Combination Dosing Regimen Not Obvious Despite Overlapping Prior-Art Ranges

Written by:Justin J. Gillett and Alex Martin del Campo

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

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

Summary: The Federal Circuit found that claims reciting a dosing regimen with unequal loading doses were not obvious and that a presumption of obviousness based on overlapping ranges did not apply.

Janssen sued Teva for infringing patent claims directed to dosing regimens for an injectable form of paliperidone palmitate.  Teva stipulated to infringement and challenged validity on grounds of obviousness and indefiniteness.  In a prior appeal, the Federal Circuit affirmed the district court’s rejection of the indefiniteness challenge but vacated its obviousness ruling.  On remand, after a bench trial, the district court held that Teva had not proved any of the asserted claims invalid for obviousness or indefiniteness.

The Federal Circuit affirmed.  First, it declined to apply the presumption of obviousness based on overlapping ranges, even though the prior art taught both claimed dosage amounts separately.  It found the claimed combination included a novel dosing sequence with a higher first dose followed by a lower second dose.  The Federal Circuit explained that the presumption typically applies when a single variable overlaps with prior art ranges and when the skilled artisan could optimize it through routine experimentation.  The Federal Circuit also upheld findings by the district court that Teva failed to show a motivation to combine the cited references.  It agreed with the district court that a skilled artisan would not have expected success with the claimed regimen due to missing safety data and differing drug behavior in the prior art.

Editor: Sean Murray