Secondary Considerations: Commercial success and the existence of other patents

Secondary considerations may be presented as evidence to rebut a prima facie of obviousness over the prior art as proscribed by the Supreme Court's decision in Graham v. John Deere. These secondary considerations may include commercial success, long-felt but unmet need, and copying by competitors.

An interesting discussion of secondary considerations, and specifically commercial success, is the Federal Circuit's recent decision of Merck Sharp & Dohme Corp. v. Hospira, Inc., 2017 U.S. App. LEXIS 21201. Merck had presented objective evidence to the district court to show nonobviousness of its U.S. Patent No. 6,486,150 ("'150 patent"). The district court found that Merck's evidence of secondary considerations could not overcome Hospira's strong showing of obviousness based on the teachings of the prior art. This is interesting because the district court found that there was commercial success of Merck's Invanz® product. It even found that there was a "sufficient link" to the asserted claims of Merck's '150 patent. Nevertheless, the district court found that this evidence was "weakened" by the "blocking effect" of another patent, of which Merck was the exclusive licensee.

The Federal Circuit discussed the effects of the existence of other patents on the commercial success inquiry. First, the Court refused the notion that the mere existence of other patents automatically destroyed commercial success showings, noting 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." This is perhaps in tension with a previous holding that "where market entry was precluded by another patent and by exclusive statutory rights stemming from FDA marketing approvals, the inference of nonobviousness . . . from evidence of commercial success is weak." Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005). Still, the Federal Circuit reasoned that "packages" of patents covering compounds, formulations, uses and processes are common. These may be due to restriction requirements or other technicalities, or from continuing improvements. 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."

Practitioners should continue to look closely at relevant patents when examining secondary considerations. These patents may be owned by the plaintiff, the defendant or third parties. In deciding whether commercial success would be enough to rebut obviousness, a careful examination of the relevant art as a whole, including other patents, is warranted.