Court Opinion

ID: 2757942
Source: CourtListenerOpinion
Date Created: 2014-12-05 16:01:04.463769+00
Date Added: 2024-06-11T10:34:19.471851
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
                ______________________

                    SANDOZ INC.,
                   Plaintiff-Appellant,

                            v.

  AMGEN INC. AND HOFFMANN-LA ROCHE INC.,
              Defendants-Appellees.
             ______________________

                      2014-1693
                ______________________

   Appeal from the United States District Court for the
Northern District of California in No. 3:13-cv-02904
MMC, Judge Maxine M. Chesney.
               ______________________

               Decided: December 5, 2014
                ______________________

     JAMES F. HURST, Winston & Strawn LLP, of Chicago,
Illinois, argued for plaintiff-appellant. With him on the
brief were MAUREEN L. RURKA and JAMES M. HILMERT.

    DAVID T. PRITIKIN, Sidley Austin LLP, of Chicago, Il-
linois, argued for defendants-appellees. With him on the
brief were VERNON M. WINTERS, of San Francisco, Cali-
fornia, and JEFFREY P. KUSHAN, of Washington, DC. Of
counsel on the brief were WENDY A. WHITEFORD, J. DREW
DIAMOND, and GAIL A. KATZ, Amgen, Inc., of Thousand
Oaks, California, for Amgen Inc. Of counsel were JAMES
A. HIGH, JR., of Washington, DC, M. PATRICIA THAYER, of
2                                  SANDOZ INC.   v. AMGEN INC.

San Francisco, California, and SAMUEL N. TIU, of Los
Angeles, California.
                 ______________________

     Before DYK, TARANTO, and CHEN, Circuit Judges.
TARANTO, Circuit Judge.
     Sandoz Inc. sued Amgen Inc. and Hoffman-La Roche
Inc. to obtain a declaratory judgment that two patents,
owned by Hoffman-La Roche and exclusively licensed to
Amgen, are invalid and unenforceable and will not be
infringed if Sandoz uses, offers to sell or sells, or imports
a drug product “biosimilar” to Amgen’s Enbrel®. At the
time it brought suit, Sandoz had not (as it still has not)
filed an application for approval of its contemplated
product by the Food and Drug Administration (FDA) and
had only just begun certain testing required for its con-
templated FDA filing. The district court dismissed the
case, determining that no Article III controversy (yet)
existed between the parties and also that the suit was
barred by the Biologics Price Competition and Innovation
Act of 2009 (BPCIA), Pub. L. No. 111-148, §§ 7001–7003,
124 Stat. 119, 804–21 (2010) (codified principally at 42
U.S.C. § 262). Sandoz Inc. v. Amgen Inc., No. CV-13-
2904 MMC, 2013 WL 6000069, at *2–3 (N.D. Cal. Nov. 12,
2013). We affirm, concluding that Sandoz did not allege
an injury of sufficient immediacy and reality to create
subject matter jurisdiction. We do not address the district
court’s interpretation of the BPCIA.
                       BACKGROUND
   Amgen markets Enbrel®, a “biological product” under
42 U.S.C. § 262(i), as a therapy for rheumatoid arthritis.
The active ingredient in Enbrel® is the protein etaner-
SANDOZ INC.   v. AMGEN INC.                                 3

cept. 1 Amgen’s predecessor, Immunex, received an FDA
Biologics License for Enbrel®, under 42 U.S.C. § 262(a)
and 21 C.F.R. pt. 601, in 1998. Sandoz began developing
its own etanercept product in 2004.
    In late 2011 and early 2012, the Patent and Trade-
mark Office issued Patent Nos. 8,063,182 and 8,163,522
to Hoffman-LaRoche. The ’182 patent claims specified
proteins and related pharmaceutical compositions. The
’522 patent claims certain methods of using host cells that
include specified polynucleotides that encode certain
proteins, specified polynucleotides themselves, and vec-
tors and cells containing specified polynucleotides.
Amgen has identified those two patents as among four
patents “for etanercept.” J.A. 3146; see J.A. 3129 (press
release stating that the ’182 patent is “related to
Enbrel®”).     Sandoz alleges in its complaint that,
“[a]ccording to Amgen, the patents cover . . . ‘etanercept,’ ”
J.A. 2002; see Sandoz, 2013 WL 6000069, at *1, although
Sandoz alleges that Amgen is wrong, J.A. 2010.
    Sandoz needs FDA approval to enter the market with
its own etanercept drug, and in 2010 Sandoz began a
series of meetings with the FDA to plan for an application
based on biosimilarity to Enbrel®. That year, Congress
enacted the BPCIA, borrowing from (though not copying)
the Hatch-Waxman Act’s process for use of an Abbreviat-
ed New Drug Application (ANDA), rather than a full New
Drug Application, to obtain approval of generic versions of
previously approved drugs. E.g., 21 U.S.C. § 355(j). The
BPCIA establishes an FDA regulatory-approval process—

    1    Etanercept is a dimeric fusion protein, i.e., a pro-
tein composed of two subunits, each of which itself is a
combination of portions of two different proteins. Specifi-
cally, each etanercept subunit consists of a portion of the
human tumor necrosis factor receptor joined with a por-
tion of the human antibody IgG1.
4                                  SANDOZ INC.   v. AMGEN INC.

more abbreviated than the full Biologics License Applica-
tion process—for biological products that are shown to be
“biosimilar” to a “reference product” already approved by
the FDA. See 42 U.S.C. § 262(k). 2 On June 24, 2013,
after close consultation with the FDA, Sandoz announced
a large-scale human (Phase III) trial for its contemplated
etanercept product. See 21 C.F.R. § 312.21 (Phase III
trials “usually include from several hundred to several
thousand subjects”). This trial, expected to run into 2015,
was to be completed before Sandoz filed any application
for FDA approval.
    The same day that Sandoz began its Phase III trial,
Sandoz filed a complaint against Amgen and Hoffman-
LaRoche (hereafter collectively “Amgen”). Sandoz sought
a declaratory judgment that “the manufacture, use, sale,
offering for sale, or importation of its etanercept product
will not infringe, directly or indirectly, any valid claim of”
either the ’182 or the ’522 patent, that both patents are
unenforceable due to prosecution laches, and that both
patents are invalid. J.A. 2015–18. Sandoz had not—and

    2    Under the BPCIA, “biosimilar” means “(A) that
the biological product is highly similar to the reference
product notwithstanding minor differences in clinically
inactive components; and (B) there are no clinically mean-
ingful differences between the biological product and the
reference product in terms of the safety, purity, and
potency of the product.” 42 U.S.C. § 262(i)(2). In con-
trast, an ANDA requires a showing of “bioequivalen[ce].”
21 U.S.C. § 355(j)(2)(A)(iv); 21 C.F.R. § 320.1.
    The BPCIA also provides for approval based on “inter-
changeability,” which confers certain benefits on the
applicant and which the FDA may find if it finds biosimi-
larity and additional facts. 42 U.S.C. § 262(i)(3), (k)(2)(B),
(k)(4), (k)(6).
SANDOZ INC.   v. AMGEN INC.                              5

still has not—filed an application for FDA approval to
market an etanercept product.
    Amgen moved to dismiss the complaint, arguing,
among other things, that the court lacked jurisdiction
because no immediate, real controversy between the
parties yet existed. The district court granted the motion.
It agreed with Amgen that Sandoz had not “established a
‘real and immediate injury or threat of future injury’ ”
caused by Amgen and so had not established a case or
controversy. Sandoz, 2013 WL 6000069, at *2 (quoting
Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329, 1339
(Fed. Cir. 2008)).
    The district court also relied on a separate ground for
dismissal—that the BPCIA prohibited Sandoz’s suit.
Among its provisions, the BPCIA establishes procedures
for the narrowing and resolution of patent disputes be-
tween biosimilarity applicants and reference-product
sponsors. See 42 U.S.C. § 262(l). The district court con-
cluded that Sandoz could not obtain a declaratory judg-
ment before filing an FDA biosimilarity application. The
court reasoned that, because Sandoz planned to enter the
market by the biosimilarity route, it had to follow the
BPCIA’s patent-related procedures applicable to biosimi-
larity applicants—which it had not done. Sandoz, 2013
WL 6000069, at *1–2.
   Sandoz timely appealed. We have jurisdiction under
28 U.S.C. § 1295(a)(1).
                         DISCUSSION
    We review de novo the dismissal of a declaratory-
judgment action for lack of subject-matter jurisdiction.
3M Co. v. Avery Dennison Corp., 673 F.3d 1372, 1377
(Fed. Cir. 2012). Sandoz bears the burden of establishing
jurisdiction. McNutt v. Gen. Motors Acceptance Corp. of
Ind., 298 U.S. 178, 189 (1936).
6                                  SANDOZ INC.   v. AMGEN INC.

                             A
    Under the Declaratory Judgment Act, “[i]n a case of
actual controversy within its jurisdiction . . . any court of
the United States . . . may declare the rights and other
legal relations of any interested party seeking such decla-
ration, whether or not further relief is or could be sought.”
28 U.S.C. § 2201. The Act creates a remedy, not an
independent source of subject-matter jurisdiction. Skelly
Oil Co. v. Phillips Petroleum Co., 339 U.S. 667, 671
(1950). Indeed, “the phrase ‘case of actual controversy’ in
the Act refers to the type of ‘Cases’ and ‘Controversies’
that are justiciable under Article III.” MedImmune, Inc.
v. Genentech, Inc., 549 U.S. 118, 127 (2007).
     To answer the underlying case-or-controversy ques-
tion in this context, we ask “whether the facts alleged,
under all the circumstances, show that there is a substan-
tial controversy, between parties having adverse legal
interests, of sufficient immediacy and reality to warrant
the issuance of a declaratory judgment.” Id. (internal
quotation marks omitted). The inquiry, focused on the
combination of immediacy and reality, involves no bright-
line test. See id. The required distinction is between a
suit involving a “real and substantial” dispute that “ad-
mit[s] of specific relief through a decree of a conclusive
character” and a suit that calls for “an opinion advising
what the law would be upon a hypothetical state of facts.”
Id. (internal quotation marks omitted).
    We have frequently applied MedImmune’s “all the cir-
cumstances” standard to determine, in the patent context,
whether a declaratory-judgment plaintiff has presented a
case of sufficient “immediacy and reality.” See, e.g.,
Arkema Inc. v. Honeywell Int’l, Inc., 706 F.3d 1351, 1356–
60 (Fed. Cir. 2013); Matthews Int’l Corp. v. Biosafe Eng’g,
LLC, 695 F.3d 1322, 1328–31 (Fed. Cir. 2012); Cat Tech
LLC v. TubeMaster, Inc., 528 F.3d 871, 878–83 (Fed. Cir.
2008); Benitec Austl., Ltd. v. Nucleonics, Inc., 495 F.3d
SANDOZ INC.   v. AMGEN INC.                               7

1340, 1343–49 (Fed. Cir. 2007). The immediacy require-
ment is not concerned in the abstract with the amount of
time that will occur between the filing of the declaratory
judgment action and the liability-creating event. An
event that is several years in the future may be an appro-
priate subject for a declaratory judgment. The immediacy
requirement is concerned with whether there is an imme-
diate impact on the plaintiff and whether the lapse of
time creates uncertainty. The two issues—immediacy
and reality—are thus related.
    We have assessed “immediacy” by considering how far
in the future the potential infringement is, whether the
passage of time might eliminate or change any dispute,
and how much if any harm the potential infringer is
experiencing, at the time of suit, that an adjudication
might redress. See Matthews, 695 F.3d at 1329–30 (citing
cases). We have assessed “reality” by examining any
uncertainties about whether the plaintiff will take an
action that will expose it to potential infringement liabil-
ity and, if so, exactly what action. Arkema, 706 F.3d at
1360 (noting absence of “uncertainty about whether the
supplier’s product is going to be used in a way that might
or might not infringe the patentee’s rights”); Matthews,
695 F.3d at 1330–31 (discussing cases requiring that
plaintiff’s conduct be “substantially fixed”). In short, we
have focused on related questions of timing and contin-
gency regarding the existence and content of any needed
patent adjudication, as well as current concrete harms to
the declaratory-judgment plaintiff from delaying an
adjudication.
    Reflecting MedImmune’s suggestion that “justiciabil-
ity problem[s]” can be described in terms of standing and
ripeness, 549 U.S. at 128 n.8, we have said that standing
and ripeness, as well as mootness, serve as “helpful
guide[s] in applying the all-the-circumstances test” be-
cause “satisfying these doctrines represents the absolute
constitutional minimum for a justiciable controversy”
8                                 SANDOZ INC.   v. AMGEN INC.

under Article III. Prasco, 537 F.3d at 1336; see also
Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc., 527 F.3d
1278, 1291 (Fed. Cir. 2008). Here, ripeness principles in
particular reinforce the importance of contingency in the
analysis. “A claim is not ripe for adjudication if it rests
upon contingent future events that may not occur as
anticipated, or indeed may not occur at all.” Texas v.
United States, 523 U.S. 296, 300 (1998) (internal quota-
tion marks omitted). More broadly, a ripeness analysis
considers whether “further factual development would
significantly advance [the court’s] ability to deal with the
legal issues presented,” Nat’l Park Hospitality Ass’n v.
Dep’t of Interior, 538 U.S. 803, 812 (2003) (internal quota-
tion marks omitted), and whether “the complained-of
conduct has an ‘immediate and substantial impact’ on the
plaintiff,” Caraco, 527 F.3d at 1295 (quoting Gardner v.
Toilet Goods Ass’n, 387 U.S. 167, 171 (1967)).
                             B
    We conclude that Sandoz’s complaint does not present
a case or controversy. We reach this conclusion on the
particular facts before us. See Matthews, 695 F.3d at
1328 (“[I]n determining whether a justiciable controversy
is present, the analysis must be calibrated to the particu-
lar facts of each case . . . .”). We do not address distinct
questions that may arise as Sandoz continues its efforts to
develop and obtain approval to market an etanercept
product. In particular, we do not address Sandoz’s ability
to seek a declaratory judgment if and when it files an
FDA application under the BPCIA.
    The Supreme Court has not had occasion to address
the justiciability requirements in the context presented by
Sandoz’s complaint. In MedImmune and, more recently,
in Medtronic, Inc. v. Mirowski Family Ventures, LLC, 134
S. Ct. 843 (2014), there was no dispute that the challenger
was ready to engage in commercial activities immediately
and with a specific, fixed product, without any suggestion
SANDOZ INC.   v. AMGEN INC.                               9

that regulatory hurdles still had to be cleared for the
activities to begin. MedImmune, 549 U.S. 118 (licensed
seller of FDA-approved product challenged the licensed
patent’s validity, wishing to continue its sales free of
royalties); Medtronic, 134 S. Ct. 843 (factually similar
situation    involving   medical-device     manufacturer).
Sandoz’s position is quite different. Amgen has not
suggested that anything Sandoz is currently doing expos-
es it to infringement liability, 3 and there is no dispute
that Sandoz cannot engage in the only liability-exposing
conduct at issue without FDA approval of an application
precisely defining the products it may market. Sandoz
has not even filed such an application.
    Unlike the Supreme Court, our court has addressed
justiciability in contexts similar to the one before us. In
Telectronics Pacing Sys., Inc. v. Ventritex, Inc., 982 F.2d
1520 (Fed. Cir. 1992), we concluded that the district court
could have found no case or controversy where the ac-
cused medical device—at the relevant time being used
only under an Investigational Device Exemption, in a way
protected against infringement charges by 35 U.S.C.
§ 271(e)(1), see 982 F.2d at 1521, 1525—“had only recently
begun clinical trials, and was years away from potential
FDA approval,” 982 F.2d at 1527. In Benitec, decided
after MedImmune, the court held that the potentially
infringing future activity of Nucleonics did not meet the
immediacy and reality requirements, explaining: “The

   3     Sandoz is conducting its clinical trial outside the
United States. Moreover, 35 U.S.C. § 271(e)(1) provides a
“safe harbor” that “exempt[s] from infringement all uses
of patented compounds ‘reasonably related’ to the process
of developing information for submission under any
federal law regulating the manufacture, use, or distribu-
tion of drugs.” Merck KGaA v. Integra Lifesciences I, Ltd.,
545 U.S. 193, 206 (2005) (emphasis in original).
10                                SANDOZ INC.   v. AMGEN INC.

fact that Nucleonics may file [a New Drug Application] in
a few years does not provide the immediacy and reality
required for a declaratory judgment.” 495 F.3d at 1346.
We are aware of no decision in which we have found a
case or controversy when the only activity that would
create exposure to potential infringement liability was a
future activity requiring an FDA approval that had not
yet been sought. 4
    Without adopting a categorical rule, we conclude that
the present case does not meet the requirements of imme-
diacy and reality. We begin with the immediacy require-
ment, noting again that contingency plays a role in
applying this requirement as it does in applying the
reality requirement. When Sandoz filed its suit, it was
conducting a Phase III trial of a drug it hopes to make the
subject of an FDA application. It told the National Insti-
tutes of Health that its trial would last until April 2015.
Even that date, let alone any FDA approval, was several
years away when Sandoz brought this suit. And if the
Phase III trial uncovers material problems, Sandoz may,
at a minimum, need to delay any FDA application consid-
erably longer.
    In considering what may occur during this period, as
in assessing contingencies directly, we can hardly proceed

     4  Amgen Inc. v. F. Hoffman-LaRoche Ltd., 580 F.3d
1340 (Fed. Cir. 2009), cited to us by Sandoz, involved a
declaratory-judgment action by a patent holder asserting
that the defendant would infringe if it imported a product
into the United States. Id. at 1346. We did not discuss
any case-or-controversy issue. The district court ulti-
mately granted both declaratory and injunctive relief, id.,
and it found jurisdiction based on an amended complaint
reciting that the defendant had sought FDA approval for
its product, Amgen, Inc. v. F. Hoffman-LaRoche Ltd., 456
F. Supp. 2d 267, 271 & n.1 (D. Mass. 2006).
SANDOZ INC.   v. AMGEN INC.                                 11

by simply assuming that the Phase III trial will wholly
succeed.      Sandoz undertook the costly and time-
consuming Phase III trial in close consultation with the
FDA, even after completing other extensive studies. As
those circumstances suggest, we may assume on the
record here (and Sandoz does not deny) that the FDA
effectively required the trial. Perhaps, like many studies,
the trial’s purpose was “confirmation” of what earlier
studies had already strongly indicated. See Sandoz
Opening Br. at 13 (emphasis in original). Even accepting
that characterization, we cannot assume that there was
no meaningful uncertainty to resolve. The biosimilarity
approval standard is new; indeed, the FDA has not yet
applied the new standard to complete its review of and
approve any product under the BPCIA. See FDA, Purple
Book: Lists of Licensed Biological Products with Reference
Product Exclusivity and Biosimilarity or Interchangeabil-
ity Evaluations, www.fda.gov/Drugs/DevelopmentAppro
valProcess/HowDrugsareDevelopedandApproved/Appro
valApplications/TherapeuticBiologicApplications/Biosimi
lars/ucm411418.htm (as of October 2014). Perhaps the
FDA is exercising a caution that will prove excessive over
time. But we have no basis for saying so.
     Any dispute about patent infringement is at present
subject to significant uncertainties—concerning whether
it will actually arise and if so what specific issues will
require decision. Sandoz’s Phase III trial may fail in
material ways. If so, perhaps Sandoz will not file for
approval, thereby eliminating altogether the patent
dispute it has asked the district court to adjudicate.
Perhaps, if the trial materially fails, i.e., uncovers signifi-
cant problems, Sandoz will instead modify its proposed
product and ultimately file for FDA approval of the modi-
fied product. At a minimum, that scenario could alter the
content of any patent dispute: notably, infringement of
the specific claims of the specific patents—which cover,
e.g., particular proteins, pharmaceutical compositions,
12                                SANDOZ INC.   v. AMGEN INC.

polynucleotides, and methods—could present different
questions depending on the precise product. In fact,
modifying the product now being tested might even elimi-
nate a genuine patent dispute. Sandoz already asserts in
its complaint that “the ’182 and ’522 patents do not cover”
the “etanercept product” it seeks to market in the United
States—or Amgen’s product. J.A. 2010. Conceivably,
some modifications would put non-infringement beyond
reasonable dispute, even while allowing FDA approval
under the agency’s still-evolving approach to applying the
biosimilarity standard. See generally J.A. 1575–93, 3846–
60 (draft FDA guidance documents).
    Sandoz has not demonstrated that these possibilities
for changing or eliminating the patent dispute are so
unlikely to arise that they should play no significant role
in the Article III determination. Sandoz’s complaint says
nothing about the specific patent claims and how they do
or do not map onto the product Sandoz contemplates or is
currently testing (except for denying that the claims cover
the product). The complaint relies on the assertions that
Amgen has said that the patents cover Enbrel® (which the
complaint denies), that Amgen intends to invoke its
patents against products that compete with Enbrel®, and
that Sandoz seeks to market a competitive product.
Neither those allegations nor anything Sandoz has
demonstrated about the new FDA biosimilarity standard
(or the role of Phase III trials in applying that standard)
enables us, on this record, to discount the potential for
elimination or alteration of any needed adjudication.
    In the pre-application context presented here, we con-
clude that the events exposing Sandoz to infringement
liability “may not occur as anticipated, or indeed may not
occur at all,” Texas, 523 U.S. at 300 (internal quotation
marks omitted), and that “further factual development
would significantly advance” a court’s ability to identify
and define the issues for resolution, Nat’l Park Hospitality
Ass’n, 538 U.S. at 812 (internal quotation marks omitted).
SANDOZ INC.   v. AMGEN INC.                             13

In these respects, this case is unlike Arkema, which
involved no needed regulatory approvals and no meaning-
ful contingencies affecting the reality or content of the
patent dispute. 706 F.3d at 1357–60.
    Our conclusion is consistent with our cases under the
Hatch-Waxman Act. As noted above, we have found no
justiciability where a declaratory-judgment plaintiff had
not filed an application for the FDA approval required to
engage in the arguably infringing activity. On the other
hand, where we have found a case or controversy in the
Hatch-Waxman setting, we have focused on the presence
of an application for the required FDA approval. 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.”); Glaxo, Inc. v. Novopharm, Ltd.,
110 F.3d 1562, 1571 (Fed. Cir. 1997) (“Novopharm also
indicated that it had submitted an ANDA accompanied by
data sufficient to make FDA approval imminent. Thus,
unlike Telectronics . . . the threat of Novopharm entering
the U.S. market was not years away . . . .”) (internal
quotation marks omitted).
    The Supreme Court and this court have indicated that
Congress may act to “articulate chains of causation that
will give rise to a case or controversy where none existed
before”—thus, in some circumstances, effectively creating
justiciability that attenuation concerns would otherwise
preclude. Massachusetts v. EPA, 549 U.S. 497, 516–18
(2007); see Consumer Watchdog v. Wis. Alumni Research
Found., 753 F.3d 1258, 1261 (Fed. Cir. 2014). But
Sandoz, in its current posture, cannot invoke any statuto-
ry relaxation of otherwise-applicable immediacy and
reality requirements. Congress has not specifically pro-
vided for suits where the potential infringer has not filed
an FDA application for the approval required before it can
undertake the activity that might expose it to liability.
14                                SANDOZ INC.   v. AMGEN INC.

    In the Hatch-Waxman Act, Congress did provide for
certain early adjudications of patent issues that would be
presented by future market-entry activity in the FDA
setting. It created an “artificial” act of infringement to
allow suit by a patent holder, 35 U.S.C. § 271(e)(2)(A);
Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316,
1318 (Fed. Cir. 2012); and in the BPCIA, Congress ex-
tended the provision to biological products, 35 U.S.C.
§ 271(e)(2)(C). The essential requirement for such ac-
tions, however, is the defendant’s filing of the FDA appli-
cation needed for market entry—an application that
defines what the applicant would be permitted to do (upon
approval) and thus circumscribes and dominates the
assessment of potential infringement. See Ferring B.V. v.
Watson Labs., Inc.-Fla., 764 F.3d 1401, 1408–09 (Fed. Cir.
2014) (discussing earlier cases). Sandoz has not filed such
an application. Accordingly, no congressional judgment
aids Sandoz in diminishing the significance of the present
uncertainties about whether and when an adjudication
will be needed and what issues it will involve if it occurs.
    At the same time, Sandoz has not shown that it will
suffer an immediate and substantial adverse impact from
not being able to seek or secure a patent adjudication
before filing an application for FDA approval. Sandoz
cannot lawfully enter the market now anyway, wholly
apart from the ’182 and ’522 patents, so there is no ques-
tion of its taking immediate action that risks building up
infringement liability. And while Sandoz has alleged that
it has begun investing in expansion of a production facili-
ty in Europe, and that the potential American market
influenced the expansion decision, it has not argued to us
that it is suspending or even delaying this investment
until a patent adjudication occurs or that it would do so
upon receiving an adverse patent judgment. See J.A.
2009, 2055–56, 4047–51; Sandoz Opening Br. at 17, 53–
54; Sandoz Reply Br. at 25. To the extent that particular
hardships can affect the overall evaluation, we see none
SANDOZ INC.   v. AMGEN INC.                             15

in the circumstances of this case that override the contin-
gency problems that lead us to conclude that Sandoz does
not meet the Article III requirements of immediacy and
reality.
    Our resolution of this case makes it unnecessary for
us to address the district court’s BPCIA rationale. We
also do not decide whether, once an application is filed
under the BPCIA, that statute forecloses a declaratory-
judgment action concerning whether the ultimate market-
ing of the application-defined product would infringe
under 35 U.S.C. § 271(a).
                         CONCLUSION
    For the foregoing reasons, we affirm the judgment of
the district court.
                         AFFIRMED