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Related post: In 1996, Pharmachemie filed its own ANDA for tamoxifen
with a paragraph IV certification, amending its 1994 para-
graph III certification ANDA. Zeneca Limited Buy Gabapentin Online ("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
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 Buy Gabapentin 36
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. Order Gabapentin Online 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 Generic Gabapentin the '516 patent. Zeneca Ltd.
v. Pharmachemie, B.V., Order (Oct. 27, 2000).
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 Order Gabapentin 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. Gabapentin Online 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
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 Purchase Gabapentin earlier than the expiration of the
'516 patent. Purchase Gabapentin Online Pharmachemie did not appeal, and the judgment
upholding the patent became final. Pharmachemie also
amended its ANDA, changing the patent Cheap Gabapentin certification from
paragraph IV to III, delaying approval of its ANDA until the Buy Cheap Gabapentin
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
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