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

Heading: facts

Text: 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.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. 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 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 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, 111 S.Ct. 1344, 113 L.Ed.2d 382 (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., 437 F.Supp.2d 79 (D.C.Cir.2006), 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.