In Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., [2018-2273] (April 23, 2020), the Federal Circuit dismissed the appeal, noting that the appellant remaining after settlement lacked Article III standing to appeal the PTAB’s IPR decision.
The Federal Circuit said that although it had jurisdiction to review final decisions of the Board under 28 U.S.C. § 1295(a)(4)(A), an appellant must meet the irreducible constitutional minimum of standing. This is true even if there is no such requirement in order to appear before the administrative agency being reviewed.
The Federal Circuit said that to prove standing, Argentum bears the burden of showing that the following:
- That it has suffered an injury in fact;
- That the injury is fairly traceable to the challenged conduct of the defendant;
- And that the injury is likely to be redressed by a favorable judicial decision.
The Federal Circuit added that Argentum must supply the requisite proof of an injury in fact when it seeks review of an agency’s final action in a federal court, by creating a necessary record in this court, if the record before the Board does not establish standing.
To establish injury in fact, an appellant must show that he or she suffered an invasion of a legally protected interest that is concrete and particularized and actual or imminent, not conjectural or hypothetical. An injury is particularized if it affects the appellant in a personal and individual way.
Argentum argued that it demonstrated at least three concrete injuries in fact. First, without an opportunity to appeal, it faces a real and imminent threat of litigation as it jointly pursues a generic version of Novartis’ Gilenya® product; but the Federal Circuit found that any ANDA would not be filed by Argentum, but by its manufacturing and marketing partner.
Second, Argentum argued that it will incur significant economic injury as its investments in developing a generic version of Gilenya® and preparing an ANDA would be at risk, but the Federal Circuit found that Argentum had not provided sufficient evidence to establish an injury in fact through economic harm.
Third, Argentum argued that it would be estopped under 35 U.S.C. § 315(e) from raising the patentability and validity issues in a future infringement action, but the Federal Circuit said that it had already rejected invocation of the estoppel provision as a sufficient basis for standing.
Accordingly, the Federal Circuit held that Argentum has failed to prove that it has suffered an injury in fact necessary to establish standing.