Purdue Pharma L.P., et al. v. Accord Healthcare, Inc.

In Graham v. John Deere Co., this Court established four factors for evaluating whether a patent is obvious, and therefore invalid, under 35 U.S.C. § 103. 383 U.S. 1 (1966). The first three factors examine technical aspects of the invention and the prior art. To help avoid hindsight bias and an overly narrow approach to obviousness, Graham also requires courts to evaluate a fourth factor focused on “economic and motivational” considerations—known as the objective “indicia” of non-obviousness or “secondary considerations.” Id. at 17-18, 36. These include “commercial success, long felt but unsolved needs, [and] failure of others.” Id. at 17-18. As this Court explained in KSR International Co. v. Teleflex Inc., courts must analyze “any secondary considerations that would prove instructive” in conducting an “expansive and flexible” analysis of obviousness. 550 U.S. 398, 415 (2007). Despite this clear instruction, the Federal Circuit has adopted a rigid “nexus” requirement to dismiss out of hand clear objective indicia of non-obviousness. It doubled down on that practice in this case. Invoking lack of “nexus,” the Federal Circuit held that Purdue’s novel abuse-deterrent formulation of OxyContin was obvious even though the formulation indisputably filled a long-felt need in the market, was initially met by skepticism by the Food & Drug Administration, and averted the impending collapse of OxyContin sales. The question presented is: Whether, as this Court has held, the objective indicia of non-obviousness should be analyzed flexibly to combat hindsight bias or instead subject to the Federal Circuit’s rigid rules restricting the inquiry.