Opinion ID: 187198
Heading Depth: 2
Heading Rank: 1

Heading: Inability to Purchase Taztia from Andrx (Original Theory)

Text: 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, 97 S.Ct. 690, 50 L.Ed.2d 701 (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, 89 S.Ct. 1562, 23 L.Ed.2d 129 (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, 110 S.Ct. 1884, 109 L.Ed.2d 333 (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  n. 2; see also Zenith Radio Corp., 395 U.S. at 126 89 S.Ct. 1562; 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.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 -. 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 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 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 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 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. 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.