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 pharmaceutical 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 parties thereafter stipulated to a final judgment of noninfringement. 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, challenging 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 research 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 HatchWaxman 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 application (“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 publication known as the “Orange Book.” 

A generic company may then seek FDA approval using 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 infringement. 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 noninfringement 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 employed 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 Constitution,” 35 U.S.C. § 271(e)(5). Under this amended HatchWaxman framework, if the first ANDA filer “parked” its 

180-day exclusivity under an agreement with the brandname company, a subsequent ANDA filer could independently 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 patent”), 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 subject-matter jurisdiction. 

On January 30, 2009, the district court denied Sunovion’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 asserted 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 decisions 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 sufficient 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 judgment jurisdiction is created when “the facts alleged, under 

all the circumstances, show that there is a substantial 

controversy, between parties having adverse legal interests, 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 expiration 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 declaratory 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 “potentially exclud[ing] non-infringing generic drugs from 

the market.” Id. at 1292. We also held that the declaratory 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). Because 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 patents. 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 decisions 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 declaratory 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 declaratory judgment that the [’289 patent] is not infringed.” 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 infringement 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 declaratory 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 exclusivity 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 required 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 eliminate 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 noninfringement 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 pending 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 covenant 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 argument has two parts: (1) It urges that as a practical matter, 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 trigger 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 MedImmune “all the circumstances” test, the court should not 

allow a declaratory action challenging any Orange Book 

patent to proceed unless all actions challenging the Orange 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 assumption is incorrect. The district court will not lose 

jurisdiction simply because the period of possible first 

generic market entry arrives. Even after Breath is entitled 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 companies.” 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 invalidity 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 agreement, under which Breath could purchase Xopenex from 

Sunovion on a cost-plus-margin basis to sell under Sunovion’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 exclusivity 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 triggering 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 noninfringement 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 information, 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 forward with the subsequent events that have produced 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 bringing 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. Concentrated 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 uncontested 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.