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

Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC

Searchability, Indexing Not Strict Requirements for Finding a Printed Publication Online

Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, __ F.3d __, 2018 WL 3400764 (Fed. Cir. July 13, 2018) (Newman, LOURIE, Reyna) (PTAB) (3 of 5 stars)

Fed Cir affirms IPR determination of obviousness. The case related to Jazz’s patents for tracking prescriptions of a “sensitive” (i.e., abuse-prone) drug. Jazz’s Xyrem anti-narcolepsy drug is a Schedule III depressant due to instances of illicit use of its active ingredient GHB (gamma-hydroxybutyrate) as a date-rape drug. In 2001 the FDA had held an advisory committee meeting to deliberate risk management issues for Xyrem. The PTAB correctly determined that certain meeting materials posted to the FDA website and cited in the Federal Register relating to that meeting were printed publications, and thus prior art to Jazz’s patents. The opinion reasons that the FDA-distributed material was “disseminated more broadly and for a longer duration to persons of ordinary skill” than other disclosures found to be printed publications in MIT (774 F.2d 1104 (Fed. Cir. 1985)), Klopfenstein (380 F.3d 1345 (Fed. Cir. 2004)), and Medtronic (891 F.3d 1368 (Fed. Cir. 2018)). It notes that the material was specifically directed to individuals of ordinary skill, was online for a significant amount of time pre-patent, and had no possible expectation of confidentiality. It rejects Jazz’s argument that the material had to be indexable or searchable to meet the requirements of a printed publication, and notes that in any case the Federal Register was indexed.

The opinion also finds no error in the Board’s claim interpretation, and the record supported its determination of obviousness. The opinion rejects Jazz’s argument that there were inconsistencies in the Board’s determination of motivation to combine. KSR, 550 U.S. 398 (2007), did not impose a rigid requirement of findings as to a specific problem to be solved, and a finite number of solutions. While those may be part of an obviousness analysis, they are not mandatory.

KEYWORDS: INTER PARTES REVIEW; OBVIOUSNESS (YES); PRINTED PUBLICATION