FOR THE DISTRICT OF COLUMBIA CIRCUIT
ON THEIR OWN BEHALF AND ON BEHALF OF ALL OTHERS
MEIJER DISTRIBUTION, INC., ON THEIR OWN BEHALF AND ON
Appeals from the United States District Court
(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,
Richard J. Kilsheimer
, Robert F. Muse
, David Fierst
, DavidWallace Stanley
, Erin Cathleen Burns
, Joseph M. Vanek
, andJeffrey 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
Before: GINSBURG, ROGERS, and KAVANAUGH, Circuit
Opinion for the Court filed by Circuit Judge
GINSBURG, Circuit Judge
: The plaintiff-appellants in these
four antitrust class actions are wholesale purchasers of Tiazac(extended-release Diltiazem Hydrochloride, hereinafterDiltiazem HCl), a controlled-release drug for hypertension andangina. They alleged that Biovail Corporation, whichmanufactures Tiazac, misused a patent to keep off the market ageneric equivalent manufactured by Andrx Pharmaceuticals,Inc., in violation of federal and state antitrust laws. The districtcourt entered summary judgment for Biovail, which we affirm.
The would-be manufacturer of a “generic” bioequivalent to
a previously approved “branded” drug may file an abbreviatednew drug application (ANDA) with the Food and DrugAdministration while the branded drug is purportedly protectedby 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.
2006). In its ANDA the applicant may certify under ParagraphIV of the governing section of the Food, Drug, and CosmeticAct either that the patent is invalid or that the generic drugwould not infringe it. 21 U.S.C. § 355(j)(2)(A)(vii)(IV); seealso
21 C.F.R. § 314.94(a)(12).* The FDA may tentativelyapprove an ANDA with such a certification, but that approvaldoes not become “effective” (i.e.
, final) for 45 days; if withinthat time the manufacturer of the branded drug brings an actionfor infringement of its patent, then the effective date of theapproval is stayed for 30 months from the date of the ParagraphIV certification or until the patent case is resolved, whicheveroccurs first. 21 U.S.C. § 355(j)(4), (j)(5)(B)(iii); see also
21C.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 approvalletter from the agency, result in an effective approval”). Nordoes 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
In June 1998 Andrx filed an ANDA seeking approval to
market Diltiazem HCl under the name Taztia; Andrx includeda Paragraph IV certification both challenging the validity ofBiovail’s U.S. Patent No. 5,529,791 (filed Sept. 23, 1994) (the’791 patent), which Biovail claimed protected the formula forTiazac, 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).
Biovail sued Andrx in federal district court in Florida, therebyextending the statutory stay for up to 30 months. In March2000, the district court determined Andrx’s product would notinfringe Biovail’s patent, Biovail Corp. v. Andrx Pharms., Inc.
,158 F. Supp. 2d 1318 (S.D. Fla.), whereupon Biovail appealedto the Federal Circuit.
In September 2000 the FDA “tentative[ly]” approved
Andrx’s ANDA, noting that Biovail’s pending appeal preventedit from giving final approval at that time.* The agency went onto explain that, if and when Andrx prevailed on appeal, the FDAwould have to be “assured there is no new information thatwould 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 FDAasked Andrx for its position with regard to that patent. OnFebruary 13 the Federal Circuit affirmed the judgment forAndrx in the ’791 patent litigation, 239 F.3d 1297, therebyterminating the statutory stay. Three days later, Andrx filed aParagraph 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. 21U.S.C. § 355(j)(5)(B)(iii). The FDA at that time took the position thatthe stay would expire only upon the resolution of any appeal. AfterTorpharm 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 adoptedthe district court’s view that the judgment of a district court in favorof the generic applicant terminates the stay. FDA, Guidance forIndustry (Mar. 2000), available at
http://www.fda.gov/cder/guidance/3659fnl.pdf. The FDA amended 21 C.F.R. § 314.107 accordingly, 65Fed. Reg. 43,233 (July 13, 2000), but did not apply the rule toANDAs, such as Andrx’s, then pending, id.
triggering a new 45-day stay, which Biovail extended by suingAndrx anew in Florida. Meanwhile, Andrx had filed its ownaction against Biovail and the FDA in the same district court,challenging as baseless Biovail’s claim that the ’463 patentcovered Tiazac and seeking an injunction requiring the FDA toremove the ’463 patent from the Orange Book. See AndrxPharms., Inc. v. Biovail Corp
., 175 F. Supp. 2d 1362 (S.D. Fla.
, 276 F.3d 1368 (Fed. Cir. 2002). On May 14,2001, while these suits were pending, the FDA tentativelyapproved Andrx’s ANDA a second time. In April 2002, Biovailwithdrew 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 Taztiafor dissolution in the human body. In January 2001 Andrxmanufactured a new batch of the drug, which it initially foundsatisfactory pursuant to a new testing methodology, but on May18, 2001 the Company discovered that samples from the newbatch also failed to dissolve as required. Andrx eventuallyrejected that entire batch because the manufacturing process wasfaulty, and continued to encounter manufacturing problems into2003. Because of those problems, the FDA did not finallyapprove Andrx’s ANDA until April 2003 -- a full year afterBiovail had withdrawn its claim that the ’463 patent covered itsdrug.
Much as Andrx had done in its suit against Biovail, see
F. Supp. 2d 1362, the plaintiffs in these four class actionsalleged in the district court that Biovail unlawfully forestalledthe FDA’s final approval of Andrx’s ANDA by filing with theFDA documents claiming falsely and in bad faith that the ’463patent covered Tiazac, and by engaging in bad faith or “sham”litigation over that patent. According to the plaintiffs, Biovail
thus unlawfully excluded Andrx from “the market for Tiazacand its generic equivalents,” in violation of federal and stateantitrust laws,* see United States v. Microsoft Corp.
, 253 F.3d34, 58 (D.C. Cir. 2001) (en banc) (“Whether any particular actof a monopolist is exclusionary, rather than merely a form ofvigorous competition, can be difficult to discern: the means ofillicit exclusion, like the means of legitimate competition, aremyriad”); 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 seekinganticompetitive action from the government,” but they do reach“sham[s],” as when “persons use the governmental process
-- asopposed to the outcome
of that process -- as an anticompetitiveweapon”). But for Biovail’s exclusionary conduct, the plaintiffsclaim, the FDA would have finally approved Andrx’s ANDA onor about February 13, 2001, when the Federal Circuit ruledagainst Biovail in the ’791 patent litigation; the plaintiffs couldhave begun soon thereafter purchasing Taztia from Andrx at alower 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 whetherBiovail had violated the antitrust laws, the plaintiffs could notshow Biovail had caused them any harm. The district courtagreed, Twin Cities Bakery Workers Health & Welfare Fund v.
, Nos. Civ.A. 01-2197, Civ.A. 03-2075, 2005 WL3675999 (Mar. 31, 2005), and subsequently entered judgmentfor Biovail in a third case, SAJ Distribs., Inc. v. Biovail Corp.
,No. Civ.A. 04-799 (May 25, 2005), which it foundindistinguishable.
Seeking to avoid the same fate, the plaintiffs in the fourth
action, Louisiana Wholesale Drug Co.
) v. Biovail Corp.
Plaintiffs make no argument specific to the law of any state.
No. Civ.A. 04-2235, amended their complaint to allege that, butfor Biovail’s wrongful use of the ’463 patent, they could havepurchased generic drugs manufactured and sold either by Andrxor 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 subjectof any allegation of wrongdoing -- had conspired to distribute ageneric version of Tiazac before Andrx and other manufacturerscould get to market, but abandoned that plan in favor of usingthe ’463 patent to forestall final approval of Andrx’s ANDA;they cite no overt act in furtherance of this conspiracy afterBiovail dropped its claim the ’463 patent protected Tiazac. TheLWD
plaintiffs also sought further discovery pursuant to FederalRule of Civil Procedure 56(e). See also
FED. R. CIV. P. 56(f)(2007).
Applying its Twin Cities
ruling to LWD
the Rule 56(e) affidavit, the district court entered summaryjudgment for the defendants insofar as the LWD
plaintiffsclaimed the defendants had prevented the plaintiffs frompurchasing Taztia from Andrx; the court held that no reasonablejuror could find Biovail’s use of the ’463 patent prevented theFDA’s final approval of Andrx’s ANDA. 437 F. Supp. 2d 79,82-84 (2006). The court then entered judgment for thedefendants insofar as the LWD
plaintiffs advanced in theiramended complaint their new theory that they could havepurchased generic Diltiazem HCl from the defendants but forBiovail’s misuse of the ’463 patent; the court reasoned that theamendment did not relate back to the filing of the originalcomplaint and was thus time-barred. Id.
The plaintiffs in all four class actions appeal, contending
they proffered evidence sufficient to defeat Biovail’s motion for
summary judgment. In addition, the LWD
plaintiffs argue thedistrict court improperly dismissed the amendment to theircomplaint as untimely and erroneously failed to address theiraffidavit 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 intendedto 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 AndrxPharms., 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-beentrant suing an incumbent firm for excluding it from a relevantmarket in violation of the Sherman Act must demonstrate itintended and was prepared to enter that market, Zenith RadioCorp. v. Hazeltine Research, Inc.
, 395 U.S. 100, 126-29 (1969);2 AREEDA & HOVENKAMP, supra
, ¶ 349, so a would-bepurchaser suing an incumbent monopolist for excluding apotential competitor from which it might have bought a productat a lower price must prove the excluded firm was willing andable to supply it but for the incumbent firm’s exclusionaryconduct, 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, thatmeans the plaintiffs must prove Andrx was prepared to sellTaztia and could have obtained approval from the FDA to do soat some point between February 2001, when the ’791 patent nolonger barred the FDA’s final approval, and April 2002, whenBiovail withdrew its claim that the ’463 patent protected Tiazac.See Twin Cities
, 2005 WL 3675999, at *5 n.2; see also Zenith
, 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 areasonable juror to find that but for Biovail’s conduct, the FDAwould have granted Andrx final approval in February 2001 andthat 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 noreasonable juror could conclude that, but for Biovail’s allegedmisuse of the ’463 patent, the FDA would have granted Andrxfinal approval in February 2001. Accordingly, we affirm thejudgment of the district court without reaching Biovail’salternative argument that the plaintiffs could not show Andrxwas ever prepared to manufacture a safe drug.** See
In principle, the plaintiffs could establish antitrust injury by
showing that, but for Biovail’s misuse of the ’463 patent, they couldhave purchased generic Diltiazem HCl from Andrx at any time duringthe pendency of the stay caused by the ’463 patent. The plaintiffs,however, have not argued that Andrx would have obtained approvalfrom the FDA and been ready to market the drug at any time afterFebruary 2001 but before the expiration of the statutory stay -- a wisestrategy in view of the problems Andrx encountered trying tomanufacture Taztia during that period. Therefore, it is crucial to theplaintiffs’ case, as counsel acknowledged at oral argument, that theymake 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 evidenceinsufficient to defeat the defendants’ motion for summary judgment,however, we need not concern ourselves with the effort of certain ofthe plaintiffs to rely on appeal upon evidence they did not adducebefore the district court.
Civ. P. 56(c) (district court must enter summary judgment when“there is no genuine issue as to any material fact and . themovant 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 formisconduct by Biovail, the plaintiffs first point to the affidavitsof Dr. Nicholas Fleischer and Mr. Jeffrey Gibbs, each of whomhad once worked for the FDA. The district court, invokingFederal Rules of Evidence 702 (admissibility of experttestimony) and 403 (exclusion of otherwise admissible evidenceon ground of unfair prejudice), excluded those affidavitsbecause they were speculative and ungrounded in fact and, inany event, “their value is substantially outweighed by the dangerof unfair prejudice or misleading the jury.” See
2005 WL3675999 at *4-*5. The plaintiffs challenge the district court’sreliance upon Rule 702 but not upon Rule 403. In keeping withgood sense and our established practice, we will not disturb theruling of a district court where, as here, an independent basis forthat ruling is uncontested. N.Y. Rehab. Care Mgmt., LLC v.
, 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 theFDA, that the agency would have finally approved Andrx’sANDA in February 2001 but for Biovail’s misuse of the ’463patent, 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 disputedfact,” 437 F. Supp. 2d at 83-84, and none determined whether areasonable juror could conclude the FDA would have grantedfinal approval in February 2001. Although the likely timing of
the FDA’s final approval was placed at issue in the SouthernDistrict of Florida when Andrx sought a preliminary injunction-- thus requiring it to prove irreparable harm -- that court did notreach the issue because it determined that it lacked subjectmatter jurisdiction. Andrx Pharms.
, No. 01-6194-Civ, slip op.
at 18-19. Neither did that court in its decision of September2001, which addressed various motions to dismiss and forsummary judgment, decide when the FDA would have grantedfinal approval of Andrx’s ANDA. See
175 F. Supp. 2d 1362.
Instead, in its recitation of the facts the court assumed, as did theFederal Circuit on appeal, see
276 F.3d at 1372 & n.2, thatbecause the FDA had given its initial approval in September2000 it would have given its final approval as soon as thestatutory bar was lifted in February 2001, 175 F. Supp. 2d at1365-66. The likely timing of the FDA’s approval was not adisputed 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’stentative approval in September 2000, a February 2001 fax fromthe FDA to Andrx, the FDA’s filings in the case Andrx broughtto compel the agency to withdraw the ’463 patent from theOrange 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 . infringementsuit.” No such conclusion is to be found in the record of this case,however, and the plaintiffs do not provide the statement itself butinstead quote the opinion in Andrx Pharmaceuticals, Inc.
Supp. 2d at 1366. We disregard that purported “evidence”; if theunderlying evidence exists and is in the record of the cited case, thenthe plaintiffs, who have access to that record, should have producedit. Cf. Cmty. Hosps. of Cent. Cal. v. NLRB
, 335 F.3d 1079, 1086-87(D.C. Cir. 2003) (presumption may arise from failure to produceevidence to which party has access) (citing United States v. Young
the basis of this evidence, we hold no reasonable juror couldconclude that but for Biovail’s misuse of the ’463 patent theFDA 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 onlyhurdle to final approval was resolution of the ’791 patentdispute. That first tentative approval made clear, however, thatfinal approval was also subject to the FDA being “assured thereis no new information that would affect whether final approvalshould be granted.” For that reason, the FDA instructed theapplicant, “when you believe that your application may beconsidered for final approval,” file “[u]pdated informationrelated to labeling or chemistry, manufacturing and controlsdata, or any other change in the conditions outlined in th[e]abbreviated application.” A reasonable juror would not inferupon the basis of this letter that final approval would have beenforthcoming in February 2001.
As Biovail points out, the FDA’s second tentative approval,
issued in May 2001, further undermines the plaintiffs’ treatmentof the September 2000 tentative approval as tantamount to finalapproval subject only to the lifting of the statutory stay. Theplaintiffs belittle the May 2001 approval as “simply areaffirmance of the September 2000 approval,” but the recordcontradicts that contention. The FDA’s letter of May 14, 2001referred not only to the September 2000 tentative approval butalso to several amendments to Andrx’s ANDA that postdatedthe 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)).
approval, it could easily have said so.* At best the secondtentative approval suggests the FDA could have given finalapproval 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 furtherquestions at this time,” and even that explicitly “preliminary”observation was made “subject to revision after review of theentire application.” In the same fax the FDA also asked Andrxto “provide a . certification” as to the ’463 patent, but the FDAnowhere suggested the agency would approve Andrx’s ANDAwhen 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 briefingdemonstrat[es] that because [Biovail] listed the ’463 Patent,Andrx’s ANDA was no longer eligible for final FDA approvalin February 2001.” Relatedly, the plaintiffs note that whenAndrx filed a statement of undisputed facts in that litigation --to the effect that only litigation over the ’791 patent preventedthe FDA’s final approval -- the FDA responded that the ’463patent also barred final approval. These documents areunhelpful, however, because they demonstrate only that endingthe 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, butthat assertion is as conclusory as it is untimely. See United States v.
, 111 F.3d 956, 958 (D.C. Cir. 1997) (“absent extraordinarycircumstances (not present here) we do not entertain an argumentraised for the first time in a reply brief or for that matter, in a footnote”(citations omitted)).
final approval; a reasonable juror could not infer from them thatit was a sufficient condition. In keeping with applicable law, 21C.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 uponthe termination of the litigation Andrx would be “eligible for,”not that it would be “entitled to,” final approval. Similarly, theFDA’s response to Andrx’s statement of undisputed facts doesnot imply it would have granted final approval but for Biovail’smisuse of the second patent. Nor could it have: The FDA’sfinal approval was by law subject to Andrx updating itsapplication to the satisfaction of the FDA once the statutory barwas 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 ’463patent from the Orange Book, Lodin filed an affidavit stating“the FDA had informed Andrx that it was prepared to grant finalapproval to Andrx’s ANDA upon the expiration of the 30-monthstay period” triggered by Biovail’s first patent infringementcase. The Lodin affidavit, however, cites only the tentativeapproval of September 2000, which we have already determinedis an insufficient basis for a reasonable juror to find the FDAwould have granted final approval in February 2001; beyondthat it is merely conclusory. Cf. Greene v. Dalton
, 164 F.3d671, 675 (D.C. Cir. 1999) (“Although, as a rule, statementsmade by the party opposing a motion for summary judgmentmust be accepted as true for the purpose of ruling on thatmotion, some statements are so conclusory as to come within anexception to that rule”); see also Ginger v District of Columbia
,527 F.3d 1340, 1346-47 (D.C. Cir. 2008). Nor could Lodinknow how the FDA would react to any update Andrx would filein order to obtain final approval.
We conclude the plaintiffs have not adduced evidence
sufficient for a reasonable juror to find the FDA would haveapproved Andrx’s ANDA in February 2001 but for Biovail’sclaim the ’463 patent covered Tiazac and Biovail’s subsequentsuit for infringement of that patent. The plaintiffs’ originaltheory of the case, in which they blamed Biovail for theirinability to purchase Taztia from Andrx, turned upon the jurybeing able to make that finding. Accordingly, we affirm theentry of summary judgment in favor of the defendants in all fourcases inasmuch as the plaintiffs blame Biovail for their inabilityto purchase Taztia from Andrx.
B. Inability to Purchase Generic Diltiazem HCl from Biovail
plaintiffs alleged in their amended complaint that
Biovail and Forest conspired preemptively to manufacture anddistribute their own generic version of Diltiazem HCl while the’791 patent litigation precluded competitors from entering themarket, a scheme they abandoned in late 2000 or early 2001 infavor of misusing the ’463 patent to exclude potentialcompetitors.* The defendants argue, and the district court held,the complaint does not relate back and does not allege factssufficient to establish a claim of injury within the limitationperiod. Reviewing the court’s dismissal de novo
, while“assum[ing] ‘all the allegations in the complaint are true (evenif doubtful in fact),’” Aktieselskabet AF 21. November 2001 v.
Fame Jeans Inc.
, 525 F.3d 8, 17 (D.C. Cir. 2008) (quoting BellAtl. 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.
derived from the facts alleged,’” id.
(quoting Stewart v. Nat’lEduc. Ass’n
, 471 F.3d 169, 173 (D.C. Cir. 2006)), we affirm.
Federal Rule of Civil Procedure 15(c)(1)(B) provides: “An
amendment . relates back to the date of the original pleadingwhen . the amendment asserts a claim . that arose out of theconduct, transaction, or occurrence set out -- or attempted to beset out -- in the original pleading.” See also
Fed. R. Civ. P.
15(c)(2) (2007). The underlying question is whether the originalcomplaint adequately notified the defendants of the basis forliability the plaintiffs would later advance in the amendedcomplaint. 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 thatit cannot be said that defendant was given adequate notice of theconduct, transaction, or occurrence that forms the basis of theclaim . then the amendment will not relate back”); see alsoAktieselskabet
, 525 F.3d at 16 (complaint must “give adefendant ‘fair notice of the claims against him’” (quotingCiralsky v. CIA
, 355 F.3d 661, 668-70 (D.C. Cir. 2004)). Thedefendants argue, and we agree, that the original complaint inthis case does not give that notice and therefore does not, asamended, relate back.
plaintiffs alleged for the first time in the amended
complaint that Biovail and Forest had conspired to exclude newentrants into the market for generic Diltiazem HCl and (beforeBiovail acquired the ’463 patent) had planned preemptively tocapture that market by launching their own generic drug. Forprior notice, they point out that their original complaint referredto their inability to purchase “generic versions of Tiazac,” i.e.
,in the plural, and contend the amendment “simply add[ed] detail
generic versions [of Diltiazem HCl] would havebeen 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 beclaiming the defendants’ decision not to sell their own genericDiltiazem HCl violated the antitrust laws. The originalcomplaint chronicles the tale of a single firm, Biovail, bent uponpreventing the FDA from granting final approval of the genericdrug proposed by Andrx (and perhaps others), but it did notallege Forest had engaged in any specific misconduct; Forestwas made a defendant solely because, as Biovail’s exclusivedistributor, it “benefitted from [Biovail’s] wrongful conduct toextend the Tiazac monopoly” unlawfully. The amendedcomplaint alleges for the first time that Biovail and Forestunlawfully conspired to extend their lawful monopoly, that theyplanned preemptively to introduce their own generic DiltiazemHCl, and that they unlawfully abandoned that plan in favor ofmisusing the ’463 patent to prevent the FDA from approving theapplications of their would-be generic competitors. Althoughthe original and amended claims have some elements and somefacts in common, the whole thrust of the amendments is to faultboth Biovail and Forest, and to fault them for conduct differentfrom that identified in the original complaint. Consequently, theamended complaint does not relate back.
(2) Adequacy of the Amendment to the Complaint
plaintiffs filed their amended complaint on June
1, 2005; because that complaint does not relate back to the filingof the original complaint, the LWD
plaintiffs, who claim thedefendants violated § 2 of the Sherman Act, 15 U.S.C. § 2, mustallege the defendants injured them during the four year periodstarting June 1, 2001, or state facts sufficient reasonably to giverise to an inference of such an injury. See
§ 4B of the Clayton
Act, 15 U.S.C. § 15b (providing any suit for damages under thefederal antitrust laws “shall be forever barred unless commencedwithin four years after the cause of action accrued”); see alsoTwombly
, 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 February2001 would have entered into long-term contracts to sell towholesalers, including the plaintiffs, generic Diltiazem HClbeyond June 1, 2001 and the plaintiffs were injured because theywere unable to purchase generic drugs from the defendantspursuant to those hypothetical contracts. They made no similarallegation, however, in the amended complaint, their oppositionto 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 thisargument in the district court and as far as we can tell they neverdid. Absent a showing that “‘injustice might otherwise result,’”and the plaintiffs offer none, we do not entertain an argumentmade 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 sellwholesalers generic Diltiazem HCl, the LWD
plaintiffs have nobasis upon which to claim that, but for Biovail’s acquisition ofthe ’463 patent, the defendants would have sold them genericDiltiazem HCl after June 1, 2001. Because, as we have held, theLWD
plaintiffs cannot show Andrx would have sold DiltiazemHCl prior to May 2003, when Andrx received final approval andlong after they allege either defendant had engaged in anymisconduct, it follows that the defendants would have faced no
competition until then.* There is no provision of law that wouldhave required Biovail and Forest to sell or continue selling ageneric version of Diltiazem HCl in competition with Biovail’sbranded product once it became clear, as it would have done inearly 2001, that Andrx could not get FDA approval to enter themarket. Nor does the complaint advance any fact suggestingBiovail and Forest would have done so. (The plaintiffs do notargue on appeal that any firm other than Andrx sought to enterthe market.) These gaps are fatal to the plaintiffs’ case.
In sum, the factual allegations of the LWD
amended complaint, taken as true, are inadequate to make out atimely action under the antitrust laws. Therefore, we affirm thedismissal of the amended complaint.
Finally, we turn to the LWD
plaintiffs’ objection to the
failure of the district court to address their Rule 56(e) affidavitbefore entering judgment. The LWD
plaintiffs sought todiscover from Andrx any communications between it and theFDA tending to show the FDA would have given final approvalof Andrx’s ANDA in February 2001. They also sought todiscover 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 theplaintiffs cannot show Andrx would have competed with Biovail butfor the latter company’s misconduct. Cf.
5B WRIGHT, MILLER &KANE, supra
, § 1357 (“Numerous cases . have allowed considerationof matters incorporated by reference or integral to the claim, itemssubject to judicial notice, matters of public record, orders, itemsappearing in the record of the case, and exhibits attached to thecomplaint whose authenticity is unquestioned; these items may beconsidered by the district judge without converting the motion intoone for summary judgment”).
done had it obtained final approval from the FDA in February2001 but subsequently discovered problems manufacturing thedrug, and from Biovail and Forest information relating to theiralleged 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). Asfor the first request, the communications the plaintiffs seekwould be insufficient to sustain a jury verdict in their favor; theFDA did not again even tentatively approve Andrx’s ANDAuntil May 2001 and final approval remained by law subject tothe FDA being satisfied with any update Andrx might file.* Anyinformation responsive to the plaintiffs’ second request wouldbe immaterial because, as we have held, no reasonable jurorcould find that but for Biovail’s conduct the FDA would havefinally approved Andrx’s application in February 2001.
Because the proposed amendments to the complaint wereuntimely and insufficient, any information responsive to thethird request is likewise immaterial.
With respect to their original theory of the case, the
plaintiffs have not shown a reasonable juror could find the FDAwould have granted Andrx final approval in February 2001 and,without such proof, they are unable to show Andrx was readyand 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
plaintiffshave had access to the full record of the litigation in Florida; Andrxobviously would have introduced in that case any documentresponsive to this request in its attempt to have the FDA remove the’463 patent from the Orange Book.
the expiration of the statutory stay. Therefore, the plaintiffs areunable to establish the facts required to make out antitrustinjury.
The amendment to the LWD
complaint was both untimely
and insufficient because (1) the amended complaint claimingthat Biovail and Forest conspired to prevent the plaintiffs’purchase of generic Diltiazem HCl from Biovail does not relateback to the filing of their original complaint and (2) theplaintiffs have not alleged facts sufficient to establish Biovailand Forest would have harmed them within the four-yearlimitation period for antitrust claims, which began to run in June2001. Nor does their affidavit for additional discovery underRule 56(e) require a remand.
Accordingly, the judgment of the district court is in all
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