United States Court of Appeals
for the Federal Circuit
______________________
APOTEX INC.,
Plaintiff-Appellant
v.
DAIICHI SANKYO, INC., DAIICHI SANKYO CO.,
LTD.,
Defendants-Appellees
v.
MYLAN PHARMACEUTICALS INC.,
Movant-Cross-Appellant
______________________
2014-1282, 2014-1291
______________________
Appeals from the United States District Court for the
Northern District of Illinois in No. 1:12-cv-09295, Judge
Sharon Johnson Coleman.
______________________
Decided: March 31, 2015
______________________
STEVEN ERIC FELDMAN, Husch Blackwell LLP, Chica-
go, IL, argued for plaintiff-appellant. Also represented by
SHERRY LEE ROLLO, JAMES PATRICK WHITE, DANIEL
RONALD CHERRY.
2 APOTEX INC. v. DAIICHI SANKYO, INC.
DOMINICK A. CONDE, Fitzpatrick, Cella, Harper &
Scinto, New York, NY, argued for defendants-appellees.
Also represented by CHARLES AUSTIN GINNINGS, NINA
SHREVE.
MICHAEL SHUMSKY, Kirkland & Ellis LLP, Washing-
ton, DC, argued for movant-cross-appellant. Also repre-
sented by JOHN KEVIN CRISHAM, STEPHEN S. SCHWARTZ.
______________________
Before TARANTO, MAYER, and CLEVENGER, Circuit
Judges.
TARANTO, Circuit Judge.
Apotex, Inc. brought this action against Daiichi
Sankyo Co., Ltd. and Daiichi Sankyo, Inc. (collectively,
Daiichi) to obtain a declaratory judgment that Apotex will
not infringe a patent owned but disclaimed by Daiichi if
Apotex manufactures or sells a generic drug bioequivalent
to Daiichi’s Benicar®. Apotex cannot infringe the patent,
because Daiichi has disclaimed it, but Apotex neverthe-
less claims a concrete interest in obtaining a judgment of
non-infringement for its generic drug because such a
judgment would enable Apotex to receive marketing
approval from the United States Food and Drug Admin-
istration and to enter the market sooner than otherwise.
The district court dismissed Apotex’s complaint for lack of
a case or controversy. We reverse. Under the statute that
governs marketing approval of generics, Apotex has a
concrete, potentially high-value stake in obtaining the
judgment it seeks; and Daiichi has a concrete, potentially
high-value stake in denying Apotex that judgment and
thereby delaying Apotex’s market entry—as does Mylan
Pharmaceuticals, Inc., the first applicant for approval of a
generic version of Benicar®. We also reverse the district
court’s denial of Mylan’s motion to intervene in this
action.
APOTEX INC. v. DAIICHI SANKYO, INC. 3
BACKGROUND
Under the authority of the FDA’s approval of its New
Drug Application (NDA), 21 U.S.C. § 355(a), (c), Daiichi
markets Benicar® for treating hypertension. In seeking
FDA approval for Benicar®, Daiichi listed two patents in
the FDA’s Approved Drug Products with Therapeutic
Equivalence Evaluations publication, or “Orange Book.”
See 21 U.S.C. § 355(b)(1) (requiring listing of patents that
“could reasonably be asserted if a person not licensed by
the owner engaged in the manufacture, use, or sale of the
drug”); 21 C.F.R. §§ 314.3, 314.53. The first, U.S. Patent
No. 5,616,599, covers the active ingredient of the drug,
olmesartan medoxomil. It expires on April 25, 2016, but
because Daiichi provided the FDA certain data concerning
the drug’s effects on children, the FDA must wait six
months longer—i.e., until October 25, 2016—before ap-
proving a generic version of the drug. See 21 U.S.C.
§ 355a(b)(1)(B)(i). Daiichi’s second listed patent, U.S.
Patent No. 6,878,703, covers methods of treatment. It
expires on November 19, 2021.
At least two generic manufacturers have sought ap-
proval from the FDA to market generic olmesartan me-
doxomil products. All parties agree that Mylan (actually
Matrix Laboratories, which is now Mylan) was the first to
seek approval: it filed an Abbreviated New Drug Applica-
tion (ANDA) with the FDA, under 21 U.S.C. § 355(j), in
April 2006. In that application, Mylan certified under
paragraph IV of § 355(j)(2)(A)(vii) that both the ’599 and
’703 patents were invalid or would not be infringed by
Mylan’s proposed drug.
In early July 2006, after receiving notice of Mylan’s
paragraph IV certification, Daiichi disclaimed all claims
of the ’703 patent. See 35 U.S.C. § 253. The record does
not tell us why. We have no information about whether,
for example, Daiichi recognized the invalidity of the
patent or, even, that it never should have been listed
4 APOTEX INC. v. DAIICHI SANKYO, INC.
under § 355(b)(1)’s “could reasonably be asserted” stand-
ard.
Having disclaimed the ’703 patent, Daiichi sued
Mylan for infringing the ’599 patent, invoking the decla-
ration of 35 U.S.C. § 271(e)(2)(A) that the submission of a
paragraph IV certification constitutes an act of infringe-
ment. Only validity was disputed in the case, and after a
full trial, the district court upheld the validity of the ’599
patent and entered judgment of infringement against
Mylan. Daiichi Sankyo Co. v. Mylan Pharm. Inc., 670 F.
Supp. 2d 359, 387 (D.N.J. 2009). We affirmed. Daiichi
Sankyo Co. v. Matrix Labs., Ltd., 619 F.3d 1346 (Fed. Cir.
2010). With the ’703 patent disclaimed and the ’599
patent upheld, Mylan’s earliest date of market entry—the
earliest effective date of any FDA approval for Mylan—is
October 25, 2016, six months after the expiration date of
the ’599 patent.
In June 2012, four years before that date and roughly
two years after the ’599 litigation was over, Apotex filed
its own ANDA for generic olmesartan medoxomil. Apotex
included two different certifications under 21 U.S.C.
§ 355(j)(2)(A)(vii). One was a paragraph III certification
accepting, rather than disputing, the result of the 2006–
2010 litigation. That certification states that the ’599
patent is valid and that Apotex’s product would infringe,
thereby barring an effective date of FDA approval any
earlier than October 25, 2016. See § 355(j)(5)(B)(ii).
Apotex’s other certification was a paragraph IV certifica-
tion stating that Apotex’s product would not infringe the
’703 patent.
As is undisputed here, non-infringement of the ’703
patent follows as a matter of law from the fact that
Daiichi has formally disclaimed it. See Altoona Publix
Theatres, Inc. v. American Tri-Ergon Corp., 294 U.S. 477,
492 (1935); Guinn v. Kopf, 96 F.3d 1419, 1422 (Fed. Cir.
1996). Indeed, in its July 2006 letter asking the FDA to
APOTEX INC. v. DAIICHI SANKYO, INC. 5
remove the ’703 patent from the Orange Book, Daiichi
stated: “The effect of the disclaimer is that the 6,878,703
patent no longer exists.” J.A. 99. And in July 2012, it
wrote to Apotex stating that, because of its disclaimer of
the ’703 patent, it “cannot . . . sue any entity . . . for
infringement of that patent.” J.A. 104.
Daiichi did not sue Apotex for infringing the ’703 pa-
tent, and the FDA has not removed the ’703 patent from
the Orange Book, despite Daiichi’s 2006 request. See
Teva Pharm. USA, Inc. v. Sebelius, 595 F.3d 1303, 1317–
18 (D.C. Cir. 2010) (patent owner’s unilateral request to
remove patent from Orange Book is not a sufficient basis
for FDA to do so). But Apotex sued Daiichi in the United
States District Court for the Northern District of Illinois
under 21 U.S.C. § 355(j)(5)(C)(i) and 35 U.S.C. § 271(e)(5),
seeking a declaratory judgment that its product would not
infringe the disclaimed ’703 patent. Mylan moved to
intervene, and both it and Daiichi moved to dismiss
Apotex’s complaint. Given the non-infringement conse-
quence of the Daiichi disclaimer, the dispute in the dis-
trict court was not over the merits of infringement.
Rather, the dispute was over whether, precisely because
non-infringement is indisputable, the district court must
deny the requested declaratory judgment for lack of a case
or controversy.
Apotex asserted that it has a concrete stake in secur-
ing the requested declaratory judgment because, under
the governing statutory provisions, the requested judg-
ment would allow it to enter the market earlier than it
could without the judgment. Two statutory provisions are
key. First: Under § 355(j)(5)(B)(iv), because Mylan was
the first to file an ANDA for generic olmesartan medox-
omil and has maintained a paragraph IV certification
regarding the ’703 patent, Mylan is presumptively enti-
tled to a period of 180 days of exclusivity—starting when-
ever, after October 25, 2016, it enters the market—before
facing competition from another seller of generic olmesar-
6 APOTEX INC. v. DAIICHI SANKYO, INC.
tan medoxomil. That exclusivity period would end no
earlier than April 23, 2017. Second: Under § 355(j)(5)(D),
the exclusivity period may be forfeited in certain specified
circumstances. According to Apotex, a court judgment of
non-infringement would cause Mylan to forfeit the exclu-
sivity period if Mylan has not marketed its drug 75 days
after appeal rights are exhausted (certiorari aside) and
Apotex has obtained tentative approval for its generic
product from the FDA. § 355(j)(5)(D)(i)(I)(bb)(AA). If that
is correct, and the judgment comes soon enough, Apotex
could enter the market substantially before April 23, 2017
(even longer before a later end of Mylan’s exclusivity
period if Mylan delays entry past October 25, 2016); such
entry would likely transfer sales from Daiichi and Mylan
to Apotex and, because of the greater competition, reduce
the price Daiichi and Mylan would charge.
Daiichi and Mylan did not dispute that an earlier-
than-otherwise Apotex entry into the market would likely
have the identified effects, to Apotex’s benefit and
Daiichi’s and Mylan’s detriment. But Daiichi argued that
no controversy exists because it could not now assert the
disclaimed ’703 patent against Apotex. Mylan added
arguments based on the fact that Apotex lacked (and
lacks) a “tentative approval” from the FDA for its ANDA. 1
Specifically, Mylan argued that redress of Apotex’s de-
layed-market-entry injury is unduly speculative before
tentative approval is in hand. Mylan also made an argu-
1 Congress has defined “tentative approval” to
mean the FDA’s determination that the ANDA has met
the substantive requirements for obtaining generic mar-
keting approval (by demonstrating, among other things,
bioequivalence to the listed drug) but that final approval
by the FDA is blocked by other barriers, such as a live
patent, a 30-month stay caused by ongoing litigation, or
certain exclusivity periods. § 355(j)(5)(B)(iv)(II)(dd)(AA).
APOTEX INC. v. DAIICHI SANKYO, INC. 7
ment based on the fact that tentative approval is a neces-
sary statutory condition for the forfeiture of Mylan’s
presumptive exclusivity period based on the declaratory
judgment requested here. § 355(j)(5)(D). It argued that
the forfeiture provision should be read to mean that, for a
declaratory judgment brought by a second ANDA filer to
cause forfeiture, the second ANDA filer must have had
tentative FDA approval when it brought the declaratory-
judgment action. Under that interpretation, Mylan
contended, the present action cannot provide Apotex
forfeiture relief—even if Apotex could file an identical
declaratory-judgment action as soon as it obtains tenta-
tive approval.
The district court granted Daiichi’s motion. It rea-
soned that “both Daiichi and Apotex no longer hold any
meaningful interest in the now disclaimed patent” and
that the FDA’s continuing to list the ’703 patent in the
Orange Book “does not create a case or controversy by
which Apotex may seek a declaratory judgment regarding
a nonexistent patent.” Apotex, Inc. v. Daiichi Sankyo,
Inc., No. 12-CV-9295, 2014 WL 114127, at *4 (N.D. Ill.
Jan. 9, 2014). The court denied Mylan’s motion to inter-
vene as moot in light of its grant of Daiichi’s dismissal
motion. Id.
Apotex appeals, and Mylan cross-appeals the denial of
its motion to intervene. We have jurisdiction under 28
U.S.C. § 1295(a)(1).
DISCUSSION
We review de novo a district court’s dismissal of a de-
claratory-judgment action for lack of subject-matter
jurisdiction. Sandoz Inc. v. Amgen Inc., 773 F.3d 1274,
1277 (Fed. Cir. 2014). Where, as here, no timeliness issue
is present, we review denial of intervention as of right de
novo. See Stauffer v. Brooks Bros., Inc., 619 F.3d 1321,
1328 (Fed. Cir. 2010) (denial of intervention reviewed
under regional circuit’s law); Sokaogon Chippewa Cmty. v.
8 APOTEX INC. v. DAIICHI SANKYO, INC.
Babbitt, 214 F.3d 941, 945 (7th Cir. 2000) (de novo review
of denial of motion to intervene).
A
We begin by confirming Mylan’s right to be a party in
this case because of its obvious stake in the dispute. Rule
24(a) of the Federal Rules of Civil Procedure establishes a
right to intervene when a person “claims an interest
relating to the property or transaction that is the subject
of the action, and is so situated that disposing of the
action may as a practical matter impair or impede the
movant’s ability to protect its interest, unless existing
parties adequately represent that interest.” Mylan readi-
ly meets that standard.
In this action, Apotex seeks to cause a forfeiture of
Mylan’s presumed market-exclusivity period, and Mylan
has a concrete monetary interest in retaining such exclu-
sivity—six months of more sales and/or higher prices than
are likely when Apotex enters the market. Although
Daiichi likely benefits from the 180-day exclusivity period
as well, Mylan’s interest exists apart from that of Daiichi,
which, as a rival of Mylan’s, has its own incentives affect-
ing decisions about how to conduct this litigation. Keith v.
Daley, 764 F.2d 1265, 1268 (7th Cir. 1985) (interest must
“belong[] to the proposed intervenor rather than to an
existing party in the suit”). Mylan’s interest here is “ ‘of
such a direct and immediate character that [Mylan] will
either gain or lose by the direct legal operation and effect
of the judgment’ ” sought by Apotex. Am. Mar. Transp.,
Inc. v. United States, 870 F.2d 1559, 1561 (Fed. Cir. 1989)
(emphases removed) (quoting United States v. AT&T Co.,
642 F.2d 1285, 1292 (D.C. Cir. 1980)). And Apotex does
not defend the district court’s conclusion that Mylan’s
interest in the case was rendered moot by the dismissal of
the case, where, as here, Apotex is seeking to reverse the
dismissal. Mylan has a strong, concrete interest in de-
APOTEX INC. v. DAIICHI SANKYO, INC. 9
fending the dismissal on this appeal. Accordingly, we
reverse the denial of Mylan’s motion to intervene.
B
We also reverse the district court’s dismissal of Apo-
tex’s complaint for lack of a case or controversy. The
stakes over which the parties are vigorously fighting are
concrete and substantial: the amount of revenue there
will be from sales of olmesartan medoxomil, and who will
get what portions of it, during a period of at least six
months. We conclude that “the facts alleged, under all
the circumstances, show that there is a substantial con-
troversy, between parties having adverse legal interests,
of sufficient immediacy and reality to warrant the issu-
ance of a declaratory judgment.” MedImmune, Inc. v.
Genentech, Inc., 549 U.S. 118, 127 (2007) (internal quota-
tion marks and citation omitted).
The case-or-controversy analysis, as relevant here,
has borrowed from decisions on standing and ripeness.
See Sandoz, 773 F.3d at 1277–78; Prasco, LLC v. Medicis
Pharm. Corp., 537 F.3d 1329, 1335–36 (Fed. Cir. 2008).
“Standing under Article III of the Constitution requires
that an injury be concrete, particularized, and actual or
imminent; fairly traceable to the challenged action; and
redressable by a favorable ruling.” Monsanto Co. v.
Geertson Seed Farms, 561 U.S. 139, 149 (2010). Where,
as here, no further facts are needed for the requested
adjudication (non-infringement is beyond dispute, given
the disclaimer), ripeness depends on any harm to the
plaintiff from delaying adjudication and the degree of
uncertainty about whether an adjudication will be need-
ed. Sandoz, 773 F.3d at 1277–78. In this case, these
overlapping formulations have led the parties to focus on
(1) whether Daiichi’s disclaimer of the patent means that
the parties lack concrete stakes in the dispute over the
declaratory judgment; (2) whether the alleged harm is
traceable to Daiichi; (3) whether the real-world impact is
10 APOTEX INC. v. DAIICHI SANKYO, INC.
too contingent on future events—specifically, FDA tenta-
tive approval of Apotex’s ANDA; and (4) whether Apotex’s
alleged harm would not be redressed even if Apotex
receives the requested judgment because ultimate relief is
independently blocked by the statutory standards for
triggering forfeiture of Mylan’s exclusivity period. We
address those issues in turn.
1
We first reject Daiichi’s contention, adopted by the
district court, that Daiichi’s statutory disclaimer of the
’703 patent itself means that there is no adversity be-
tween it and Apotex over stakes of a concrete character.
See Hollingsworth v. Perry, 133 S. Ct. 2652, 2662 (2013)
(“To have standing, a litigant . . . must possess a ‘direct
stake in the outcome’ of the case.”) (quoting Arizonans for
Official English v. Arizona, 520 U.S. 43, 64 (1997)); Warth
v. Seldin, 422 U.S. 490, 498–99 (1975). The concrete
stakes over which Daiichi and Apotex are fighting are the
revenues to be earned through selling olmesartan medox-
omil. The patent disclaimer eliminates one, but only one,
potential legal barrier to Apotex’s ability to make such
sales sooner rather than later. The listing of the patent,
with its current consequence of preventing FDA approval
during Mylan’s presumptive exclusivity period, is another,
and the parties have adverse concrete interests in the
truncation or preservation of that period.
Apotex, Daiichi, and Mylan are all likely affected,
though not in perfect mirror-image ways, by whether
Apotex can cause the forfeiture of Mylan’s exclusivity
period. Until that period ends, Apotex cannot make sales,
and delay of entry may have lingering adverse effects on
market share. See Teva Pharm., USA, Inc. v. FDA, 182
F.3d 1003, 1011 n.8 (D.C. Cir. 1999) (second-filing generic
manufacturers “face continued harm because of their
denied access to the market . . . , harm potentially height-
ened because of [the first filer’s] period of market exclusiv-
APOTEX INC. v. DAIICHI SANKYO, INC. 11
ity”). Once Apotex enters, Daiichi and Mylan can expect
to lose sales they otherwise would have made. It is plau-
sible, too, that entry by Apotex would produce prices
noticeably lower than those Daiichi and Mylan would
charge during a duopoly period (with Mylan the exclusive
generic seller). 2 Daiichi and Mylan will thereby be
harmed by Apotex’s entry (even if the lowered prices
benefit consumers as much as or more than Apotex).
In these circumstances, by any common-sense meas-
ure, the parties have substantial, concrete stakes in
whether Apotex secures the non-infringement judgment it
seeks to advance its entry into the market. If the judg-
ment issues, there is every likelihood that Daiichi and
Mylan will lose substantial revenues, and Apotex will
gain substantial revenues. This case is quite different
from cases in which a case or controversy has been held
missing because the plaintiffs had mere generalized or
bystander interests in others’ compliance with law.
Of course, other requirements for a case or controver-
sy have to be met: most significantly, the desired advanc-
ing of FDA approval and of Apotex’s market entry must
not be too speculative a consequence of the requested non-
2 See FDA, Center for Drug Evaluation and Research,
Generic Competition and Drug Prices (last updated Mar.
1, 2010), www.fda.gov/AboutFDA/CentersOffices/Officeof
MedicalProductsandTobacco/CDER/ucm129385.htm (“On
average, the first generic competitor prices its product
only slightly lower than the brand-name manufacturer.
However, the appearance of a second generic manufactur-
er reduces the average generic price to nearly half the
brand name price.”); Teva Pharm. USA, Inc. v. Pfizer
Inc., 405 F.3d 990, 993 (Fed. Cir. 2005) (Gajarsa, J.)
(dissenting from denial of rehearing en banc) (exclusivity
period creates a “comfortable duopoly” for the NDA holder
and the first ANDA filer).
12 APOTEX INC. v. DAIICHI SANKYO, INC.
infringement judgment. Lujan v. Defenders of Wildlife,
504 U.S. 555, 560–61 (1992). And Daiichi and Mylan
argue that the advancing of approval and entry actually
cannot follow because, under the governing statutory
provisions, the present Apotex lawsuit cannot strip them
of what they say is their legal entitlement to hold onto the
benefits of delaying Apotex’s entry. We discuss those
questions infra. But Daiichi is wrong in its threshold
argument that its disclaimer of the ’703 patent itself
eliminates a case or controversy.
2
Daiichi is also wrong to the extent it contends that the
delayed entry of Apotex at issue here is not “fairly tracea-
ble” to Daiichi. Allen v. Wright, 468 U.S. 737, 751 (1984).
If Daiichi had not listed the ’703 patent in the Orange
Book in the first place, the ’599 patent would be the only
listed patent, and Mylan undisputedly would have no
exclusivity period at present, because it lost its challenge
to the ’599 patent. Since 2003, the statute has expressly
conditioned a first filer’s eligibility for marketing exclusiv-
ity on its ability to “lawfully maintain[ ]” a Paragraph IV
certification. 21 U.S.C. § 355(j)(5)(B)(iv)(II)(bb). Where,
as here, a first ANDA filer lists a patent in a paragraph
IV certification and loses in litigation through a judgment
that confirms infringement and rejects invalidity, that
applicant may no longer lawfully maintain its paragraph
IV certification. 3 Thus, Mylan would currently not be
3 FDA regulations provide that “[a]n applicant who
has submitted a [paragraph IV certification] and is sued
for patent infringement . . . shall amend the certification
if a final judgment . . . is entered finding the patent to be
infringed. In the amended certification, the applicant
shall certify under paragraph [III] that the patent will
expire on a specific date. Once an amendment or letter
for the change has been submitted, the application will no
APOTEX INC. v. DAIICHI SANKYO, INC. 13
eligible for an exclusivity period had Daiichi never listed
the ’703 patent. Oral Argument at 2:30–46 (Apotex),
Apotex Inc. v. Daiichi Sankyo, Inc., No. 2014-1282, -1291;
id. at 16:50–17:10 (Daiichi). It is only Daiichi’s original
listing of that patent—which Daiichi has disclaimed—
that now supports Mylan’s exclusivity period, which
Apotex filed this action to bring to an end.
Daiichi is therefore responsible for the current exist-
ence of Mylan’s exclusivity-period rights. Importantly, by
so stating, we are not asserting that such responsibility is
a necessary condition for the case or controversy here. We
do not decide, and do not have to decide, whether it would
be enough, for a justiciable dispute, that a requested
judgment of non-infringement would lead the FDA to
allow a market entry that would have concrete revenue-
transferring effects on all parties. In this case, Daiichi’s
act of listing the ’703 patent in the Orange Book created
the entry barrier that Apotex, through a declaratory
judgment, seeks to eliminate.
Relatedly, for case-or-controversy purposes, it is im-
material whether Daiichi acted contrary to the statutory
standard in listing the ’703 patent in the Orange Book—
which we do not know, one way or the other. Daiichi is
causally responsible for the current existence of the
exclusivity period; Apotex seeks a judgment of non-
longer be considered to be one containing a [Paragraph IV
certification].” 21 C.F.R. § 314.94(a)(12)(viii)(A) (2015).
The required application amendment causes the first filer
to forfeit its eligibility for any market exclusivity based on
that certification. 21 U.S.C. § 355(j)(5)(D)(i)(III); see
Letter from G. Buehler, Director, Office of Generic Drugs,
to ANDA Applicant regarding 180-day exclusivity for
dorzolamide/timolol ophthalmic solution, Docket No.
FDA-2008-N-0483-0017 at 5–6 (Oct. 28, 2008), available
at www.regulations.gov (Dorzolamide/Timolol Letter).
14 APOTEX INC. v. DAIICHI SANKYO, INC.
infringement that does not depend on whether the origi-
nal listing was proper; and there has been no suggestion
that, under the statute, the forfeiture of the exclusivity
period depends on the original listing’s propriety. Neither
the logic nor precedents controlling the Article III deter-
mination would make the entry of the requested judgment
in these circumstances something other than the resolu-
tion of a case or controversy—as long as it is “likely, as
opposed to merely speculative,” that the consequence
would be the concrete one of advancing the date of ap-
proval by the FDA and market entry by Apotex. Lujan,
504 U.S. at 560–61 (internal quotation marks omitted).
We turn to that critical question.
3
One aspect of that question is whether, putting aside
the statutory provisions governing the exclusivity period,
tentative FDA approval for Apotex’s proposed drug is a
prerequisite for a case or controversy here. Specifically,
exclusivity-period provisions aside, is the prospect of
concrete relief for Apotex too uncertain to support an
adjudication of the request for a non-infringement judg-
ment until Apotex obtains tentative approval? We con-
clude that the answer is no.
The general principle governing the inquiry, including
in situations where ultimate relief from harm depends on
the action of a third party (here, the FDA’s approval of the
ANDA to allow marketing), is whether there is too high a
degree of uncertainty about whether the judicial resolu-
tion, if in the plaintiff’s favor, will matter in alleviating
the harm alleged by the plaintiff. See Lujan, 504 U.S. at
560–61 (likely, as opposed to speculative); Warth, 422
U.S. at 504, 507 (“substantial probability,” not “remote
possibility”); Linda R.S. v. Richard D., 410 U.S. 614, 618
(1973) (not too “speculative”). That context-dependent
standard has been applied to allow adjudication to remove
one legal barrier to the plaintiff’s obtaining the concrete
APOTEX INC. v. DAIICHI SANKYO, INC. 15
alleviation of harm it seeks, notwithstanding potential
independent barriers to achieving that result, as long as
such other potential barriers are not unduly likely to
deprive the adjudication of concrete effect. Thus, in
Arlington Heights v. Metropolitan Housing Development
Corp., 429 U.S. 252 (1977), the Court found that a devel-
oper and a would-be resident had standing to challenge a
zoning scheme that stood “as an absolute barrier to con-
structing the housing” the developer sought to build,
stating: “If [the developer] secures the injunctive relief it
seeks, that barrier will be removed.” Id. at 261. Other
barriers that might doom actual development, such as
inability to obtain financing, though real, were not so
certain as to bar standing to obtain removal of the barrier
at issue, id. at 261 & n.7, because there was a “substan-
tial probability” that the “project w[ould] materialize” if
the adjudication occurred, id. at 264. As a result, the
injuries to the developer and would-be resident were
“ ‘likely to be redressed by a favorable decision.’ ” Id. at
262 (quoting Simon v. Eastern Ky. Welfare Rights Org.,
426 U.S. 26, 38 (1976)); id. at 264.
Because the likelihood of ultimate alleviation of harm
involves a judgment call about a causal chain, congres-
sional action is relevant. The Supreme Court and our
court have recognized the potential significance of con-
gressional action in “articulat[ing] chains of causation
that will give rise to a case or controversy where none
existed before.” Massachusetts v. EPA, 549 U.S. 497, 516
(2007); see Consumer Watchdog v. Wis. Alumni Research
Found., 753 F.3d 1258, 1261 (Fed. Cir. 2014). By deeming
certain series of links from conduct to harm or from
judgment to alleviation of harm not to be unduly specula-
tive, Congress may “effectively creat[e] justiciability that
attenuation concerns would otherwise preclude.” Sandoz,
773 F.3d at 1281.
In the present context, the congressional judgment
embodied in the “Hatch-Waxman Amendments” to the
16 APOTEX INC. v. DAIICHI SANKYO, INC.
Food, Drug, and Cosmetic Act, 4 as consistently imple-
mented in our case law, makes clear that tentative ap-
proval for Apotex is not a precondition to adjudicating the
patent issue. When a generic manufacturer seeks to enter
the market, the concrete stakes are the market sales upon
entry. See Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc.,
527 F.3d 1278, 1292 (Fed. Cir. 2008) (“exclud[ing] non-
infringing generic drugs from the market . . . is a suffi-
cient Article III injury-in-fact”). Yet Congress, in 35
U.S.C. § 271(e)(2), defined an “artificial act of infringe-
ment,” Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661,
678 (1990), that allows litigation to take place well before
any product is actually placed on the market and before
any FDA regulatory approval, the litigation serving to
remove one barrier to such approval and marketing. See
Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed.
Cir. 1997) (under Hatch-Waxman, the focus of infringe-
ment litigation is on “what the ANDA applicant will likely
market if its application is approved, an act that has not
yet occurred”) (emphases added); cf. Amgen Inc. v. Int’l
Trade Comm’n, 565 F.3d 846, 851–52 (Fed. Cir. 2009)
(noting that the Supreme Court has “stressed the con-
gressional purpose of removing patent-based barriers to
proceeding with federal regulatory approval of medical
products”).
Critically, the statute authorizing the litigation upon
filing of an ANDA nowhere requires tentative FDA ap-
proval as a precondition: the filing of the ANDA, with a
paragraph IV certification, is itself deemed an act of
infringement. 35 U.S.C. § 271(e)(2); see Caraco Pharm.
Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670, 1677
4 Drug and Price Competition and Patent Term
Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585
(codified at 21 U.S.C. § 355, 28 U.S.C. § 2201, and 35
U.S.C. §§ 156, 271, & 282).
APOTEX INC. v. DAIICHI SANKYO, INC. 17
(2012) (“The patent statute treats such a filing as itself an
act of infringement, which gives the brand an immediate
right to sue.”). Moreover, Congress required the ANDA
filer to provide prompt notice to the relevant patent
owners (and NDA holder), 21 U.S.C. § 355(j)(2)(B), and for
the patent owners to bring suit within 45 days to obtain a
30-month delay in any effective date of approval for the
ANDA, § 355(j)(5)(B)(iii). It is undisputed that it would
be rare for tentative approval to have occurred 45 days
into the ANDA process. See also § 355(j)(5)(D)(i)(IV)
(provision triggering forfeiture based on first filer’s failure
to obtain tentative approval, presumptively giving first
filer a full 30 months to obtain tentative approval). The
statute evidently contemplates litigation well before such
tentative approval.
Our decisions reflect that fact. In all of our cases in-
volving litigation over ANDA applications, we have never
required tentative approval, including in suits brought
almost immediately after the ANDA’s filing. See, e.g.,
Caraco, 527 F.3d at 1295 (“Caraco has a complete generic
drug product that has been submitted to the FDA for
approval, and no additional facts are required to deter-
mine whether this drug product infringes the claims of
Forest’s ’941 patent.”); Teva Pharm. USA, Inc. v. Novartis
Pharm. Corp., 482 F.3d 1330, 1342 (Fed. Cir. 2007) (be-
cause the patent owner, upon a generic’s filing of a para-
graph IV certification, “would have an immediate
justiciable controversy, . . .[i]t logically follows that . . . the
same action should create a justiciable declaratory judg-
ment controversy for the opposing party”). 5
5 See Pozen Inc. v. Par Pharm., Inc., 696 F.3d 1151
(Fed. Cir. 2012); Sanofi-Aventis v. Apotex Inc., 659 F.3d
1171 (Fed. Cir. 2011); Ortho-McNeil Pharm., Inc. v. Mylan
Labs., Inc., 520 F.3d 1358 (Fed. Cir. 2008); Sanofi-
Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008);
18 APOTEX INC. v. DAIICHI SANKYO, INC.
Accordingly, tentative approval of an ANDA is gener-
ally not a precondition to the existence of a case or contro-
versy concerning patents listed in the Orange Book.
Moreover, that general case-or-controversy conclusion
does not depend on whether the patent owner or the
ANDA applicant initiates the litigation, the latter specifi-
cally authorized by Congress to bring a declaratory-
judgment action if the former does not sue. 21 U.S.C.
§ 355(j)(5)(C). For those reasons, we conclude that tenta-
tive approval is not required for the present dispute to
constitute a case or controversy unless there is an addi-
tional context-specific reason tied to statutory provisions
that distinguishes this situation from those in which we
have deemed tentative approval unnecessary to satisfy
Article III.
4
That conclusion brings us to the objection to justicia-
bility based on the specific statutory provisions governing
forfeiture of the exclusivity period. It is undisputed here
that Mylan currently has an exclusivity period available
to it, based on the original listing of the now-disclaimed
’703 patent and Mylan’s continued maintenance of its
paragraph IV certification regarding that patent. It is
also undisputed that the only basis asserted for Apotex to
enter earlier than the end of the exclusivity period is a
forfeiture of the period under § 355(j)(5)(D)(ii)—
specifically, one triggered by a “forfeiture event” defined
by § 355(j)(5)(D)(i)(I)(bb)(AA). The only arguments pre-
sented to us are arguments directly about those provi-
Apotex, Inc. v. Thompson, 347 F.3d 1335 (Fed. Cir. 2003);
Andrx Pharm., Inc. v. Biovail Corp., 276 F.3d 1368 (Fed.
Cir. 2002); Minn. Mining And Mfg. Co. v. Barr Labs., Inc.,
289 F.3d 775 (Fed. Cir. 2002). See also Teva Pharm. USA,
Inc. v. EISAI Co., 620 F.3d 1341, 1350 (Fed. Cir. 2010),
judgment vacated for mootness, 131 S. Ct. 2991 (2011).
APOTEX INC. v. DAIICHI SANKYO, INC. 19
sions—specifically, whether they permit Apotex to trigger
forfeiture by the judgment requested in this case. Daiichi
and Mylan do not suggest that, were a non-infringement
judgment to issue in this case, the FDA would nonetheless
consider it inadequate to trigger forfeiture of Mylan’s
exclusivity period based on a restrictive view of the forfei-
ture provisions that is entitled to judicial deference. Nor
do they argue that any FDA approval would come too late
to advance Apotex’s market entry in any event. We
conclude that Apotex can trigger forfeiture by obtaining
the non-infringement judgment it seeks in this case and,
thus, that a case or controversy exists here.
The provisions at issue are best read with a little
background and context. The provisions were added to
the statute by the Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003 (MMA), Pub. L. No.
108–173, § 1102, 117 Stat. 2066, 2457–60 (2003) (codified
as amended at 21 U.S.C. § 355(j)).
For ANDA applications filed before the December
2003 enactment of the MMA, the statute, as this court
read it, was more protective of a first ANDA filer’s exclu-
sivity period than it became under the MMA. In particu-
lar, and “[s]ignificantly, the first Paragraph IV ANDA
filer [was] entitled to the 180-day exclusivity period
regardless of whether it establishe[d] that the Orange
Book patents [were] invalid or not infringed by the drug
described in its ANDA.” Janssen Pharmaceutica, N.V. v.
Apotex, Inc., 540 F.3d 1353, 1356 (Fed. Cir. 2008); see
Caraco, 527 F.3d at 1283; 21 U.S.C. § 355(j)(5)(B)(iii), (iv)
(2000). 6 Moreover, the pre-MMA statute contained no
6 This court’s Janssen decision thus ruled that ex-
clusivity was not defeated when a patent identified in a
paragraph IV certification was held valid and infringed—
even though an FDA regulation required alteration of the
certification to become a paragraph III certification. 21
20 APOTEX INC. v. DAIICHI SANKYO, INC.
express requirement that the first filer lawfully maintain
its paragraph IV certification, and it offered no express
path for subsequent ANDA filers to eliminate a first filer’s
exclusivity period, i.e., to trigger its forfeiture. The stat-
ute merely provided that, when a first filer had not acti-
vated its 180-day clock, a subsequent filer could do so—
even where the first filer was blocked from marketing its
drug by a later-expiring patent—by securing a judgment
of non-infringement or invalidity. See Janssen, 540 F.3d
at 1357; Caraco, 527 F.3d at 1284; 21 U.S.C.
§ 355(j)(5)(B)(iv) (2000). Notably, Janssen (like Caraco)
was decided under the pre-MMA scheme, see 540 F.3d at
1357 n.2, and it was under that scheme that Janssen
concluded that the second filer’s “inability to promptly
C.F.R. § 314.94(a)(12)(viii)(A) (2003). By 2003, the FDA
had been moving toward denying exclusivity, as a regula-
tory matter, in various circumstances where an initial
paragraph IV certification lost its foundation, and the
courts expressed different views on the FDA’s evolving
position. See Dr. Reddy’s Labs., Inc. v. Thompson, 302 F.
Supp. 2d 340 (D.N.J. 2003) (upholding the FDA’s denial of
exclusivity based on pre-approval expiration of patent
subject to paragraph IV certification); Mylan Pharm., Inc.
v. Thompson, 207 F. Supp. 2d 476 (N.D. W. Va. 2001)
(rejecting the FDA’s denial of exclusivity based on treat-
ing first filer’s settlement with patent owner as effectively
changing certification); Mylan Pharm., Inc. v. Henney, 94
F. Supp. 2d 36 (D.D.C. 2000) (rejecting the FDA’s refusal
to interpret its regulation to deny exclusivity based on
first filer’s agreement to change certification from para-
graph IV to III), vacated and dismissed as moot sub nom.
Pharmachemie B.V. v. Barr Labs., Inc., 276 F.3d 627
(D.C. Cir. 2002); Mova Pharm Corp. v. Shalala, 140 F.3d
1060, 1071 (D.C. Cir. 1998) (noting the FDA’s view that
exclusivity is not lost upon certification change after
adjudication of validity and infringement).
APOTEX INC. v. DAIICHI SANKYO, INC. 21
launch its generic” product “because of [the first filer’s]
180-day exclusivity period is not a cognizable Article III
controversy, but a result envisioned by the Hatch-
Waxman Act.” Id. at 1361.
Section 1102 of the MMA altered the exclusivity
scheme in two fundamental ways. First: It expressly
conditioned the first filer’s eligibility for exclusivity on its
“lawfully maintain[ing]” a paragraph IV certification,
§ 355(j)(5)(B)(iv)(II)(bb). As already described, a first filer
may not lawfully maintain an initial paragraph IV certifi-
cation as to which it lost a litigation challenge regarding
infringement and validity. See supra p. 12 & n.3. In
other words, the exclusivity period is no longer guaran-
teed just for the effort of challenging a patent (its scope or
its validity), as Janssen had said of the pre-2003 statute.
Losing in the challenge eliminates the patent from the
group of patents that can support an exclusivity period.
Second: The MMA added to the statute an elaborate
new forfeiture provision that declares that “[t]he 180-day
exclusivity period described in [§ 355(j)(5)(B)(iv)] shall be
forfeited by a first applicant if a forfeiture event occurs
with respect to that first applicant.” § 355(j)(5)(D)(ii).
The provision defines “forfeiture event,” § 355(j)(5)(D)(i),
and one group of such events is the first filer’s “failure to
market” “by the later of” two dates. § 355(j)(5)(D)(i)(I).
One of those dates is specified in (aa): the earlier of 75
days after the first filer’s effective date for approval or 30
months after the first filer submitted its application.
§ 355(j)(5)(D)(i)(I)(aa). In the present case, because Mylan
filed in April 2006, the 30-month date arrived in October
2008. The second of the “later of” dates is specified in
(bb), which is what is at issue here: 7
7 No one here disputes that the “later of” language
applies only if one of the (bb)-specified events occurs, i.e.,
22 APOTEX INC. v. DAIICHI SANKYO, INC.
(bb) with respect to the first applicant or any
other applicant (which other applicant has re-
ceived tentative approval), the date that is 75 days
after the date as of which, as to each of the pa-
tents with respect to which the first applicant
submitted and lawfully maintained a certification
qualifying the first applicant for the 180-day ex-
clusivity period under subparagraph (B)(iv), at
least 1 of the following has occurred:
(AA) In an infringement action brought
against that applicant with respect to the
patent or in a declaratory judgment action
brought by that applicant with respect to
the patent, a court enters a final decision
from which no appeal (other than a peti-
tion to the Supreme Court for a writ of
certiorari) has been or can be taken that
the patent is invalid or not infringed.
(BB) In an infringement action or a de-
claratory judgment action described in
subitem (AA), a court signs a settlement
order or consent decree that enters a final
judgment that includes a finding that the
patent is invalid or not infringed.
(CC) The patent information submitted
under subsection (b) or (c) of this section
[§ 355] is withdrawn by the holder of the
application approved under subsection (b)
of this section [the NDA].
§ 355(j)(5)(D)(i)(I)(bb) (emphases added).
that the arrival of one of the (aa)-specified dates is not
itself enough if no (bb) event has occurred. See also Teva
v. Sebelius, 595 F.3d at 1316–17.
APOTEX INC. v. DAIICHI SANKYO, INC. 23
The first step in applying that provision to the present
case is to note that, although Mylan (the “first applicant”)
initially made a paragraph IV certification for both the
’599 and ’703 patents, the ’599 certification is no longer
“lawfully maintained,” because Mylan lost its litigation
over that patent. As a result, the only lawfully main-
tained certification involves the ’703 patent, and the (bb)
standards must be applied only to that patent. As to that
patent, then, (bb)(AA) specifies that Mylan forfeits its
exclusivity period if it has not entered the market by the
following date: with respect to Apotex, a second-filing
applicant, “which other applicant has received tentative
approval,” 75 days after what we may, for convenience,
call the “non-infringement finality date”—more precisely,
when the appeal time ends without an appeal after the
district court enters a non-infringement judgment, see 28
U.S.C. § 2107(a) (30-day period); Fed. R. App. P. 4, or
when this court enters its judgment affirming the non-
infringement judgment if there has been an appeal.
This provision, which separates the tentative-
approval phrase from its specification of certain forfei-
ture-triggering dates, including the non-infringement-
finality date of (AA), admits of a simple reading. There
are two requirements for forfeiture: a court must have
entered a final decision of non-infringement that is no
longer appealable (certiorari aside), and the second (or
later) filer must have received tentative approval. The
first filer forfeits its exclusivity if it has not entered 75
days after those two requirements are satisfied. Under
that reading, Apotex can trigger forfeiture in this case by
obtaining the judgment it seeks here and by obtaining
tentative approval, if it does both early enough in relation
to Mylan’s market entry.
Mylan argues for a different interpretation of the
statute—that the second filer (the “other applicant” in
(bb)) must have tentative approval before it initiates the
declaratory-judgment action. Mylan Br. 5, 21–22. Mylan
24 APOTEX INC. v. DAIICHI SANKYO, INC.
contends that the text of (bb) and (AA) taken together
unambiguously mandates that tentative approval is a
prerequisite for entry into court if the action is ultimately
to have a forfeiture effect. We reject that reading of the
provision.
The statutory text does not compel Mylan’s interpre-
tation. The provision’s language, standing alone, leaves
ambiguous the time at which the “received tentative
approval” requirement must be met—at the institution of
the declaratory-judgment action or at some later time.
We must therefore look to the statutory context and
policy. That analysis points convincingly against Mylan’s
view.
The textual contrast with another relevant provision
added to the statute by the MMA, namely, § 355(j)(5)(C)—
under which Apotex filed its declaratory-judgment ac-
tion—confirms the facial ambiguity of the (bb)(AA) lan-
guage at issue and reinforces our interpretation that
tentative approval is not required at the outset of the
action. Section 355(j)(5)(C) imposes clear preconditions on
an ANDA filer’s bringing of a declaratory-judgment action
against the patent owner: “No action may be brought
under [the Declaratory Judgment Act] . . . unless” the
patent owner declines to sue the ANDA applicant 45 days
after it gives notice of filing a paragraph IV certification.
Id. (emphasis added); see 35 U.S.C. § 271(e)(5). No such
initiation-focused mandatory language is found in the
forfeiture provision at issue here. The contrast is signifi-
cant.
Indeed, it would be surprising to find an entry-into-
court prerequisite in the forfeiture provision, given how
the forfeiture provision is plainly intended to operate.
The only role to be played by the declaratory-judgment
action referred to in § 355(j)(5)(D)(i)(I)(bb)(AA) is a role
played at the end of the action—a “final decision” in the
defined sense of completing as-of-right appeals—namely,
APOTEX INC. v. DAIICHI SANKYO, INC. 25
forfeiture no earlier than 75 days after that event. The
provision does not give the mere filing of the action any
effect. It makes no sense, where not compelled by the text
or context, to give the provision an interpretation extra-
neous to its evident function.
Moreover, Mylan’s view that tentative approval is re-
quired for a second filer to be “that applicant” under (AA)
would, for all we can tell, have to apply even when, as
(AA) expressly contemplates, the patent owner brings “an
infringement action . . . against that applicant.” For
reasons we have noted, such as preventing immediate
approval of an ANDA and triggering a 30-month delay in
the effectiveness of any approval, § 355(j)(5)(B)(iii), it is
commonplace and expected that the patent owner will
bring an infringement action under 35 U.S.C. § 271(e)(2)
within 45 days of receiving notice of the ANDA, well
before any tentative approval. It appears that, under
Mylan’s “that applicant” view, such a suit, even when the
second filer wins, would fall outside the (AA) provision at
issue here and thus not have any forfeiture effect. Mylan
has not shown us why that result is a sensible one.
Indeed, in that instance, where the second filer has been
responsible for winning a contested invalidity or non-
infringement ruling, it would be the second filer that
conferred the public benefit that Mylan has touted before
us: clearing the particular patent from the field of poten-
tial competition.
Not only does it make no sense to read the forfeiture
provision as requiring tentative approval at the outset of
the second filer’s declaratory-judgment action. It makes
good sense to read the provision as providing for forfeiture
simply when there has been no entry 75 days after the
non-infringement finality date and the date of tentative
approval. That reading serves the evident congressional
policy of triggering forfeiture when a second filer is ready
to launch. See 149 Cong. Rec. 31,200 (2003) (statement of
Sen. Schumer) (“If it forfeits, then the exclusivity is lost
26 APOTEX INC. v. DAIICHI SANKYO, INC.
and any other generic applicant that is ready to be ap-
proved and go to market can go.”).
Tentative approval is required before a second filer
can actually trigger forfeiture, because exclusivity should
not be lost unless the second filer is on the verge of having
an approved product to deliver the benefits of competition.
It would be arbitrary, in terms of the discernible policy, to
require tentative approval earlier. Thus, for this case, the
purpose of requiring tentative approval has nothing to do
with Apotex’s approval status at the time it brought the
declaratory-judgment action, and it has everything to do
with its approval status when forfeiture is triggered. Our
interpretation—the 75-day clock for Mylan starts to run
when Apotex has both tentative approval and a no-longer-
appealable judgment of non-infringement—fits the con-
crete function of the provision, whereas Mylan’s does not.
Mylan argues that its view is required by the statuto-
ry policy underlying the exclusivity period. But its argu-
ment is too detached from the particulars of the statute.
The exclusivity period, § 355(j)(5)(B)(iv), rests on a balanc-
ing of interests: encouraging early entry by generics into
the market by providing a reward to first filers (substan-
tially higher prices for a time and a first-mover ad-
vantage, see Mova Pharm. Corp. v. Shalala, 140 F.3d
1060, 1066 n.6 (D.C. Cir. 1998)), but only up to a point (as
that reward creates higher prices for consumers, see Teva,
595 F.3d at 1318). There is no a priori right balance. We
must look to what Congress enacted—specifically, the
MMA provisions that reset the statutory balance. See
Teva Pharm. Indus. Ltd. v. Crawford, 410 F.3d 51, 54
(D.C. Cir. 2005) (“Because the balance struck between
these competing goals is quintessentially a matter for
legislative judgment, the court must attend closely to the
terms in which the Congress expressed that judgment.”).
Here, as we have explained, when Mylan lost its case
regarding the ’599 patent, it lost its right to invoke that
patent to support an exclusivity period. And there is no
APOTEX INC. v. DAIICHI SANKYO, INC. 27
evident “policy” supporting maintenance of that period
based on the ’703 patent once (it is 75 days after) Apotex
secures a no-longer-appealable judgment of non-
infringement, no matter how quick and easy the litiga-
tion, and has tentative approval, whenever that occurs.
The decision by the D.C. Circuit in Teva v. Sebelius is
not contrary to our interpretation of “tentative approval”
and its role in (bb)(AA). 595 F.3d at 1317–18. That case
addressed whether an NDA holder’s unilateral request to
the FDA to delist a patent, if granted by the FDA, could
terminate a first filer’s eligibility for exclusivity under
subparagraph (CC) of § 355(j)(5)(D)(i)(I)(bb)—without any
judicial involvement, and indeed without a disclaimer of
the patent. 595 F.3d at 1315. The court read the lan-
guage of (CC), which provides for forfeiture upon the
“withdrawal” of an Orange Book listing by the NDA
holder, as of a piece with subparagraphs (AA) and (BB),
which specify judicial actions as prerequisites for the
causing of a “failure to market” forfeiture. Id. at 1317–18.
So read, the Teva court held, (CC) did not authorize
forfeiture of the exclusivity period by unilateral action of
the NDA holder (even with FDA ratification) without
judicial involvement. In the present case, in contrast, the
forfeiture Apotex seeks to produce is not to be effected by
Daiichi’s unilateral action but by a court judgment.
The Teva rationale does not carry over to curtail the
forfeiture effects prescribed by (AA) and (BB), which
require judicial involvement and which were not invoked
as forfeiture bases in Teva. The D.C. Circuit in Teva did
not say that forfeiture is rendered unavailable, even with
judicial involvement, just because the NDA holder/patent
owner has agreed to non-infringement. Indeed, (BB)
expressly provides for forfeiture based on a “settlement
order or consent decree” signed by a court where the
judgment includes a non-infringement or invalidity find-
ing. As a statutory matter, the judicial role is key in
distinguishing two situations, both of which may involve
28 APOTEX INC. v. DAIICHI SANKYO, INC.
an NDA holder/patent owner that has given up on one of
its patents.
CONCLUSION
For the foregoing reasons, we hold that Apotex has al-
leged facts supporting the conclusion “that there is a
substantial controversy, between parties having adverse
legal interests, of sufficient immediacy and reality to
warrant the issuance of a declaratory judgment.”
MedImmune, 549 U.S. at 127 (internal quotation marks
and citation omitted). We reverse the judgment of the
district court dismissing the case, as well as the denial of
Mylan’s motion to intervene.
REVERSED