Addressing the issue of Article III standing in an appeal of an inter partes review (IPR) decision, the US Court of Appeals for the Federal Circuit dismissed the appeal because the party appealing failed to establish an injury sufficient to confer standing. Argentum Pharms. LLC v. Novartis Pharms. Corp., Case No. 18-2273 (Fed. Cir. Apr. 23, 2020) (Moore, J.).

Apotex filed an IPR petition of a patent owned by Novartis. The Patent Trial and Appeal Board (PTAB) instituted proceedings and granted Sun (and related entities), Teva, Actavis and Argentum’s (collectively, Petitioners) requests for joinder under 35 U.S.C. § 315(c). After PTAB concluded that Petitioners did not demonstrate unpatentability of the patent claims, Petitioners appealed.

Before opening briefs were filed, Novartis filed a motion to dismiss Argentum’s appeal for lack of standing. Argentum opposed and included declarations from the CEOs of Argentum and KVK, Argentum’s manufacturing and marketing partner. KVK was working with Argentum to develop a generic version of Novartis’ Gilenya® product and prepare an Abbreviated New Drug Application (ANDA). The Court directed the parties to address the standing issue in their briefs. During the appeal, all Petitioners settled with Novartis, except Argentum. Novartis submitted a notice of supplemental authority arguing that Article III standing was a threshold issue that must be assessed before addressing the merits of the case because Argentum was the only remaining appellant.

The Federal Circuit granted Novartis’ motion to dismiss the appeal, finding that Argentum failed to prove that it has suffered an injury in fact necessary to establish Article III standing. Argentum had the burden of proving standing by showing it has suffered an injury in fact that is fairly traceable to the challenged conduct, and that the injury is likely to be redressed by a favorable judicial decision. The Court rejected Argentum’s three arguments that it demonstrated concrete injuries in fact.

First, the Court stated that Argentum had not presented evidence that it would bear the risk of an infringement suit because no ANDA has been filed, and any ANDA to be filed would be filed by KVK – not Argentum. Second, the Federal Circuit found that Argentum’s alleged economic injury from investments in developing a generic product were stated only in generalities, and thus were conclusory and speculative. Finally, the Court noted that Argentum cannot invoke estoppel under 35 U.S.C. § 315(e) as a sufficient basis for standing where it has not established that it is engaged in any activity that would give rise to a possible infringement suit.