Allergan, Inc. v. Sandoz Inc.

United States Court of Appeals
for the Federal Circuit
______________________
ALLERGAN, INC.,
Plaintiff-Appellee,
v.
SANDOZ INC., ALCON LABORATORIES, INC.,
ALCON RESEARCH, LTD., ALCON, INC.,
AND FALCON PHARMACEUTICALS, LTD.,
Defendants-Appellants,
AND
APOTEX INC. AND APOTEX CORP.,
Defendants-Appellants,
AND
WATSON LABORATORIES, INC.,
Defendant-Appellant.
______________________
2011-1619, -1620, -1635, -1639
______________________
Appeals from the United States District Court for the
Eastern District of Texas in consolidated No. 09-CV-0097,
Judge T. John Ward.
______________________
Decided: May 1, 2013
______________________
JUANITA R. BROOKS, Fish & Richardson P.C., of San
Diego, California, argued for plaintiff-appellee. With her
ALLERGAN v. SANDOZ 2
on the brief were JONATHAN E. SINGER and DEANNA J.
REICHEL, of Minneapolis, Minnesota; W. CHAD SHEAR, of
Wilmington, Delaware.
DEANNE E. MAYNARD, Morrison & Foerster, LLP, of
Washington, DC, argued for all defendants-appellants.
With her on the brief was BRIAN R. MATSUI; BRIAN M.
KRAMER, of San Diego, California. Of counsel on the brief
were KERRY B. MCTIGUE, BARRY P. GOLOB, and W. BLAKE
COBLENTZ, Duane Morris LLP, of Washington, DC. Also
on the brief were ROBERT B. BREISBLATT, STEPHEN P.
BENSON, CHRISTINE E. BESTOR and DENNIS C. LEE, Kat-
ten, Muchin & Rosenman LLP, of Chicago, Illinois, for
defendants-appellants Apotex Inc., et al, and GARY E.
HOOD, Polsinelli Shughart PC, of Chicago, Illinois, for
defendant-appellant Watson Laboratories, Inc. Of coun-
sel was RICHARD T. RUZICH, Katten, Muchin & Rosenman
LLP, of Chicago, Illinois, for defendants-appellants
Sandoz Inc., et al.
______________________
Before DYK, PROST, and O’MALLEY Circuit Judges.
Opinion for the court filed by Circuit Judge PROST. Opin-
ion concurring-in-part and dissenting-in-part filed by
Circuit Judge DYK.
This patent infringement case involves a combination
ophthalmic drug treatment. The issues on appeal are
invalidity and claim construction. Sandoz Inc., Alcon
Laboratories, Inc., Alcon Research Ltd., Alcon, Inc., and
Falcon Pharmaceuticals, Ltd. (collectively, “Sandoz”)
challenge the district court’s finding that the claims of
U.S. Patent Nos. 7,642,258 (“’258 patent”); 7,320,976
(“’976 patent”); 7,323,463 (“’463 patent”); and 7,030,149
(“’149 patent”) are not invalid under 35 U.S.C. § 103.
Allergan challenges the court’s construction of certain
claims. We find that the district court erred in finding the
claims of the ’463 patent not invalid as obvious. The
ALLERGAN v. SANDOZ 3
defendants, however, failed to prove by clear and convinc-
ing evidence that claim 4 of the ’149 patent would have
been obvious. Additionally, we find no error in the dis-
trict court’s claim construction. Accordingly, we affirm-in-
part and reverse-in-part.
I. PROCEDURAL HISTORY
This action arises under the Hatch-Waxman Act,
which enables the approval and marketing of generic
drugs. Each of the Appellants in this case submitted to
the U.S. Food and Drug Administration (“FDA”) an Ab-
breviated New Drug Application (“ANDA”) seeking ap-
proval to market a generic version of Allergan’s
Combigan®, a combination eye-drop product used for
treating glaucoma comprising 0.2% brimonidine and 0.5%
timolol. Allergan sued under 35 U.S.C. § 271(e)(2)(A)
claiming that the Appellants infringed each and every
claim of Allergan’s four Orange Book-listed patents for
Combigan® including the ’258, ’976, ’463, and ’149 pa-
tents, each of which stems from an application filed on
April 19, 2002. According to the Orange Book, the ’258,
’976, and ’149 patents expire on April 19, 2022 and the
’463 patent expires on January 19, 2023.
Prior to trial, but after claim construction, the district
court granted summary judgment of non-infringement as
to claims 1-3 of the ’149 patent. The parties stipulated to
infringement of the other asserted claims. As such, the
only issue tried to the district court was the issue of
invalidity. After a bench trial, the court entered judg-
ment finding each of the asserted claims not invalid.
On appeal, Sandoz challenges the district court’s find-
ing that the asserted claims are not invalid as obvious
under 35 U.S.C. § 103. Allergan attempted to cross-
appeal the district court’s construction of claims 1-3 of the
’149 patent and the subsequent entry of summary judg-
ment of non-infringement. We found that, with respect to
Allergan, there was no adverse judgment on the validity
ALLERGAN v. SANDOZ 4
of claims 1-3 of the ’149 patent and, therefore, a cross-
appeal would be improper. Allergan, Inc. v. Sandoz Inc.,
2012 U.S. App. LEXIS 6926, *6 (Fed. Cir. Apr. 4, 2012).
We did, however, explain that Allergan was free to raise
their claim construction arguments in its response brief
as part of the present appeal. Id.II. BACKGROUND
Combigan®, which is used to treat glaucoma, is a
combination of the well-known alpha2-agonist Alphagan®
(0.2% brimonidine) and the well-known beta-blocker
Timoptic® (0.5% timolol), both of which are also used to
treat glaucoma. Notably, Combigan® contains the pre-
servative benzalkonium chloride (“BAK”), which is widely-
used in ophthalmic formulations including Alphagan®
and Timoptic®.
A. The Asserted Claims
Allergan holds four patents related to Combigan®: the
’463 patent, the ’149 patent, the ’258 patent, and the ’976
patent. The asserted claims are directed to a composition
of 0.2% brimonidine and 0.5% timolol, expressed in differ-
ent ways, some claims are directed to a fixed combination
of brimonidine and timolol, others are directed to a meth-
od of treating glaucoma or ocular hypertension by admin-
istering the composition twice daily, and others are
directed to an article of manufacture comprising packag-
ing material indicating that twice daily administration of
the composition is useful for treating glaucoma or ocular
hypertension. Claim 1 of the ’463 patent is exemplary
and provides:
1. A composition comprising about 0.2% timolol by
weight and about 0.5% brimonidine by weight as
the sole active agents, in a single composition.
The other claims of the ’463 patent include additional
limitations directed to the amount of BAK in the composi-
tion and to packaging material that indicates that the
ALLERGAN v. SANDOZ 5
composition is useful for treating glaucoma or ocular
hypertension by twice a day topical administration of the
composition to a person’s eye. In their briefs, the parties
generally treat the claims as a group and, with the excep-
tion of claim 4 of the ’149 patent, do not argue them
individually. As such, with the exception of claim 4, we
treat the claims collectively.
Claim 4 of the ’149 patent is directed to reducing the
daily number of doses of brimonidine without loss of
efficacy by administering brimonidine in a fixed combina-
tion with timolol. Claim 4 reads as follows:
4. A method of reducing the number of daily topi-
cal ophthalmic doses of brimondine administered
topically to an eye of a person in need thereof for
the treatment of glaucoma or ocular hypertension
from 3 to 2 times a day without loss of efficacy,
wherein the concentration of brimonidine is 0.2%
by weight, said method comprising administering
said 0.2% brimonidine by weight and 0.5% timolol
by weight in a single composition.
B. The Prior Art
Sandoz’s obviousness argument is based primarily
upon U.S. Patent No. 5,502,052 titled “Use of a Combina-
tion of Apraclonidine and Timolol to Control Intraocular
Pressure” (“DeSantis”), which teaches fixed combinations
of alpha2-agonists and beta-blockers for the treatment of
glaucoma. DeSantis explains that a significant number of
glaucoma patients require more than one drug to achieve
therapeutic reduction of intraocular pressure. col. 1 ll. 42-
46. DeSantis also teaches that then-existing treatment
regimens requiring administration of two or more medica-
tions in separate, spaced dosages, several times a day
often resulted in poor patient compliance, particularly in
elderly patients. col. 2 ll. 1-9. DeSantis teaches the
amount of alpha2-agonist included in the fixed combina-
tion is from 0.02 to 2.0% by weight. col. 4 ll. 58-61.
ALLERGAN v. SANDOZ 6
DeSantis expressly teaches the use of the beta-blocker
timolol in a fixed combination with alpha2-agonists. col. 5
l. 34. Moreover, timolol is the only beta-blocker claimed
in DeSantis. col. 6 ll.4 2-48. DeSantis teaches that the
preferred amount of beta-blocker in the fixed combination
is from 0.01 to 3.0% by weight. col. 5 ll. 37-40. DeSantis
also discloses the use of BAK as a preservative. col. 5 l.
41–col. 6 l. 1. DeSantis specifically discloses BAK when it
discusses “formulatory ingredients” such as “benzalkoni-
um chloride” that “will typically be employed in an
amount of from, about 0.001% to 1.0% by weight (wt. %).”
Id.DeSantis does not expressly state that brimonidine is
one of the alpha2-agonists that can be used in the combi-
nation. DeSantis does, however, teach that the alpha2-
agonists that may be used in the invention are described
in a publication by Timmermans et al. titled “Structure-
Activity Relationships in Clonidine-Like Imidazolidines
and Related Compounds,” which DeSantis incorporates by
reference. col. 4 ll. 43-50. Timmermans discloses both
brimonidine and its tartrate salt. J.A. 1093–94; J.A.
1104–05.
Sandoz adduced other evidence relevant to obvious-
ness. For instance, at the time of the invention, the
topical administration of 0.2% brimonidine with 0.5%
timolol in combination—spaced five minutes apart—was
taught in an article published in the Archives of Oph-
thalmology, titled “Aqueous Humor Flow in Normal
Human Eyes Treated With Brimonidine and Timolol”
(“Larsson”). Additionally, it was common at the time of
the invention to dose the serial application of brimonidine
and timolol twice per day rather than the three times per
day as was common to stand alone brimonidine therapy.
J.A. 633–36; see also J.A. 7586. It was also known that
both the commercially available forms of brimonidine and
timolol contained BAK. J.A. 60.
ALLERGAN v. SANDOZ 7
Moreover, at the time of the invention, there were on-
ly three known pharmaceutically acceptable alpha2-
agonists for treating glaucoma or ocular hypertension,
clonidine, apraclonidine, and brimonidine. J.A. 587–89,
780, 537. At that time, only brimonidine was available in
the United States for chronic use. J.A. 536–37. There
were at least four other fixed combination products for the
treatment of ocular hypertension and glaucoma on the
market at the time of invention. J.A. 631. Additionally,
the prior art taught advantages associated with certain
fixed combinations including a 1998 article in Journal of
the American Academy of Ophthalmology by
Clineschmidt that concluded that a fixed combination of
dorzolamide and timolol dosed twice a day was more
effective than dorzolamide alone dosed three times a day;
and a 1987 article in American Journal of Ophthalmology
by Airaksinen that concluded that the fixed combination
of timolol and pilocarpine dosed twice a day had a similar
intraocular pressure reduction as pilocarpine alone dosed
four times a day.
III. OBVIOUSNESS
The determination of obviousness under 35 U.S.C.
§ 103 is a legal conclusion based on underlying facts.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966). After a
bench trial, we “review the district court’s factual findings
for clear error and its conclusions of law de novo.” Winner
Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1344–45 (Fed.
Cir. 2000).
The underlying factual considerations in an obvious-
ness analysis include the scope and content of the prior
art, the differences between the prior art and the claimed
invention, the level of ordinary skill in the art, and any
relevant secondary considerations. See Graham, 383 U.S.
at 17–18. Relevant secondary considerations include
commercial success, long-felt but unsolved needs, failure
of others, and unexpected results. KSR Int’l Co. v. Tele-
ALLERGAN v. SANDOZ 8
flex Inc., 550 U.S. 398, 406 (2007); In re Soni, 54 F.3d 746,
750 (Fed.Cir. 1995). Patents are presumed valid; accord-
ingly, Sandoz was required to prove that the asserted
claims were obvious by clear and convincing evidence.
See Microsoft Corp. v. i4i Ltd. P’ship, 131 S. Ct. 2238,
2242 (2011).
A. The ’463 Patent
Sandoz makes a strong case that the claims of the
’463 patent would have been obvious. Both timolol and
brimonidine were commercially available drugs used for
opthamalic conditions at the time of the invention. More-
over, they were available in their claimed concentrations,
contained the preservative BAK, and the commercially
available form of brimonidine—Alphagan®—contained
BAK in the claimed concentration. At the time of the
invention, it was known that the serial administration of
brimonidine and timolol reduced intraocular pressure
greater than either timolol or brimonidine alone. Moreo-
ver, DeSantis expressly provided a motivation to formu-
late fixed combinations of alpha2-agonists and beta
blockers, including timolol, in order to increase patient
compliance.
In finding that Sandoz failed to prove the asserted
claims obvious, the district court made a series of findings
that are relevant to the obviousness analysis. First, the
court found that there would be no motivation to create
the combination product because the FDA did not view
patient compliance as a factor for approval. Second, the
court found that the formulation arts are unpredictable.
Third, the court also found that there were some teach-
ings in the prior art that taught away from the claimed
invention. Finally, the court found that there were sec-
ondary considerations that support the finding of nonob-
viousness including long-felt need and unexpected results.
We discuss each of these findings in turn.
ALLERGAN v. SANDOZ 9
1. Motivation to Combine
As noted above, DeSantis provides an express motiva-
tion to combine alpha2-agonists and beta blockers in order
to increase patient compliance. The district court, howev-
er, found that “while patient compliance may have creat-
ed a need for fixed combination products, it did not
motivate a person of skill in the art to develop fixed
combinations with a reasonable expectation of success,
because the FDA did not consider improving patient
compliance as a factor in its approval decision.” Allergan,
Inc. v. Sandoz Inc., 818 F. Supp. 2d 974, 1016 (E.D. Tex.
2011). We agree with the district court that FDA approv-
al may be relevant to the obviousness analysis, however,
we find clear error in the court’s conclusion that one of
ordinary skill would not be motivated to develop fixed
combinations with a reasonable expectation of success.
We have previously noted that FDA approval may be
relevant to the obviousness inquiry. See Knoll Pharm.
Co., Inc. v. Teva Pharms. USA, Inc., 367 F.3d 1381, 1385
(Fed. Cir. 2004) (considering the failure of others to obtain
FDA approval as relevant objective indicia of nonobvious-
ness). The potential for FDA approval also may properly
be considered, as it was here, in determining whether one
of ordinary skill would be motivated to develop a drug
product and whether there was skepticism regarding the
efficacy of such a product. Nevertheless, we find the
district court erred in concluding that one of ordinary skill
would not be motivated to develop a fixed combination
product to increase patient compliance because the FDA
did not consider that particular motivation when evaluat-
ing drug applications. There is no requirement in patent
law that the person of ordinary skill be motivated to
develop the claimed invention based on a rationale that
forms the basis for FDA approval. Motivation to combine
may be found in many different places and forms; it
cannot be limited to those reasons the FDA sees fit to
consider in approving drug applications.
ALLERGAN v. SANDOZ 10
When viewed under the proper standard, the evidence
of record establishes a motivation to combine brimonidine
and timolol into a fixed combination product. Not only
does DeSantis teach the fixed combination of timolol with
an alpha2-agonist, numerous other references teach the
fixed combination of other ophthalmic drugs. Allergan,
Inc., 818 F. Supp. 2d at 1016-17. In fact, there were at
least four other fixed combination products for the treat-
ment of ocular hypertension and glaucoma on the market
at the time of invention. J.A. 631. Moreover, it was
common at the time of the invention to provide brimoni-
dine and timolol to a patient in serial fashion and DeSan-
tis taught that by combining drugs in a fixed-combination
formulation, patient compliance could be increased.
Accordingly, we find clear error in the district court’s
finding that there was no motivation to develop a fixed
combination brimonide/timolol product.
2. Reasonable Expectation of Success
The district court found that unpredictability in the
chemical arts also weighed in favor of nonobviousness. In
reaching this conclusion, the district court relied both on
general statements regarding the unpredictability associ-
ated with developing drug formulations and specific
challenges associated with the development of
Combigan®. While we agree that formulation science
carries with it a degree of unpredictability, “obviousness
cannot be avoided simply by a showing of some degree of
unpredictability in the art so long as there was a reasona-
ble probability of success.” Pfizer, Inc. v. Apotex, Inc., 480
F.3d 1348, 1364 (Fed. Cir. 2007). Here, there was a
reasonable expectation of success based upon the teach-
ings of DeSantis. DeSantis showed that alpha2-agonists
and beta blockers are complementary and should be used
together. DeSantis further provided that BAK could be
successfully used in the formulation. In view of DeSantis,
one of ordinary skill would have a reasonable expectation
ALLERGAN v. SANDOZ 11
of success in formulating a fixed combination product
containing brimonidine, timolol, and BAK.
We find no error in the district court’s factual finding
that Allergan’s formulators faced difficulties in developing
Combigan®. However, these difficulties are not particu-
larly probative with respect to obviousness for a number
of reasons. For example, the claims are not drawn to the
Combigan® formulation with any specificity given that
Combigan® contains many elements in addition to those
embodied in the claims. There is no requirement that one
of ordinary skill have a reasonable expectation of success
in developing Combigan®. Rather, the person of ordinary
skill need only have a reasonable expectation of success of
developing the claimed invention. More importantly,
much of the formulators’ struggles were associated with
their attempts to utilize a proprietary preservative, rather
than BAK. There is little evidence that once the formula-
tors switched their focus to BAK they struggled to develop
a formulation containing the claimed composition of
brimonidine, timolol, and BAK. Accordingly, we find that
the district court erred in finding that there was no rea-
sonable expectation of success in view of the general
unpredictability of the formulation arts and particular-
ized, yet irrelevant, difficulties associated with the devel-
opment of Combigan®.
3. Teaching Away
The district court also found that certain aspects of
the prior art taught away from the claimed invention
including the potential side effects, the different dosing
regimens in commercially available forms of brimonidine
and timolol, and the disparate half-lives of brimonidine
and timolol. Notably, the district court did not consider
what, if any, impact these aspects of the prior art would
have on the clear motivation to combine expressed in
DeSantis. Moreover, the district court did not find that
the prior art as a whole taught away from the invention
ALLERGAN v. SANDOZ 12
and we will not do so now on appeal. While we accept the
district court’s factual findings on these matters, we
cannot conclude that they render the invention nonobvi-
ous.
4. Secondary Factors
Finally, the court found that there were secondary
considerations that support the finding of nonobviousness
including long-felt need and unexpected results. We
accept the district court’s factual findings regarding the
existence of these secondary factors; however, we conclude
that these factors do not weigh heavily in the obviousness
analysis.
With respect to long-felt need, the district court’s find-
ings are entirely conclusory. The district court, without
explanation, found that there was a need for combination
products and that Combigan®, at some level, met that
need. Such perfunctory language provides us with little
help in performing our de novo review of obviousness.
The district court also found that unexpected results
weigh in favor of nonobviousness. Specifically, the court
found that there was increased efficacy of the drug and a
reduction in side-effects. The court found that previous
attempts to treat patients twice per day with brimonidine
resulted in a loss of efficacy eight to nine hours post
administration. This loss of efficacy is referred to as the
“afternoon trough.” The court found that a twice per day
dosage regimen of Combigan® unexpectedly did not suffer
from the afternoon trough issue. We agree with the
court’s finding that this result was unexpected. However,
we do not find that these unexpected results are sufficient
to outweigh the other evidence of obviousness as to these
formulation claims. While the unexpected benefits of
twice a day dosing of the combination formula are rele-
vant to Sandoz’s attack on the validity of the method
claims, we do not find it similarly meaningful to our
ALLERGAN v. SANDOZ 13
analysis of the formulation claims. There is extensive
evidence in the prior art showing the concomitant admin-
istration of brimonidine and timolol multiple times per
day, that the combination had benefits over the admin-
istration of either alone, and that there was a motivation
to combine the two to achieve better patient compliance.
KSR, 550 U.S. at 426. Whether or not that combination
also solved problems associated with the afternoon
trough, we find the motivation to make the combination
was real. Accordingly, we conclude that the claims of the
’463 patent are invalid as obvious.
B. The ’149 Patent
The district court also found that claim 4 of the ’149
patent was not invalid as obvious. Claim 4 is similar to
the claims of the ’463 patent with the exception that it
contains the additional limitation that the daily number
of doses of brimonidine be reduced from 3 to 2 times a day
without loss of efficacy. Sandoz has the burden to show by
clear and convincing evidence that claim 4 would have
been obvious. See Microsoft Corp, 131 S. Ct. at 2242. On
this front, Sandoz has a problem.
The record firmly establishes that when brimonidine
is dosed twice per day as opposed to three times per day,
there is a loss of efficacy in the afternoon—the so called,
afternoon trough. Sandoz has failed to point to evidence
in the prior art that would allow us to conclude that the
addition of timolol to brimonidine dosed twice per day
would eliminate the afternoon trough issue. At the out-
set, we note that Sandoz does not argue that this efficacy
limitation is inherent to fixed combination products
containing timolol and brimonidine, nor that a dose
reduction without loss of efficacy would inherently flow
from the obvious fixed-combination of timolol and
ALLERGAN v. SANDOZ 14
brimonidine. 1 Moreover, while it is true that the prior art
shows concomitant administration of brimonidine and
timolol was dosed twice per day, this art does not show
that there was no loss of efficacy associated with that
treatment, let alone an elimination of the afternoon
trough.
Sandoz attempts to bolster its argument by showing
that, at the time of the invention, timolol had been com-
bined with other ophthalmic drugs, though not alpha2-
1 The dissent would find claim 4 obvious on the
grounds that it merely claims the result of treatment with
an obvious composition. In support of its position, the
dissent cites a series of cases in which a patentee claimed
either a previously unknown result or an undisclosed
inherent property of an otherwise anticipated claim. In
the context of anticipation, “[n]ewly discovered results of
known processes directed to the same purpose are not
patentable because such results are inherent.” Bristol-
Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368,
1376 (Fed. Cir. 2001). We agree with the dissent that the
inherency doctrine may apply to an otherwise obvious
claim as well. There is, however, a problem with applying
that doctrine in this case.
The evidence of record does not establish that the
dose reduction “from 3 to 2 times a day without loss of
efficacy” limitation is an inherent property or a necessary
result of the administration of 0.2% brimonidine and 0.5%
timolol in a single composition. Of course, it may be true
that the mere administration of 0.2% brimonidine and
0.5% timolol twice daily in any fixed combination formu-
lation inherently produces the claimed result. Alterna-
tively, it may also be true that only certain fixed-
combination formulations produce this result. On the
present record, we cannot draw a conclusion in favor of
either proposition.
ALLERGAN v. SANDOZ 15
agonists, to effectively treat glaucoma with a reduced
number of doses. However, we see no reason why the
success of unrelated drugs would make it obvious to one of
ordinary skill that a fixed combination of brimonidine and
timolol could be dosed twice per day without loss of effica-
cy. Similarly, Sandoz attempts to rely on DeSantis’s
teaching that fixed-combination drug products will have a
greater reduction in intraocular pressure than either drug
alone. Even if we accept that this generalized teaching of
DeSantis is true for all fixed-combination products, we
cannot equate a greater reduction in intraocular pressure
with “no loss of efficacy” as required by claim 4, particu-
larly where, as the trial court found, DeSantis did not
provide clinical data on any of the possible combinations
it disclosed. Accordingly, we find that Sandoz failed to
prove by clear and convincing evidence that claim 4 of the
’149 patent is invalid as obvious. 2
IV. CLAIM CONSTRUCTION
Allergan argues that the district court erred in con-
struing claims 1-3 of the ’149 patent. Claim 1, from which
claims 2 and 3 depend, recites:
1. A method of treating glaucoma or ocular
hypertension by topical administration of about
0.2% brimonidine by weight to an eye of a person
in need thereof, said improvement comprising
topically administering to said eye, in a single
composition, about 0.2% brimonidine by weight
and about 0.5% timolol by weight twice a day; as
the sole active agents; wherein said method is as
2 The ’258, ’976, and ’149 patents each expire on
April 19, 2022. Because we conclude that claim 4 of the
’149 patent is not invalid, the Appellants will be unable to
enter the market until that date. Accordingly, we find it
unnecessary to address the claims of the ’258 and ’976
patents.
ALLERGAN v. SANDOZ 16
effective as administration of 0.5% timolol twice a
day and 0.2% brimonidine three times a day to
said eye, wherein the two compounds are admin-
istered in separate compositions.
The district court construed the term “administered in
separate compositions” to require that serial administra-
tion of brimonidine and timolol be compared to the fixed-
combination product. Allergan argues that the claims
should be construed as comparing either drug individually
to the combination product. Sandoz argues that the
limitation of applying the separate compositions to “said
eye” would make no sense unless the claim required serial
application of the two drugs. We find no error in the
district court’s construction. Rather, the plain language
of the claim contemplates the administration of both
compositions to the same eye be compared to the fixed
combination product.
In conclusion, we find that the district court erred in
finding the claims of the ’463 patent not invalid as obvi-
ous. However, we find that the defendants failed to prove
by clear and convincing evidence that claim 4 of the ’149
patent would have been obvious. Finally, we find no error
in the district court’s claim construction.
AFFIRM-IN-PART AND REVERSE-IN-PART
United States Court of Appeals
for the Federal Circuit
______________________
ALLERGAN, INC.,
Plaintiff-Appellee,
v.
SANDOZ INC., ALCON LABORATORIES, INC.,
ALCON RESEARCH, LTD., ALCON, INC.,
AND FALCON PHARMACEUTICALS, LTD.,
Defendants-Appellants,
AND
APOTEX INC. AND APOTEX CORP.,
Defendants-Appellants,
AND
WATSON LABORATORIES, INC.,
Defendant-Appellant.
______________________
2011-1619, -1620, -1635, -1639
______________________
Appeals from the United States District Court for the
Eastern District of Texas in consolidated No. 09-CV-0097,
Judge T. John Ward.
______________________
DYK, Circuit Judge, concurring in part and dissenting in
part.
I join in the majority’s holding that the claims of U.S.
Patent No. 7,323,463 (“the ’463 patent”) are invalid as
2 ALLERGAN v. SANDOZ
obvious, and that the district court correctly construed the
relevant claims of the patents. I would hold, however, that
claim 4 of U.S. Patent No. 7,030,149 (“the ’149 patent”) is
also invalid as obvious.
Claim 4 of the ’149 patent recites:
A method of reducing the number of daily topi-
cal ophthalmic doses of brimondine [sic] adminis-
tered topically to an eye of a person in need
thereof for the treatment of glaucoma or ocular
hypertension from 3 to 2 times a day without loss
of efficacy, wherein the concentration of brimoni-
dine is 0.2% by weight, said method comprising
administering said 0.2% brimonidine by weight
and 0.5% timolol by weight in a single composi-
tion.
’149 patent col. 10 ll. 10-17 (emphases added).
The majority concludes, correctly, that the composi-
tion claimed in the ’463 patent would have been obvious,
even though it has the unexpected property that it can be
dosed twice a day without a loss of efficacy (specifically,
without the appearance of a so-called “afternoon trough”).
Yet the majority affirms the validity of a claim drawn to
the method of dosing that same composition twice a day,
because the prior art did not disclose that this dosing
regimen “would eliminate the afternoon trough issue.”
Maj. Op. 13. I think that the different results as between
the claims of the ’463 patent and claim 4 of the ’149
patent cannot be reconciled.
While a new and nonobvious method of using an exist-
ing (or obvious) composition may itself be patentable, see
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1378
(Fed. Cir. 2005), a newly-discovered result or property of
an existing (or obvious) method of use is not patentable.
See Abbott Labs. v. Baxter Pharm. Prods., 471 F.3d 1363,
1368-69 (Fed. Cir. 2006); Brassica Prot. Prods. LLC v.
ALLERGAN v. SANDOZ 3
Sunrise Farms (In re Cruciferous Sprout Litig.), 301 F.3d
1343, 1350-51 & n.4 (Fed. Cir. 2002); Bristol-Myers
Squibb Co. v. Ben Venue Labs., 246 F.3d 1368, 1376 (Fed.
Cir. 2001).
In this case, the method of claim 4 consists of a single
step: applying a fixed combination of 0.2% brimonidine
and 0.5% timolol twice a day. See ’149 patent col. 10 ll. 10-
17. This method was surely obvious to try. See KSR Int’l
Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). The majority
recognizes that “it was common at the time of the inven-
tion to dose the serial application of brimonidine and
timolol twice per day,” and that “the prior art shows
concomitant administration of brimonidine and timolol
. . . dosed twice per day.” Maj. Op. 6, 14. Moreover, the
record shows that reducing the number of daily doses of
anti-glaucoma drugs was seen as valuable for improving
patient compliance and for reducing exposure to toxic
ingredients. The method of applying a fixed combination
of 0.2% brimonidine and 0.5% timolol twice a day would
therefore have been obvious over the prior art.
The majority’s outcome appears to rest, therefore, on
the notion that claim 4 was not obvious because it claims
the result of twice-a-day dosing—avoiding “a loss of
efficacy in the afternoon.” See Maj. Op. 13. Avoiding a
“loss of efficacy” is not a separate step, but rather a result
of the claimed method. See Bristol-Myers Squibb, 246 F.3d
at 1374-78; see also Abbott Labs., 471 F.3d at 1369. We
should recognize in this case, as we did in Bristol-Myers
Squibb, that “[n]ewly discovered results of known pro-
cesses directed to the same purpose are not patentable.”
Bristol-Myers Squibb, 246 F.3d at 1376. 1
1 The majority appears not to dispute that claiming
the result of an otherwise unpatentable process cannot
render the process patentable, but suggests that this rule
should not apply here because there may exist specific
4 ALLERGAN v. SANDOZ
For these reasons, I respectfully dissent from the ma-
jority’s holding that claim 4 of the ’149 patent is not
invalid as obvious.
formulations of a fixed combination of 0.2% brimonidine
and 0.5% timolol that do not inherently achieve this
result. See Maj. Op. 14 n.1. Claim 4, however, is not
limited to any particular formulation. See ’149 patent col.
10 ll. 10-17. The majority’s argument therefore only
suggests that the claim would have been even more
clearly obvious, since it would cover the use of composi-
tions that do not even achieve the allegedly unexpected
result. “Claims [that] are broad enough to read on obvious
subject matter are unpatentable even though they also
read on nonobvious subject matter.” In re Lintner, 458
F.2d 1013, 1015 (CCPA 1972); see also ArcelorMittal Fr. v.
AK Steel Corp., 700 F.3d 1314, 1325 (Fed. Cir. 2012)
(citing Lintner); Muniauction, Inc. v. Thomson Corp., 532
F.3d 1318, 1328 n.4 (Fed. Cir. 2008) (same).