Fingolimod – USA

On Apr. 23, 2020, Federal Circuit dismissed Argentum’s appeal for lack of standing without reaching merit of the case.

Petitioners such as Apotex, Sun pharma, Teva/Actavis & Argentum filed IPRs on US 9,187,405 patent with PTAB. On July 11, 2018, the Board concluded that Apotex, Sun, Teva, Actavis, and Argentum had not demonstrated unpatentability of the claims. Petitioners appealed the Board’s findings. During the appeal process, all Petitioners other than Argentum settled their respective appeal with Novartis. On August 29, 2018, before opening briefs had been filed, Novartis filed a motion to dismiss Argentum’s appeal for lack of standing.

Court said that to prove standing, Argentum bears the burden of showing that it has “(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” Argentum argued that it demonstrated at least three concrete injuries in fact.

First, Argentum argued that without an opportunity to seek this Court’s redress, it faces a real and imminent threat of litigation as it jointly pursues, along with its partner KVK-Tech, Inc., a generic version of Novartis’ Gilenya® product for which they are in the process of filing an ANDA. It  further argued that given that Novartis already sued multiple generic companies to protect Gilenya®, “it is virtually certain that Novartis will sue Argentum and KVK,” which is “far from conjectural” and “constitutes an imminent injury for purposes of standing.” Novartis responded that any ANDA to be filed for a generic version of Gilenya® “will be filed by KVK, Argentum’s manufacturing and marketing partner”, and thus KVK, not Argentum is at risk of being sued. And even if the litigation were personal to Argentum, it would not confer standing because it is merely conjectural. Citing decision in “Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc.”, Argentum responded that “showing a concrete injury-in-fact does not necessitate an already-filed ANDA.” Court said that in Altaire, Altaire was the company which intended to file an ANDA and would be at imminent risk of being sued. Unlike in Altaire, according to Mr. Gardner (Argentum’s CEO), any ANDA to be filed will be filed by KVK, Argentum’s manufacturing and marketing partner & Novartis will inevitably sue KVK for patent infringement.

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 with a “looming infringement action by Novartis.” Novartis argued that Argentum’s alleged “economic injury,” which is entirely speculative and not personal to Argentum, does not suffice to establish injury in fact because it is not concrete or particularized. Court sided with Novartis & said that Argentum has not provided sufficient evidence to establish an injury in fact through economic harm. Argentum has failed to provide sufficient evidence that it invested in KVK’s generic Gilenya® product or ANDA. It stated only in generalities that both “KVK and Argentum have been diligent in working toward FDA submission of the ANDA” and that “Argentum has invested significant man-power and resources to the endeavor.”

Third, Argentum argued that absent relief from this court, Argentum would be estopped under 35 U.S.C. § 315(e) from raising the patentability and validity issues in a future infringement action. Novartis argued that Argentum has not shown that it will be harmed by estoppel where it has not established there is risk of an infringement suit. Court sided with Novartis & said that § 315(e) does not constitute an injury in fact when, as here, the appellant is not engaged in any activity that would give rise to a possible infringement suit.

Court held that Argentum failed to prove that it has suffered an injury in fact necessary to establish standing & thus, dismissed the appeal.