In Merck Sharp & Dohme Corp. v. Hospira, Inc., [2017-1115] (October 26, 2017), the Federal Circuit affirmed the district court’s determination at a bench trial, that claims 21-34 of U.S. Patent 6,486,150, on a method for preparing the antibiotic ertapenem were invalid for obviousness.

The district court reviewed Merck’s objective evidence and concluded that commercial success and copying by others were shown, but that the objective evidence could not overcome the “strong prima facie case of obviousness” established by Hospira. The district court found that, while there was commercial success tied to the asserted claims, the evidence was weakened” by the “blocking effect” of U.S. Patent 5,478,820 on ertapenem, which was a disincentive to others to develop new ertapenem formulations.

The Federal Circuit agreed with Hospira that the district court did not
err in finding that the claimed process would have been obvious at the time the invention was made.  While Merck argued that the specific order and detail of the claimed steps constitute a novel solution to minimizing degradation by hydrolysis and minimizing dimerization, Merck’s problem was that the purported “solution” constituted nothing more than conventional manufacturing steps that implement principles disclosed in the prior art.  The Federal Circuit said that it was reasonable for the district court to deduce from the evidence that the order and detail of the steps, if not already known, would have been discovered by routine experimentation while implementing known
principles. The Federal Circuit found that the district court’s analysis thus involved no legal error.

Regarding Merck’s objective evidence of non-obviousness, the Federal Circuit agreed with Merck that Merck’s evidence of commercial success should not have been discounted simply because of the existence of
another patent of which Merck was the exclusive licensee.  The Federal Circuit said that:

developers of new compounds often obtain a package of patents protecting the product, including compound, formulation, use, and process patents. Often such patents result from Patent Office restriction requirements  relating to the technicalities of patent classifications and rulings that various aspects of claiming an invention cannot be claimed in the same patent. Or they may result from continuing improvements in a product or process. Thus, multiple patents do not necessarily detract from evidence of commercial success of a product or process, which speaks to the merits of the invention, not to how many patents are owned by a patentee. Commercial success is thus a fact-specific inquiry that may be relevant to an inference of nonobviousness, even given the existence of other relevant patents.

Nonetheless, the Federal Circuit did not discern error in the district
court’s determination that Merck’s evidence of commercial success could not overcome the weight of the evidence that the claimed process was substantially described in the prior art and required only improvement by the use of established variations. Thus, even giving the evidence of commercial success its full and proper weight, the court did not err in concluding that the claims would have been obvious at the time the invention.

The Federal Circuit also agreed that the evidence of Hospira’s copying could not overcome the weight of the competing evidence of obviousness.