BAYER PHARMA AG, BAYER INTELLECTUAL PROPERTY GMBH, BAYER HEALTHCARE PHARMACEUTICALS, INC., Plaintiffs-Appellees
WATSON LABORATORIES, INC., ACTAVIS PHARMA, INC., Defendants-Appellants
from the United States District Court for the District of
Delaware in No. 1:12-cv-00517-GMS, Judge Gregory M. Sleet.
I. Berl, Williams & Connolly LLP, Washington, DC, argued
for plaintiffs-appellees. Also represented by Bruce
Genderson, Dov Philip Grossman, Aaron P. Maurer, Adam
Lawrence Perlman, Thomas S. Fletcher, Galina I. Fomenkova.
William M. Jay, Goodwin Procter LLP, Washington, DC, argued
for defendants-appellants. Also represented by Elizabeth
Holland, Robert V. Cerwinski, Brian Robinson, New York, NY;
David Zimmer, Boston, MA.
Lourie, Moore, and O'Malley, Circuit Judges.
Laboratories, Inc. appeals the District of Delaware's
final judgment holding Watson failed to prove by clear and
convincing evidence that claims 9 and 11 of U.S. Patent No.
8, 613, 950 ("the '950 patent") would have been
obvious. We hold the district court clearly erred in finding
a skilled artisan would not have been motivated to use the
claim elements. Considering the district court's clear
error together with the remainder of its fact findings, we
conclude that claims 9 and 11 of the '950 patent would
have been obvious. We therefore reverse.
2003, the Food & Drug Administration ("FDA")
granted Bayer approval to market vardenafil
hydrochlo-ride trihydrate to treat erectile dysfunction
("ED") under the name Levitra. Vardenafil belongs
to a class of ED drugs called phosphodiesterase inhibitors.
When the FDA approved Levitra, two other phosphodiesterase
inhibitors were already on the market: Pfizer launched
sildenafil under the name Viagra in 1998, and Eli Lilly
launched tadalafil under the name Cialis in 2003. Levitra,
Viagra, and Cialis are each formulated as immediate-release
tablets that are swallowed whole.
'950 patent issued on December 24, 2013. It claims
priority to March 1, 2005 and lists Bayer as its assignee. It
is directed to a formulation of vardenafil "in the form
of an uncoated tablet which disintegrates rapidly in the
mouth, " commonly referred to as an oral disintegrating
tablet ("ODT"). See '950 patent at
claim 8. Bayer markets a commercial embodiment of the
'950 patent, vardenafil ODT, under the name Staxyn.
filed an Abbreviated New Drug Application ("ANDA")
with the FDA seeking approval to market a generic version of
Staxyn. Bayer filed the instant case asserting infringement
of the '950 patent. Claims 9 and 11, both of which depend
from claim 8, are the only claims at issue:
8. A drug formulation in the form of an uncoated tablet which
disintegrates rapidly in the mouth and releases the drug in
the mouth without swallowing the tablet comprising vardenafil
hydro-chloride trihydrate, and at least two sugar alcohols.
9. The drug formulation according to claim 8, wherein said
sugar alcohols are a mixture of sorbitol and mannitol.
11. The drug formulation of claim 8, wherein at least one
sugar alcohol is sorbitol.
parties agree that claim 8's requirement that the
formulation "releases the drug in the mouth" means
it is an immediate-release formulation.
district court held a six-day bench trial to consider the
validity of the '950 patent. Watson argued the claimed
formulation of vardenafil would have been obvious to a person
of ordinary skill in the art based on multiple exemplary
references showing a motivation to: (1) create an ODT
formulation of vardenafil; (2) select mannitol and sorbitol as
sugar alcohols; and (3) make the ODT formulation
immediate-release. The district court rejected each of
Watson's arguments. It found a person of ordinary skill
in the art would not have been motivated to create an ODT
formulation of vardenafil and would not have used mannitol
and sorbitol as excipients. It found the prior art taught
away from formulating vardenafil ODT as immediate-release.
The district court also addressed Bayer's objective
evidence of nonobviousness and found it supported its
conclusion that Watson failed to prove by clear and
convincing evidence that claims 9 and 11 would have been
obvious. Watson appeals. We have jurisdiction pursuant to 28
U.S.C. § 1295(a)(1).
patent may not issue "if the differences between the
subject matter sought to be patented and the prior art are
such that the subject matter as a whole would have been
obvious at the time the invention was made to a person having
ordinary skill in the art to which said subject matter
pertains." 35 U.S.C. § 103. Obviousness depends on
the following factual determinations: "(1) the scope and
content of the prior art; (2) the differences between the
prior art and the claims at issue; (3) the level of ordinary
skill in the art at the time the invention was made; and (4)
objective evidence of nonobviousness, if any." In re
Kubin, 561 F.3d 1351, 1356 (Fed. Cir. 2009) (citing
Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966)).
On appeal from a bench trial, we review the district
court's findings of fact for clear error. Pfizer,
Inc. v. Apotex, Inc., 480 F.3d 1348, 1359 (Fed. Cir.
2007). "A finding is 'clearly erroneous' when[,
] although there is evidence to support it, the reviewing
court on the entire evidence is left with the definite and