IPR Petitioner Has No Standing Without Showing of Injury in Fact

In Argentum Pharm. LLC v. Novartis Pharm. Corp., No. 2018-2273 (Fed. Cir. Apr. 23, 2020), the Federal Circuit dismissed Argentum’s appeal from a PTAB decision, finding that Argentum failed to show “injury in fact” required for Article III standing.

Argentum joined an IPR challenging a Novartis patent covering Gilenya®. After the Board found the challenged claims not unpatentable, petitioners appealed to the Federal Circuit. All petitioners other than Argentum subsequently settled with the Patent Owner, leaving Argentum as the only appellant.

Attempting to establish injury-in-fact required to establish standing, Argentum presented three arguments. Argentum first argued it faces a real and imminent “threat of litigation” by Novartis, based on the argument that Argentum was jointly pursuing, with its partner KVK, a generic copy of Gilenya® in connection with an ANDA, which they were in the process of filing. The Court rejected this argument because any future ANDA filing would be by KVK, and therefore KVK, not Argentum, would risk being sued. Second, Argentum argued it will incur economic injury in pursuing a generic copy of Gilenya® and filing an ANDA. The Court rejected Argentum’s economic injury argument, finding Argentum failed to show investments specific to a generic copy of Gilenya® or an ANDA, and therefore Argentum’s alleged loss was “conclusory and speculative.” Third, Argentum argued that estoppel under § 315(e) satisfies the injury-in-fact requirement. The Court also rejected Argentum’s estoppel argument, noting that it previously had concluded that invocation of the estoppel provision is not sufficient to establish standing. Accordingly, the Court dismissed Argentum’s appeal for lack of standing.

For more discussion on Article III standing, please see Navigating Evolving Standing Requirements for Appeals from the PTAB.