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

Impax Laboratories Inc. v. Lannett Holdings Inc.

Obviousness Analysis Considers Prior Art Record As a Whole

Impax Laboratories Inc. v. Lannett Holdings Inc., __ F.3d __, 2018 WL 3150007 (Fed. Cir. June 28, 2018) (LOURIE, Dyk, Taranto) (D. Del.: Andrews) (2 of 5 stars)

Fed Cir affirms Hatch-Waxman judgment that Impax’s claims were not proved invalid. Impax’s patents related to formulations of zolmitriptan (Zomig) for intranasal administration (treatment of migraines is a listed use for Zomig). Taking the prior art as a whole, the district court did not err in determining that the prior art taught away from nasal formulations. The opinion discusses the references, noting that intranasal formulation of zolmatriptan is “barely mentioned” therein, and the testimony of an expert that the metabolic characteristics of zolmatriptan (as opposed to other triptans) were of particular importance. Taking the record as a whole, there was no reversible error by the district court. The district court also did not err in taking into account the value of a license covering Zomig, a portion of which was held to relate to intranasal formulations. The district court also did not err on the ultimate issue of obviousness. The opinion discusses the record and, although the case was “close,” the Fed Cir defers to the district court and its findings, noting particularly the testimony of Impax’s expert and the license as evidence of nonobviousness.

KEYWORDS: HATCH-WAXMAN; OBVIOUSNESS (NO)