Addressing the issue of prima facie obviousness, the US Court of Appeals for the Federal Circuit affirmed a district court’s ruling that evidence of secondary considerations failed to overcome a strong showing of obviousness. Merck Sharp & Dohme Corp. v. Hospira, Inc., Case No. 17-1115 (Fed. Cir., Oct. 26, 2017) (Lourie, J) (Newman, J, dissenting).

Merck owns a patent directed to a process for preparing a degradation-free formulation of the antibiotic ertapenem. The claimed process involves mixing ertapenem in a carbon dioxide solution having a pH between 6.0 and 9.0 with a temperature between -3°C and 15°C. The combined solution is then lyophilized to obtain the final formulation. Merck sued Hospira for infringement of the patent based on Hospira’s filing of an abbreviated new drug application (ANDA). 

Following a bench trial, the district court found the claims of the asserted patent obvious over a combination of two prior art references. The court found that the claimed formulation was disclosed in the prior art and that the steps leading to that formulation were nothing more than conventional manufacturing steps that would have been obvious from the prior art disclosures. The district court also reviewed Merck’s evidence of secondary considerations, finding that while commercial success and copying by others were shown, that evidence could not overcome the strong prima facie case of obviousness. Merck appealed.

The Federal Circuit affirmed the district court’s obviousness finding. The Court found that substantial evidence supported the district court’s factual finding that the prior art combination expressly taught forming the carbon dioxide adduct of ertapenem at pH 6.0–9.0 and that the final formulation was to be obtained using “standard lyophilization techniques.” The Court also found that while the claimed temperature range was not explicitly disclosed in the prior art, it was understood that degradation is minimized at low temperatures, and a skilled artisan would therefore have wanted to keep the temperature as low as possible without freezing. Turning to Merck’s evidence of secondary considerations, the Federal Circuit found that the district court did not err in finding that Merck’s evidence of commercial success and copying could not overcome the weight of the evidence that the claimed process was described in the prior art.

In dissent, Judge Newman called for a return to the obviousness standard set forth in the Supreme Court of the United States’ decision in Graham v. John Deere Co. (1966). Judge Newman criticized the inconsistency of Federal Circuit decisions converting the four-factor test from Graham into one where the first three Graham factors operate as a self-standing prima facie case of obviousness and the fourth Graham factor (secondary considerations) serves as rebuttal evidence. Judge Newman appears concerned that the district courts will diminish the stability, predictability and fairness of obviousness inquiries if the inconsistent application of the Graham factors continues. 

Practice Note: Until the Graham factor analysis is clarified, consider formulating the inquiry in the most advantageous way for your particular situation. For example, practitioners may argue with the majority when challenging validity on § 103 grounds but endorse Judge Newman’s view when defending against an obviousness attack using objective indicia.