Search Team

Search by Last Name
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z

Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp.

Plans to Have Partner File ANDA Insufficient to Establish Article III Standing for IPR Appeal

Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., __ F.3d __, 2020 WL ___ (Fed. Cir. Apr. 23, 2020) (Lourie, MOORE, Reyna) (PTAB) (2 of 5 stars)

Fed Cir dismisses Argentum’s appeal from IPR decision confirming patentability of Novartis’s claims. The opinion describes joinders by the PTAB that resulted in three appeals from the FWD, but prior to the present opinion the other appellants (Sun, Teva, Actavis, and Apotex) settled with Novartis and the Fed Cir dismissed their appeals. Argentum, the sole remaining appellant, lacks Article III standing because it is unable to demonstrate an injury in fact from the FWD. Argentum’s plans to have its manufacturing and marketing partner KVK-Tech file an ANDA for a generic of Novartis’s Gilenya product do not suffice because no ANDA has yet been filed and, even if one had been, it would be against KVK. Further “Argentum has not provided evidence showing that it would bear the risk of any infringement suit or anything related to its involvement in the ANDA process beyond generic statements.” Op. at 5. Altaire, 889 F.3d 1274 (Fed. Cir. 2018), does not require otherwise because in that case the appellant had identified a real and imminent threat of litigation affecting it personally. Argentum’s contention of economic injury associated with potential litigation by Novartis is also deficient because Argentum did not provide sufficient evidence to establish an injury in fact. And per AVX, 923 F.3d 1357 (Fed. Cir. 2019), the imposition of § 315(e) estoppel on Argentum, without more, does not establish standing.

KEYWORDS: INTER PARTES REVIEW; STANDING; HATCH-WAXMAN