A judge in the Southern District of Florida has dismissed patent infringement claims under Rule 12(b)(6) on the basis of an affirmative defense which defeated all of the allegations. The plaintiff and defendant had entered into a clinical manufacturing activities agreement in which the defendant explored whether it could make an oral formulation of its injected drugs by applying the technology of the plaintiff’s patents. The plaintiff and defendant terminated the agreement, and shortly thereafter the defendant conducted Phase I clinical trials using the technology of the plaintiff’s patents. Subsequently, the plaintiff filed suit for infringement, amongst other things.

The defendant moved to dismiss for failure to state a claim on the basis its activity was covered by the Hatch-Waxman Act’s safe harbor provision for clinical testing during the term of the patent. The plaintiff countered that the safe harbor was an affirmative defense and it was entitled to discovery to test the factual basis for the defense.

The court accepted that “generally an affirmative defense cannot serve as a basis for a [12(b)(6)] dismissal.” However, the court noted that if a complaint’s own allegations on the face of the complaint indicated the existence of an affirmative defense, dismissal could be proper under 12(b)(6). The court then likened the case before it to two other cases where the claims had been dismissed because the plaintiff had failed to allege any specific act of infringement not covered by safe harbor provisions. Finally, the court held dismissal of the infringement contentions was warranted because the plaintiff had only alleged the defendant used the patented technology in protected new drug investigational activity.

Enteris Biopharma, Inc. v. Clinical Pharmacology of Miami, Inc., No. 1-14-cv-227700-UU (Mar. 20, 2015) [Ungaro, J.].