Bristol-Myers Squibb Company v. Nanocopoeia, LLC

Background

Bristol-Myers Squibb manufactures Sprycel, a drug used to treat certain types of leukemia. Sprycel contains dasatinib in crystalline monohydrate form. Bristol-Myers alleged that Nanocopoeia’s proposed drug, if approved and manufactured as described in its application to the Food and Drug Administration, would infringe United States Patent Nos. 7,491,725 and 8,680,103. Bristol-Myers also asserted infringement of another patent, but that patent was not involved in this motion.

Because Bristol-Myers filed the action after Nanocopoeia submitted its drug application, the Hatch-Waxman Act created a technical or “artificial” act of infringement that allowed the court to consider the dispute before the proposed drug entered the market. The filing also triggered an automatic thirty-month stay on Food and Drug Administration approval, subject to the statutory conditions described in the opinion.

Motion and standard

Nanocopoeia moved under Federal Rule of Civil Procedure 12(c) for judgment on the pleadings. It sought dismissal of Bristol-Myers’s infringement claims involving the two patents and judgments of non-infringement on corresponding counterclaims. Judgment on the pleadings is appropriate only when no material factual issue remains and the moving party is entitled to judgment as a matter of law. At this stage, the court accepts the complaint’s factual allegations as true and draws reasonable inferences for the nonmoving party.

Procedural arguments

Bristol-Myers argued that merely pleading the statutory elements of Hatch-Waxman infringement should allow its claims to continue until discovery. The court rejected that argument. It explained that the Hatch-Waxman cause of action establishes jurisdiction but does not eliminate the patent owner’s burden to prove infringement or prevent a court from entering judgment on the pleadings when non-infringement is clear as a matter of law.

Bristol-Myers also argued that the court could not consider the contents of the patents and Nanocopoeia’s pending Food and Drug Administration application. The court rejected that argument as well. It concluded that those documents were authentic, undisputed, legally operative documents necessarily embraced by the pleadings, and central to comparing Nanocopoeia’s proposed drug with the patent claims.

Merits of the motion

The court explained that some Hatch-Waxman cases can be resolved from the specifications in the defendant’s drug application. If those specifications directly establish that the proposed drug either meets or falls outside the limitations of a patent claim, the court may rely on them to decide infringement. In other cases, however, the specifications do not completely answer the infringement question. Those cases may require evidence such as testing of drug samples, batch data, expert testimony, and other evidence that generally cannot be considered on a Rule 12(c) motion.

The court found that this case involved a genuine dispute of material fact about whether Nanocopoeia’s application specifications directly answered the infringement question. The opinion’s reproduced text contains several obscured or missing passages, so it does not clearly identify every disputed specification or the parties’ precise competing interpretations. The court nevertheless stated that the dispute was genuine and material and that it involved issues requiring claim construction—the process of determining what patent-claim terms mean—and possibly evidence outside the pleadings.

The court distinguished cases in which the plaintiff had conceded that the defendant’s application specifications showed non-infringement, cases involving different patented uses of a drug, and cases presenting only legal disputes. According to the court, those circumstances were not present here. Nanocopoeia therefore had not shown that no material factual issue remained or that it was entitled to judgment as a matter of law.

Disposition

Judge Katherine Menendez denied Nanocopoeia’s Motion for Judgment on the Pleadings [Dkt. No. 72]. The court did not enter judgment of non-infringement, did not dismiss the challenged infringement claims, and allowed the litigation to proceed. The court stated that the case would benefit from claim construction and consideration of evidence outside the pleadings.