Granting a motion to dismiss, US District Court for the District of New Jersey held that the statutory act of patent infringement no longer exists; therefore, there is no “case or controversy” necessary for the court to exercise subject-matter jurisdiction over, as a result of the US Food and Drug Administration’s (FDA) action which vitiated the justiciable controversy. Amarin Pharma, Inc. v. Apotex, Inc., et al. (D.N.J., January 22, 2016) (Cooper, M.).
The plaintiff, Amarin Pharma, Inc., holds 16 patents related to a pharmaceutical product known as Vascepa® (icosapent ethyl), an adjunct to diet to reduce triglyceride levels in patients. Named defendant Apotex and five other defendants previously filed abbreviated new drug applications (ANDA) with the FDA under Paragraph IV. Amarin alleged in six separate actions that defendants were infringing the patents. Amarin also challenged the FDA’s determination that Vascepa is entitled to only three-year market exclusivity, not five-year exclusivity. The US District Court for the District of Columbia agreed with Amarin and vacated and remanded the FDA’s decision denying five-year exclusivity for Vascepa. Based on the court order, the agency suspended review of all ANDAs filed by the defendants and informed the defendants that if it determines Vascepa qualifies for five-year exclusivity, the exclusivity would bar submission of an ANDA that references Vascepa until at least July 26, 2016, and that it considers the ANDAs by the defendants to have been “submitted, but not yet received.” Amarin filed a motion to dismiss under Rule 41(a)(2).
Acceptance of an ANDA by the FDA triggers the statutory act of patent infringement under 35 USC §271(e). It is this act of infringement that provides the case or controversy for the court to exercise subject-matter jurisdiction over Hatch-Waxman patent infringement cases. The court stated that the FDA’s role in accepting an ANDA for review, so that it is received and not merely delivered, acts as a safeguard against premature litigation. In this case, the FDA effectively informed the defendants that it had suspended review and considered the ANDAs not yet received. Granting the motion to dismiss, the court concluded that the FDA had effectively revoked its acceptance for the ANDAs at issue due to a recent court order, which rendered the dispute no longer judiciable. The court stated that there was nothing for the court to adjudicate because the ANDA litigation process cannot proceed without the existence of a “received” ANDA by the FDA. Thus, the statutory act of patent infringement no longer existed and there was no case or controversy. The court also held that any pending counterclaims in the consolidated action would be also dismissed without prejudice.
This case affirms that an ANDA is not considered filed until the FDA acknowledges receipt. Accordingly, an ANDA applicant must notify the patent holder following confirmation from the FDA that the ANDA has been accepted as received. Further, even if an ANDA had been filed with the FDA, courts would not exercise subject-matter jurisdiction over an ANDA action if the FDA suspended review and revoked a previously accepted ANDA as a result of a court order, e.g., a pending decision on the length of market exclusivity by the agency.