Argument Preview

A pharmaceutical patent case being argued next week involves Sanofi-Aventis Deutschland (“Sanofi”) and Mylan Pharmaceuticals Inc. (“Mylan”). This case presents two related issues on the subject of the law of obviousness: (1) whether “obviousness may be shown even when the prior art did not ‘expressly articulate’ or even implicitly ‘suggest’” a modification to the prior art, and (2) whether “the teachings of the challenged patents-in-suit, rather than the prior art,” are sufficient to show that a person of skill in the art (“POSITA”) “would have had a reason to modify the prior art.”

Elizabeth Weiswasser of Weil, Gotshal & Manges LLP will argue on behalf of Sanofi. The case addresses what theory the PTAB may use when determining whether modifying prior art to achieve the solution of the challenged patent would have been obvious to a POSITA. Sanofi’s opening brief suggests that not only did the PTAB misapply the Supreme Court’s holding in KSR—that “obviousness requires a showing that ‘there was an apparent reason to combine the known elements [of the invention] in the fashion claimed by the patent at issue’”—but also that the PTAB erroneously considered “whether there was motivation to modify different prior art elements than are claimed in the invention.”

Douglas Carsten of Wilson, Sonsini, Goodrich & Rosati, PC will argue on behalf of Mylan. Mylan’s brief argues that “Sanofi attempts to convert fact disagreement into legal error on appeal,” which further “lacks basis in the cases it cites and is contradicted by a wealth of precedent.”

In reply, Sanofi takes the position that Mylan has failed to acknowledge “the PTAB’s legal error of bypassing the requirement to prove that a POSITA would have recognized and been motivated to solve a known problem in the prior art.”