Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., Appeal No. 2018-2273 (Fed. Cir., April 23, 2020).
Argentum and other petitioners filed IPRs against Novartis’ patent related to methods of treating relapsing-remitting multiple sclerosis. Novartis prevailed before the PTAB. All petitioners then settled but for Argentum.
On appeal, Novartis challenged Argentum’s Article III standing to proceed in federal court. Argentum provided three arguments to show that is would suffer an injury in fact to support Article III standing: (1) Novartis would sue Argentum and its partner KVK-Tech, Inc. upon the filing of an ANDA; (2) Argentum would suffer economic injury since a lawsuit would be “looming” over Argentum; and (3) Argentum faces an estoppel due to 35 USC §315. Novartis countered that: (1) KVK, and not Argentum, would be sued; (2) any alleged economic injury was speculative; and (3) estoppel was not shown to be harmful since Argentum had not shown that there was a risk of an infringement suit by Novartis.
The Federal Circuit rejected each of Argentum’s arguments, and dismissed Argentum’s appeal for lack of standing.