by Dennis Crouch
Apotex Inc. v. Cephalon, Inc. (Supreme Court 2022)
In its petition for writ of certiorari, Apotex asks the Supreme Court to revisit motivation to combine, obvious to try and whether the non-obvious contribution needs to be an improvement over the prior art. The petition argues that KSR v. Teleflex (2007) requires a flexible analysis, but that “over the ensuing decade-and-a-half, the Federal Circuit has … reverted to its old rigid ways.” The petition also complains that the Federal Circuit has again masked its jurisprudence via Summary Affirmance without opinion.
The accused infringers here were seeking to market a drug treatment for chronic lymphocytic leukemia covered by several Cephalon patents and sold as Bendeka. The defendants challenged the patent claims as obvious, but the district court sided with the patentee — finding a lack of motivation to combine the references with a reasonable expectation of success. This test has become the sina non quo of post-KSR Federal Circuit obviousness decisions. See, for example, Accorda Therap. v. Roxane Labs., 903 F.3d 1310 1328 (Fed. Cir. 2018) (“motivation to modify or combine with a reasonable expectation of success”); In re Stepan, 868 F.3d 1342, 1345-46 (Fed. Cir. 2017) (“requires finding both that a skilled artisan would have been motivated to combine the teachings of the prior art … and that the skilled artisan would have had a reasonable expectation of success in doing so.”), etc. Apotex’s petition explains this as follows:
[T]he Federal Circuit seems to believe that if there is any uncertainty about whether an obvious-to-try approach will succeed, that potentially compromises the motivation to try an obvious solution to a pressing problem, and therefore produces patent monopolies for what is obvious to try. Indeed, so ingrained has the motive-to-try-what-is-likely-to-succeed test now become in the Federal Circuit’s obviousness psyche, that the Federal Circuit now sometimes includes motivation as a fifth Graham factor.
I also write about this same issue in the Federal Circuit’s recent decision in Teva v. Corcept (Fed. Cir. 2021). Cephalon’s response is due in about 2 weeks.