Locke Lord QuickStudy: Process Step Order Cannot Save Claim with Conventional Manufacturing Steps From Obviousness

On October 26, 2017, the Federal Circuit, in a split decision, upheld the invalidity of the asserted claims of U.S. Patent No. 6,486,150 (“the ’150 patent”) as obvious under 35 U.S.C. § 103. See Merck Sharp & Dohme Corp. v. Hospira, Inc., C.A. No. 2017-1115, 2017 WL 4819091 (Fed. Cir. Oct. 26, 2017). In Merck, the majority panel affirmed (1) the district court’s ruling that it would have been obvious to a person of ordinary skill in the art (“POSA”) based on the prior art and the POSA’s common knowledge in the art to arrive at the claimed manufacturing processes for a final formulation of ertapenem (an antibiotic compound) that purportedly minimizes both dimerization and hydrolysis degradation pathways, and (2) the alleged secondary considerations of non-obviousness failed to overcome Hospira’s strong evidence of obviousness. See, e.g., id. at *3-*5.

Obviousness Based on Implementing Principles Disclosed in the Prior Art

On appeal, the Federal Circuit considered whether the district court “erred in finding that the claims would have been obvious over [the prior art] because it is undisputed that none of the claimed steps is disclosed in the prior art.” Id. at *2. Specifically, Merck argued that the district court erred in relying on the POSA’s “knowledge, creativity, and common sense” to supply a missing claim limitation rather than to support a motivation to combine prior art. Id. 

The majority disagreed with Merck’s argument noting that although not all of the specifics of the ordered claimed steps were expressly stated in the prior art (pH and temperature), the specifics and the order of the manufacturing steps were simply experimental details that a POSA, “armed with the principles disclosed in the prior art,” would have utilized in routine experimentation. Id. at *4. Indeed, “Merck’s problem is that the purported ‘solution’ for minimizing degradation pathways constitutes nothing more than conventional manufacturing steps that implement principles disclosed in the prior art.” Id. at *3. Thus, obviousness predicated on the teachings of the prior art coupled with the POSA’s knowledge and utilization of well-known, routine experimentation was not legal error on the part of the district court.

Secondary Considerations Insufficient to Outweigh Strong Obviousness Showing

The district court held that although Merck presented evidence of secondary considerations, i.e., commercial success and copying, Merck’s evidence “could not overcome the weight of the competing evidence of obviousness of the claimed process.” Id. at *5. With respect to commercial success, the majority did not agree that existence of an earlier blocking patent does not allow for commercial success evidence to be “discounted,” but instead does indicate the weakness of such evidence. See id. at *5. In addition, the majority agreed with the district court’s finding that evidence of copying—i.e., Hospira’s multiple attempts to design around the ’150 patent—did weigh in favor of a finding of non-obviousness, but was also insufficient to overcome the strong evidence of obviousness based on the prior art. See id. at *5.

On dissent, Judge Newman contended that the majority, as well as other Federal Circuit opinions, incorrectly rely on secondary considerations as rebuttal evidence rather than as a component of the “entirety of the evidence” when assessing obviousness. Id. at *5-*8.

Merck v. Hospira provides a foundation for obviousness based upon a POSA’s utilization of conventional manufacturing steps that implement known prior art principles, including how those steps are ordered. Accordingly, consideration must be given to a POSA’s knowledge and the methods that a POSA would use in order to execute prior art principles. In addition, this decision provides affirmation that evidence of secondary considerations of non-obviousness must be weighed in light of all of the evidence of obviousness—thus, a finding of secondary considerations weighing in favor of non-obviousness does not automatically preclude a determination of obviousness based on strong prior art.