United States Court of Appeals
for the Federal Circuit
__________________________
DEY PHARMA, LP AND DEY INC.,
Plaintiffs-Appellees,
v.
SUNOVION PHARMACEUTICALS INC.,
Defendant-Appellant.
__________________________
2011-1507
__________________________
Appeal from the United States District Court for the
District of Delaware in case no. 08-CV-0372, Judge
Leonard P. Stark.
___________________________
Decided: April 16, 2012
___________________________
ELIZABETH A. LEFF, Frommer Lawrence & Haug LLP,
of Washington, DC, argued for plaintiffs-appellees. With
her on the brief were EDGAR H. HAUG and SAM V. DESAI, of
New York, New York.
ERIC W. DITTMANN, Paul Hastings, LLP, of New York,
New York, argued for defendant-appellant. With him on
the brief were JOSEPH M. O’MALLEY, JR., BRUCE M.
WEXLER and PRESTON K. RATLIFF, II; STEPHEN B.
KINNAIRD, of Washington, DC.
__________________________
DEY PHARMA v. SUNOVION PHARMA 2
Before BRYSON, DYK, and MOORE, Circuit Judges.
DYK, Circuit Judge.
Dey Pharma, LP and Dey Inc. (“Dey”) brought suit
against Sunovion Pharmaceuticals, Inc. (“Sunovion”)
seeking a declaratory judgment that Dey’s generic phar-
maceutical product does not infringe Sunovion’s U.S.
Patent No. 6,451,289 (“the ’289 patent”), and that the ’289
patent is invalid. The district court concluded that it had
subject-matter jurisdiction over the action, and the par-
ties thereafter stipulated to a final judgment of nonin-
fringement. See Dey Pharma, L.P. v. Sunovion Pharms.
Inc., No. 08-372 (D. Del. June 20, 2011) (final judgment);
Dey LP v. Sepracor Inc., No. 08-372, 2009 WL 1043892 (D.
Del. Apr. 16, 2009) (denying motion for certification); Dey,
L.P. v. Sepracor, Inc., 595 F. Supp. 2d 355 (D. Del. 2009)
(denying motion to dismiss). 1 Sunovion appeals, challeng-
ing the district court’s subject-matter jurisdiction. We
affirm.
BACKGROUND
I
This declaratory judgment action involves the Drug
Price Competition and Patent Term Restoration Act of
1984, Pub. L. No. 98-417, 98 Stat. 1585 (“Hatch-Waxman
Act”), in which “Congress struck a balance between two
competing policy interests: (1) inducing pioneering re-
search and development of new drugs and (2) enabling
competitors to bring low-cost, generic copies of those
drugs to market,” Andrx Pharms., Inc. v. Biovail Corp.,
276 F.3d 1368, 1371 (Fed. Cir. 2002). Under the Hatch-
Waxman framework, a brand-name company seeking
1 Sunovion was formerly known as Sepracor.
3 DEY PHARMA v. SUNOVION PHARMA
FDA approval of a new drug must file a new drug applica-
tion (“NDA”) with the Food and Drug Administration
(“FDA”), which must include information about patents
“with respect to which a claim of patent infringement
could reasonably be asserted.” 21 U.S.C. § 355(b)(1). The
FDA publishes this patent information, see id., in a publi-
cation known as the “Orange Book.”
A generic company may then seek FDA approval us-
ing an abbreviated new drug application (“ANDA”) with a
certification for each patent in the Orange Book, such as a
“paragraph III certification” (that approval is not sought
until the patent expires) or a “paragraph IV certification”
(“that such patent is invalid or will not be infringed”). Id.
§ 355(j)(2)(A)(vii). If an ANDA contains only paragraph
IV certifications, the ANDA may be approved unless the
NDA holder sues the ANDA filer for patent infringement
within 45 days. See id. § 355(j)(5)(B)(iii). 2 The first
generic company to file an ANDA containing a paragraph
IV certification receives a 180-day exclusivity period from
the date of its “first commercial marketing” before other
generic companies will be approved by the FDA to enter
the market. See 21 U.S.C. § 355(j)(5)(B)(iv). The 180-day
period is not impacted by the NDA filer’s decision not to
sue a subsequent ANDA filer on patents listed in the
subsequent filer’s paragraph IV certifications.
Before the 2003 amendments to the Hatch-Waxman
Act, the first generic filer’s 180-day exclusivity period was
triggered by either its “first commercial marketing” or a
court judgment “holding the patent which is the subject of
the certification to be invalid or not infringed.” 21 U.S.C.
§ 355(j)(5)(B)(iv) (2000). Under the 2003 amendments,
the exclusivity period is only triggered by the first-filing
2 The filing of the ANDA is treated as an act of in-
fringement. See 35 U.S.C. § 271(e)(2).
DEY PHARMA v. SUNOVION PHARMA 4
generic’s first commercial marketing, but the exclusivity
period can be forfeited under certain conditions, including
failure to launch after a final court judgment of nonin-
fringement or invalidity. See Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (“MMA”),
Pub. L. No. 108-173, § 1102, 117 Stat. 2066, 2457-60. For
example, if a second ANDA filer obtained a final judgment
that the patents were invalid or not infringed, then the
first ANDA filer would forfeit its 180-day exclusivity
period if it did not market the drug within 75 days. See
21 U.S.C. § 355(j)(5)(D). This change in the statutory
trigger makes no difference to the issues in this case, and
for simplicity we refer to a final judgment that triggers
the 75-day countdown to forfeiture of the exclusivity
period as a “trigger” of the 180-day exclusivity period.
Also before the 2003 amendments, “NDA holders em-
ployed several methods of delaying the early resolution of
patent disputes.” Janssen Pharmaceutica, N.V. v. Apotex,
Inc., 540 F.3d 1353, 1357 (Fed. Cir. 2008). “For example,
the brand drug company might have several patents
listed in the . . . Orange Book with respect to a particular
drug. It could be in the company’s interest to bring suit
within 45 days on one patent and to hold the others in
reserve.” Teva Pharms. USA, Inc. v. Novartis Pharms.
Corp., 482 F.3d 1330, 1343-44 (Fed. Cir. 2007) (quoting
149 Cong. Rec. 31,784 (2003) (statement of Sen. Edward
Kennedy)). The benefits of this strategy were noted in the
legislative history, including the threat of an infringement
suit on the reserved patent against the first ANDA filer
after it secured FDA approval, and the ability to delay
triggering the first ANDA filer’s exclusivity period by
preventing adjudication of noninfringement or invalidity
of the reserved patent. See 149 Cong. Rec. 31,784.
To address this problem, Congress specified that an
ANDA filer who is not sued within 45 days could bring a
5 DEY PHARMA v. SUNOVION PHARMA
declaratory judgment action under 28 U.S.C. § 2201
against the NDA holder, see 21 U.S.C. § 355(j)(5)(C), and
that the federal courts would have declaratory judgment
jurisdiction “to the extent consistent with the Constitu-
tion,” 35 U.S.C. § 271(e)(5). Under this amended Hatch-
Waxman framework, if the first ANDA filer “parked” its
180-day exclusivity under an agreement with the brand-
name company, a subsequent ANDA filer could independ-
ently trigger the first filer’s exclusivity period through a
declaratory judgment action leading to a final judgment of
invalidity or noninfringement, thereby accelerating the
second ANDA filer’s ability to market its drug.
II
This case involves such a declaratory judgment claim
by the second ANDA filer (Dey) against the patent holder
and NDA filer (Sunovion), designed to trigger the first
ANDA filer’s (Breath’s) exclusivity period. The FDA
approved Sunovion’s NDA 20-837 for Xopenex in 1999.
Sunovion listed three patents relating to Xopenex in the
Orange Book: U.S. Patent No. 5,362,755 (“the ’755 pat-
ent”), U.S. Patent No. 5,547,994 (“the ’994 patent”), and
the ’289 patent. 3 The ’755 patent expires on March 25,
2013; the ’994 patent expires on August 20, 2013; and the
’289 patent expires on March 21, 2021.
In June 2005, Breath filed the first ANDA for generic
Xopenex, which contained paragraph IV certifications for
all three patents. In October 2005, Sunovion sued Breath
for infringement of all three patents in a case that was
transferred to the U.S. District Court for the District of
Massachusetts. In May 2008, the suit was dismissed
3 Three other patents, U.S. Patent Nos. 5,760,090,
5,844,002, and 6,083,993, were also listed, but they have
expired and are not pertinent here. For simplicity we
omit them from the description of the litigation.
DEY PHARMA v. SUNOVION PHARMA 6
based on a settlement agreement between Sunovion and
Breath. Sepracor Inc. v. Breath Ltd., No. 06-10043 (D.
Mass. May 1, 2008). Under the settlement, Breath, by
paying a license fee, may sell generic Xopenex under its
ANDA starting on August 20, 2012 (or on the date of an
earlier third-party commercial launch). See J.A. 187-88.
In July 2005, Dey filed a second ANDA for generic
Xopenex, which also contained paragraph IV certifications
for all three Orange Book patents. In February 2006,
Sunovion sued Dey over two of the patents in the District
Court for the District of Delaware, but Sunovion did not
assert the ’289 patent. Dey later filed a different ANDA
on a “concentrate” version of Xopenex, and after Sunovion
again sued Dey with respect to the two patents but not
the ’289 patent, the actions were consolidated in district
court in December 2006. On June 20, 2008, Dey brought
this declaratory judgment action, seeking a declaration
that the ’289 patent is invalid or not infringed by either
ANDA product. In response, Sunovion provided Dey with
a covenant not to sue on the ’289 patent and moved to
dismiss the declaratory judgment action for lack of sub-
ject-matter jurisdiction.
On January 30, 2009, the district court denied Suno-
vion’s motion to dismiss in a thorough and well-reasoned
opinion. Dey, 595 F. Supp. 2d at 362-63. In accordance
with our precedent, the court held that the covenant not
to sue did not defeat declaratory judgment jurisdiction.
See id. at 360, 362. The court also agreed with Dey that
even if it invalidated the two Orange Book patents as-
serted by Sunovion, the ’289 patent would remain a legal
barrier to its ANDA approval, and that this potential
barrier was a cognizable injury that could be redressed
through the declaratory judgment action under our deci-
sions in Caraco and Janssen, discussed below. See id. at
358-62 (citing Caraco Pharm. Labs., Ltd. v. Forest Labs.,
7 DEY PHARMA v. SUNOVION PHARMA
Inc., 527 F.3d 1278 (Fed. Cir. 2008); Janssen, 540 F.3d
1353).
Pursuant to a stipulation of the parties, the district
court entered a final judgment of noninfringement on
June 20, 2011. Dey Pharma, L.P. v. Sunovion Pharms.
Inc., No. 08-372 (D. Del. June 20, 2011). Sunovion timely
appealed solely on jurisdictional grounds. This court has
jurisdiction over the appeal under 28 U.S.C. § 1295(a)(1).
Sunovion’s Delaware suit against Dey over the ’755
and ’994 patents is still pending. On February 14, 2012,
the district court entered judgment following a jury
verdict in favor of Sunovion on the infringement and
invalidity claims. See Sunovion Pharms. Inc. v. Dey
Pharma, L.P., No. 06-113 (D. Del. Feb. 14, 2012), ECF No.
581. The district court is currently considering post-trial
motions.
DISCUSSION
I
Whether an “actual controversy” exists that is suffi-
cient to sustain federal jurisdiction under the Declaratory
Judgment Act, 28 U.S.C. § 2201(a), is a question of law
that we review de novo. Teva v. Novartis, 482 F.3d at
1336. In the Hatch-Waxman context, Congress extended
declaratory judgment jurisdiction to ANDA paragraph IV
disputes, 21 U.S.C. § 355(j)(5)(C), and has directed federal
courts to exercise jurisdiction over these disputes “to the
extent consistent with the Constitution,” 35 U.S.C. §
271(e)(5). Under the Supreme Court’s decision in
MedImmune, Inc. v. Genentech, Inc., declaratory judg-
ment jurisdiction is created when “the facts alleged, under
all the circumstances, show that there is a substantial
controversy, between parties having adverse legal inter-
ests, of sufficient immediacy and reality to warrant the
DEY PHARMA v. SUNOVION PHARMA 8
issuance of a declaratory judgment.” 549 U.S. 118, 127
(2007) (quoting Md. Cas. Co. v. Pac. Coal & Oil Co., 312
U.S. 270, 273 (1941)) (internal quotation mark omitted).
In a number of past cases we have considered the
scope of declaratory jurisdiction in this context. Most
pertinent are our decisions in Caraco and Janssen. In
Caraco, 527 F.3d at 1286, the patents listed in the Orange
Book were U.S. Patent No. RE34,712 (“the ’712 patent”),
which expired in 2012, and U.S. Patent No. 6,916,941
(“the ’941 patent”), which expires in 2023. The first
ANDA filer (Ivax) was entitled to launch upon the expira-
tion of the ’712 patent. 4 The NDA holder (Forest) sued
the second ANDA filer (Caraco) for infringement of the
’712 patent. Id. at 1288. Caraco then brought a declara-
tory judgment action over the later-expiring ’941 patent.
Id. To trigger the first ANDA filer’s 180-day exclusivity,
the court concluded that Caraco would have needed to
succeed in both the declaratory judgment action over the
’941 patent and the separate infringement suit over the
’712 patent. Id. at 1287. We held there was declaratory
jurisdiction because the NDA holder’s actions were “po-
tentially exclud[ing] non-infringing generic drugs from
the market.” Id. at 1292. We also held that the declara-
tory judgment action was not mooted by Forest’s covenant
not to sue Caraco over the ’941 patent because only a
court judgment of noninfringement or invalidity would
trigger Ivax’s exclusivity period and accelerate Caraco’s
market entry. Id. at 1297.
4 The NDA holder only sued Ivax for infringement
of the ’712 patent, and we affirmed a judgment that the
patent was valid and infringed. See Forest Labs., Inc. v.
Ivax Pharms., Inc., 501 F.3d 1263 (Fed. Cir. 2007). Be-
cause the NDA holder did not sue over the ’941 patent,
the FDA could approve Ivax’s ANDA upon the expiration
of the ’712 patent. See Caraco, 527 F.3d at 1287.
9 DEY PHARMA v. SUNOVION PHARMA
In Janssen, 540 F.3d at 1357-58, the patents listed in
the Orange Book were U.S. Patent No. 4,804,663 (“the
’663 patent”), which expired in 2008, and U.S. Patent Nos.
5,453,425 and 5,616,587 (“the ’425 and ’587 patents”),
which both expire in 2014. The first ANDA filer (Teva)
was entitled to launch upon the expiration of the ’663
patent. 5 The NDA holder (Janssen) sued the second
ANDA filer (Apotex) for infringement of the ’663 patent.
Id. at 1358. Apotex then asserted declaratory judgment
counterclaims over the later-expiring ’425 and ’587 pat-
ents. Id. We held that there would have been declaratory
judgment jurisdiction under Caraco, except that Apotex
stipulated to the validity, infringement, and enforceability
of the ’663 patent. Id. at 1360. Thus, unlike in Caraco,
there was no immediate controversy: Apotex’s success on
the ’425 and ’587 patents would not trigger Teva’s 180-
day exclusivity period. Id. at 1361. And once the ’663
patent expired in 2008, Teva was entitled to launch, so
Apotex would only be “excluded from the market by
Teva’s 180-day exclusivity period—a period to which Teva
is entitled to under the Hatch-Waxman Act.” Id.
II
We first address the question whether, under our de-
cisions in Caraco and Janssen, declaratory judgment
jurisdiction existed when Dey first brought this action on
June 20, 2008. We agree with the district court that Dey
has done “nothing equivalent to Apotex’s stipulation to
the infringement and validity of the [first-expiring] patent
[in Janssen].” Dey, 595 F. Supp. 2d at 362. Just as in
5 Teva filed a paragraph III certification for the ’663
patent and was not sued over the ’425 and ’587 patents
(for which it filed paragraph IV certifications), so the FDA
would approve Teva’s ANDA upon the expiration of the
’663 patent. See id. at 1358.
DEY PHARMA v. SUNOVION PHARMA 10
Caraco, the second ANDA filer (Dey) brought a declara-
tory judgment action over the last-expiring Orange Book
patent (the ’289 patent) after the NDA holder (Sunovion)
only sued for infringement of the other Orange Book
patents (the ’755 and ’994 patents). And like the second
ANDA filer in Caraco, Dey “alleges it is being excluded
from selling a non-infringing product,” and this injury is
“fairly traceable” to Sunovion and “redressible by a de-
claratory judgment that the [’289 patent] is not in-
fringed.” 527 F.3d at 1291-93.
As Sunovion conceded at argument, its only argument
against finding that declaratory jurisdiction existed in
June 2008 is that success in the declaratory judgment
action alone is insufficient to redress Dey’s injury because
Dey would still need to succeed in the separate infringe-
ment litigation over the other Orange Book patents. See
Oral Argument at 30:52–31:28. But this was also true in
Caraco. We concluded that “only a judgment of invalidity
or noninfringement with respect to both the ’712 and ’941
patents can trigger [the first ANDA filer’s] exclusivity
period.” Caraco, 527 F.3d at 1295 (emphasis added). 6 We
further explained the redressibility element:
If Caraco obtains a favorable judgment [in its de-
claratory judgment action], then it will only need
a judgment of invalidity or noninfringement on
[the other Orange Book patent] in order to acti-
6 Sunovion argues that Caraco is distinguishable
because Caraco, in fact, could have triggered Ivax’s exclu-
sivity period with a final judgment on the ’941 patent in
its declaratory judgment action (because Ivax enjoyed
exclusivity only with respect to the ’941 patent), and that
the ’712 patent challenge was thus immaterial. See
Appellant’s Br. 23. But our decision in Caraco did not
rest on this ground. We assumed that success was re-
quired for both patents.
11 DEY PHARMA v. SUNOVION PHARMA
vate [the first ANDA filer’s] exclusivity period and
obtain FDA approval as swiftly as possible. Thus,
a favorable judgment in this action would elimi-
nate the potential for the [declaratory judgment]
patent to exclude Caraco from the drug market.
Id. at 1293. Similarly, a favorable declaratory judgment
for Dey on the ’289 patent will eliminate the potential for
that patent to exclude Dey from the market, and Dey
would then only need a judgment of invalidity or nonin-
fringement on the other Orange Book patents to trigger
Breath’s exclusivity period.
Under Sunovion’s logic, if the Orange Book patents
were divided between two declaratory judgment actions,
then each case would preclude a finding of jurisdiction in
the other. But the only reason there are two cases here is
that Sunovion declined to sue Dey on all the Orange Book
patents, and there is no reason to deny jurisdiction over
the second action until the initial litigation has been
resolved. As we held under materially identical facts in
Caraco, simply eliminating one barrier is sufficient for
declaratory jurisdiction, so long as litigation is also pend-
ing that could eliminate the other barriers. See 527 F.3d
at 1293.
III
Having concluded that jurisdiction existed when Dey
filed its declaratory judgment action in June 2008, we
turn to Sunovion’s argument that jurisdiction no longer
exists. Sunovion does not attempt to argue that its cove-
nant not to sue Dey over the ’289 patent moots this case,
as that argument is foreclosed by our contrary holding in
Caraco. See 527 F.3d at 1297. Rather, Sunovion’s argu-
ment has two parts: (1) It urges that as a practical mat-
ter, the separate litigation over the ’755 and ’994 patents
cannot be concluded by a final judgment before Breath is
DEY PHARMA v. SUNOVION PHARMA 12
entitled to launch its generic product on August 20, 2012; 7
the final resolution of that litigation is necessary to trig-
ger Breath’s exclusivity period. (2) Sunovion further
argues that once Breath is entitled to launch its generic
product, there will no longer be a case or controversy
necessary to support declaratory judgment jurisdiction.
In other words, Sunovion argues that under the MedIm-
mune “all the circumstances” test, the court should not
allow a declaratory action challenging any Orange Book
patent to proceed unless all actions challenging the Or-
ange Book patents can be completed before the date of
potential generic entry will arrive and, in Sunovion’s
view, deprive the district court of jurisdiction.
The problem with Sunovion’s view is that its last as-
sumption is incorrect. The district court will not lose
jurisdiction simply because the period of possible first
generic market entry arrives. Even after Breath is enti-
tled to launch, the possibility remains that Breath will
not do so. Breath has not announced plans to launch on
August 20, and it is well known that the first generic
often elects to delay entry for various reasons, including
possible payments from the brand-name manufacturer to
delay the launch. In the debate leading up to the 2003
Hatch-Waxman amendments, Congress was concerned by
7 Under its settlement with Sunovion, Breath may
launch generic Xopenex on August 20, 2012, which would
trigger its exclusivity period and allow Dey to launch its
product 180 days later. Sunovion urges that the correct
date is actually June 6, 2012, which is 75 days before the
August 20 date. It urges that to cause Breath to forfeit its
exclusivity under 21 U.S.C. § 355(j)(5)(D), Dey must
obtain a final judgment on all Orange Book patents more
than 75 days before Breath may launch on August 20; i.e.,
by June 6, 2012. Whether the correct date is August 20 or
June 6 makes no difference for purposes of the legal
issues involved here.
13 DEY PHARMA v. SUNOVION PHARMA
the Federal Trade Commission (“FTC”) report that “the
[180-day] exclusivity has at times been parked through
collusive agreements between brand and generic compa-
nies.” 149 Cong. Rec. 31,783 (2003) (statement of Sen.
Edward Kennedy). For example, brand-name companies
were alleged to have paid the first generic filer to not
enter the market. Fed. Trade Comm’n, Generic Drug
Entry Prior to Patent Expiration, at vii-viii (2002). 8
Indeed, it is that very concern that in part led Congress to
enact the forfeiture provisions of the 2003 amendments,
which were discussed earlier. See MMA § 1102. While
those forfeiture provisions are not directly applicable here
unless there is a judgment of noninfringement or invalid-
ity on all Orange Book patents, the forfeiture legislation
confirms that the first generic entry may often be delayed.
See also C. Scott Hemphill, An Aggregate Approach to
Antitrust: Using New Data and Rulemaking To Preserve
Drug Competition, 109 Colum. L. Rev. 629, 646-47 (2009)
(finding that 60 out of 143 Hatch-Waxman settlements
between 1984 and 2008 involved delayed generic entry
and some form of payment from the brand-name company
to the generic). If Breath chooses to delay triggering its
180-day exclusivity period, Dey and other generics could
8 The 2002 FTC report also noted that under some
settlement agreements, the “generic was marketing the
brand-name company’s product as a generic,” rather than
“under its own ANDA.” Id. at vii. In this case, Breath
and Sunovion have entered into a separate supply agree-
ment, under which Breath could purchase Xopenex from
Sunovion on a cost-plus-margin basis to sell under Suno-
vion’s NDA, also effective August 20, 2012. See J.A. 132,
507. We do not decide whether this would necessarily be
“commercial marketing” that triggers the 180-day exclu-
sivity under 21 U.S.C. § 355(j)(5)(B)(iv)(I). We also note
that because no discovery has been allowed in this case, it
is unclear whether Breath has incentives to delay trigger-
ing its 180-day exclusivity period.
DEY PHARMA v. SUNOVION PHARMA 14
potentially be kept off the market until the expiration of
the ’289 patent in 2021, absent a judgment of nonin-
fringement or invalidity.
Sunovion urges, however, that we held in Janssen
that “a possible delay in the future of a first Paragraph IV
ANDA filer in launching its generic product does not give
rise to declaratory judgment jurisdiction.” Appellant’s Br.
34 (quoting Janssen, 540 F.3d at 1363). What Sunovion
ignores is that there is a difference between finding that a
controversy exists to initiate a suit and determining that
the controversy has become moot. While Article III
requires that “an actual controversy must be extant at all
stages of review, not merely at the time the complaint is
filed,” the question of whether a controversy exists at a
later stage of the proceeding is governed by mootness
doctrine. Arizonans for Official English v. Arizona, 520
U.S. 43, 67 (1997) (quoting Preiser v. Newkirk, 422 U.S.
395, 401 (1975)). As the Supreme Court explained in
Cardinal Chemical Co. v. Morton International, Inc.:
[W]hile the initial burden of establishing the trial
court’s jurisdiction rests on the party invoking
that jurisdiction, once that burden has been met
courts are entitled to presume, absent further in-
formation, that jurisdiction continues. If a party
to an appeal suggests that the controversy has,
since the rendering of judgment below, become
moot, that party bears the burden of coming for-
ward with the subsequent events that have pro-
duced that alleged result.
508 U.S. 83, 98 (1993). As we noted in Benitec Australia,
Ltd. v. Nucleonics, Inc., 495 F.3d 1340, 1345 (Fed. Cir.
2007), Cardinal Chemical requires that the party arguing
that a case has become moot bears “[t]he burden of bring-
ing forth such further information” of mootness. “The
15 DEY PHARMA v. SUNOVION PHARMA
‘heavy burden of persua[ding]’ the court” that a case is
moot “lies with the party asserting mootness.” Friends of
the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528
U.S. 167, 189 (2000) (quoting United States. v. Concen-
trated Phosphate Exp. Ass’n, 393 U.S. 199, 203 (1968)).
We conclude that Sunovion has not met this burden.
Indeed, Sunovion conceded at argument that this case
will not be moot until Breath actually goes on the market
in a way that would trigger its 180-day exclusivity period.
See Oral Argument at 10:50; see also Eisai Co. v. Teva
Pharms. USA, Inc., 131 S. Ct. 2991 (2011) (remanding a
case with instructions to dismiss as moot where the first
ANDA filer launched prior to a final judgment in the
second ANDA’s declaratory judgment action). It is uncon-
tested that Breath has not yet marketed generic Xopenex,
and that its failure to do so, absent a triggering event,
could delay Dey’s ability to market until 2021, when the
’289 patent expires. Since there was jurisdiction when
Dey filed this declaratory judgment action in June 2008,
this case may proceed until rendered moot. We affirm the
district court’s judgment of noninfringement.
AFFIRMED
COSTS
Costs to appellees.