Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-05-07066/USCOURTS-caDC-05-07066-0/pdf.json

Parties Involved:
Biovail Corporation
Appellee
Meijer Distribution, Inc.
Appellant
Meijer, Inc.
Appellant

Document Text:

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,

USCA Case #05-7066 Document #1129708 Filed: 07/25/2008 Page 1 of 21
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* The FDA maintains in its Orange Book a list of the patents

that, according to the manufacturer, protect each branded drug.

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.

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* 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).

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.

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* 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.

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

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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

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

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.,

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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

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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 anticompetitive 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

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* 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.

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.

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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

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* 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,

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

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

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

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* 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)).

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

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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.

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* 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.

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

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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

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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

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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

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* 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”).

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

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* 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.

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

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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.

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