The opinion
United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued December 5, 2001 Decided January 18, 2002
No. 00-5206
Pharmachemie B.V.,
Appellee
v.
Barr Laboratories, Inc.,
Appellant
Consolidated with
No. 00-5207
Appeals from the United States District Court
for the District of Columbia
(No. 99cv00801)
(No. 99cv00862)
James F. Hurst argued the cause for appellant. With him
on the briefs was Christine J. Siwik.
John F. Cooney argued the cause and filed the brief for
appellee.
Before: Sentelle and Rogers, Circuit Judges, and
Williams, Senior Circuit Judge.
Opinion for the Court filed by Circuit Judge Rogers.
Rogers, Circuit Judge: Barr Laboratories, Inc. ("Barr")
appeals the district court's grant of summary judgment,
interpreting the Hatch-Waxman Amendments of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. ss 301 et seq., and
regulations promulgated thereunder, 21 C.F.R. ss 314.94,
314.107, to Pharmachemie, B.V., a potential competitor of
Barr's. Barr contends that the district court erred in vacat-
ing an administrative ruling of the Food and Drug Adminis-
tration ("FDA") that Barr, as the first company to file a
paragraph IV certification for tamoxifen, a breast cancer
drug, as part of its application for FDA review and approval
of its generic version of tamoxifen, had a statutory right to
180 days of generic exclusivity. After the district court
granted summary judgment, Pharmachemie lost its court
challenge to the underlying patent of the pioneer drug manu-
facturer's tamoxifen. As a result, Pharmachemie cannot mar-
ket its generic version of tamoxifen until the patent expires.
Because the FDA's ruling no longer causes any redressible
harm to Pharmachemie, we conclude that the case is moot
and, accordingly, we dismiss the appeal for lack of jurisdic-
tion, vacate the judgment of the district court, and remand
the case to the district court with instructions to dismiss the
complaint.
I.
The Hatch-Waxman Amendments simplified the procedure
for obtaining approval of generic drugs. See Pub. L. No.
98-417, 98 Stat. 1585 (1984). While a pioneer drug manufac-
turer must file a New Drug Application with safety and
effectiveness data, subsequent applicants who want to manu-
facture generic versions of the original drug need only file an
Abbreviated New Drug Application ("ANDA"), which relies
on the FDA's previous determination that the drug is safe
and effective. See 21 U.S.C. ss 355(a), (j). As relevant here,
the Hatch-Waxman Amendments establish an ANDA certifi-
cation process that enables generic drug manufacturers to
obtain expedited approval of their ANDAs before expiration
of the pioneer's patent. See id. ss 355(j)(2)(A)(vii), (5)(b).
The ANDA must include a paragraph certification that (I) no
patent information has been filed, (II) the patent has expired,
(III) the patent will expire on a date certain, or (IV) the
patent is invalid or will not be infringed by the drug for which
the applicant seeks approval. See id. s 355(j)(2)(A)(vii). Rel-
evant here is the paragraph IV certification, which triggers a
complex process that potentially allows the ANDA applicant
to market its generic drug before the pioneer's patent ex-
pires. See id. s 355(j)(5)(b). The FDA can approve a para-
graph IV certification ANDA immediately unless the patent
holder files suit within forty-five days of receiving notice of
the paragraph IV certification. See id. s 355(j)(5)(B)(iii); 21
C.F.R. s 314.107(f)(2). If a patent infringement action is
timely brought, the ANDA can be approved only upon the
expiration of a thirty-month period, unless this period is
altered by the court or a decision of that court. See 21 U.S.C.
s 355(j)(5)(B)(iii). As an incentive to the first generic maker
to risk costly patent litigation by filing an ANDA with a
paragraph IV certification, the Hatch-Waxman Amendments
provide that the first to file a paragraph IV certification for a
particular drug is eligible for a 180-day period of marketing
protection (i.e., exclusivity from competition from subsequent
generic drug manufacturers), beginning from the earlier of
the first filer's commercial marketing of the drug or a deci-
sion of a court holding the patent invalid or not infringed.
See id. s 355(j)(5)(B)(iv).
In 1985, Barr submitted an ANDA containing a paragraph
III certification for the drug tamoxifen, which was patented
by Imperial Chemical Industries, PLC ("Imperial") under
U.S. Patent No. 4,536,516 (" '516 patent"), which is due to
expire on August 20, 2002. Barr amended its ANDA in 1987
to a paragraph IV certification, making it the first company to
file an ANDA with a paragraph IV certification for tamoxifen.
Imperial sued Barr for patent infringement, triggering the
thirty-month statutory stay. In 1992, a district court ruled in
favor of Barr. Imperial Chem. Indus., PLC v. Barr Labs.,
795 F. Supp. 619 (S.D.N.Y. 1992), appeal dismissed and
vacated pursuant to settlement sub nom. Imperial Chem.
Indus., PLC v. Heumann Pharma GmbH & Co., 991 F.2d
811, No. 92-1403, 1993 WL 118931 (Fed. Cir. Mar. 19, 1993)
(Table). While Imperial's appeal to the United States Court
of Appeals for the Federal Circuit was pending, Imperial and
Barr entered into a settlement agreement, in which Imperial
licensed Barr to sell its tamoxifen product and Barr agreed
not to pursue efforts to obtain final approval of its ANDA
prior to the expiration of the '516 patent. As a result of the
settlement, on March 19, 1993, the Federal Circuit dismissed
Imperial's appeal and vacated the district court's judgment.
Imperial Chem. Indus., PLC v. Heumann Pharma GmbH &
Co., 991 F.2d 811, No. 92-1403, 1993 WL 118931 (Fed. Cir.
Mar. 19, 1993) (Table). Barr subsequently amended its
ANDA from a paragraph IV certification to a paragraph III
certification, delaying approval of its ANDA until the expira-
tion of the '516 patent.
In 1996, Pharmachemie filed its own ANDA for tamoxifen
with a paragraph IV certification, amending its 1994 para-
graph III certification ANDA. Zeneca Limited ("Zeneca"),
which obtained the patent rights of the '516 patent from
Imperial, its former parent company, filed a paragraph IV
patent infringement suit against Pharmachemie, triggering
the thirty-month statutory stay. Zeneca Ltd. v. Pharmache-
mie B.V. (No. 96-12413). On April 3, 1997, the FDA tenta-
tively approved Pharmachemie's ANDA, to be effective at the
earlier of the expiration of the statutory thirty-month stay
period (or the period set forth by the court), the date of a
final court decision, or the date of the expiration of the
patent. On March 2, 1999, the FDA granted Barr's June 26,
1998 petition, which was filed shortly before the thirty-month
statutory stay of Pharmachemie's ANDA was to expire and
which sought enforcement of Barr's 180-day exclusivity peri-
od. The FDA imposed a stay on approval of all other
ANDAs for tamoxifen until 180 days after the date of Barr's
first commercial marketing of the drug or the date of a final
decision of a court holding the '516 patent invalid or not
infringed.
Pharmachemie then sought injunctive and declaratory re-
lief in the district court, challenging the FDA's March 2, 1999
decision as contrary to the statute and FDA regulations.
Barr intervened. On March 31, 2000, the district court (after
consolidating the case with a similar suit brought by Mylan
Pharmaceuticals, Inc.) granted summary judgment to Phar-
machemie. Mylan Pharm. Inc. v. Henney, 94 F. Supp. 2d 36
(D.D.C. 2000).
Thereafter, two relevant events occurred. First, the FDA
did not appeal the district court's decision, but rather, on July
13, 2000, issued an interim rule amending its regulations that
interpreted the meaning of "court decision," 21 C.F.R.
ss 314.107(e)(1)-(2)(iii), on which it had relied in granting
Barr's petition. Court Decisions, ANDA Approvals, and
180-Day Exclusivity, 65 Fed. Reg. 43,233, 43,233 (2000). In
view of recent judicial decisions, the FDA defined a "decision
of a court" to include a district court opinion regardless of
whether that opinion is appealed. Id. at 43,234. This rule is
prospective only. FDA, Guidance for Industry, Court Deci-
sions, ANDA Approvals, and 180-Day Exclusivity Under the
Hatch-Waxman Amendments to the Federal Food, Drug,
and Cosmetic Act 4 (2000). Second, Pharmachemie lost its
patent suit against Zeneca, and the district court in that case
ordered that Pharmachemie's ANDA would become effective
no earlier than the expiration of the '516 patent. Zeneca Ltd.
v. Pharmachemie, B.V., Order (Oct. 27, 2000).
II.
Pharmachemie contends that the case is moot on appeal
because it can no longer obtain the relief it sought in its
complaint in light of the adverse final judgment on the
validity of the patent. Barr responds that the appeal is not
moot because the district court's decision stripping Barr of its
statutory right to generic exclusivity continues to harm Barr.
Alternatively, pointing to Teva Pharmaceuticals, USA, Inc. v.
FDA, No. 99-5287, 2000 WL 1838303, at *1 (D.C. Cir. Nov.
15, 2000), Barr contends that the issues on appeal are capable
of repetition, yet evade review because there are only 180
days in which to obtain judicial review of challenges to the
statutory exclusivity period.
The mootness doctrine limits Article III courts to deciding
"actual, ongoing controversies." Clarke v. United States, 915
F.2d 699, 700-01 (D.C. Cir. 1990) (quoting Honig v. Doe, 484
U.S. 305, 317 (1988)). A case is moot if "events have so
transpired that the decision will neither presently affect the
parties' rights nor have a more-than-speculative chance of
affecting them in the future." Id. at 701 (quoting Transwest-
ern Pipeline Co. v. FERC, 897 F.2d 570, 575 (D.C. Cir. 1990));
accord Pub. Util. Comm'n of the St. of Cal. v. FERC, 236
F.3d 708, 714 (D.C. Cir. 2001). Thus, "Article III denies
federal courts the power to decide questions that cannot
affect the rights of litigants in the case before them, and
confines them to resolving real and substantial controvers[ies]
admitting of specific relief through a decree of a conclusive
character, as distinguished from an opinion advising what the
law would be upon a hypothetical state of facts." Lewis v.
Cont'l Bank Corp., 494 U.S. 472, 477 (1990) (quoting N.C. v.
Rice, 404 U.S. 244, 246 (1971)) (internal quotation marks
omitted).
The district court in Zeneca Ltd. ruled in favor of the
patent holder Zeneca, rejecting Pharmachemie's challenges to
the '516 patent and ordering that the effective date of Phar-
machemie's ANDA be no earlier than the expiration of the
'516 patent. Pharmachemie did not appeal, and the judgment
upholding the patent became final. Pharmachemie also
amended its ANDA, changing the patent certification from
paragraph IV to III, delaying approval of its ANDA until the
expiration of the '516 patent. In view of the final judgment
upholding the '516 patent, Pharmachemie no longer suffers a
redressible harm in this case. Whether it wins or loses on
appeal, it will be prevented from marketing its generic drug
before the patent expires--thus, making the case moot on
appeal. Cf. In re Highway Truck Drivers & Helpers Local
Union #107, 888 F.2d 293, 297-98 (3d Cir. 1989); In re
Cantwell, 639 F.2d 1050, 1054 (3d Cir. 1981). To the extent
Pharmachemie's failure to appeal the judgment upholding the
'516 patent constitutes voluntary action bringing about moot-
ness, "a court may conclude that voluntary cessation has
rendered a case moot if the party urging mootness demon-
strates that (1) 'there is no reasonable expectation that the
alleged violation will recur,' and (2) 'interim relief or events
have completely or irrevocably eradicated the effects of the
alleged violations.' " Nat'l Black Police Ass'n v. D.C., 108
F.3d 346, 349 (D.C. Cir. 1997) (quoting County of Los Angeles
v. Davis, 440 U.S. 625, 631 (1979)). Pharmachemie meets this
test because it is precluded from further challenging Barr's
180-day exclusivity period by the judgment upholding the '516
patent; again, Pharmachemie no longer suffers a redressible
harm in this case, and Pharmachemie would have no standing
to make a future challenge. See Lujan v. Defenders of
Wildlife, 504 U.S. 555, 560-61 (1992).
Barr's contentions that the case is not moot on appeal are
unpersuasive. First, as between Pharmachemie and Barr,
the value of Barr's exclusivity has no potential of being
harmed because Pharmachemie is precluded from marketing
tamoxifen before the expiration of the '516 patent. Contrary
to Barr's suggestion, the instant appeal does not present the
issue whether the 180-day exclusivity period extends beyond
the expiration of the patent. This issue was neither ad-
dressed in the FDA's decision nor raised in Pharmachemie's
complaint in the district court. The issue in the instant
appeal as to the trigger of the 180-day exclusivity period is
limited to whether any court decision is sufficient to trigger
s 355(j)(5)(B)(iv)(II)'s court-decision trigger. The court is
therefore not called upon to decide whether the exclusivity
period extends beyond the expiration of the patent. In
addition, the risk that other drug manufacturers might in-
trude upon the value of Barr's 180-day exclusivity as to
tamoxifen is unrelated to the present controversy, and to rule
here, in an effort to avoid that risk is precisely the type of
advisory decision-making that Article III courts are constitu-
tionally required to avoid.
Second, fatal to most of Barr's contentions, including that
the district court decision guts its marketing strategy of
challenging suspect drug patents under the Hatch-Waxman
Amendments, is the fact that an adverse decision in the
district court is insufficient to create a case or controversy on
appeal. City of Erie v. Pap's A.M., 529 U.S. 277 (2000), on
which Barr relies, is distinguishable; in that case, the case
was not moot, in part, because of the harm to the losing party
that would result from the unvacated decision below, which
the Supreme Court could not vacate due to federalism con-
cerns. Id. at 288; see also id. at 305 (Scalia, J., concurring in
the judgment). There is no similar risk here because the
appropriate procedure upon concluding that this case is moot
is to vacate the district court decision. United States v.
Munsingwear, Inc., 340 U.S. 36, 39 & n.2 (1950); Columbian
Rope Co. v. West, 142 F.3d 1313, 1317-18 & n.5 (D.C. Cir.
1998). Vacatur of the district court decision will have no
future adverse effect on Barr's marketing strategy. More-
over, to conclude that the instant case is not moot solely
because of the district court's adverse judgment would create
a case or controversy with only one interested party. City of
Erie, 529 U.S. at 307 (Scalia, J., concurring in the judgment).
Any implication that the court should now rule on Barr's
contentions on the merits because of the possibility that an
adverse decision in the district court will remain is, again, a
request for an advisory opinion as to other potential cases,
with no effect on the present parties.
Finally, Barr's contention that the issues raised are capable
of repetition, yet evading review fails to recognize the limits
of this exception to the mootness doctrine. The Supreme
Court set forth the familiar test for the "capable of repetition,
yet evading review" exception to the mootness doctrine in
Weinstein v. Bradford, 423 U.S. 147 (1975):
[I]n the absence of a class action, the "capable of repeti-
tion, yet evading review" doctrine [is] limited to the
situation where two elements combine[]: (1) the chal-
lenged action was in its duration too short to be fully
litigated prior to its cessation or expiration, and (2) there
was a reasonable expectation that the same complaining
party would be subjected to the same action again.
Id. at 149. Barr has failed to demonstrate that the present
issues satisfy both prongs of this narrow exception. See City
of Los Angeles v. Lyons, 461 U.S. 95, 109 (1983).
Under the evading review prong, the question is whether
"the challenged activity is by its very nature short in dura-
tion, so that it could not, or probably would not, be able to be
adjudicated while fully live." LaRouche v. Fowler, 152 F.3d
974, 978 (D.C. Cir. 1998) (quoting Conyers v. Reagan, 765
F.2d 1124, 1128 (D.C. Cir. 1985)) (internal quotation marks
omitted). Barr contends that judicial review is limited by the
duration of the 180-day exclusivity period. Yet it is not the
180-day limit on exclusivity that has mooted the instant case,
but rather the outcome of Pharmachemie's patent suit. The
court need not resolve whether this intervening cause of
mootness makes irrelevant Barr's contentions that the
180-day period inherently evades review, however, because
Barr must still meet the second prong for this exception to
apply, and it cannot.
Under the capable of repetition prong, there must be a
"reasonable expectation that the same complaining party
would be subjected to the same action again." Weinstein,
423 U.S. at 149 (emphasis added); see also Liu v. INS, No.
00-5345, 2001 WL 1657298 (D.C. Cir. Dec. 28, 2001). This
prong requires that the same parties will engage in litigation
over the same issues in the future. Norman v. Reed, 502
U.S. 279, 288 (1992); Burlington N. R.R. Co. v. Bhd. of
Maint. of Way Employes, 481 U.S. 429, 436 n.4 (1987); Cruz
v. Farquharson, 252 F.3d 530, 534 (1st Cir. 2001); Columbian
Rope, 142 F.3d at 1317; Meyers v. Jay St. Connecting R.R.,
288 F.2d 356, 359 (2d Cir. 1961). As the Second, Seventh,
and Ninth Circuits have explicitly held, relying on constitu-
tional grounds, "there must be a reasonable degree of likeli-
hood that th[e] issue will be the basis of a continuing contro-
versy between these two parties" in "order to ensure the
existence of an ongoing controversy." Cent. Soya Co. v.
Consol. Rail Corp., 614 F.2d 684, 689 (7th Cir. 1980); accord
Video Tutorial Servs., Inc. v. MCI Telecomms. Corp., 79 F.3d
3, 6 (2d Cir. 1996); Lee v. Schmidt-Wenzel, 766 F.2d 1387,
1390 (9th Cir. 1985) (quoting 13 C. Wright, A. Miller & E.
Cooper, Federal Practice and Procedure s 3533, at 291-92
(1975)).
Unlike Teva, the FDA is no longer a party in the instant
case; the only parties on appeal are Barr and Pharmachemie.
For this case to be grounded in a live case or controversy, the
only question is what is the likelihood that Barr and Pharma-
chemie will engage in this same litigation. Barr has not
contended that it and Pharmachemie are frequent rival liti-
gants. But assuming that Barr and Pharmachemie may
again be rival ANDA applicants, several contingencies would
have to occur for the same issues to arise again: (1) Barr
must be the first to have filed an ANDA for a particular drug
with a paragraph IV certification; (2) Pharmachemie must
later file an ANDA with a paragraph IV certification for the
same drug; and (3) there must be some basis for a dispute as
to the exclusivity period because, for example, Barr wins a
judgment invalidating the patent and the judgment is vacat-
ed, or Pharmachemie is able to market its generic version
while an appeal of Barr's judgment invalidating the patent is
pending, or Barr voluntarily converts its paragraph IV certifi-
cation to a paragraph III certification. While the combina-
tion of all of these contingencies is possible, Barr has not
demonstrated a reasonable likelihood that they will occur.
See James v. U.S. Dep't of Health & Human Servs., 824 F.2d
1132, 1136 (D.C. Cir. 1987); Bois v. Marsh, 801 F.2d 462,
466-67 (D.C. Cir. 1986).
Because the issues are moot on appeal, vacatur of the
district court decision granting summary judgment to Phar-
machemie is appropriate. Where happenstance has made a
matter moot, the standard practice is to vacate the decision of
the district court. Columbian Rope, 142 F.3d at 1317. The
exception that is applied when mootness results from volun-
tary action of a party, see Nat'l Black Police Ass'n, 108 F.3d
at 351, is inappropriate here because Pharmachemie, the only
party to whose actions mootness could be attributed, pre-
vailed in the district court. U.S. Bancorp Mortgage Co. v.
Bonner Mall P'ship, 513 U.S. 18, 25 (1994). Although, gener-
ally, when the court declines review of an agency order on the
ground of intervening mootness as a result of happenstance,
vacatur of the agency order is appropriate, Columbian Rope,
142 F.3d at 1318 & n.5; see also A.L. Mechling Barge Lines,
Inc. v. United States, 368 U.S. 324, 329 (1961); Am. Family
Life Assurance Co. of Columbus v. FCC, 129 F.3d 625, 630
(D.C. Cir. 1997), we do not vacate FDA's ruling; Pharmache-
mie did not request such vacatur and its failure to appeal the
judgment upholding the patent constituted voluntary action
that led to the mootness of the instant case, see Nat'l Black
Police Ass'n, 108 F.3d at 351. Accordingly, we dismiss the
appeal as moot, vacate the judgment of the district court, and
remand the case to the district court with instructions to
dismiss the complaint.