Warner Chilcott Company, LLC v. Teva Pharmaceuticals USA, Inc.

NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
WARNER CHILCOTT COMPANY, LLC AND
HOFFMANN-LA ROCHE INC.,
Plaintiffs-Appellants,
v.
TEVA PHARMACEUTICALS USA, INC.,
APOTEX CORP., APOTEX INC., MYLAN
PHARMACEUTICALS INC. AND SUN PHARMA
GLOBAL FZE,
Defendants-Appellees.
______________________
2014-1439, -1441, -1444, -1445, -1446
______________________
Appeals from the United States District Court for the
District of Delaware in Nos. 1:08-cv-00627-LPS, 1:09-cv-
00061-LPS, 1:09-cv-00143-LPS, 1:10-cv-00285-LPS, 1:10-
cv-01085-LPS, 1:10-cv-01111-LPS, 1:11-cv-00081-LPS,
and 1:11-cv-00236-LPS, Judge Leonard P. Stark.
______________________
Decided: November 18, 2014
______________________
MARK C. FLEMING, Wilmer Cutler Pickering Hale and
Dorr LLP, of Boston, Massachusetts, argued for plaintiffs-
appellants. With him on the brief for Warner Chilcott
Company, LLC, were VINITA FERRERA, SYDENHAM B.
2 WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC.
ALEXANDER, III and TASHA J. BAHAL, of Boston, Massa-
chusetts; and DAVID B. BASSETT, CHRISTOPHER NOYES and
MARTIN GILMORE, of New York, New York. On the brief
for Hoffmann-La Roche Inc. were MARK E. WADDELL,
WARREN K. MACRAE, and KATHLEEN GERSH, Loeb & Loeb
LLP, of New York, New York.
PHILIP D. SEGREST, JR., Husch Blackwell LLP, of Chi-
cago, Illinois, argued for defendants-appellees. With him
on the brief for Apotex Inc., et al., were STEVEN E.
FELDMAN, JAMES P. WHITE, DANIEL R. CHERRY, SHERRY L.
ROLLO and SAMUEL A. BROWN. On the brief for Teva
Pharmaceuticals USA, Inc. were JAMES GALBRAITH,
MARIA LUISA PALMESE, A. ANTONY PFEFFER and PETER L.
GIUNTA, Kenyon & Kenyon LLP, of New York, New York.
On the brief for Mylan Pharmaceuticals Inc. were EDGAR
H. HAUG, RICHARD E. PARKE and RICHARD F. KURZ,
Frommer Lawrence & Haug LLP, of New York, New
York. On the brief for Sun Pharma Global, FZE, was
ERIC C. COHEN, Katten Muchin Rosenman LLP, of Chica-
go, Illinois.
______________________
Before LOURIE, REYNA, and TARANTO, Circuit Judges.
LOURIE, Circuit Judge.
In these consolidated appeals, Warner Chilcott Com-
pany, LLC (“Warner”) and Hoffmann-La Roche Inc.
(“Roche”) (collectively, the “Plaintiffs”) appeal from the
decision of the United States District Court for the Dis-
trict of Delaware granting summary judgment that claims
6, 8, 9, and 13–15 of U.S. Patent 7,192,938 (the “’938
patent”) and claims 9 and 10 of U.S. Patent 7,718,634 (the
“’634 patent”) (collectively, “the asserted claims”) were
invalid for obviousness. See Warner Chilcott Co. v. Teva
Pharm. USA, Inc., __ F. Supp. 2d __, No. 08-cv-00627,
2014 WL 1285656 (D. Del. Mar. 28, 2014) (“Opinion”).
WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC. 3
Because the district court did not err in granting sum-
mary judgment of invalidity, we affirm.
BACKGROUND
Osteoporosis is a chronic bone disorder characterized
by reduced bone density and quality that can lead to
increased susceptibility to fractures. Roche owns the ’938
and ’634 patents, both of which have a priority date of
May 10, 2002 and are directed to methods of treating
osteoporosis by orally administering a single, monthly
dose of 150 mg of risedronate.
Risedronate is a salt of risedronic acid and belongs to
a class of pharmaceutical compounds known as bisphos-
phonates. Bisphosphonates “bind strongly to bone miner-
al” and are “potent inhibitors of bone resorption.” ’634
patent col. 1 ll. 46–53. As of May 2002, the U.S. Food and
Drug Administration (“FDA”) had approved several oral
regimens of bisphosphonates for the treatment of osteopo-
rosis, including risedronate dosed daily at 5 mg, which
was marketed under the Actonel® brand name, and alen-
dronate dosed daily at 5 mg or weekly at 35 mg, which
was marketed under the Fosamax® brand name. Daily
oral dosing of bisphosphonates caused irritation to mu-
cous membranes and significant adverse esophageal and
gastrointestinal side effects, which resulted in noncompli-
ance of patients on the daily regimens. Id. at col. 1 ll. 62–
66. Those problems were somewhat alleviated by weekly
dosing of bisphosphonates. The patents at issue provide
that a monthly dose of 150 mg of a bisphosphonate,
among other infrequent dosing regimens, is effective at
treating osteoporosis. Id. at col. 2 ll. 43–59.
Claim 9 of the ’634 patent is representative of the
claims on appeal and reads as follows:
9. A method for treating or inhibiting postmeno-
pausal osteoporosis in a postmenopausal
woman in need of treatment or inhibition of
4 WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC.
postmenopausal osteoporosis by administra-
tion of a pharmaceutically acceptable salt of
risedronic acid, comprising:
(a) commencing the administration of the
pharmaceutically acceptable salt of risedronic
acid by orally administering to the postmeno-
pausal woman, on a single day, a first dose in
the form of a tablet, wherein the tablet com-
prises an amount of the pharmaceutically ac-
ceptable salt of risedronic acid that is
equivalent to about 150 mg of risedronic acid;
and
(b) continuing the administration by orally ad-
ministering, once monthly on a single day, a
tablet comprising an amount of the pharma-
ceutically acceptable salt of risedronic acid
that is equivalent to about 150 mg of
risedronic acid.
Id. col. 8 ll. 19–36 (emphases added).
The claims at issue cover the monthly administration
of Actonel® (risedronate sodium) 150 mg tablets, which
were approved by the FDA in April 2008 for treating
postmenopausal osteoporosis in the United States and
marketed by Warner, a licensee of Roche. From August
2008 through February 2011, generic pharmaceutical
manufacturers Teva Pharmaceuticals USA, Inc., Apotex
Corp., Apotex Inc., Mylan Pharmaceuticals Inc., and Sun
Pharma Global FZE (collectively, the “Defendants”)
submitted Abbreviated New Drug Applications (“ANDAs”)
to the FDA, seeking approval to engage in the commercial
manufacture, use, or sale of generic versions of Actonel®
150 mg tablets. In response, the Plaintiffs sued each of
the Defendants in the United States District Court for the
District of Delaware, asserting that the Defendants’
ANDA filings infringed the ’938 and ’634 patents under
35 U.S.C. § 271(e)(2).
WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC. 5
While the Actonel® ANDA litigation was pending, the
United States District Court for the District of New
Jersey granted summary judgment of invalidity for obvi-
ousness in an ANDA litigation involving another bisphos-
phonate oral drug: ibandronate dosed monthly at 150 mg
and marketed by Roche under the Boniva® brand name.
Opinion, 2014 WL 1285656, at *1–2. Specifically, the
New Jersey court held that claims 1–8 of the ’634 patent,
which are directed to monthly oral administration of
150 mg of ibandronate, would have been obvious in view
of several prior art references, and we later affirmed that
decision. Hoffmann-La Roche Inc. v. Apotex Inc., No. 07-
4417, 2012 WL 1637736, at *1 (D.N.J. May 7, 2012), aff’d,
748 F.3d 1326 (Fed. Cir. 2014), reh’g & reh’g en banc
denied, No. 13-1128, ECF No. 87 (Fed. Cir. July 11, 2014).
In the Delaware court, the Defendants similarly
moved for summary judgment of obviousness of the claims
directed to monthly administration of 150 mg of
risedronate. The district court granted the motion on
March 28, 2014, holding that the asserted claims would
have been obvious in view of the cited prior art, which
included: (1) Update: Bisphosphonates, Lunar News,
Winter 2000, at 32 (“Lunar News”); (2) Schofield et al.,
U.S. Patent Application Publication 2003/0118634
(“Schofield”); (3) Riis et al., Ibandronate: A Comparison of
Oral Daily Dosing Versus Intermittent Dosing in Post-
menopausal Osteoporosis, 16 J. Bone & Mineral Research
1871 (2001) (“Riis”); (4) Delmas et al., Bisphosphonate
Risedronate Prevents Bone Loss in Women With Artificial
Menopause Due to Chemotherapy of Breast Cancer: A
Double-Blind, Placebo-Controlled Study, 15 J. Clinical
Oncology 955 (1997) (“Delmas”); (5) Zegels et al., Effect of
High Doses of Oral Risedronate (20 mg/day) on Serum
Parathyroid Hormone Levels and Urinary Collagen Cross-
link Excretion in Postmenopausal Women With Spinal
Osteoporosis, 28 Bone 108 (2001) (“Zegels”); and (6) Daifo-
6 WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC.
tis et al., U.S. Patent 6,432,932 (“Daifotis”). Opinion,
2014 WL 1285656, at *3–6.
In particular, the district court examined the sum-
mary judgment opinion of the New Jersey court, which
relied on eight prior art references, including Daifotis,
Riis, and Schofield, to invalidate the claims at issue there.
Id. at *2–3. The district court then reviewed the record
before it relating to risedronate, including the prior art,
expert declarations, and proffered evidence of secondary
considerations. Id. at *3. The court found that Lunar
News, Schofield, Riis, Delmas, Zegels, and Daifotis dis-
closed the three limitations of the asserted claims: (1) oral
administration of risedronate for the treatment of osteo-
porosis, (2) once monthly, and (3) at a dose of 150 mg. Id.
at *7. The court also found that the prior art, viewed as a
whole, would have suggested the efficacy and safety of the
claimed dosing regimen. Id. The court determined that
the Plaintiffs’ expert declarations and the proffered
evidence of secondary considerations failed to raise any
genuine issue of material fact. Id. The court therefore
concluded that the Defendants had proven by clear and
convincing evidence that the asserted claims would have
been obvious and that “[n]o reasonable finder of fact could
conclude otherwise.” Id. at *3, *7.
The district court entered final judgment on April 1,
2014. The Plaintiffs timely appealed, and we have juris-
diction pursuant to 28 U.S.C. § 1295(a)(1). *
* The Plaintiffs filed eight actions in the district
court, separately asserting the two patents against the
four ANDA filers, Teva, Apotex, Mylan, and Sun Pharma,
and the district court consolidated those actions into one
lead case. After the court entered final judgment in each
of the eight actions, the Plaintiffs filed several copies of an
identical notice of appeal. That notice listed just five of
WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC. 7
DISCUSSION
We apply regional circuit law, here the law of the
Third Circuit, when reviewing a district court’s grant of a
motion for summary judgment. Teva Pharm. Indus. Ltd.
v. AstraZeneca Pharm. LP, 661 F.3d 1378, 1381 (Fed. Cir.
2001). The Third Circuit “review[s] an order granting
summary judgment de novo, applying the same standard”
used by the district court. Azur v. Chase Bank, USA,
Nat’l Ass’n, 601 F.3d 212, 216 (3d Cir. 2010) (quotation
omitted). Summary judgment is appropriate when,
drawing all justifiable inferences in the nonmovant’s
favor, “there is no genuine dispute as to any material fact
the eight cases in the caption (a captioning confusion in
which the district court took part), and copies were rec-
orded in the dockets of those five actions, including the
lead case. The caption did not list, and copies were not
recorded in the dockets of, the three actions in which the
Plaintiffs asserted the ’634 patent against Apotex, Mylan,
and Sun Pharma. On appeal, the Defendants argue that
we lack jurisdiction to review the judgment on the ’634
patent as to those Defendants. We disagree. Rule 3(c)(1)
of the Federal Rules of Appellate Procedure requires a
notice of appeal to “designate the judgment, order, or part
thereof being appealed.” In the lead case below, the
Plaintiffs timely filed a notice of appeal in which they
expressly appealed from the March 2014 summary judg-
ment, an appealable “judgment” for purposes of Rule 54(a)
of the Federal Rules of Civil Procedure. In its March 2014
decision, the district court granted summary judgment of
invalidity of the asserted claims in both patents as to all
defendants. On these particular facts, we conclude that
the Plaintiffs have perfected their appeal in all eight
consolidated actions and that we have jurisdiction to
review the invalidity judgment on the ’634 patents as to
all of the Defendants.
8 WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC.
and the movant is entitled to judgment as a matter of
law.” Fed. R. Civ. P. 56(a); Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 255 (1986).
Obviousness is ultimately a question of law premised
on underlying issues of fact, including: (1) the scope and
content of the prior art; (2) the level of ordinary skill in
the pertinent art; (3) the differences between the claimed
invention and the prior art; and (4) objective evidence
such as commercial success, long-felt need, and the failure
of others. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 427
(2007); Graham v. John Deere Co., 383 U.S. 1, 17–18
(1966); Monarch Knitting Mach. Corp. v. Sulzer Morat
GmBH, 139 F.3d 877, 881 (Fed. Cir. 1998). A patent
claim is invalid as obvious if an alleged infringer proves
that the differences between the claimed subject matter
and the prior art are such that the subject matter as a
whole would have been obvious at the time of invention to
a person having ordinary skill in the art. 35 U.S.C.
§ 103(a) (2006). Patents are presumed to be valid, and
overcoming that presumption requires clear and convinc-
ing evidence. 35 U.S.C. § 282; Microsoft Corp. v. i4i Ltd.
P’ship, 564 U.S. __, 131 S. Ct. 2238, 2242 (2011).
The Plaintiffs argue that the district court erred in
granting summary judgment of invalidity because there
was a genuine dispute of material fact as to whether a
person of ordinary skill in the art would have reasonably
expected that dosing 150 mg of risedronate once monthly
would be safe and effective. According to the Plaintiffs,
researchers would not have been able to predict the
bioavailability of risedronate or its retention in the bone
over the month-long dose-free interval. The Plaintiffs also
assert that there was a long felt need for and skepticism
of others toward the claimed monthly regimen. Finally,
the Plaintiffs argue that our recent decision affirming the
New Jersey court’s invalidity judgment in the Boniva®
litigation does not control this case because ibandronate
WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC. 9
and risedronate are different compounds and the record
here contains additional evidence of nonobviousness.
The Defendants respond that there is no genuine dis-
pute that the prior art taught monthly administration of
risedronate for the treatment of osteoporosis, suggested a
dose of 150 mg, and provided a person of ordinary skill in
the art with a motivation to pursue that regimen and with
a reasonable expectation of success. According to the
Defendants, the Plaintiffs’ arguments, their expert decla-
rations, and their proffered evidence of secondary consid-
erations fail to raise any genuine issue of material fact to
preclude summary judgment of invalidity. The Defend-
ants also maintain that our decision affirming the sum-
mary judgment of invalidity in the Boniva® litigation
supports a conclusion of obviousness in this case.
We agree with the Defendants that the district court
did not err in granting summary judgment that the
asserted claims would have been obvious over the consid-
ered prior art. There is no dispute that the asserted
claims are directed to a method of treating osteoporosis,
which requires the following limitations: (1) oral admin-
istration of risedronate, (2) once monthly, and (3) at a
dose of 150 mg. The district court correctly determined
that the cited prior art references disclosed or suggested
each of those limitations and provided an express motiva-
tion to pursue the claimed monthly regimen and a rea-
sonable expectation of success in doing so. See Opinion,
2014 WL 1285656, at *3, *6.
As of May 2002, the priority date of the asserted pa-
tents, the FDA had approved several oral regimens of
bisphosphonates for the treatment of osteoporosis, includ-
ing risedronate dosed daily at 5 mg and alendronate
dosed daily at 5 mg or weekly at 35 mg. Lunar News, an
article published in 2000, reviewed the clinical efficacy of
risedronate and stated that “risedronate ha[d] met all
standards for efficacy and should receive FDA approval in
10 WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC.
the USA for prevention and treatment of osteoporosis in
spring 2000.” J.A. 9498. The prior art thus indisputably
disclosed the first limitation of the asserted claims: oral
administration of risedronate for treating osteoporosis.
In addition, the district court correctly found that the
prior art taught once-monthly dosing of risedronate, the
second limitation of the asserted claims. It was well
recognized that daily oral dosing of bisphosphonates
resulted in adverse esophageal and gastrointestinal side
effects, which were somewhat mitigated by weekly dosing.
Appellants’ Br. 13. Specifically discussing risedronate
and alendronate, Lunar News provided that “[w]eekly, or
even monthly, dosing if done properly could foster long-
term compliance as well as minimiz[e] side-effects.” J.A.
9498. Schofield likewise taught that “[e]quivalent doses
[of bisphosphonates] can be given every other day, twice a
week, weekly, biweekly, or monthly.” J.A. 11696, at
[0037]. The prior art thus expressly suggested monthly
dosing of risedronate.
The prior art also established a reasonable expecta-
tion that once-monthly dosing of risedronate could suc-
cessfully treat osteoporosis. The district court correctly
found that Riis, Delmas, and Zegels disclosed that
“bisphosphonates were effective treatments for osteoporo-
sis, even when dosed in intervals exceeding two weeks,”
and that “risedronate . . . [wa]s effective in preventing
bone loss even when given at long intervals.” Opinion,
2014 WL 1285656, at *4. Delmas, a reference not consid-
ered by the United States Patent and Trademark Office
during the prosecution of the patents at issue, described a
study observing an increase in bone mineral density in
patients treated with 30 mg of risedronate every day for
2 weeks, followed by a 10-week period of no treatment,
and with that 12-week cycle repeated eight times over
2 years. Delmas thus demonstrated that risedronate
could be efficacious even with a dose-free interval of up to
10 weeks. Zegels and Riis similarly described studies on
WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC. 11
intermittent dosing of risedronate or ibandronate with
dose-free intervals longer than a month. Accordingly, any
serious doubt about the efficacy of a monthly regimen of
risedronate based on its bone retention profile would have
been put to rest. As longer dosing intervals suit patient
convenience and compliance, the prior art therefore
provided express motivation to pursue a monthly dosing
regimen.
Furthermore, the record shows that there would have
been a reasonable expectation of success in pursuing the
150 mg monthly dose, the third limitation of the asserted
claims. Riis presented evidence, through a study on
intermittent dosing of ibandronate, that “a total dose
administered over a defined period provides equivalent
results irrespective of the dosing schedule.” Opinion,
2014 WL 1285656, at *4 (quotation marks omitted); see
also J.A. 11921 (“These results confirm previous preclini-
cal findings indicating that the efficacy of ibandronate
depends on the total oral dose given rather than on the
dosing schedule.”). Zegels similarly taught that the total
amount of risedronate, rather than the dosing frequency,
“would be more important . . . in terms of the impact on
bone metabolism.” J.A. 11934. Notably, in Delmas, the
total dose given during the 12-week cycle was equivalent
to a daily dose of 5 mg. The prior art thus suggested that,
in setting the dose for a once-monthly regimen, one could
extrapolate from a known effective daily dose to achieve
an equivalent total dose over one month.
As indicated, the FDA had approved a 5 mg daily dose
of risedronate for the treatment of osteoporosis. Moreo-
ver, both Schofield and Daifotis taught an equivalent once
weekly dose of 35 mg of risedronate. J.A. 9638; J.A.
11697, at [0042]. Accordingly, a person skilled in the art
looking to select a monthly oral dose of risedronate would
have reasonably expected success in administering a dose
of 150 mg (5 mg/day times 30 days/month). Indeed, the
Plaintiffs’ own expert testified that risedronate was
12 WARNER CHILCOTT CO. v. TEVA PHARMACEUTICALS USA, INC.
known to exhibit a linear bioavailability from 2.5 mg to 50
mg, and that linear scaling of risedronate to a higher dose
was merely unknown. While it is true that, as of May
2002, the highest single dose of risedronate that had
actually been tested in a patient was 50 mg, obviousness
does not require absolute certainty or a guarantee of
success. In re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir.
1988) (“Obviousness does not require absolute predictabil-
ity of success. . . . For obviousness under § 103, all that is
required is a reasonable expectation of success.”). The
district court therefore did not err in concluding that the
asserted claims would have been obvious in view of the
prior art.
The Plaintiffs’ arguments do not support a contrary
conclusion. The Plaintiffs rely on the testimony of their
experts and assert that there was uncertainty regarding
the safety and efficacy of a once-monthly regimen of
150 mg of risedronate and that there was a long-felt need
for and skepticism of others toward the claimed regimen.
However, lack of certainty does not preclude a conclusion
of obviousness. Therefore, upon a careful review of the
record as a whole, and drawing all justifiable inferences in
the Plaintiffs’ favor, we agree with the district court that
the Plaintiffs fail to raise any genuine issue of material
fact to preclude summary judgment. We therefore con-
clude as a matter of law that the asserted claims would
have been obvious.
CONCLUSION
We have considered the Plaintiffs’ remaining argu-
ments and find them unpersuasive. For the foregoing
reasons, we conclude that the asserted claims would have
been obvious in view of the cited references and therefore
affirm the judgment of the district court.
AFFIRMED