Meijer, Inc. v. Biovail Corp.

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued September 7, 2007 Decided July 25, 2008

No. 05-7066

MEIJER, INC.,
ON THEIR OWN BEHALF AND ON BEHALF OF ALL OTHERS
SIMILARLY SITUATED AND
MEIJER DISTRIBUTION, INC., ON THEIR OWN BEHALF AND ON
BEHALF OF ALL OTHERS SIMILARLY SITUATED,
APPELLANTS

v.

BIOVAIL CORPORATION,
APPELLEE

Consolidated with
05-7069, 05-7084, 06-7118

Appeals from the United States District Court
for the District of Columbia
(No. 01cv02197)
(No. 03cv02075)
(No. 04cv00799)
(No. 04cv02235)

Bruce E. Gerstein argued the cause for appellants. With
him on the briefs were Kevin S. Landau, Anne Fornecker,
 2

Richard J. Kilsheimer, Robert F. Muse, David Fierst, David
Wallace Stanley, Erin Cathleen Burns, Joseph M. Vanek, and
Jeffrey J. Corrigan. Scott L. Adkins entered an appearance.

Steven Edward Obus argued the cause for appellees. With
him on the brief were Ronald S. Rauchberg, Stefanie S. Kraus,
Peter J. Venaglia, and Andrew Kanter. Mark J. Biros entered an
appearance.

Before: GINSBURG, ROGERS, and KAVANAUGH, Circuit
Judges.

Opinion for the Court filed by Circuit Judge GINSBURG.

GINSBURG, Circuit Judge: The plaintiff-appellants in these
four antitrust class actions are wholesale purchasers of Tiazac
(extended-release Diltiazem Hydrochloride, hereinafter
Diltiazem HCl), a controlled-release drug for hypertension and
angina. They alleged that Biovail Corporation, which
manufactures Tiazac, misused a patent to keep off the market a
generic equivalent manufactured by Andrx Pharmaceuticals,
Inc., in violation of federal and state antitrust laws. The district
court entered summary judgment for Biovail, which we affirm.

I. Background

The would-be manufacturer of a “generic” bioequivalent to
a previously approved “branded” drug may file an abbreviated
new drug application (ANDA) with the Food and Drug
Administration while the branded drug is purportedly protected
by a patent.* See generally 21 U.S.C. § 355(j); 21 C.F.R.
§ 314.94; Ranbaxy Labs. Ltd. v. Leavitt, 469 F.3d 120 (D.C. Cir.

*
The FDA maintains in its Orange Book a list of the patents
that, according to the manufacturer, protect each branded drug.
 3

2006). In its ANDA the applicant may certify under Paragraph
IV of the governing section of the Food, Drug, and Cosmetic
Act either that the patent is invalid or that the generic drug
would not infringe it. 21 U.S.C. § 355(j)(2)(A)(vii)(IV); see
also 21 C.F.R. § 314.94(a)(12).* The FDA may tentatively
approve an ANDA with such a certification, but that approval
does not become “effective” (i.e., final) for 45 days; if within
that time the manufacturer of the branded drug brings an action
for infringement of its patent, then the effective date of the
approval is stayed for 30 months from the date of the Paragraph
IV certification or until the patent case is resolved, whichever
occurs first. 21 U.S.C. § 355(j)(4), (j)(5)(B)(iii); see also 21
C.F.R. §§ 314.105(d), 314.107(b).

Tentative approval of an ANDA does not entail the right to
market the subject drug. See §§ 314.105(d), 314.107(b)(3)(v)
(“Tentative approval of an application does not constitute
‘approval’” under FDCA “and cannot, absent a final approval
letter from the agency, result in an effective approval”). Nor
does it guarantee final approval, which may depend upon an
“additional review of the application” by the FDA. 21 U.S.C.
§ 355(j)(5)(B)(iv)(II)(dd)(BB); see also 21 C.F.R.
§ 314.107(b)(3).

In June 1998 Andrx filed an ANDA seeking approval to
market Diltiazem HCl under the name Taztia; Andrx included
a Paragraph IV certification both challenging the validity of
Biovail’s U.S. Patent No. 5,529,791 (filed Sept. 23, 1994) (the
’791 patent), which Biovail claimed protected the formula for
Tiazac, and asserting Taztia would not infringe that patent.

*
The FDA may not approve an application that does not
account for a claimed patent, see 21 U.S.C. § 355(j)(2)(A)(vii),
(j)(4)(J), or that “contains an untrue statement of material fact,”
§ 355(j)(4)(K).
 4

Biovail sued Andrx in federal district court in Florida, thereby
extending the statutory stay for up to 30 months. In March
2000, the district court determined Andrx’s product would not
infringe Biovail’s patent, Biovail Corp. v. Andrx Pharms., Inc.,
158 F. Supp. 2d 1318 (S.D. Fla.), whereupon Biovail appealed
to the Federal Circuit.

In September 2000 the FDA “tentative[ly]” approved
Andrx’s ANDA, noting that Biovail’s pending appeal prevented
it from giving final approval at that time.* The agency went on
to explain that, if and when Andrx prevailed on appeal, the FDA
would have to be “assured there is no new information that
would affect whether final approval should be granted.”

On January 8, 2001, with its appeal still pending, Biovail
claimed its newly acquired U.S. Patent No. 6,162,463 (filed Apr.
28, 1998) (the ’463 patent) also protected Tiazac, and the FDA
asked Andrx for its position with regard to that patent. On
February 13 the Federal Circuit affirmed the judgment for
Andrx in the ’791 patent litigation, 239 F.3d 1297, thereby
terminating the statutory stay. Three days later, Andrx filed a
Paragraph IV declaration challenging the ’463 patent, thereby

*
The statute provides that the stay terminates when “the court”
determines the patent at issue is invalid or would not be infringed. 21
U.S.C. § 355(j)(5)(B)(iii). The FDA at that time took the position that
the stay would expire only upon the resolution of any appeal. After
Torpharm v. Shalala, No. Civ.A. 97-1925, 1997 WL 33472411
(D.D.C. Sept. 15, 1997), and Mylan Pharmaceuticals v. Shalala, 81 F.
Supp. 2d 30 (D.D.C. 2000), were decided, however, the FDA adopted
the district court’s view that the judgment of a district court in favor
of the generic applicant terminates the stay. FDA, Guidance for
Industry (Mar. 2000), available at http://www.fda.gov/cder/guidance/
3659fnl.pdf. The FDA amended 21 C.F.R. § 314.107 accordingly, 65
Fed. Reg. 43,233 (July 13, 2000), but did not apply the rule to
ANDAs, such as Andrx’s, then pending, id. at 43,234-35.
 5

triggering a new 45-day stay, which Biovail extended by suing
Andrx anew in Florida. Meanwhile, Andrx had filed its own
action against Biovail and the FDA in the same district court,
challenging as baseless Biovail’s claim that the ’463 patent
covered Tiazac and seeking an injunction requiring the FDA to
remove the ’463 patent from the Orange Book. See Andrx
Pharms., Inc. v. Biovail Corp., 175 F. Supp. 2d 1362 (S.D. Fla.
2001), vacated, 276 F.3d 1368 (Fed. Cir. 2002). On May 14,
2001, while these suits were pending, the FDA tentatively
approved Andrx’s ANDA a second time. In April 2002, Biovail
withdrew its claim the ’463 patent covered Tiazac.

Meanwhile, Andrx had begun to encounter problems
manufacturing its version of Diltiazem HCl. In December 2000,
shortly after having received tentative approval from the FDA,
Andrx identified problems in its methodology for testing Taztia
for dissolution in the human body. In January 2001 Andrx
manufactured a new batch of the drug, which it initially found
satisfactory pursuant to a new testing methodology, but on May
18, 2001 the Company discovered that samples from the new
batch also failed to dissolve as required. Andrx eventually
rejected that entire batch because the manufacturing process was
faulty, and continued to encounter manufacturing problems into
2003. Because of those problems, the FDA did not finally
approve Andrx’s ANDA until April 2003 -- a full year after
Biovail had withdrawn its claim that the ’463 patent covered its
drug.

Much as Andrx had done in its suit against Biovail, see 175
F. Supp. 2d 1362, the plaintiffs in these four class actions
alleged in the district court that Biovail unlawfully forestalled
the FDA’s final approval of Andrx’s ANDA by filing with the
FDA documents claiming falsely and in bad faith that the ’463
patent covered Tiazac, and by engaging in bad faith or “sham”
litigation over that patent. According to the plaintiffs, Biovail
 6

thus unlawfully excluded Andrx from “the market for Tiazac
and its generic equivalents,” in violation of federal and state
antitrust laws,* see United States v. Microsoft Corp., 253 F.3d
34, 58 (D.C. Cir. 2001) (en banc) (“Whether any particular act
of a monopolist is exclusionary, rather than merely a form of
vigorous competition, can be difficult to discern: the means of
illicit exclusion, like the means of legitimate competition, are
myriad”); see also City of Columbia v. Omni Outdoor Adver.,
Inc., 499 U.S. 365, 379-80 (1991) (“The federal antitrust laws”
exempt “the conduct of private individuals in seeking
anticompetitive action from the government,” but they do reach
“sham[s],” as when “persons use the governmental process -- as
opposed to the outcome of that process -- as an anticompetitive
weapon”). But for Biovail’s exclusionary conduct, the plaintiffs
claim, the FDA would have finally approved Andrx’s ANDA on
or about February 13, 2001, when the Federal Circuit ruled
against Biovail in the ’791 patent litigation; the plaintiffs could
have begun soon thereafter purchasing Taztia from Andrx at a
lower price than they had to pay Biovail for Tiazac.

Biovail moved for summary judgment in two of the four
present class actions on the ground that, regardless whether
Biovail had violated the antitrust laws, the plaintiffs could not
show Biovail had caused them any harm. The district court
agreed, Twin Cities Bakery Workers Health & Welfare Fund v.
Biovail Corp., Nos. Civ.A. 01-2197, Civ.A. 03-2075, 2005 WL
3675999 (Mar. 31, 2005), and subsequently entered judgment
for Biovail in a third case, SAJ Distribs., Inc. v. Biovail Corp.,
No. Civ.A. 04-799 (May 25, 2005), which it found
indistinguishable.

Seeking to avoid the same fate, the plaintiffs in the fourth
action, Louisiana Wholesale Drug Co. (LWD) v. Biovail Corp.,

*
Plaintiffs make no argument specific to the law of any state.
 7

No. Civ.A. 04-2235, amended their complaint to allege that, but
for Biovail’s wrongful use of the ’463 patent, they could have
purchased generic drugs manufactured and sold either by Andrx
or by Biovail itself. According to their amended complaint,
Biovail and its exclusive distributor, Forest Laboratories Inc. --
which was a defendant in the original action but not the subject
of any allegation of wrongdoing -- had conspired to distribute a
generic version of Tiazac before Andrx and other manufacturers
could get to market, but abandoned that plan in favor of using
the ’463 patent to forestall final approval of Andrx’s ANDA;
they cite no overt act in furtherance of this conspiracy after
Biovail dropped its claim the ’463 patent protected Tiazac. The
LWD plaintiffs also sought further discovery pursuant to Federal
Rule of Civil Procedure 56(e). See also FED. R. CIV. P. 56(f)
(2007).

Applying its Twin Cities ruling to LWD without addressing
the Rule 56(e) affidavit, the district court entered summary
judgment for the defendants insofar as the LWD plaintiffs
claimed the defendants had prevented the plaintiffs from
purchasing Taztia from Andrx; the court held that no reasonable
juror could find Biovail’s use of the ’463 patent prevented the
FDA’s final approval of Andrx’s ANDA. 437 F. Supp. 2d 79,
82-84 (2006). The court then entered judgment for the
defendants insofar as the LWD plaintiffs advanced in their
amended complaint their new theory that they could have
purchased generic Diltiazem HCl from the defendants but for
Biovail’s misuse of the ’463 patent; the court reasoned that the
amendment did not relate back to the filing of the original
complaint and was thus time-barred. Id. at 85-87.

II. Analysis

The plaintiffs in all four class actions appeal, contending
they proffered evidence sufficient to defeat Biovail’s motion for
 8

summary judgment. In addition, the LWD plaintiffs argue the
district court improperly dismissed the amendment to their
complaint as untimely and erroneously failed to address their
affidavit seeking further discovery under Rule 56(e).

A. Inability to Purchase Taztia from Andrx (Original Theory)

A plaintiff seeking damages under the antitrust laws must
prove the defendant has caused the plaintiff “antitrust injury,”
meaning an “injury of the type the antitrust laws were intended
to prevent and that flows from that which makes defendants’
acts unlawful.” Brunswick Corp. v. Pueblo Bowl-O-Mat, Inc.,
429 U.S. 477, 489 (1977) (emphasis omitted); see also Andrx
Pharms., Inc. v. Biovail Corp. Int’l, 256 F.3d 799, 806 (D.C.
Cir. 2001); 2 PHILIP E. AREEDA & HEBERT HOVENKAMP,
ANTITRUST LAW ¶¶ 337, 338 (3d ed. 2007). Just as a would-be
entrant suing an incumbent firm for excluding it from a relevant
market in violation of the Sherman Act must demonstrate it
intended and was prepared to enter that market, Zenith Radio
Corp. v. Hazeltine Research, Inc., 395 U.S. 100, 126-29 (1969);
2 AREEDA & HOVENKAMP, supra, ¶ 349, so a would-be
purchaser suing an incumbent monopolist for excluding a
potential competitor from which it might have bought a product
at a lower price must prove the excluded firm was willing and
able to supply it but for the incumbent firm’s exclusionary
conduct, see Atl. Richfield Co. v. USA Petroleum Co., 495 U.S.
328, 334 (1990) (injury must be “attributable to an anti-
competitive aspect of the practice under scrutiny”). Here, that
means the plaintiffs must prove Andrx was prepared to sell
Taztia and could have obtained approval from the FDA to do so
at some point between February 2001, when the ’791 patent no
longer barred the FDA’s final approval, and April 2002, when
Biovail withdrew its claim that the ’463 patent protected Tiazac.
See Twin Cities, 2005 WL 3675999, at *5 n.2; see also Zenith
 9

Radio Corp., 395 U.S. at 126; Andrx Pharms., 256 F.3d. at 806-
07.

Biovail argues, and the district court held, no reasonable
juror could conclude Biovail caused the plaintiffs any harm.
The plaintiffs submit they presented evidence sufficient for a
reasonable juror to find that but for Biovail’s conduct, the FDA
would have granted Andrx final approval in February 2001 and
that Andrx would have marketed Taztia soon thereafter.*
Reviewing the summary judgment de novo, Galvin v. Eli Lilly
& Co., 488 F.3d 1026, 1031 (D.C. Cir. 2007), we hold no
reasonable juror could conclude that, but for Biovail’s alleged
misuse of the ’463 patent, the FDA would have granted Andrx
final approval in February 2001. Accordingly, we affirm the
judgment of the district court without reaching Biovail’s
alternative argument that the plaintiffs could not show Andrx
was ever prepared to manufacture a safe drug.** See Fed. R.

*
In principle, the plaintiffs could establish antitrust injury by
showing that, but for Biovail’s misuse of the ’463 patent, they could
have purchased generic Diltiazem HCl from Andrx at any time during
the pendency of the stay caused by the ’463 patent. The plaintiffs,
however, have not argued that Andrx would have obtained approval
from the FDA and been ready to market the drug at any time after
February 2001 but before the expiration of the statutory stay -- a wise
strategy in view of the problems Andrx encountered trying to
manufacture Taztia during that period. Therefore, it is crucial to the
plaintiffs’ case, as counsel acknowledged at oral argument, that they
make the showing stated in the text.
**
Not all the plaintiffs invoked all the evidence upon which they
all now rely; because we find the totality of competent evidence
insufficient to defeat the defendants’ motion for summary judgment,
however, we need not concern ourselves with the effort of certain of
the plaintiffs to rely on appeal upon evidence they did not adduce
before the district court.
 10

Civ. P. 56(c) (district court must enter summary judgment when
“there is no genuine issue as to any material fact and ... the
movant is entitled to judgment as a matter of law”).

In arguing that a reasonable juror could find the FDA would
have approved Andrx’s ANDA in February 2001 but for
misconduct by Biovail, the plaintiffs first point to the affidavits
of Dr. Nicholas Fleischer and Mr. Jeffrey Gibbs, each of whom
had once worked for the FDA. The district court, invoking
Federal Rules of Evidence 702 (admissibility of expert
testimony) and 403 (exclusion of otherwise admissible evidence
on ground of unfair prejudice), excluded those affidavits
because they were speculative and ungrounded in fact and, in
any event, “their value is substantially outweighed by the danger
of unfair prejudice or misleading the jury.” See 2005 WL
3675999 at *4-*5. The plaintiffs challenge the district court’s
reliance upon Rule 702 but not upon Rule 403. In keeping with
good sense and our established practice, we will not disturb the
ruling of a district court where, as here, an independent basis for
that ruling is uncontested. N.Y. Rehab. Care Mgmt., LLC v.
NLRB, 506 F.3d 1070, 1076 (D.C. Cir. 2007); Veitch v. England,
471 F.3d 124, 132 (D.C. Cir. 2006).

The plaintiffs next direct us to decisions of courts they
claim determined, in litigation involving Andrx, Biovail, and the
FDA, that the agency would have finally approved Andrx’s
ANDA in February 2001 but for Biovail’s misuse of the ’463
patent, see Andrx Pharms., Inc. v. Biovail Corp. Int’l, No. 01-
6194-Civ (S.D. Fla. Mar. 6, 2001); Andrx Pharms., Inc., 175 F.
Supp. 2d at 1365-66; Andrx Pharms., Inc., 276 F.3d at 1372 &
n.2. As the district court pointed out in the present case,
however, none of those decisions made “a finding of disputed
fact,” 437 F. Supp. 2d at 83-84, and none determined whether a
reasonable juror could conclude the FDA would have granted
final approval in February 2001. Although the likely timing of
 11

the FDA’s final approval was placed at issue in the Southern
District of Florida when Andrx sought a preliminary injunction
-- thus requiring it to prove irreparable harm -- that court did not
reach the issue because it determined that it lacked subject
matter jurisdiction. Andrx Pharms., No. 01-6194-Civ, slip op.
at 18-19. Neither did that court in its decision of September
2001, which addressed various motions to dismiss and for
summary judgment, decide when the FDA would have granted
final approval of Andrx’s ANDA. See 175 F. Supp. 2d 1362.
Instead, in its recitation of the facts the court assumed, as did the
Federal Circuit on appeal, see 276 F.3d at 1372 & n.2, that
because the FDA had given its initial approval in September
2000 it would have given its final approval as soon as the
statutory bar was lifted in February 2001, 175 F. Supp. 2d at
1365-66. The likely timing of the FDA’s approval was not a
disputed issue of fact before either court.

Of the evidence upon which the plaintiffs rely in their brief
to this court, we accordingly confine our analysis to the FDA’s
tentative approval in September 2000, a February 2001 fax from
the FDA to Andrx, the FDA’s filings in the case Andrx brought
to compel the agency to withdraw the ’463 patent from the
Orange Book, and the affidavit of an Andrx employee.* Upon

*
In addition to the evidence described in the text, the plaintiffs
refer in their brief to the FDA’s “conclu[sion] in writing ... that
[Andrx’s] generic drug would be approved, but for the ... infringement
suit.” No such conclusion is to be found in the record of this case,
however, and the plaintiffs do not provide the statement itself but
instead quote the opinion in Andrx Pharmaceuticals, Inc., 175 F.
Supp. 2d at 1366. We disregard that purported “evidence”; if the
underlying evidence exists and is in the record of the cited case, then
the plaintiffs, who have access to that record, should have produced
it. Cf. Cmty. Hosps. of Cent. Cal. v. NLRB, 335 F.3d 1079, 1086-87
(D.C. Cir. 2003) (presumption may arise from failure to produce
evidence to which party has access) (citing United States v. Young,
 12

the basis of this evidence, we hold no reasonable juror could
conclude that but for Biovail’s misuse of the ’463 patent the
FDA would have approved Andrx’s ANDA in February 2001.

The plaintiffs maintain the tentative approval of September
2000 demonstrates that, apart from the ’463 patent, the only
hurdle to final approval was resolution of the ’791 patent
dispute. That first tentative approval made clear, however, that
final approval was also subject to the FDA being “assured there
is no new information that would affect whether final approval
should be granted.” For that reason, the FDA instructed the
applicant, “when you believe that your application may be
considered for final approval,” file “[u]pdated information
related to labeling or chemistry, manufacturing and controls
data, or any other change in the conditions outlined in th[e]
abbreviated application.” A reasonable juror would not infer
upon the basis of this letter that final approval would have been
forthcoming in February 2001.

As Biovail points out, the FDA’s second tentative approval,
issued in May 2001, further undermines the plaintiffs’ treatment
of the September 2000 tentative approval as tantamount to final
approval subject only to the lifting of the statutory stay. The
plaintiffs belittle the May 2001 approval as “simply a
reaffirmance of the September 2000 approval,” but the record
contradicts that contention. The FDA’s letter of May 14, 2001
referred not only to the September 2000 tentative approval but
also to several amendments to Andrx’s ANDA that postdated
the decision of the Federal Circuit in the ’791 patent dispute;
had the FDA meant merely to “reaffirm” its previous tentative

463 F.2d 934, 939 (D.C. Cir. 1972)).
 13

approval, it could easily have said so.* At best the second
tentative approval suggests the FDA could have given final
approval of Andrx’s ANDA in May, not February, 2001.

Nor is the FDA’s fax of February 2, 2001 helpful to the
plaintiffs. It states only that a division of the FDA “ha[d]
completed its review” of the December 2000 amendment
(relating to Andrx’s testing methodology) and “ha[d] no further
questions at this time,” and even that explicitly “preliminary”
observation was made “subject to revision after review of the
entire application.” In the same fax the FDA also asked Andrx
to “provide a ... certification” as to the ’463 patent, but the FDA
nowhere suggested the agency would approve Andrx’s ANDA
when Biovail’s patents were no longer a bar.

The plaintiffs also point out that in the litigation Andrx
brought against Biovail and the agency, “FDA briefing
demonstrat[es] that because [Biovail] listed the ’463 Patent,
Andrx’s ANDA was no longer eligible for final FDA approval
in February 2001.” Relatedly, the plaintiffs note that when
Andrx filed a statement of undisputed facts in that litigation --
to the effect that only litigation over the ’791 patent prevented
the FDA’s final approval -- the FDA responded that the ’463
patent also barred final approval. These documents are
unhelpful, however, because they demonstrate only that ending
the patent litigation was a necessary condition for the FDA’s

*
The plaintiffs assert in a footnote in their reply brief that the
various amendments were minor matters (relating to product labeling)
that would not have prevented final approval in February 2001, but
that assertion is as conclusory as it is untimely. See United States v.
Whren, 111 F.3d 956, 958 (D.C. Cir. 1997) (“absent extraordinary
circumstances (not present here) we do not entertain an argument
raised for the first time in a reply brief or for that matter, in a footnote”
(citations omitted)).
 14

final approval; a reasonable juror could not infer from them that
it was a sufficient condition. In keeping with applicable law, 21
C.F.R. § 314.107(b); 21 U.S.C. § 355(j)(5)(B)(iii),
(j)(5)(B)(iv)(II)(dd)(BB), the FDA’s brief stated only that upon
the termination of the litigation Andrx would be “eligible for,”
not that it would be “entitled to,” final approval. Similarly, the
FDA’s response to Andrx’s statement of undisputed facts does
not imply it would have granted final approval but for Biovail’s
misuse of the second patent. Nor could it have: The FDA’s
final approval was by law subject to Andrx updating its
application to the satisfaction of the FDA once the statutory bar
was lifted.

The plaintiffs finally rely upon the February 9, 2001
affidavit of Scott Lodin, then the General Counsel of Andrx.
When Andrx sought to compel the FDA to remove the ’463
patent from the Orange Book, Lodin filed an affidavit stating
“the FDA had informed Andrx that it was prepared to grant final
approval to Andrx’s ANDA upon the expiration of the 30-month
stay period” triggered by Biovail’s first patent infringement
case. The Lodin affidavit, however, cites only the tentative
approval of September 2000, which we have already determined
is an insufficient basis for a reasonable juror to find the FDA
would have granted final approval in February 2001; beyond
that it is merely conclusory. Cf. Greene v. Dalton, 164 F.3d
671, 675 (D.C. Cir. 1999) (“Although, as a rule, statements
made by the party opposing a motion for summary judgment
must be accepted as true for the purpose of ruling on that
motion, some statements are so conclusory as to come within an
exception to that rule”); see also Ginger v District of Columbia,
527 F.3d 1340, 1346-47 (D.C. Cir. 2008). Nor could Lodin
know how the FDA would react to any update Andrx would file
in order to obtain final approval.
 15

We conclude the plaintiffs have not adduced evidence
sufficient for a reasonable juror to find the FDA would have
approved Andrx’s ANDA in February 2001 but for Biovail’s
claim the ’463 patent covered Tiazac and Biovail’s subsequent
suit for infringement of that patent. The plaintiffs’ original
theory of the case, in which they blamed Biovail for their
inability to purchase Taztia from Andrx, turned upon the jury
being able to make that finding. Accordingly, we affirm the
entry of summary judgment in favor of the defendants in all four
cases inasmuch as the plaintiffs blame Biovail for their inability
to purchase Taztia from Andrx.

B. Inability to Purchase Generic Diltiazem HCl from Biovail
(Amended Complaint)

The LWD plaintiffs alleged in their amended complaint that
Biovail and Forest conspired preemptively to manufacture and
distribute their own generic version of Diltiazem HCl while the
’791 patent litigation precluded competitors from entering the
market, a scheme they abandoned in late 2000 or early 2001 in
favor of misusing the ’463 patent to exclude potential
competitors.* The defendants argue, and the district court held,
the complaint does not relate back and does not allege facts
sufficient to establish a claim of injury within the limitation
period. Reviewing the court’s dismissal de novo, while
“assum[ing] ‘all the allegations in the complaint are true (even
if doubtful in fact),’” Aktieselskabet AF 21. November 2001 v.
Fame Jeans Inc., 525 F.3d 8, 17 (D.C. Cir. 2008) (quoting Bell
Atl. Corp. v. Twombly, 127 S. Ct. 1955, 1965 (2007)), and
“giv[ing] the plaintiff ‘the benefit of all reasonable inferences

*
The plaintiffs do not allege the defendants engaged in any
misconduct after April 2002, when Biovail dropped its claim that the
’463 patent protected Tiazac.
 16

derived from the facts alleged,’” id. (quoting Stewart v. Nat’l
Educ. Ass’n, 471 F.3d 169, 173 (D.C. Cir. 2006)), we affirm.

(1) Relation Back

Federal Rule of Civil Procedure 15(c)(1)(B) provides: “An
amendment ... relates back to the date of the original pleading
when ... the amendment asserts a claim ... that arose out of the
conduct, transaction, or occurrence set out -- or attempted to be
set out -- in the original pleading.” See also Fed. R. Civ. P.
15(c)(2) (2007). The underlying question is whether the original
complaint adequately notified the defendants of the basis for
liability the plaintiffs would later advance in the amended
complaint. United States v. Hicks, 283 F.3d 380, 388 (D.C. Cir.
2002); 6A CHARLES ALAN WRIGHT, ARTHUR R. MILLER, &
MARY KAY KANE, FEDERAL PRACTICE & PROCEDURE § 1497
(“if the alteration of the original statement is so substantial that
it cannot be said that defendant was given adequate notice of the
conduct, transaction, or occurrence that forms the basis of the
claim ... then the amendment will not relate back”); see also
Aktieselskabet, 525 F.3d at 16 (complaint must “give a
defendant ‘fair notice of the claims against him’” (quoting
Ciralsky v. CIA, 355 F.3d 661, 668-70 (D.C. Cir. 2004)). The
defendants argue, and we agree, that the original complaint in
this case does not give that notice and therefore does not, as
amended, relate back.

The LWD plaintiffs alleged for the first time in the amended
complaint that Biovail and Forest had conspired to exclude new
entrants into the market for generic Diltiazem HCl and (before
Biovail acquired the ’463 patent) had planned preemptively to
capture that market by launching their own generic drug. For
prior notice, they point out that their original complaint referred
to their inability to purchase “generic versions of Tiazac,” i.e.,
in the plural, and contend the amendment “simply add[ed] detail
 17

regarding which generic versions [of Diltiazem HCl] would have
been marketed but for Defendants’ scheme.”

As we read their original complaint, however, it did not put
Biovail and Forest sufficiently on notice the plaintiffs might be
claiming the defendants’ decision not to sell their own generic
Diltiazem HCl violated the antitrust laws. The original
complaint chronicles the tale of a single firm, Biovail, bent upon
preventing the FDA from granting final approval of the generic
drug proposed by Andrx (and perhaps others), but it did not
allege Forest had engaged in any specific misconduct; Forest
was made a defendant solely because, as Biovail’s exclusive
distributor, it “benefitted from [Biovail’s] wrongful conduct to
extend the Tiazac monopoly” unlawfully. The amended
complaint alleges for the first time that Biovail and Forest
unlawfully conspired to extend their lawful monopoly, that they
planned preemptively to introduce their own generic Diltiazem
HCl, and that they unlawfully abandoned that plan in favor of
misusing the ’463 patent to prevent the FDA from approving the
applications of their would-be generic competitors. Although
the original and amended claims have some elements and some
facts in common, the whole thrust of the amendments is to fault
both Biovail and Forest, and to fault them for conduct different
from that identified in the original complaint. Consequently, the
amended complaint does not relate back.

(2) Adequacy of the Amendment to the Complaint

The LWD plaintiffs filed their amended complaint on June
1, 2005; because that complaint does not relate back to the filing
of the original complaint, the LWD plaintiffs, who claim the
defendants violated § 2 of the Sherman Act, 15 U.S.C. § 2, must
allege the defendants injured them during the four year period
starting June 1, 2001, or state facts sufficient reasonably to give
rise to an inference of such an injury. See § 4B of the Clayton
 18

Act, 15 U.S.C. § 15b (providing any suit for damages under the
federal antitrust laws “shall be forever barred unless commenced
within four years after the cause of action accrued”); see also
Twombly, 127 S. Ct. at 1966; Aktieselskabet, 525 F.3d at 17.

On appeal the LWD plaintiffs argue that, but for Biovail’s
acquisition of the ’463 patent, Biovail and Forest in February
2001 would have entered into long-term contracts to sell to
wholesalers, including the plaintiffs, generic Diltiazem HCl
beyond June 1, 2001 and the plaintiffs were injured because they
were unable to purchase generic drugs from the defendants
pursuant to those hypothetical contracts. They made no similar
allegation, however, in the amended complaint, their opposition
to Biovail’s motion to dismiss, or their request under Rule 56(e)
for further discovery. At oral argument, counsel for the LWD
plaintiffs was unable to say when, if ever, they made this
argument in the district court and as far as we can tell they never
did. Absent a showing that “‘injustice might otherwise result,’”
and the plaintiffs offer none, we do not entertain an argument
made for the first time on appeal. Ben-Kotel v. Howard Univ.,
319 F.3d 532, 535 (D.C. Cir. 2003).

As the defendants argue, without the allegation that Biovail
and Forest would have entered into long-term contracts to sell
wholesalers generic Diltiazem HCl, the LWD plaintiffs have no
basis upon which to claim that, but for Biovail’s acquisition of
the ’463 patent, the defendants would have sold them generic
Diltiazem HCl after June 1, 2001. Because, as we have held, the
LWD plaintiffs cannot show Andrx would have sold Diltiazem
HCl prior to May 2003, when Andrx received final approval and
long after they allege either defendant had engaged in any
misconduct, it follows that the defendants would have faced no
 19

competition until then.* There is no provision of law that would
have required Biovail and Forest to sell or continue selling a
generic version of Diltiazem HCl in competition with Biovail’s
branded product once it became clear, as it would have done in
early 2001, that Andrx could not get FDA approval to enter the
market. Nor does the complaint advance any fact suggesting
Biovail and Forest would have done so. (The plaintiffs do not
argue on appeal that any firm other than Andrx sought to enter
the market.) These gaps are fatal to the plaintiffs’ case.

In sum, the factual allegations of the LWD plaintiffs’
amended complaint, taken as true, are inadequate to make out a
timely action under the antitrust laws. Therefore, we affirm the
dismissal of the amended complaint.

C. The Rule 56(e) Affidavit

Finally, we turn to the LWD plaintiffs’ objection to the
failure of the district court to address their Rule 56(e) affidavit
before entering judgment. The LWD plaintiffs sought to
discover from Andrx any communications between it and the
FDA tending to show the FDA would have given final approval
of Andrx’s ANDA in February 2001. They also sought to
discover from Andrx information regarding what it would have

*
Rule 12(b)(6) requires us to assume the truth of the facts
alleged in the complaint but not to disregard our own holding that the
plaintiffs cannot show Andrx would have competed with Biovail but
for the latter company’s misconduct. Cf. 5B WRIGHT, MILLER &
KANE, supra, § 1357 (“Numerous cases ... have allowed consideration
of matters incorporated by reference or integral to the claim, items
subject to judicial notice, matters of public record, orders, items
appearing in the record of the case, and exhibits attached to the
complaint whose authenticity is unquestioned; these items may be
considered by the district judge without converting the motion into
one for summary judgment”).
 20

done had it obtained final approval from the FDA in February
2001 but subsequently discovered problems manufacturing the
drug, and from Biovail and Forest information relating to their
alleged plan preemptively to sell a generic version of Tiazac.

If the district court’s inattention to the plaintiffs’ affidavit
was an error, then it was surely harmless. 28 U.S.C. § 2111;
Colbert v. Potter, 471 F.3d 158, 165, 168 (D.C. Cir. 2006). As
for the first request, the communications the plaintiffs seek
would be insufficient to sustain a jury verdict in their favor; the
FDA did not again even tentatively approve Andrx’s ANDA
until May 2001 and final approval remained by law subject to
the FDA being satisfied with any update Andrx might file.* Any
information responsive to the plaintiffs’ second request would
be immaterial because, as we have held, no reasonable juror
could find that but for Biovail’s conduct the FDA would have
finally approved Andrx’s application in February 2001.
Because the proposed amendments to the complaint were
untimely and insufficient, any information responsive to the
third request is likewise immaterial.

III. Conclusion

With respect to their original theory of the case, the
plaintiffs have not shown a reasonable juror could find the FDA
would have granted Andrx final approval in February 2001 and,
without such proof, they are unable to show Andrx was ready
and able to market generic Diltiazem HCl at any time prior to

*
In any event, the plaintiffs have not explained why they would
need additional discovery: It is undisputed that the LWD plaintiffs
have had access to the full record of the litigation in Florida; Andrx
obviously would have introduced in that case any document
responsive to this request in its attempt to have the FDA remove the
’463 patent from the Orange Book.
 21

the expiration of the statutory stay. Therefore, the plaintiffs are
unable to establish the facts required to make out antitrust
injury.

The amendment to the LWD complaint was both untimely
and insufficient because (1) the amended complaint claiming
that Biovail and Forest conspired to prevent the plaintiffs’
purchase of generic Diltiazem HCl from Biovail does not relate
back to the filing of their original complaint and (2) the
plaintiffs have not alleged facts sufficient to establish Biovail
and Forest would have harmed them within the four-year
limitation period for antitrust claims, which began to run in June
2001. Nor does their affidavit for additional discovery under
Rule 56(e) require a remand.

Accordingly, the judgment of the district court is in all
respects
Affirmed.