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

In re Copaxone Consolidated Cases

“Obvious to Try” Permissible Where Prior Art Narrowed POSITA’s Options

In re Copaxone Consolidated Cases906 F.3d 1013 (Fed. Cir. Oct. 12, 2018) (REYNA, Bryson, Stoll) (D. Del.: Sleet) (3 of 5 stars)

Fed Cir affirms judgment of invalidity for obviousness in Hatch-Waxman case. The asserted patents describe and claim glatiramer acetate (“GA”), sold by Teva as Copaxone, used to treat relapsing-remitting multiple sclerosis. The district court did not err in construing certain claim terms as non-limiting statements of intended effect. As in Bristol Myers, 246 F.3d 1368 (Fed. Cir. 2001), the terms merely recited a purpose/intended result of the claimed method. The opinion rejects Teva’s arguments that the terms were added during prosecution to overcome rejections; the amendment in question also included separate language aimed at overcoming a § 112 rejection; thus the addition of the disputed term was neither necessary nor relevant to the examiner’s approval.

The district court also did not err in its obviousness analysis. The opinion rejects Teva’s argument that the district court applied an “obvious to try” analysis prohibited under KSR, 550 U.S. 398 (2007). The opinion describes how, in this case, “a POSITA had only a limited number of permutations of dose and frequency to explore that were not already disclosed in the prior art.” 906 F.3d at 1025. It rejects Teva’s argument that the district court applied hindsight, and notes that the prior art gave direction toward a successful result. It also rejects Teva’s argument that the district court failed to apply the whole claim, but analyzed dose and frequency limitations separately. The district court’s approach was appropriate under the frequency-and-dosage approach of Hoffman-La Roche, 748 F.3d 1326 (Fed. Cir. 2014). The opinion also rejects Teva’s various challenges to the district court’s factual findings.

The opinion rejects Teva’s argument that In re Cyclobenzaprine, 676 F.3d 1063 (Fed. Cir. 2012), barred an obviousness determination absent evidence that certain details of GA’s pharmacokinetic and pharmacodynamic (“pk/pd”) was in the prior art. Cyclobenzaprine does not establish a “rigid rule categorically precluding obviousness findings without pk/pd date,” 906 F.3d at 1028, and is distinguishable in any event, as the present case does not rely on bioequivalence.

The opinion also rejects other factual attacks by Teva concerning the state of the prior art and the evidence relied on to support the district court’s findings.

KEYWORDS: HATCH-WAXMAN; OBVIOUSNESS; OBVIOUS TO TRY; CLAIM CONSTRUCTION