In re Bendamustine Consolidated Cases (D. Del. April 29, 2015)

Not often is a patent infringement lawsuit filed pursuant to the Hatch-Waxman Act dismissed as a result of a judgment on the pleadings. However, precisely that happened recently in In Re Bendamustine Consolidated Cases, C.A. No. 13-2046, 2015 WL 1951399 (April 29, 2015) (Sleet, J). Generally, a motion for judgment on the pleadings is a party’s request to the court to rule in their favor based only on the pleadings on file, without accepting evidence. Due to the fact-intensive nature of patent infringement, this procedural device is rarely invoked in patent cases and even more rarely granted.

The plaintiff, Cephalon, Inc. filed patent infringement lawsuits pursuant to the Hatch-Waxman Act against several generic companies; Cephalon alleged the companies’ abbreviated new drug applications (ANDA) infringed (under the doctrine of equivalents) two patents claiming compositions and preparations that contain tertiary-butyl alcohol; however the defendants’ ANDA products do not contain tertiary-butyl alcohol. The defendants filed motions for judgment on the pleadings seeking dismissal of the infringement charges, because the doctrine of equivalents was barred under the “disclosure-dedication rule.”

In its first line of defense, Cephalon argued that the U.S. District Court for the District of Delaware could not properly entertain and grant a motion for judgment on the pleadings if it considered matters outside of the pleadings, such as content from the defendants’ respective ANDAs. If the court chose to rely on such extraneous matter, Celaphon argued, it must consider the motions under the summary judgment standard. Not so, Judge Gregory Sleet retorted, if the extraneous matter is “integral to or explicitly relied upon in the complaint.” The court concluded that the two asserted patents, their file histories and the defendants’ ANDAs were properly before the court, because the patent infringement claims in Cephalon’s complaint were based, in part, on these extrinsic documents.

Finding no procedural flaw in the generic defendants’ motions, the district court turned to the merits of the “disclosure-dedication rule.” The rule states that, when a patent drafter discloses in the patent specification, but declines to claim subject matter, he or she thereafter dedicates the disclosed but unclaimed subject matter to the public. Application of the doctrine of equivalents to recapture subject matter deliberately left unclaimed conflicts with the primacy of the claims in defining the proper scope of the patentee’s exclusive rights under the patent. But in order for the “disclosure-dedication rule” to trump the doctrine of equivalents, the disclosure must be of such specificity that skilled artisans could identify the subject matter that was disclosed but not claimed. This poses a question of law.

The patents at issue disclosed a lengthy list of possible organic solvents, which included tertiary-butyl alcohol as the most preferred solvent. The claims of the patents, however, were directed to compositions or preparations containing only tertiary-butyl alcohol;  the other solvents listed in the specification were not explicitly claimed. As the court explained, “The question therefore becomes whether the moving defendants ANDA products contain one or more solvents that are disclosed but not claimed in the [] patents. The ANDA filings confirm that they do.” Therefore, Judge Sleet concluded that the “disclosure-dedication rule” barred Cephalon from arguing infringement of the patents on a doctrine of equivalents theory. “A patentee cannot narrowly claim an invention to avoid prosecution scrutiny by the [Patent and Trademark Office], and then, after patent issuance, use the doctrine of equivalents to establish infringement because the specification discloses equivalents.” By narrowly claiming only tertiary-butyl alcohol from the list of disclosed organic solvents, Cephalon was not permitted to employ the doctrine of equivalents to expand the scope of the asserted claims to ensnare the defendants’ ANDA products that used other solvents listed in the patent specifications.

Cephalon then argued that application of the “disclosure-dedication rule” was not appropriate in the context of this case because Cephalon “did not decline” to claim the additional solvents, but had attempted, unsuccessfully, to include other solvents in the claims during prosecution of the patents. In fact, Cephalon later succeeded in claiming the additional solvents in a later continuation patent. The district court rejected this argument, stating that “Federal Circuit law is well settled that intent is not relevant to the “disclosure-dedication rule.” Accordingly, the court applied the rule, and, in a rare occurrence, entered judgment on the pleadings dismissing Cephalon’s patent infringement claims under the doctrine of equivalents. This case demonstrates that defendants can short-circuit protracted and expensive ANDA litigation under the right circumstances, such as when application of the “disclosure-dedication rule” would trump infringement claims under the doctrine of equivalents.