United States Court of Appeals
for the Federal Circuit
__________________________
TEVA PHARMACEUTICALS USA, INC.,
THROUGH ITS GATE PHARMACEUTICALS DIVISION,
Plaintiff-Appellant,
v.
EISAI CO., LTD. AND EISAI MEDICAL RESEARCH,
INC.,
Defendants-Appellees.
__________________________
2009-1593
__________________________
Appeal from the United States District Court for the
District of New Jersey in case no. 08-CV-2344, Chief
Judge Garrett E. Brown, Jr.
__________________________
Decided: October 6, 2010
__________________________
FRANCIS C. LYNCH, Goodwin Proctor LLP, of Boston,
Massachusetts, argued for plaintiff-appellant. With him
on the brief were HENRY C. DINGER and LAURIE S. GILL.
BRUCE M. WEXLER, Paul, Hastings, Janofsky &
Walker LLP, of New York, New York, argued for defen-
dants-appellees. With him on the brief were JOSEPH M.
TEVA PHARMACEUTICALS v. EISAI CO 2
O’MALLEY, JR. and ANTHONY MICHAEL; and STEPHEN B.
KINNAIRD, of Washington, DC.
__________________________
Before RADER, Chief Judge ∗ , DYK and PROST, Circuit
Judges.
PROST, Circuit Judge.
This is a declaratory judgment action arising under
the Hatch-Waxman Act. We must decide whether the
district court properly dismissed the case for lack of
jurisdiction, specifically, lack of a justiciable controversy
under Article III of the United States Constitution.
Teva Pharmaceuticals, Inc. (“Teva”) seeks to manu-
facture and market a generic version of the drug donepe-
zil hydrochloride (“donepezil”), an approved treatment for
Alzheimer’s disease. Eisai Co. and Eisai Medical Re-
search, Inc. (collectively “Eisai”) hold the approved New
Drug Application (“NDA”) for donepezil, which Eisai
currently markets as Aricept®. Eisai also owns the five
patents listed for Aricept® in the Orange Book. Teva
requests a declaratory judgment that its generic version
of donepezil does not infringe four of these Orange Book
patents, Patent Nos. 5,985,864 (“’864 patent”); 6,140,321
(“’321 patent”); 6,245,911 (“’911 patent”); and 6,372,760
(“’760 patent”), (collectively the “DJ patents”).
Aside from the value of such a judgment in itself, a
finding of noninfringement has special significance to
generic drug manufacturers like Teva under the Hatch-
Waxman Act. To market a generic version of a previ-
ously-approved drug, manufacturers must file and receive
∗
Randall R. Rader assumed the position of
Chief Judge on June 1, 2010.
3 TEVA PHARMACEUTICALS v. EISAI CO
approval of an Abbreviated New Drug Application
(“ANDA”). In conjunction with an ANDA, manufacturers
must also submit a certification with respect to each of
the drug’s Orange Book patents. The first manufacturer
to file what is called a “Paragraph IV Certification” for a
given Orange Book patent is entitled to 180 days of ge-
neric marketing exclusivity. Until the first-filer’s exclu-
sivity period has run, the FDA may not approve ANDA
applications by other manufacturers who have filed
Paragraph IV certifications for that same patent. The
first-filer’s exclusivity period can be triggered by either
the (1) commercial marketing of the drug by the first
Paragraph IV filer or (2) entry of a court judgment finding
that patent invalid or not infringed, whichever happens
first. A subsequent Paragraph IV filer can thus trigger
the first-filer’s exclusivity period by obtaining a court
judgment.
Teva is a subsequent Paragraph IV filer. This case
turns on whether a subsequent Paragraph IV filer has a
legally cognizable interest in when the first-filer’s exclu-
sivity period begins, such that delay in triggering that
period qualifies as “injury-in-fact” for the purposes of
Article III.
In this case, the alleged injury-in-fact stems from a
pending ANDA filed by Gate Pharmaceuticals (“Gate
ANDA” or “second ANDA”), an unincorporated division of
Teva. FDA approval of the Gate ANDA has been delayed
indefinitely because the exclusivity period of the first-
filer, a company called Ranbaxy Laboratories Ltd. (“Ran-
baxy”), has not been triggered. Before the district court,
patent owner Eisai argued that Teva failed to establish
the existence of an Article III controversy. The district
court agreed and dismissed the case for lack of jurisdic-
tion. In finding that Teva failed to allege a controversy of
TEVA PHARMACEUTICALS v. EISAI CO 4
sufficient immediacy and reality for Article III purposes,
the district court relied in part on a preliminary injunc-
tion entered against Teva and Gate in a separate, still-
pending patent infringement action regarding Patent No.
4,895,841 (“’841 patent”). 1
Teva appeals the dismissal of its declaratory judg-
ment action and argues the case should proceed. We
agree. Under this court’s decision in Caraco Pharmaceu-
tical Laboratories, Ltd. v. Forest Laboratories, Inc., 527
F.3d 1278 (Fed. Cir. 2008), Teva has alleged a sufficiently
concrete injury fairly traceable to Eisai’s actions. Fur-
ther, the injury can be redressed by the requested relief:
a declaratory judgment of noninfringement would trigger
the first-filer’s exclusivity period, which currently blocks
FDA approval of the Gate ANDA. The district court’s
decision is reversed and the case remanded for further
proceedings consistent with this opinion.
BACKGROUND
Because Teva’s declaratory judgment claims were dis-
posed of at the motion to dismiss stage, we take the
following facts from Teva’s amended complaint and the
materials submitted in response to Eisai’s motion to
dismiss. See MedImmune, Inc. v. Genentech, Inc., 549
U.S. 118, 121 (2007).
Eisai holds the approved New Drug Application
(“NDA”) for donepezil, which it markets as the prescrip-
tion drug Aricept®. For Aricept®, Eisai listed five pat-
ents in the Orange Book, thus attesting that those
1 The ’841 patent is listed in the Orange Book for
Aricept®. It is not, however, one of the patents as to
which Teva seeks a declaratory judgment of noninfringe-
ment in this case.
5 TEVA PHARMACEUTICALS v. EISAI CO
patents claim either donepezil or a method for using it,
and accordingly could reasonably be asserted against any
unlicensed party seeking to manufacture, use, or sell the
drug. Of the five patents, the ’841 patent is the subject of
separate patent infringement litigation brought by Eisai
against Teva and Gate. The four DJ patents are at issue
here.
A significant number of events occurred before Teva
brought this action. While the timeline and statutory
scheme is complex, for our purposes, only the following
facts matter.
The first ANDA for a generic form of donepezil was
filed by Ranbaxy in 2003. For the ’841 patent, Ranbaxy
submitted a Paragraph III certification, thus agreeing not
to market a generic version of Aricept® until after the
’841 patent expires in November 2010. For the DJ pat-
ents, Ranbaxy submitted Paragraph IV certifications,
meaning that in Ranbaxy’s opinion the four patents are
invalid or will not be infringed by its drug. 21 U.S.C.
§ 355(j)(2)(A)(vii). Because Ranbaxy filed the first Para-
graph IV certifications for the DJ patents, Ranbaxy is
eligible for 180 days of market exclusivity upon FDA
approval of its ANDA. Id. § 355(j)(5)(B)(iv). The exclusiv-
ity period begins when Ranbaxy begins commercially
marketing its drug or upon issuance of a court judgment
holding the relevant listed patents invalid or not in-
fringed. Id. § 355(j)(5)(B)(iv) (2000). 2
2 In 2003, Congress altered the scheme for trigger-
ing the 180-day exclusivity period by amending the
Hatch-Waxman Act. As a result, a first-filer can now
forfeit its exclusivity period by failing to market its drug
within a certain time. See 21 U.S.C. § 355(j)(5)(D). These
changes do not apply here because Ranbaxy filed its
ANDA with the Paragraph IV certifications before enact-
TEVA PHARMACEUTICALS v. EISAI CO 6
Teva subsequently filed two separate ANDAs for ge-
neric donepezil. As initially filed with the FDA, Teva’s
first ANDA (“first ANDA” or “Teva ANDA”) had the same
certifications as Ranbaxy’s ANDA: For the ’841 patent,
Teva initially included a Paragraph III certification; for
the DJ patents, Teva included Paragraph IV certifica-
tions. Teva subsequently amended this first ANDA,
changing the ’841 patent’s certification from Paragraph
III to Paragraph IV.
Teva’s second ANDA (“second ANDA” or “Gate
ANDA”) was filed by Gate Pharmaceuticals, a division of
Teva. This second ANDA was for a different form of
generic donepezil than the one claimed in Teva’s first
ANDA. According to Teva, the FDA requested separate
ANDAs filed under different company names because the
forms of donepezil were different and the likelihood of
confusion otherwise greater. The Gate ANDA originally
included Paragraph III certifications for all five listed
patents; following an amendment, however, these were
changed to Paragraph IV certifications.
Under the Hatch-Waxman Act, filing a Paragraph IV
certification constitutes an act of patent infringement. 35
U.S.C. § 271(e)(2). After Teva filed its first and second
ANDAs in 2005 and 2007 respectively, Eisai timely sued
Teva for infringement of the ’841 patent (“’841 patent
infringement litigation”). 21 U.S.C. § 355(c)(3)(C) (2000).
Though filed separately, these two infringement actions
were consolidated in early 2008. During the course of the
litigation, Teva stipulated that its generic forms of done-
ment of the amendments. See Medicare Prescription
Drug, Improvement, and Modernization Act of 2003,
§ 1102(b), Pub. L. No. 108-173, 117 Stat. 2066 (2003).
7 TEVA PHARMACEUTICALS v. EISAI CO
pezil infringe various claims of the ’841 patent unless the
patent is invalid or unenforceable.
In February 2008, Eisai moved for a preliminary in-
junction to prevent Teva and Gate from marketing any
form of generic donepezil after expiration of the thirty-
month stay invoked by Eisai, thereby initiating the ’841
patent infringement litigation. See id. § 355(j)(5)(B)(iii).
Eisai’s motion was granted and a preliminary injunction
entered against Teva and Gate. Eisai Co. v. Teva
Pharms. USA, Inc., No. 05-5727 (D.N.J. Mar. 28, 2008)
(opinion and order granting preliminary injunction). The
preliminary injunction bars Teva and Gate from market-
ing any drug containing donepezil as claimed in the ’841
patent. In April 2008, the thirty-month stay expired and
the FDA approved Teva’s first ANDA. At the time of this
appeal, the separate ’841 patent infringement litigation is
still pending and the related preliminary injunction is
still in effect.
In May 2008, Teva filed this action. Here, Teva seeks
a declaratory judgment that the manufacture, use, offer
for sale, sale, or importation of generic donepezil covered
by the Gate ANDA will not infringe the DJ patents. 21
U.S.C. § 355(j)(5)(C); 35 U.S.C. § 271(e)(5). Eisai has
never brought suit to enforce any of the DJ patents
against Teva. Rather in 2006 and 2007, before this case
arose, Eisai filed statutory disclaimers with the United
States Patent and Trademark Office regarding two of the
DJ patents, the ’321 and ’864 patents. See 35 U.S.C. §
253. A statutory disclaimer has the effect of cancelling
the patent claims, meaning they cannot be reissued or
subsequently enforced. See Guinn v. Kopf, 96 F.3d 1419,
1422 (Fed. Cir. 1996). What matters for our purposes is
that all four of the DJ patents remain listed in the Orange
Book.
TEVA PHARMACEUTICALS v. EISAI CO 8
Eisai moved to dismiss this case for lack of subject
matter jurisdiction. While Eisai’s motion was pending,
the parties negotiated a covenant-not-to-sue covering the
two DJ patents Eisai had not disclaimed, the ’911 and
’760 patents. Pursuant to the covenant, Eisai uncondi-
tionally agreed not to assert the ’911 and ’760 patents
against Teva or its successors with respect to any formu-
lation of generic donepezil described in Teva’s first or
second ANDAs. Before the district court and on appeal,
Eisai relies in part on the statutory disclaimers and
covenant-not-to-sue in arguing that there is no justiciable
controversy.
Teva’s amended complaint acknowledges the statu-
tory disclaimers and covenant-not-to-sue. Teva nonethe-
less maintains that it is suffering an injury cognizable
under Article III because the DJ patents remain listed in
the Orange Book. Because the DJ patents remain listed,
under 21 U.S.C. § 355(j)(5)(B)(4) FDA approval of Teva’s
Gate ANDA cannot occur until the exclusivity period for
the first-filer of the DJ patents, Ranbaxy, has run. As
stated previously, the exclusivity period can only be
triggered by the first-filer’s commercial marketing of the
generic drug or a court judgment that the relevant pat-
ents are invalid or not infringed. Given the framework of
the Hatch-Waxman Act, Teva argues that the only way to
redress its “FDA-approval-blocking-injury” is through this
action for declaratory judgment.
We have jurisdiction under 28 U.S.C. § 1295(a)(1).
ANALYSIS
We review a district court’s dismissal for lack of sub-
ject matter jurisdiction de novo. Janssen Pharmaceutica,
N.V. v. Apotex, Inc., 540 F.3d 1353, 1359 (Fed. Cir. 2008).
9 TEVA PHARMACEUTICALS v. EISAI CO
Whether an actual controversy exists for purposes of a
declaratory judgment action is a question of law also
reviewed de novo. Teva Pharms. USA v. Novartis
Pharms. Corp. (“Novartis”), 482 F.3d 1330, 1336 (Fed. Cir.
2007). We review a district court’s decision to decline
jurisdiction under the Declaratory Judgment Act for
abuse of discretion. Sony Elecs., Inc. v. Guardian Media
Techs., Ltd., 497 F.3d 1271, 1287 (Fed. Cir. 2007).
Under the Hatch-Waxman Act, a party that files an
ANDA with Paragraph IV certifications may bring suit
under the Declaratory Judgment Act, 28 U.S.C. § 2201,
against the holder of the corresponding New Drug Appli-
cation (“NDA”). 35 U.S.C. § 271(e)(5). The Declaratory
Judgment Act provides that “[i]n the case of actual con-
troversy within its jurisdiction . . . any court of the United
States, upon the filing of an appropriate pleading, may
declare the rights and other legal relations of any inter-
ested party seeking such declaration, whether or not
further relief is or could be sought.” 28 U.S.C. § 2201(a)
(emphasis added). Federal courts have subject matter
jurisdiction over cases brought by ANDA filers “to the
extent consistent with the Constitution.” 35 U.S.C.
§ 271(e)(5). The Constitution requires an Article III case
or controversy. Novartis, 482 F.3d at 1337.
The Supreme Court has explained that such a contro-
versy exists when the dispute is “definite and concrete,
touching the legal relations of parties having adverse
legal interests.” MedImmune, 549 U.S. at 128 (quoting
Aetna Life Ins. Co. v. Haworth, 300 U.S. 227, 240-41
(1937)). This dispute must be “real and substantial,” and
of “sufficient immediacy and reality to warrant issuance
of a declaratory judgment.” Id. Further, the plaintiff’s
injury must be “fairly traceable” to the defendant’s con-
duct. Steel Co. v. Citizens for a Better Env’t, 523 U.S. 83,
TEVA PHARMACEUTICALS v. EISAI CO 10
102-03 (1998). Finally, the requested relief must be likely
to redress the alleged injury. Id. In other words, the
injury must “admi[t] of specific relief through a decree of a
conclusive character, as distinguished from an opinion
advising what the law would be upon a hypothetical state
of facts.” MedImmune, 549 U.S. at 128.
This case presents two questions. First, we must de-
cide whether this case presents an “actual controversy.”
Should such a controversy exist, we must then decide if
the district court abused its discretion under the Declara-
tory Judgment Act in declining to entertain this suit. We
address each question in turn.
I. Actual Controversy
We begin with the jurisdictional question. Teva ar-
gues that absent a declaratory judgment with respect to
the DJ patents, it suffers (and will continue to suffer) the
harm of being unable to launch generic donepezil products
covered by the Gate ANDA. Two decisions by this court
set out the framework for determining whether an Article
III controversy exists in a declaratory judgment action
arising under the Hatch-Waxman Act, Caraco and
Janssen. See also 21 U.S.C. § 355(j)(5)(C); 35 U.S.C.
§ 271(e)(5); 28 U.S.C. § 2201.
Caraco holds that the exclusion of non-infringing ge-
neric drugs from the market can be a judicially cognizable
injury-in-fact. 527 F.3d at 1291-92. Because a company
is not free to manufacture or market drugs until it re-
ceives FDA approval, under the Hatch-Waxman frame-
work such an injury occurs when the holder of an
approved NDA takes action that delays FDA approval of
subsequent ANDAs. See 21 U.S.C. § 355(a); Novartis, 482
F.3d at 1345. In the cases of Caraco and Janssen, the
11 TEVA PHARMACEUTICALS v. EISAI CO
alleged action taken (giving rise to the injury-in-fact) was
listing particular patents in the Orange Book. Caraco,
527 F.3d at 1292; Janssen, 540 F.3d at 1359-60. As we
explained in Caraco, the generic drug company’s injury
(i.e., exclusion from the market) is fairly traceable to the
defendant’s actions because “but-for” the defendant’s
decision to list a patent in the Orange Book, FDA ap-
proval of the generic drug company’s ANDA would not
have been independently delayed by that patent. 527
F.3d at 1292; see 21 U.S.C. § 355(j)(5)(B)(iv). When an
Orange Book listing creates an “independent barrier” to
entering the marketplace that cannot be overcome with-
out a court judgment that the listed patent is invalid or
not infringed—as for Paragraph IV filers—the company
manufacturing the generic drug has been deprived of an
economic opportunity to compete. Id. at 1293; see also 21
U.S.C. § 355(j)(5)(B)(4). A declaratory judgment redresses
this alleged injury because it eliminates the potential for
the corresponding listed patent to exclude the generic
drug from the market. Caraco, 527 F.3d at 1293 (holding
that a declaratory judgment action as to one of the listed
patents would “clear the path to FDA approval that [the
NDA holder’s] actions would otherwise deny [the generic
pharmaceutical]”).
Though its facts were slightly different, Janssen reaf-
firms Caraco’s holding that the injury-in-fact must stem
from the actions of the company that listed the patents in
the Orange Book, not the inherent framework of the
Hatch-Waxman Act. See Janssen 540 F.3d at 1360-61.
In Janssen, a subsequent Paragraph IV filer sought to
trigger the first-filer’s exclusivity period by obtaining a
declaratory judgment. While the declaratory judgment
action was pending, however, this subsequent filer stipu-
lated to the validity, infringement, and enforceability of
TEVA PHARMACEUTICALS v. EISAI CO 12
another patent listed in the Orange Book for the same
drug. Id. As a result of the stipulation, even if the subse-
quent filer had prevailed in its declaratory judgment
action, it could not have launched its generic drug before
expiration of the patent covered by the stipulation.
Accordingly, unlike in Caraco, there was no risk that
invalid patents were keeping the subsequent filer’s ge-
neric drugs off the market; regardless, the company could
not have marketed its generic drug because of the stipula-
tion. Id. at 1361. In other words, the subsequent filer’s
alleged harm, inability to enter the market, was not
“fairly traceable” to the listing of the subject patents in
the Orange Book. Rather, the cause was the stipulation.
We further held in Janssen that the subsequent filer
could not proceed with its declaratory judgment action
simply to trigger the first-filer’s exclusivity period. In
contrast to the listing of a patent in the Orange Book, a
first-filer’s exclusivity period in itself does not give rise to
an injury-in-fact because the resulting exclusion of other
generic drug companies from the market results from the
inherent framework and intended workings of the Hatch-
Waxman Act. Id. at 1360-61.
We hold that this case presents an actual controversy.
Here, as in Caraco, a favorable judgment “would elimi-
nate the potential for the [DJ patents] to exclude [Teva]
from the drug market.” 527 F.3d at 1293. Unlike the
generic drug company in Janssen, Teva has not stipulated
to the validity, infringement, or enforceability of any
other patent listed in the Orange Book for donepezil. 540
F.3d at 1360. Nor is Teva subject to any final judgment
regarding an Orange Book patent for donepezil that
would prevent Teva from selling products covered by the
13 TEVA PHARMACEUTICALS v. EISAI CO
Gate ANDA. Given the absence of such factors, Caraco
controls. 3 See id.
Eisai is correct that Teva and Gate have been subject
to a preliminary injunction arising out of the separate
’841 patent litigation, which barred Teva and Gate from
marketing any drug containing donepezil as claimed in
the ’841 patent, including products covered by the Gate
ANDA. As the name itself admits, however, that injunc-
tion was “preliminary.” Indeed, the underlying litigation
was still ongoing; there had been no final determination
as to the validity, infringement, or enforceability of the
’841 patent. Thus, unlike the generic drug company in
Janssen which stipulated to the validity, enforceability
and infringement of an Orange Book patent, there was no
equivalent final judgment regarding the ’841 patent.
Indeed, Teva and Gate would not necessarily remain
subject to an injunction, depending on the outcome of the
’841 patent infringement litigation. 4
3 Neither the statutory disclaimers nor Eisai’s
covenant-not-to-sue render this declaratory judgment
action moot because the DJ patents remain listed in the
Orange Book. Caraco, 527 F.3d at 1296-97. Thus, re-
gardless of whether Eisai could bring an infringement
action with respect to the DJ patents, under the Hatch-
Waxman Act Teva still needs a court judgment of nonin-
fringement or invalidity to obtain FDA approval and enter
the market. Id.
4 On September 28, 2010, Teva advised the court of
a subsequent stipulation the parties entered into on July
19, 2010 in the ’841 patent infringement litigation. The
parties agreed that the preliminary injunction would
remain in effect until the ’841 patent expires on Novem-
ber 25, 2010. This stipulation does not change our analy-
sis in this case for two reasons. First, it does not affect
jurisdiction at the outset of this appeal. Second, given
TEVA PHARMACEUTICALS v. EISAI CO 14
II. Discretionary Dismissal
In the alternative, the district court stated that it
would decline to entertain this suit pursuant to its broad
discretion under the Declaratory Judgment Act. In
support, the court cited the same reasons for finding no
jurisdiction under Article III, the need to conserve judicial
resources, the multiple ANDAs, and the relationship
between Teva and Gate. On appeal, Teva argues that the
Hatch-Waxman Act requires district courts to exercise
jurisdiction in all declaratory judgment cases, so long as
jurisdiction exists. According to Teva, the unequivocal
language of 35 U.S.C. § 271(e)(5) overrides the general
grant of discretion in 28 U.S.C. § 2201.
We disagree. Section 271(e)(5) (emphasis added)
states that “the courts of the United States shall, to the
extent consistent with the Constitution, have subject
matter jurisdiction.” The Declaratory Judgment Act
provides that “any court of the United States, upon the
filing of an appropriate pleading, may declare the rights
and other legal relations of any interested party seeking
such declaration.” 28 U.S.C. § 2201(a) (emphasis added).
In our view, § 271(e)(5) speaks only to the power of a court
to decide a case, not the prudence. Thus, while § 271(e)(5)
clarifies the maximum extent of a court’s jurisdiction, it
does not govern how the district court may exercise its
discretion under § 2201 in deciding whether to declare the
that the stipulation is only relevant, if at all, until the
expiration of the ’841 patent on November 25, after that
date the DJ patents would bar Teva from obtaining FDA
approval earlier and marketing the generic form of done-
pezil covered by the Gate ANDA. To be sure, in this case,
even if the DJ action resulted in a favorable outcome for
Teva, the first-filer’s 180-day exclusivity period would run
after the ’841 patent’s expiration date.
15 TEVA PHARMACEUTICALS v. EISAI CO
rights of the litigants. See MedImmune, 549 U.S. at 136-
37. Section 271(e)(5) thus leaves intact the discretion
granted by § 2201 to decline jurisdiction over declaratory
judgment actions. Sony Elecs., 497 F.3d at 1288-89. We
have thus upheld discretionary decisions declining juris-
diction when the declaratory judgment action was dupli-
cative of other proceedings, the party instituted an action
solely to enhance its bargaining power in negotiations, or
when reexamination proceedings were pending. Id.; see
also EMC Corp. v. Norand Corp., 89 F.3d 807, 813-16
(Fed. Cir. 1996), overruled in part on other grounds,
MedImmune, 549 U.S. 118 (2007).
However, while the Declaratory Judgment Act does
“confer on federal courts unique and substantial discre-
tion” to decide whether to exercise jurisdiction, that
discretion is not unbounded. See MedImmune, 549 U.S.
at 136; Sony Elecs., 497 F.3d at 1288. In exercising such
discretion, the district court must typically consider the
usefulness of the declaratory judgment remedy, the
fitness of the case for resolution, and the purposes of the
Declaratory Judgment Act. Wilton v. Seven Falls Co., 515
U.S. 277, 286 (1995); see also Serco Servs. Co. v. Keley Co.,
51 F.3d 1037, 1039 (Fed. Cir. 1995). A district court
abuses its discretion when its decision is (1) clearly un-
reasonable or arbitrary; (2) was based on an erroneous
conclusion of law; (3) the court’s findings were clearly
erroneous; or (4) the record contains no evidence upon
which the court could rationally have based its decision.
Sony Elecs., 497 F.3d at 1288.
In this case, we conclude that it was an abuse of dis-
cretion to decline jurisdiction. At least two errors infect
the district court’s exercise of discretion under § 2201(a).
First, as explained above, the district court erroneously
concluded that it lacked subject matter jurisdiction, a
TEVA PHARMACEUTICALS v. EISAI CO 16
factor it then relied upon in deciding to decline jurisdic-
tion. The district court should not have considered
whether it had subject matter jurisdiction in making the
subsequent, discretionary decision of whether to exercise
jurisdiction over the case. See Wilton, 515 U.S. at 286;
Sony Elecs., 497 F.3d at 1271. While a lack of subject
matter jurisdiction would require the district court to
dismiss the case, the existence of jurisdiction in itself is
not probative of the relevant factors under § 2201(a), such
as whether the declaratory judgment remedy will be
useful or whether the case is fit for resolution.
Second, the district court’s exercise of discretion is not
supported by the facts. The district court’s conclusion
that the relationship between Teva and Gate, combined
with the multiple ANDAs, amounted to thinly disguised,
improper gamesmanship is not what the record shows.
Nothing in the Hatch-Waxman Act bars a company from
filing multiple ANDAs covering different formulations of
the same drug, as Teva (through Gate) did here. Nor was
it improper for those ANDAs to be filed under different
corporate names, particularly since this filing decision
was made at the FDA’s request. We agree with Teva that
this case presents none of the typical factors that might
warrant the exercise of discretion to decline jurisdiction.
This case is not duplicative of other pending or decided
litigation; in the absence of this action, the validity or
infringement of the DJ patents will not be litigated.
Further, as explained above, there is an actual contro-
versy. A declaratory judgment would settle the legal
relations in dispute and afford relief from uncertainty and
insecurity. See SanDisk Corp. v. STMicroelectronics, Inc.,
480 F.3d 1372, 1383 (Fed. Cir. 2007); see also Genentech v.
Eli Lilly & Co., 998 F.2d 931, 937 (Fed. Cir. 1993).
17 TEVA PHARMACEUTICALS v. EISAI CO
Because no “sound basis” for refusing to adjudicate
this case has been shown, on remand this case should
proceed absent additional facts that might warrant a
contrary conclusion. See Elecs. for Imaging, Inc. v. Coyle,
394 F.3d 1341, 1345 (Fed. Cir. 2005); Capo, Inc. v. Diop-
tics Med. Prods., 397 F.3d 1352, 1355 (Fed. Cir. 2004).
CONCLUSION
Because this case presents an actual controversy jus-
ticiable under Article III and no well-founded basis for
declining jurisdiction has been established, we reverse the
district court’s dismissal for lack of subject matter juris-
diction. The case is remanded for further proceedings
consistent with this opinion.
REVERSED AND REMANDED