Despite Claims To The Contrary, Secondary Considerations Have Not Taken On Primary Significance

Recently, some commentators have suggested that the Federal Circuit has increased the significance of the role secondary considerations play in obviousness determinations.  This claim, however, appears to be misplaced.

One case used to justify a claim of the change in the law is Transocean Offshore Deepwater Drilling Inc. v. Maersk Contractors, 617 F.3d 1296 (Fed. Cir. 2010). In Transocean, the patent-in-suit involved “dual-activity” drilling technology, with the district court granting summary judgment of obviousness. The Federal Circuit agreed, but remanded the case to the district court, because the district court failed to consider secondary considerations prior to reaching its ultimate conclusion of obviousness.

In the pharmaceutical context, the Federal Circuit reached a similar result in In re Cyclobenzaprine Hydrochloride, 676 F.3d 1063 (Fed. Cir. 2012). There, the Federal Circuit concluded that the district court erred by (1) not considering objective indicia prior to reaching its conclusion of obviousness and (2) improperly shifting the burden of persuasion – as opposed to the burden of production – to plaintiff. Specifically, the Federal Circuit stated that the district court failed to consider all four obviousness factors from Graham v. John Deere Co. and improperly imposed a burden-shifting framework as to the burden of persuasion.

These cases do not mark a shift in Federal Circuit jurisprudence about secondary considerations.  Rather, these cases merely show that all four Graham v. John Deere Co. factors must be considered as part of the ultimate finding on obviousness and that it is improper to shift the burden of persuasion to the patentee. Federal Circuit cases decided subsequent to Transocean and In re Cyclobenzaprine Hydrochloride bolster this conclusion.

The Federal Circuit has said as much.  For example, in Novo Nordisk v. Caraco Pharmaceutical Laboratories, 719 F.3d 1346, 1353 (Fed. Cir. 2013), the Federal Circuit stated that In re Cyclobenzaprine Hydrochloride merely “reaffirmed … longstanding precedent” and was premised on the fact that the district court “reached its ultimate conclusion on obviousness based solely upon the prima facie evidence.” Further, the court went on to explain that although the burden of persuasion remains with the challenger, “the presumption of validity does not relieve the patentee of any responsibility to set forth evidence in opposition to a challenger’s prima facie case which, if left unrebutted, would be sufficient to establish obviousness.” Novo Nordisk, 719 F.3d at 1353.

Thus, secondary considerations must be considered as part of any obviousness analysis.  But, it is still the patentee’s burden of production to rebut a prima facie case of obviousness with any alleged secondary considerations.