Federal Circuit's Obviousness Test for New Pharmaceutical Compounds: Gobbledygook?

Abstract

The statutory requirement that to obtain a patent an invention must not be obvious to a person having ordinary skill in the art helps maintain a balance between the incentives provided by the grant of patents and harm resulting from too many patent grants. In 2007 the Supreme Court in KSR International Co. v. Teleflex Inc. increased what would in the future constitute obvious (and thus unpatentable) inventions by: (1) expanding the types of prior art a court must consider in determining obviousness; (2) recognizing steps that are obvious to try might result in inventions that are obvious; and (3) acknowledging that persons having ordinary skill in the art are creative and exercise common sense. However, the Federal Circuit had developed its obviousness test for new pharmaceutical compounds before KSR and has not substantially modified its test since KSR. That test is inconsistent not only with KSR, but also with the obviousness statute itself (§103) and the Federal Circuit’s treatment of obviousness for other fields. This article argues that the Federal Circuit or, if the appropriate case reaches it, the Supreme Court should reject the Federal Circuit’s obviousness test for new pharmaceutical compounds and follow instead KSR and §103 to appropriately serve the gatekeeping function of patent law’s obviousness requirement.

Keywords: patents, obviousness, pharmaceutical compounds, KSR, Federal Circuit

JEL Classification: K11, K20, O34, P14