Process Discoverable by “Merely Ordinary Experimentation” Rendered Obvious

In Merck Sharp & Dohme Corp. v. Hospira, Inc., No. 2017-1115 (Fed. Cir. Oct. 26, 2017), a divided Federal Circuit panel affirmed the district court’s finding that a claimed process for making a chemical compound was obvious. Merck sued Hospira alleging infringement of U.S. Patent Nos. 6,486,150 and 5,952,323 after Hospira filed an ANDA for a generic version of Merck’s Invanz® product. After a bench trial the district court found the ’323 patent infringed and not invalid and the ’150 patent invalid as obvious because the claimed steps could have been discovered by routine experimentation. Merck appealed the invalidity finding.

On appeal, the panel majority affirmed, holding that the claimed process recited “experimental details that one of ordinary skill would have utilized via routine experimentation, armed with the principles disclosed in the prior art.” Specifically, the majority found that the claimed “solution” was “nothing more than conventional manufacturing steps that implement principles disclosed in the prior art.” Although the majority faulted the district court for not considering Merck’s commercial success evidence because Merck owned another patent covering the ’150 patent’s product, it found no clear error in the ultimate obviousness determination. The majority agreed that Merck’s evidence of commercial success and copying did not overcome the competing evidence of obviousness.

Judge Newman dissented, arguing the majority and district court improperly “converted three of the four Graham factors into a self-standing ‘prima facie’ case, whereby the objective considerations must achieve rebuttal weight.”