This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort of flexible approach that the Supreme Court admonished it to use in KSR. The decisions of the Federal Circuit considering obviousness challenges to pharmaceuticalp atents suggest that the pharmaceutical industry does indeed have a nonobviousness problem, but that problem is not KSR. Rather, the problem is that many of the patents that the industry relies upon are invalid for obviousness under time-honored patent doctrine. Although perhaps able to survive the limited scrutiny that is possible on the basis of the information available at the prosecution stage, these patents cannot withstand a validity challenge with the benefit of a full evidentiary record at the infringement stage. It is more difficult to conduct an expansive and flexible analysis with limited information. KSR is more likely to have an impact on pharmaceutical patents if it makes it easier for the PTO to reject patent applications for obviousness in the first instance. It remains to be seen whether it will do so.
Eisenberg, Rebecca S. "Pharma's Nonobvious Problem." Lewis & Clark L. Rev. 12, no. 2 (2008): 375-430.