Astrazeneca Pharmaceuticals Lp. v. Apotex Corp. , 669 F.3d 1370 ( 2012 )

United States Court of Appeals
for the Federal Circuit
__________________________
ASTRAZENECA PHARMACEUTICALS LP,
ASTRAZENECA AB, IPR PHARMACEUTICALS
INC.,
AND THE BRIGHAM AND WOMEN’S HOSPITAL,
INC.,
Plaintiffs-Appellants,
v.
APOTEX CORP.,
Defendant-Appellee,
and
AUROBINDO PHARMA LIMITED,
Defendant-Appellee,
and
COBALT PHARMACEUTICALS INC.
AND COBALT LABORATORIES INC.,
Defendants-Appellees,
and
GLENMARK GENERICS INC. USA,
Defendant-Appellee,
and
MYLAN PHARMACEUTICALS INC.,
Defendant-Appellee,
and
PAR PHARMACEUTICALS, INC.,
Defendant-Appellee,
ASTRAZENECA PHARMA v. APOTEX CORP 2
and
SUN PHARMACEUTICAL INDUSTRIES, LTD.,
Defendant-Appellee,
and
TEVA PHARMACEUTICALS USA, INC.,
Defendant-Appellee,
and
TORRENT PHARMA INC. AND
TORRENT PHARMACEUTICALS LTD.,
Defendants.
__________________________
2011-1182, -1183, -1184, -1185, -1186, -1187, -1188, -1189,
-1190
__________________________
Appeals from the United States District Court for the
District of Delaware in Case Nos. 10-CV-0338, 10-CV-
0339, 10-CV-0340, 10-CV-0341, 10-CV-0342, 10-CV-0343,
10-CV-0345, 10-CV-0346, and 10-CV-0584, Judge Robert
B. Kugler.
____________________________
Decided: February 9, 2012
____________________________
MARY W. BOURKE, Connolly, Bove, Lodge & Hutz,
LLP, of Wilmington, Delaware, argued for plaintiffs-
appellants. With her on the brief was DANA K.
SEVERANCE. Of counsel on the brief were FORD F.
FARABOW, JR., Finnegan, Henderson, Farabow, Garrett &
Dunner, LLP, of Washington, DC; and CHARLES E. LIPSEY,
KENNETH M. FRANKEL and YORK M. FAULKNER, of Reston,
3 ASTRAZENECA PHARMA v. APOTEX CORP
Virginia; and MARY K. FERGUSON, of Cambridge, Massa-
chusetts.
SHANE A. BRUNNER, Mechant & Gould, P.C. of Madi-
son, Wisconsin, argued for defendants-appellees
Aurobindo Pharma Limited and Glenmark Generics Inc.
USA. With him on the brief were JEFFREY S. WARD and
EDWARD J. PARDON. Of counsel on the brief was RACHEL
C. HUGHEY, of Minneapolis, Minnesota.
ROBERT B. BREISBLATT and JEREMY C. DANIEL, Katten
Muchin Rosenman LLP, of Chicago, Illinois, were on the
brief for defendant-appellee Apotex Corp.
STEVEN A. MADDOX, Knobbe, Martens, Olson & Bear,
LLP, of Washington, DC; and PAYSON LEMEILLEUR and
JARED C. BUNKER, of Irvine, California, were on the brief
for defendants-appellees Cobalt Pharmaceuticals Inc., et
al.
H. KETTO SABHARWAL, DANIEL E. YONAN and DENNIES
VARUGHESE, Sterne, Kessler, Goldstein & Fox, PLLC, of
Washington, DC, were on the brief for defendant-appellee
Glenmark Generic Inc. USA.
WILLIAM A. RAKOCZY, DEANNE M. MAZZOCHI, JOSEPH
T. JAROS and ERIC R. HUNT, Rakoczy Molino Mazzochi
Siwik, LLP, of Chicago, Illinois, were on the brief for
defendant-appellee Mylan Pharmaceuticals Inc.
NICOLE W. STAFFORD, Wilson, Sonsini, Goodrich &
Roisati, of Austin, Texas; and DANIEL G. BROWN, of New
York, New York, were on the brief for defendant-appellee
Par Pharmaceutical, Inc.
ASTRAZENECA PHARMA v. APOTEX CORP 4
JAMES F. HURST, Winston & Strawn LLP, of Chicago,
Illinois, and CHARLES B. KLEIN and JOHN K. HSU, of
Washington, DC, were on the brief for defendant-appellee
Sun Pharmaceutical Industries, Ltd.
RALPH J. GABRIC, JEFFREY M. NICHOLS and JASON W.
SCHIGELONE, Brinks Hofer Gilson & Lione, of Chicago,
Illinois, were on the brief for defendant-appellee Teva
Pharmaceuticals USA, Inc.
__________________________
Before RADER, Chief Judge, and LOURIE and MOORE,
Circuit Judges.
LOURIE, Circuit Judge.
AstraZeneca Pharmaceuticals LP, AstraZeneca AB,
IPR Pharmaceuticals, Inc., and The Brigham and
Women’s Hospital, Inc. (collectively, “AstraZeneca”)
appeal from the consolidated final orders of the United
States District Court for the District of Delaware dismiss-
ing their § 271(e)(2) patent infringement claims against
Apotex Corp., Aurobindo Pharma Ltd., Cobalt Pharma-
ceuticals Inc., Cobalt Laboratories Inc., Glenmark Gener-
ics Inc. USA, Mylan Pharmaceuticals Inc., Par
Pharmaceuticals Inc., Sun Pharmaceutical Industries
Ltd., Teva Pharmaceuticals USA Inc., Torrent Pharma
Inc., and Torrent Pharmaceuticals Ltd. (collectively,
“Appellees”). AstraZeneca Pharms. LP v. Apotex Corp.,
Nos. 10-338 to -346 and 10-584, 2010 U.S. Dist. LEXIS
132727, 2010 WL 5376310 (D. Del. Dec. 22, 2010). For
the reasons indicated below, we affirm.
BACKGROUND
The dispute before us involves patented methods for
using the cholesterol-lowering drug rosuvastatin calcium.
Rosuvastatin calcium is one member of a widely pre-
5 ASTRAZENECA PHARMA v. APOTEX CORP
scribed class of drugs known as statins, which serve to
reduce circulating cholesterol by competitively inhibiting
3-hydroxy-3-methylglutaryl-CoA reductase, or HMG-CoA
reductase, a key enzyme in the cholesterol biosynthesis
pathway. AstraZeneca markets rosuvastatin calcium
under the brand name CRESTOR® and holds the rights
to three related patents relevant to this appeal. U.S.
Patent RE37,314 (“the ’314 patent”) claims rosuvastatin
compounds and pharmaceutical compositions containing
such compounds. U.S. Patent 6,858,618 (“the ’618 pat-
ent”) claims methods of using rosuvastatin compounds to
treat heterozygous familial hypercholesterolemia
(“HeFH”), a genetic condition characterized by impaired
cholesterol metabolism and clinically elevated blood
cholesterol, and U.S. Patent 7,030,152 (“the ’152 patent”)
claims methods of using rosuvastatin compounds to lower
the cardiovascular disease risk for individuals who have
normal cholesterol levels but demonstrate elevated circu-
lating C-reactive protein (“CRP”), another risk factor
associated with various cardiovascular disorders. The
’314 composition patent expires in 2016, while the ’618
and ’152 method of use patents expire in 2021 and 2018,
respectively. 1
AstraZeneca filed a New Drug Application (“NDA”) to
market rosuvastatin calcium and obtained approval from
the U.S. Food and Drug Administration (“FDA”) on Au-
gust 12, 2003. As required by the Drug Price Competition
and Patent Term Restoration Act of 1984 (popularly
known as the Hatch-Waxman Act, hereinafter “the Act”),
AstraZeneca notified the FDA of all patents that it be-
1
AstraZeneca is also the assignee of U.S. Patent
6,316,460, which discloses and claims particular pharma-
ceutical compositions comprising a rosuvastatin com-
pound and a tribasic phosphate salt. The ’460 patent is
not involved in this appeal.
ASTRAZENECA PHARMA v. APOTEX CORP 6
lieved could be infringed by the unlicensed manufacture,
use, or sale of rosuvastatin calcium to be published in the
FDA’s Approved Drug Products with Therapeutic Equiva-
lence Evaluations (known as “the Orange Book”). See 21
U.S.C. § 355(b)(1). Among those patents, AstraZeneca
listed the ’314, ’618, and ’152 patents. The approved NDA
and AstraZeneca’s corresponding CRESTOR® labeling
cover several indications for using rosuvastatin calcium,
including treatment of HeFH in pediatric patients and
preventative use in high-risk patients with elevated CRP.
J.A. 152. While these indications may fall under Astra-
Zeneca’s method patents, the FDA also approved rosuvas-
tatin calcium for treating homozygous familial
hypercholesterolemia (“HoFH”) and hypertriglyceride-
mia—uses not claimed by either of the ’618 or ’152 pat-
ents. Thus, the FDA approved rosuvastatin calcium for a
number of different treatment indications, some of which
may be protected by AstraZeneca’s ’618 and ’152 patents,
i.e., the HeFH and elevated CRP indications, as well as
others not subject to any such patent rights, e.g., treat-
ment of HoFH and hypertriglyceridemia.
Appellees are generic pharmaceutical manufacturers
that filed Abbreviated New Drug Applications (“ANDAs”)
with the FDA seeking to market generic rosuvastatin
calcium. As set forth at 21 U.S.C. § 355(j)(2)(A)(i), the Act
only allows ANDA filers to obtain approval for marketing
drugs for uses that have been approved under a preexist-
ing NDA. In this case, Appellees further restricted their
ANDAs, requesting approval to offer their generic rosu-
vastatin formulations for treating only HoFH and hyper-
triglyceridemia while omitting or “carving out” patented
indications directed toward HeFH and elevated CRP.
Mylan’s proposed labeling is representative:
7 ASTRAZENECA PHARMA v. APOTEX CORP
INDICATIONS AND USAGE
Rosuvastatin calcium tablets are an HMG-CoA
reductase inhibitor indicated for:
• patients with hypertriglyeridemia as
an adjunct to diet (1.2)
• patients with homozygous familial hy-
percholesterolemia (HoFH) to reduce
LDL-C, total-C, and ApoB (1.4)
J.A. 284. It appears undisputed that none of Appellees’
ANDAs sought approval to market rosuvastatin calcium
specifically for the HeFH or high-CRP indications dis-
closed in the ’618 and ’152 patents.
Appellees’ ANDAs also addressed each rosuvastatin-
related patent listed in the Orange Book. The Act re-
quires each ANDA applicant to certify that (1) the Orange
Book contains no patent information relevant to their
ANDA (“Paragraph I certification”), (2) the listed patents
have expired (“Paragraph II certification”), (3) the appli-
cant will not enter the market until the listed patents
expire (“Paragraph III certification”), or (4) the applicant
believes that the listed patents are invalid or will not be
infringed by the applicant’s generic compositions (“Para-
graph IV certification”). 21 U.S.C. § 355(j)(2)(A)(vii)(I)–
(IV) (2006). The Act specifies that filing an ANDA con-
taining a Paragraph IV certification constitutes an act of
infringement. 35 U.S.C. § 271(e)(2) (2006); Glaxo, Inc. v.
Novopharm, Ltd., 110 F.3d 1562, 1568–69 (Fed. Cir.
1997). Where the Orange Book lists a method of use
patent that “does not claim a use for which the applicant
is seeking approval,” an applicant may instead submit a
statement under 21 U.S.C. § 355(j)(2)(A)(viii) averring
that the ANDA excludes all uses claimed in the patent
ASTRAZENECA PHARMA v. APOTEX CORP 8
(“Section viii statement”). Warner-Lambert Co. v. Apotex
Corp., 316 F.3d 1348, 1360–61 (Fed. Cir. 2003).
Accordingly, Appellees filed Paragraph IV certifica-
tions with regard to the ’314 composition patent, but,
having only sought approval for unpatented methods of
using generic rosuvastatin calcium for treating HoFH and
hypertriglyeridemia, they submitted Section viii state-
ments regarding the ’618 and ’152 method of use patents. 2
Appellees notified AstraZeneca of their ANDA filings in
late 2007 as required under 21 U.S.C. § 355(j)(2)(B)(ii).
In December 2007, AstraZeneca responded by suing
Appellees for infringement of the ’314 composition patent
under § 271(e)(2). After a bench trial, the district court
ruled on June 29, 2010, in favor of AstraZeneca on in-
fringement, validity, and enforceability of the ’314 patent,
enjoining Appellees from making, using, or selling rosu-
vastatin calcium until the ’314 patent expires in 2016.
Appellees have separately appealed that decision. In re
Rosuvastatin Calcium Patent Litig., 719 F. Supp. 2d 388(D. Del. 2010), appeal docketed, Nos. 10-1460 to -1473
(Fed. Cir. Aug. 13, 2010).
While the ’314 infringement matter remained pending
before the district court, AstraZeneca brought a second
§ 271(e)(2) action against Appellees in April 2010 that
ultimately gave rise to this appeal. 3 AstraZeneca alleged
2
Individual appellees Aurobindo Pharma, Sun
Pharmaceutical Industries, and Teva Pharmaceuticals
USA originally submitted Paragraph IV certifications
regarding the ’618 patent but later amended their ANDAs
to replace those certifications with Section viii state-
ments.
3
Individual appellees Torrent Pharmaceuticals
Ltd. and Torrent Pharma Inc. were sued separately on
July 8, 2010, and joined in the consolidated action. J.A.
395–404.
9 ASTRAZENECA PHARMA v. APOTEX CORP
that Appellees’ ANDA filings infringed and would cause
infringement of the ’618 and ’152 method patents, even
though Appellees had not requested approval for any
patented indications and had filed Section viii statements
to that effect. In particular, AstraZeneca’s complaints
stated:
25. On information and belief, the FDA will re-
quire the label for the [Appellees’] Rosuvastatin
Calcium Tablets to include information relating to
the use to treat pediatric patients 10 to 17 years of
age having HeFH.
....
27. On information and belief, the labeling asso-
ciated with the [Appellees’] Rosuvastatin Calcium
Tablets causes [their ANDAs] to be an application
for a drug the use of which is claimed in the ’618
patent in violation of 35 U.S.C. § 271(e)(2)(A).
....
29. On information and belief, the [Appellees’]
Rosuvastatin Calcium Tablets, if approved by the
FDA, will be prescribed and administered to hu-
man patients to treat HeFH, which uses will con-
stitute direct infringement of the ’618 patent. . . .
On information and belief, [Appellees] will ac-
tively induce, encourage, and aid and abet this
prescription and administration, with knowledge
and specific intent that these uses will be in con-
travention of [AstraZeneca’s] rights under the ’618
patent. 4
4
AstraZeneca’s complaints against the individual
appellees are essentially identical; we quote representa-
tive language from AstraZeneca’s first amended com-
ASTRAZENECA PHARMA v. APOTEX CORP 10
J.A. 164–65. Each complaint also included analogous
counts alleging infringement of the ’152 patent. E.g., J.A.
166–67, ¶¶ 39–43. In short, AstraZeneca alleged that: (1)
Appellees’ ANDAs, as filed, violated § 271(e)(2) as “appli-
cation[s] for a drug the use of which is claimed” in the
’618 and ’152 patents; (2) if approved by the FDA, Appel-
lees’ proposed activities will induce infringement of the
’618 and ’152 patents; and (3) the FDA will require Appel-
lees to make labeling amendments explicitly incorporat-
ing the indications covered by the ’618 and ’152 patents.
Appellees moved to dismiss on three grounds. First,
Appellees argued that the district court lacked subject
matter jurisdiction over AstraZeneca’s claims because
§ 271(e)(2) creates a case or controversy only if the ac-
cused ANDA contains a Paragraph IV certification, but
Appellees instead filed Section viii statements concerning
the asserted method patents. In addition, Appellees
argued that the infringement claims were unripe because
AstraZeneca alleged that the FDA might, at some unde-
termined point in the future, require that Appellees
amend their ANDAs to include the patented indications.
Finally, Appellees argued that, even if the court could
exercise jurisdiction, the complaints failed to state a claim
under § 271(e)(2) because AstraZeneca had not alleged
and could not allege that Appellees’ ANDAs included
Paragraph IV certifications or sought approval to market
rosuvastatin calcium for uses claimed in the ’618 or ’152
patents.
The district court dismissed AstraZeneca’s infringe-
ment claims, ruling that it lacked jurisdiction because
AstraZeneca had not presented a valid § 271(e)(2) claim
based on Appellees’ ANDA filings. AstraZeneca, 2010 WL
plaint against Apotex Corp., filed on April 30, 2010. J.A.
160–69.
11 ASTRAZENECA PHARMA v. APOTEX CORP
5376310, at *10–14. The court also held that Astra-
Zeneca’s claims were unripe to the extent that they relied
on presumptive future labeling amendments. Id. at *15.
AstraZeneca now appeals, and we have jurisdiction
under 28 U.S.C. § 1295(a)(1).
DISCUSSION
We review de novo a district court’s decision to dis-
miss for lack of subject matter jurisdiction, and we review
any underlying factual findings for clear error. Hewlett-
Packard Co. v. Acceleron LLC, 587 F.3d 1358, 1361 (Fed.
Cir. 2009). Like the district court, we test the sufficiency
of a complaint as a matter of law, accepting as true all
non-conclusory allegations of fact. Bradley v. Chiron
Corp., 136 F.3d 1317, 1321–22 (Fed. Cir. 1998). We also
review statutory interpretation, which is a question of
law, without deference. Waymark Corp. v. Porta Sys.
Corp., 245 F.3d 1364, 1366 (Fed. Cir. 2001).
As described, AstraZeneca’s complaints advanced two
basic theories of patent infringement under § 271(e)(2).
First, AstraZeneca alleged that, as filed, Appellees’ AN-
DAs infringe the ’618 and ’152 method patents because
their approval would result in unlicensed sales of a drug
having FDA-approved, patent-protected uses, inevitably
infringing AstraZeneca’s method patents contrary to the
plain language and legislative aims of § 271(e)(2). Astra-
Zeneca also asserted that the FDA would ultimately block
Appellees’ formal efforts to carve out the patented indica-
tions by requiring amendments extending their ANDAs to
include all approved indications for rosuvastatin cal-
cium—including those covered by the ’618 and ’152 pat-
ents. The district court dismissed these claims on
separate grounds, and we address each in turn.
ASTRAZENECA PHARMA v. APOTEX CORP 12
A. Appellees’ ANDAs as Filed
The district court dismissed AstraZeneca’s primary
§ 271(e)(2) infringement claims for lack of subject matter
jurisdiction. The court reasoned that § 271(e)(2) creates
in the ANDA context a limited, technical, and artificial
cause of action where none would otherwise exist, so that
in such cases “a district court’s jurisdiction turns on
whether a plaintiff asserts a valid claim under Section
271(e)(2). . . . [I]n the absence of a Section 271(e)(2) claim,
there is no justiciable case or controversy between the
parties.” AstraZeneca, 2010 WL 5376310, at *11. Con-
cluding that AstraZeneca had failed to state a valid
§ 271(e)(2) claim because Appellees’ ANDAs excluded all
methods of using rosuvastatin calcium claimed in the
asserted patents, the district court dismissed Astra-
Zeneca’s claims pursuant to Fed. R. Civ. P. 12(b)(1).
AstraZeneca protests that, by alleging patent in-
fringement under § 271(e)(2), it has asserted a claim for
relief arising under federal patent law and has thus met
the basic jurisdictional requirements specified in 28
U.S.C. §§ 1331 and 1338(a). In addition, AstraZeneca
argues that § 271(e)(2) is not a jurisdiction-conferring
statute and that the district court improperly conflated its
jurisdictional analysis with scrutiny of the claims on their
merits. Appellees defend the district court’s dismissal as
properly premised on jurisdictional grounds.
As a preliminary matter, we agree with AstraZeneca
that its infringement claims based on Appellees’ existing
ANDAs were within the district court’s jurisdiction. The
district courts have original jurisdiction over any civil
action arising under any Act of Congress relating to
patents. 28 U.S.C. § 1338(a). The Supreme Court has
described § 271(e)(2) as creating “a highly artificial act of
infringement” triggered upon submission of an ANDA
13 ASTRAZENECA PHARMA v. APOTEX CORP
containing an erroneous Paragraph IV certification. Eli
Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 678 (1990).
We have further explained that § 271(e)(2) provided a new
cause of action so that courts could promptly resolve
infringement and validity disputes before the ANDA
applicant had engaged in the traditional statutorily
defined acts of infringement. Glaxo, 110 F.3d at 1569. By
enacting § 271(e)(2), Congress thus established a special-
ized new cause of action for patent infringement. When
patentees pursue this route, their claims necessarily arise
under an Act of Congress relating to patents. In short,
“[o]nce Congress creates an act of infringement, jurisdic-
tion in the district courts is proper under 28 U.S.C.
§ 1338(a).” Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d
1322, 1330 (Fed. Cir. 2003).
In Allergan, we addressed a similar jurisdictional
challenge to an infringement suit brought under
§ 271(e)(2). There, as here, the plaintiff held method
patents directed toward certain uses of a drug, competi-
tors filed ANDAs seeking to market the drug for other
uses, and the plaintiff brought suit claiming that the
ANDAs infringed its method of use patents under
§ 271(e)(2). Id. at 1328. The defendant competitors
argued that § 271(e)(2) did not provide jurisdiction be-
cause their ANDAs sought approval for uses not covered
by the asserted patents, but we held that “section
271(e)(2) makes it possible for the district court to exer-
cise its section 1338(a) jurisdiction in the situation in
which an ANDA has been filed.” Id. at 1330. In other
words, the requirements for jurisdiction in the district
courts are met once a patent owner alleges that another’s
filing of an ANDA infringes its patent under § 271(e)(2),
and this threshold jurisdictional determination does not
depend on the ultimate merits of the claims.
ASTRAZENECA PHARMA v. APOTEX CORP 14
Consistent with Allergan, we conclude that the dis-
trict court erred in holding that its jurisdiction hinged on
whether AstraZeneca asserted a “valid” claim under
§ 271(e)(2). AstraZeneca alleged that the Appellees’
ANDA filings infringed its listed patents under
§ 271(e)(2), and nothing more was required to establish
the district court’s subject matter jurisdiction pursuant to
§ 1338(a).
While the district court erroneously concluded that it
lacked subject matter jurisdiction over AstraZeneca’s
claims, its judgment of dismissal was nevertheless cor-
rect, for we agree with the district court’s underlying
determination that AstraZeneca failed to state a viable
claim for relief under § 271(e)(2). See Samish Indian
Nation v. United States, 419 F.3d 1355, 1364 (Fed. Cir.
2005) (“The court can affirm the trial court on any basis in
the record.”); Susquehanna Valley Alliance v. Three Mile
Island Nuclear Reactor, 619 F.2d 231, 239 (3d Cir. 1980)
(“Returning that Count to the district court for the entry
of a dismissal under Fed. R. Civ. P. 12(b)(6), rather than
under Fed. R. Civ. P. 12(b)(1), would be a futile exer-
cise.”).
We are guided in this conclusion by the language of
§ 271(e)(2) itself and by our decision in Warner-Lambert.
Section 271(e)(2) provides as follows:
It shall be an act of infringement to submit—(A)
an application [i.e., an ANDA] under section 505(j)
of the Federal Food, Drug, and Cosmetic Act [codi-
fied at 21 U.S.C. § 355(j)] for a drug claimed in a
patent or the use of which is claimed in a patent . .
. if the purpose of such submission is to obtain ap-
proval under such Act to engage in the commer-
cial manufacture, use, or sale of a drug . . .
15 ASTRAZENECA PHARMA v. APOTEX CORP
claimed in a patent or the use of which is claimed
in a patent before the expiration of such patent.
35 U.S.C. § 271(e)(2) (emphases added). In Warner-
Lambert, we construed the term “the use” as used in
§ 271(e)(2)(A) to mean “the use listed in the ANDA” based
on our evaluation of the statutory language, its context
within the Act, and the legislative history behind its
enactment. 316 F.3d at 1356–60. Accordingly, we held
that it is not necessarily an act of infringement under
§ 271(e)(2) to submit an ANDA for a drug if just any use of
that drug is claimed in a patent; rather, infringement of
method claims under § 271(e)(2) requires filing an ANDA
wherein at least one “use” listed in the ANDA is claimed
in a patent. Id. at 1358–59.
Relying on Warner-Lambert, the district court deter-
mined that AstraZeneca had not stated a claim under
§ 271(e)(2) as a predicate to its decision to dismiss for lack
of jurisdiction. The district court held that Warner-
Lambert defined the boundaries of § 271(e)(2) claims by
establishing that “ANDA applicants could carve out
patented uses from their ANDAs even if those uses were
FDA-approved.” AstraZeneca, 2010 WL 5376310, at *13.
The district court therefore concluded that there can be no
cause of action for infringement of a method of use claim
under § 271(e)(2) unless the accused ANDA actually seeks
approval for a patented indication. Id. at *14. Because
Appellees had excluded any patented treatment indica-
tions from their ANDAs, 5 the district court concluded that
5
In deciding Appellees’ motions to dismiss, the dis-
trict court held that it could consider certain documents
beyond the pleadings, including Appellees’ ANDA filings,
Section viii statements, and proposed labeling. Astra-
Zeneca, 2010 WL 5376310, at *8–9. AstraZeneca com-
plains that the district court committed legal error by
considering such documents without allowing it to take
ASTRAZENECA PHARMA v. APOTEX CORP 16
AstraZeneca “[does] not have a claim under Section
271(e)(2).” Id.AstraZeneca first asserts that the district court em-
ployed an unduly narrow reading of § 271(e)(2). It claims
that the “plain and unambiguous” language of § 271(e)(2)
supports its infringement claims, quoting the statute “in
relevant part” as follows: “It shall be an act of infringe-
ment to submit—(A) an application under section 505(j) of
the Federal Food, Drug, and Cosmetic Act [i.e., an ANDA]
. . . for a drug . . . the use of which is claimed in a patent .
. . .” Non-Confidential Br. for Plaintiffs-Appellants at 23
(formatting in original). AstraZeneca thus argues that it
stated cognizable claims under § 271(e)(2) by alleging that
Appellees filed ANDAs for “a drug,” rosuvastatin calcium,
“the use of which is claimed in a patent,” such as the ’618
and ’152 patents. However, AstraZeneca’s selective
quotation omits key language from § 271(e)(2), condensing
the statutory bases for liability to filing an ANDA for “a
drug . . . the use of which is claimed in a patent,” rather
than using the actual language of the statute reading “a
drug claimed in a patent or the use of which is claimed in
a patent.” 35 U.S.C. § 271(e)(2)(A) (emphasis added). In
fact, AstraZeneca’s argument stems from the same mis-
leading “abridged quotation” of § 271(e)(2) proffered by
the plaintiff in Warner-Lambert. See 316 F.3d at 1355.
Then as now, we rejected this parsing of the statute
discovery. However, the district court was entitled to
examine documents “integral to or explicitly relied upon
in the complaint” in evaluating motions to dismiss. In re
Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1426
(3d Cir. 1997). The district court determined, and we
agree, that AstraZeneca’s complaints referenced and
relied on Appellees’ FDA filings, and the parties do not
dispute the authenticity of the documents that were
before the court. We therefore see no error in the district
court’s decision to consider these documents.
17 ASTRAZENECA PHARMA v. APOTEX CORP
because it “eviscerated an important part of the statutory
provision by conflating the first and second clauses of
§ 271(e)(2)(A),” id., and we again reject the contention
that filing an ANDA for a drug having any patented use
automatically constitutes infringement under § 271(e)(2).
As we held in Warner-Lambert, a patented method of
using a drug can only be infringed under § 271(e)(2) by
filing an ANDA that seeks approval to market the drug
for that use. Id. at 1358–59. Thus, an ANDA seeking to
market a drug not covered by a composition patent for
unpatented methods of treatment cannot infringe under
§ 271(e)(2). AstraZeneca has not alleged, nor could it
allege, that Appellees’ ANDAs seek FDA approval for uses
of rosuvastatin calcium covered by the ’618 or ’152 pat-
ents as would be required to state a viable § 271(e)(2)
claim.
AstraZeneca attempts to distinguish Warner-Lambert
on its facts, pointing out that the patent asserted in that
case claimed an unapproved or “off-label” use, while
AstraZeneca’s ’618 and ’152 patents recite FDA-approved
uses for rosuvastatin calcium. AstraZeneca urges that a
generic manufacturer’s formal carve-out has less signifi-
cance where a patent holder has expended the consider-
able effort and resources required to obtain FDA approval
for its patented method of use. In such cases, according to
AstraZeneca, not only has the patent holder engaged in
precisely the type of innovative activity that the Act
sought to encourage, but such patentees—claiming FDA-
approved therapeutic applications already familiar in the
market—also face more compelling infringement risks
than a patentee claiming unapproved uses for a drug as in
Warner-Lambert. AstraZeneca therefore argues that
Warner-Lambert is inapposite and does not compel us to
preclude all § 271(e)(2) claims based on method of use
ASTRAZENECA PHARMA v. APOTEX CORP 18
patents where the ANDA does not expressly recite a
patented method.
These arguments are unavailing. Although Astra-
Zeneca is correct that the patent at issue in Warner-
Lambert claimed an off-label use for a drug, that distinc-
tion is irrelevant for purposes of § 271(e)(2). When con-
sidering allegations that an ANDA filing infringes a
patented method, § 271(e)(2) directs our analysis to the
scope of approval sought in the ANDA—the statute de-
fines the infringing act as filing an ANDA for “a drug
claimed in a patent or the use of which is claimed in a
patent.” 35 U.S.C. § 271(e)(2)(A). And while generic
applicants cannot obtain approval for uses beyond those
already approved by the FDA, 21 U.S.C. § 355(j)(2)(A)(i),
nothing in the Act requires that an ANDA must encom-
pass every approved indication. As we explained in War-
ner-Lambert:
Congress recognized that a single drug could have
more than one indication and yet that the ANDA
applicant could seek approval for less than all of
those indications. Congress clearly contemplated
that the FDA could grant approval . . . of an
ANDA, seeking to market a drug for a single indi-
cation even when other indications were known or
even approved. . . . [T]he applicant needs only to
certify [under Paragraph IV] with respect to use
patents that claim an indication for which the ap-
plicant is seeking approval to market the drug.
Warner-Lambert, 316 F.3d at 1360. In other words, the
Act allows generic manufacturers to limit the scope of
regulatory approval they seek—and thereby forego Para-
graph IV certification and a § 271(e)(2) infringement
suit—by excluding patented indications from their AN-
DAs. We see no reason why those provisions would, on
19 ASTRAZENECA PHARMA v. APOTEX CORP
the one hand, foreclose § 271(e)(2) liability if an ANDA
excludes a patented but unapproved use as in Warner-
Lambert, and yet, under otherwise identical circum-
stances, allow AstraZeneca to pursue § 271(e)(2) claims
based on the patented, FDA-approved uses that were
carved out in this case.
AstraZeneca also argues that following Warner-
Lambert would enable generic manufacturers to unilater-
ally insulate themselves from infringement under
§ 271(e)(2) by filing ANDAs with improper or misleading
Section viii statements. But AstraZeneca does not allege
or argue that Appellees’ Section viii statements were
erroneous, nor would an unfounded Section viii statement
necessarily immunize an ANDA that actually seeks
approval for a patented treatment or necessarily leave the
patentee without recourse under § 271(e)(2). We do not
opine on such a fact situation not before us.
AstraZeneca also argues that Section viii statements
and restricted generic labeling ignore market realities
because even if a generic drug is formally approved only
for unpatented uses, pharmacists and doctors will none-
theless substitute the generic for all indications once it
becomes available. We find this argument unpersuasive.
First, AstraZeneca’s position would, in practice, vitiate
§ 355(j)(2)(A)(viii) by enabling § 271(e)(2) infringement
claims despite the fact that Appellees’ Section viii state-
ments and corresponding proposed labeling explicitly and
undisputedly carve out all patented indications for rosu-
vastatin calcium. Moreover, if accepted, these speculative
arguments would allow a pioneer drug manufacturer to
maintain de facto indefinite exclusivity over a pharma-
ceutical compound by obtaining serial patents for ap-
proved methods of using the compound and then wielding
§ 271(e)(2) “as a sword against any competitor’s ANDA
seeking approval to market an off-patent drug for an
ASTRAZENECA PHARMA v. APOTEX CORP 20
approved use not covered by the patent. Generic manu-
facturers would effectively be barred altogether from
entering the market.” Warner-Lambert, 316 F.3d at 1359.
We cannot agree with this expansive view of § 271(e)(2),
which is contrary to the statutory scheme. If an off-
patent drug is being used for an unpatented use, that is
activity beyond the scope of § 271(a). So is filing an
ANDA seeking to market an unpatented drug for an
unpatented use beyond the scope of § 271(e)(2).
In summary, the conclusions set forth in Warner-
Lambert also govern the facts of this case. Because Ap-
pellees have submitted ANDAs seeking approval to mar-
ket rosuvastatin calcium for uses that are not subject to
AstraZeneca’s ’618 and ’152 method of use patents, Astra-
Zeneca does not state a claim for infringement of these
patents under § 271(e)(2).
B. AstraZeneca’s Proposed Labeling Amendments
In addition, AstraZeneca also alleged that “the FDA
will require the label for [Appellees’] Rosuvastatin Cal-
cium Tablets to include information relating to” the uses
claimed in the ’618 and ’152 patents. E.g., J.A. 164 (em-
phasis added). In effect, AstraZeneca alleged that the
FDA will require Appellees to amend their ANDAs at
some unspecified point in the future to include all FDA-
approved indications for rosuvastatin calcium, including
those covered by the ’618 and ’152 patents, resulting in
infringement under § 271(e)(2). The district court dis-
missed those claims under Fed. R. Civ. P. 12(b)(1), deem-
ing them insufficiently ripe for adjudication. We agree
with the district court.
Among the requirements for establishing a justiciable
case or controversy under Article III, a dispute must
present issues that are ripe for judicial resolution. “A
claim is not ripe for adjudication if it rests on contingent
21 ASTRAZENECA PHARMA v. APOTEX CORP
future events that may not occur as anticipated, or indeed
may not occur at all.” Texas v. United States, 523 U.S.
296, 300 (1998) (internal quotations omitted). In the
context of patent infringement actions under § 271(e)(2),
we have held that “Section 271(e)(2) does not encompass
‘speculative’ claims for infringement.” Warner-Lambert,
316 F.3d at 1364. Regardless what may or may not occur
in the future, the infringement analysis under § 271(e)(2)
is limited to whether the accused infringer’s ANDA seeks
approval for activities that would constitute infringement
of the asserted patents. Id. at 1364–65.
In view of the foregoing requirements, AstraZeneca’s
claims based on presumed future labeling amendments
are unripe. As we have noted, the Act permits generic
manufacturers to file ANDAs directed to a subset of FDA-
approved indications and even provides a mechanism for
ANDA applicants to affirmatively carve out patented
indications by submitting Section viii statements. In this
case, Appellees have limited their ANDAs to unpatented
methods for using rosuvastatin calcium, nothing in the
record indicates that the FDA has required Appellees to
add further indications, and we see no reason to presume
that the FDA will do so in the future. In fact, as Appel-
lees point out, the FDA has tentatively approved several
of their ANDAs without issuing any such requirements.
E.g., J.A. 206–10. Accordingly, the district court correctly
dismissed AstraZeneca’s claims as unripe to the extent
that they rely on prospective labeling amendments for
Appellees’ generic rosuvastatin calcium because these
claims rest on contingent future events that may never
occur.
CONCLUSION
While the district court erred in part by concluding
that AstraZeneca’s failure to state a cognizable § 271(e)(2)
ASTRAZENECA PHARMA v. APOTEX CORP 22
claim defeated its jurisdiction, we nonetheless agree that
(1) AstraZeneca failed to state a § 271(e)(2) claim based on
Appellees’ existing ANDA filings, and (2) AstraZeneca’s
claims premised on presumed future labeling amend-
ments were not ripe for adjudication. We therefore affirm
the district court’s judgment dismissing the complaint.
AFFIRMED