence of commercial success nor evidence of copying could overcome the weight of the competing evidence of obviousness.

Other Opinions: Newman dissented, arguing that it is incorrect to convert the first three Graham factors into a “prima facie” case, with the fourth Graham factor, i.e., objective “secondary” considerations such as commercial success, shifted to rebuttal. Such an analysis “distorts the placement and the burden of proof.” The question was whether the entirety of the evidence, including the objective evidence of commercial success and copying, established obviousness, not whether the objective evidence “could not overcome the weight of the competing evidence of obviousness of the claimed process.”