by Robert Ambrogi - Editor
BullsEye Newsletter: October 2007
It is a common litigation scenario: One side's expert
says one thing while the other side's says just the opposite. But
when – as in patent cases – expert opinion is so critical
to the outcome, is summary judgment possible when the two experts
disagree?
Summary judgment, after all, requires a judge to conclude that
there is no genuine dispute as to any material fact. If the experts
are at odds over whether a patent is infringed, isn't summary judgment
ruled out?
In a September 21st opinion, In re Gabapentin Patent Litigation,
the Federal Circuit Court of Appeals answered that very question
in a case involving a pharmaceutical patent. In ruling that the district
court erred when it granted summary judgment, the court shed light
on how judges and lawyers should handle this scenario.
At the heart of the case was drug-maker Warner Lambert's patent
covering a process for preparing a highly purified version of the
compound gabapentin, the active ingredient in the epilepsy drug Neurontin.
When several competing drug companies sought approval to market generic
versions of Neurontin, Warner Lambert filed suit against them.
Through the Judicial Panel on Multidistrict Litigation, the
various actions were consolidated in federal court in New Jersey.
There, the defendants filed motions seeking summary judgment of noninfringement
and invalidity.
A key disclosure of the Warner Lambert patent was that its
process produced a gabapentin composition with "less than 20
ppm of an anion of a mineral acid." Finding that Warner Lambert
failed to produce sufficient evidence to show that the defendants'
generic products met this limitation and therefore infringed its
patent, the district court granted summary judgment in favor of the
defendants.
In the district court, Warner Lambert had based its opposition
to summary judgment on the results of pH tests performed by its analytical
expert. Those results, it argued, countered testing done by defendants'
expert and created a genuine issue of material fact.
Conflicting Experts
On appeal to the Federal Circuit, Warner Lambert argued
that the conflicting opinions of its expert and the defendants' expert – each
based on different methods of testing –
created a genuine issue of material fact and that the trial
judge erred by resolving that factual dispute on summary judgment.
The defendants countered that Warner Lambert's pH tests were invalid
and imprecise.
The Federal Circuit sided with Warner Lambert, agreeing that
the outcome of its expert's testing provided sufficient evidence
to create a genuine issue of material fact as to whether the generic
drugs would infringe its patent.
The court gave short shrift to the defendants' argument concerning
the validity of the pH testing, finding that they had expressly excluded
that argument from their original summary judgment motion. Ironically,
they had excluded that argument in order to avoid factual disputes
that might undermine their summary judgment motions.
As to the test's precision, the court found that even after
factoring in the test's margin of error, the results showed that
the defendants' drugs could fall within the 20 ppm claim limitation
of Warner Lambert's patent.
"Based on the record before us, we conclude that the district court erred
in granting summary judgment of noninfringement based on Warner Lambert's purported
failure to meet its burden of proof,"
the court said. "The record shows that Warner Lambert proffered
sufficient evidence to create a genuine issue of material fact regarding
whether the accused products met the 20 ppm claim limitation of the
'482 patent."
Having decided that summary judgment was improper, the Federal
Circuit went on to review the trial court's construction of two key
claims in Warner Lambert's patent, one defining "anion of a
mineral acid" and another defining "adjuvant". In
both cases, the circuit court affirmed the trial court's construction.
The case is In re Gabapentin Patent Litigation, No. 2006-1572
(Sept. 21, 2007).
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