Chemicals, Combinations, and 'Common Sense': How the Supreme Court's KSR Decision is Changing Federal Circuit Obviousness Determinations in Pharmaceutical and Biotechnology Cases

Abstract:     
This article examines the impact of the U.S. Supreme Court's April 2007 decision in KSR Int'l Co. v. Teleflex Inc., with particular focus on the nonobviousness requirement as applied to the pharmaceutical and life sciences arts. Some commentators assumed that KSR, which involved a mechanical combination of an adjustable automobile gas pedal with an electronic sensor, would have little impact on pharmaceutical and biotechnology patenting. Federal Circuit decisions following KSR show otherwise. Post-KSR, it is unquestionably easier to establish a prima facie case of obviousness in the chemical arts. As a result, debate has already reframed around other issues, including (1) the level of ordinary skill in the art pertinent to a claimed invention; (2) whether prior art teachings would have been combined with a reasonable expectation of success; and (3) whether a prima facie case of obviousness, if established, can be rebutted. The Federal Circuit's opinions in Pfizer v. Apotex and Takeda v. Alphapharm illustrate two sharply contrasting applications of KSR's obvious to try definition. Taken with PharmaStem v. ViaCell, these decisions signal that the reasonable expectation of success prong for combining or modifying prior art teachings will be pivotal in nonobviousness analyses. The newly-precedential Daiichi v. Apotex suggests that KSR may have helped validity challengers bootstrap a conclusion of obviousness by asserting a heightened level of ordinary skill for a re-defined hypothetical person. These initial Federal Circuit applications of KSR in pharmaceutical and biotechnology cases show that its impact extends well beyond merely expanding the reasons for combining multiple prior art teachings. KSR is decidedly not limited in application to mechanical combinations. KSR's repercussions in the chemical arts will be equally, if not more, significant and pervasive.

Keywords: patent, patentability, nonobviousness, KSR, Federal Circuit

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