It is a typical litigation scenario: One side's expert says one thing even though the other side's says just the opposite. But when - as in patent circumstances - professional opinion is so crucial to the outcome, is summary judgment possible when the two specialists disagree?
Summary judgment, immediately after all, calls for a judge to conclude that there is no genuine dispute as to any material fact. If the professionals are at odds over regardless of 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 really should deal with this scenario.
At the heart of the case was drug-maker Warner Lambert's patent covering a process for preparing a very purified version of the compound gabapentin, the active ingredient in the epilepsy drug Neurontin. When various competing drug providers sought approval to marketplace generic versions of Neurontin, Warner Lambert filed suit against them.
By means of the Judicial Panel on Multidistrict Litigation, the many actions had been 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 approach produced a gabapentin composition with "less than 20 ppm of an anion of a mineral acid." Obtaining that Warner Lambert failed to generate adequate evidence to show that the defendants' generic items met this limitation and for that reason 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 performed by defendants' professional and designed a genuine issue of material fact.
Conflicting Specialists
On appeal to the Federal Circuit, Warner Lambert argued that the conflicting opinions of its professional and the defendants' professional - each and every based on distinct approaches of testing - produced a genuine concern 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 supplied adequate evidence to generate a genuine issue of material fact as to whether or not the generic drugs would infringe its patent.
The court gave short shrift to the defendants' argument concerning the validity of the pH testing, acquiring that they had expressly excluded that argument from their original summary judgment motion. Ironically, they had excluded that argument in order to keep away from factual disputes that may possibly undermine their summary judgment motions.
As to the test's precision, the court located that even immediately after factoring in the test's margin of error, the final results showed that the defendants' drugs could fall inside the 20 ppm claim limitation of Warner Lambert's patent.
"Based on the record ahead of 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 mentioned. "The record shows that Warner Lambert proffered adequate evidence to create a genuine problem of material fact concerning no matter whether the accused items 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 important claims in Warner Lambert's patent, 1 defining "anion of a mineral acid" and one more defining "adjuvant". In each 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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