Orange Book Blog

Cephalon, Inc. v. Watson Pharms., Inc., No. 2011-1325 (Fed. Cir. 2013)

    by Katherine H. Johnson

In Cephalon v. Watson, decided earlier this month,
the Federal Circuit reversed a finding of invalidity for lack of enablement
where the factual record of undue experimentation was insufficient.  The patented invention involved methods of
oral mucosal administration of fenatanyl with tablets including effervescent
agents used as penetration enhancers. 
The effervescent agents evolve gas as a result of exposure to a soluble
acid source.  The district court's claim
construction of "agent" required that the dosage forms of the soluble acid
source and the effervescent agent be separate but co-administered.

At trial before Judge Robinson in the District of Delaware, Watson succeeded in proving the
asserted patents (U.S. Pat. Nos. 6,200,604 and 6,974,590) were invalid for lack of enablement.  Watson's expert witness provided testimony
that co-administration would be "difficult" and "complicated."  The district court found further support for those
opinions in Cephalon’s expert testimony regarding the need for experimentation.

The Federal Circuit initially corrected the district court's
determination that Watson's prima facie case of lack of enablement was not
rebutted by Cephalon and stated that "there is no formal burden-shifting
framework when addressing the issue of enablement."  The court found that, despite the district court's
credibility finding, the largely unsupported testimony of Watson's expert
"carries little weight in this analysis." 
The court also found, contrary to the district court, that Cephalon's expert testimony regarding the need
for routine experimentation did not support the unsubstantiated opinions of
Watson's expert.  Specifically, the Federal
Circuit found that Watson failed to show how much experimentation would be
required for co-administration and that such experimentation would be
excessive, particularly where the specification provided at least some
guidance.

Notably, Watson's expert witness did not
specifically analyze the Wands factors at trial.  However, the Federal Circuit explained that such
an analysis was not required for Watson to carry its burden, and the record
lacked evidence of undue experimentation even assuming the district court's
cursory consideration of the Wands factors was accurate.

Despite the Federal Circuit's reversal of the invalidity holding, Watson still prevailed, as the Federal Circuit affirmed the district court's holding of noninfringement.