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Merck Sharp & Dohme Corp. v. Hospira, Inc.

Evidence of Commercial Success, Copying Insufficient to Establish Nonobviousness

Merck Sharp & Dohme Corp. v. Hospira, Inc., (Fed. Cir. Oct. 26, 2017) (Newman (dissenting), LOURIE, Hughes) (D. Del.: Andrews) (3 of 5 stars)

Fed Cir affirms bench judgment of obviousness in Hatch-Waxman litigation. Merck’s patent related to a process for preparing its branded antibiotic Invanz (generic name ertapenem). The opinion discusses how, in view of the prior art, Merck’s claims amounted to straightforward application of well-understood prior art principles, and so were obvious. And it rejects Merck’s argument that the prior art failed to disclose the precise order and detail of claimed steps; such “would have been determined by routine experimentation while implementing known principles.” Op. at 9. The opinion also discusses Merck’s tender of objective evidence concerning nonobviousness, particularly the commercial success of Merck’s Invanz product. Giving such evidence its “full and proper weight,” the district court committed no clear error in its obviousness analysis. However, the district court erred in reasoning that, because Merck had separate patents covering ertapenem itself, evidence of Invanz’s commercial success should be discounted. “[M]ultiple patents do not necessarily detract from evidence of commercial success of a product or process[.]” Op. at 10. But even correcting for this error, the commercial success evidence could not overcome the obviousness evidence. The district court also rejects Hospira’s argument that the district court erred in finding copying by Hospira; such evidence could be given weight in this case because the ANDA did not require Hospira to copy the patented manufacturing process—only that the result of that process match Merck’s.

Dissent: Judge Newman would have held that the district court gave insufficient weight to objective evidence of nonobviousness. Her opinion calls for the Fed Cir to “remedy our inconsistent treatment of the procedures and burdens in applying the evidentiary factors of obviousness[.]” Dissent at 1.

KEYWORDS: HATCH-WAXMAN; OBVIOUSNESS (YES); OBJECTIVE INDICIA