Obviousness Analysis Does Not Consider Unclaimed Limitations

Written by: Rhett D. Ramsey & Daniel Kiang

JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC.

Before Prost, Dyk, and Hughes.  Appeal from the United States District Court for the District of New Jersey.

Summary: District court erred by adding unclaimed limitations to the claims in analyzing obviousness.

Janssen sued Teva for infringement of a patent claiming a dosing regimen for administering paliperidone to treat schizophrenia.  Specifically, the patent claimed a long-acting dosing regimen, comprising a series of three intramuscular injections.  Teva stipulated to infringement but challenged validity.  After a bench trial, the district court found, among other things, that Teva had not proven that the claims were invalid as obvious.

On appeal, the Federal Circuit vacated the district court’s determination that the claims were not obvious.  First, Teva argued that the district court improperly considered unclaimed limitations in analyzing obviousness.  The district court found that Teva’s prior art did not demonstrate general-population-wide safety and efficacy and thus did not teach a generalized dosing regimen.  However, the Federal Circuit noted that the asserted claims recite a dosing regimen for “a psychiatric patient in need of treatment for schizophrenia” and that “[n]othing in the claims requires that the regimen be used for . . . the patient population generally or a certain percentage of the patient population.”  The Federal Circuit remanded because this misunderstanding about the claims permeated the district court’s obviousness analysis.

Second, Teva argued, and the Federal Circuit agreed, that the district court’s obviousness analysis was “erroneously rigid” and did not comport with KSR.  The district court concluded there was no reason to combine Teva’s prior art references because of differences in doses and injection sites.  The Federal Circuit explained that the district court’s “siloed and inflexible approach” left insufficient room for a POSITA’s ordinary creativity, “thereby inflating the significance of minor variations between the prior art and the claims.”  This error also required remand.

Editor: Sean Murray