Andrx Pharmaceuticals, Inc. v. Elan Corp., Plc

• Decision Date: 29 August 2005
• Docket Number: No. 03-13605.,03-13605.
• Citation: 421 F.3d 1227
• Parties: ANDRX PHARMACEUTICALS, INC., Plaintiff-Appellant, v. ELAN CORPORATION, PLC, Defendant-Appellee, SkyePharma, Inc., Defendant.
• Court: U.S. Court of Appeals — Eleventh Circuit

421 F.3d 1227

ANDRX PHARMACEUTICALS, INC., Plaintiff-Appellant, v. ELAN CORPORATION, PLC, Defendant-Appellee, SkyePharma, Inc., Defendant.

No. 03-13605.

United States Court of Appeals, Eleventh Circuit.

August 29, 2005.

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Gerald J. Houlihan, Houlihan & Partners, P.A., Miami, FL, for Plaintiff-Appellant.

Michael J. Flibbert, Paul W. Browning, James B. Monroe, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., Washington, DC, for Defendant-Appellee.

Appeal from the United States District Court for the Southern District of Florida.

Before BIRCH and WILSON, Circuit Judges, and DOWD^*, District Judge.

BIRCH, Circuit Judge:

In this appeal, we address whether the district court properly granted a patentholder's motion for judgment on the pleadings in a competitor's antitrust suit. The district court granted the motion because it found that the Noerr-Pennington doctrine immunized Defendant-appellee Elan Corporation, PLC ("Elan") from the maintenance of an antitrust suit based on the allegations of Plaintiff-appellant Andrx Pharmaceuticals, Inc. ("Andrx") that Elan engaged in patent infringement proceedings to improperly protect its monopoly on the market for a controlled release naproxen medication. In addition, the district court found that Andrx's allegations regarding a licensing agreement entered into by Elan and another competitor to settle a separate infringement suit were insufficient to support an antitrust action under the Sherman Anti-Trust Act, 15 U.S.C. §§ 1 and 2. Finally, the district court denied Andrx's motion for leave to amend its complaint. For the reasons discussed more fully in this opinion, we conclude the district court properly construed the Noerr-Pennington doctrine to immunize Elan from liability for its infringement suits, and did not abuse its discretion in denying leave to amend. The district court erred, however, in dismissing Andrx's claims regarding its settlement agreement with one of Andrx's competitors. Accordingly, the district court's order is AFFIRMED in part, REVERSED in part, and REMANDED for further proceedings.

I. BACKGROUND¹

At its core, this litigation concerns the right to manufacture and sell the drug naproxen, an analgesic medication prescribed to treat pain and other disorders. Because the complex statutory regulations which govern the manufacture and sale of drugs in the United States provide context for the facts in this case, we will begin by briefly summarizing the relevant statutory provisions, after which we will recount the relevant facts specific to the parties.

The Food and Drug Administration ("FDA") must give its approval before any new drug can be marketed or sold in the United States. 21 U.S.C. § 355(a). Under § 355, different FDA approval standards apply depending on the drug the applicant is attempting to market. See Valley Drug Co. v. Geneva Pharms., 344 F.3d 1294, 1296 (11th Cir.2003), cert. denied ___ U.S. ___, 125 S.Ct. 308, 160 L.Ed.2d 248 (2004). To gain approval for a drug that has not been introduced previously to the market, an applicant must file a new drug application ("NDA") and must meet the requirements outlined in § 355(b). Id. Section 355(b) requires the submission of "exhaustive information about the drug," including reports about the safety and efficacy of the drug. Id. To gain approval for a generic, bioequivalent version of a drug which has already gained approval under § 355(b), however, an applicant may file an abbreviated new drug application ("ANDA"), in which the applicant must satisfy the less exhaustive requirements outlined in § 355(j). See id. While § 355(j) allows an ANDA applicant to satisfy its burden by demonstrating a certain bioequivalency between its drug and a drug approved under § 355(b), § 355(j) does require the ANDA applicant to certify that the manufacture and sale of its drug would not violate any patents held on the drug approved under § 355(b). See § 355(j)(2)(A)(vii). If an ANDA applicant certifies that its generic drug would not violate an existing patent, or would only violate a patent on a § 355(b)-approved drug which is invalid, see § 355(j)(2)(A)(vii)(IV),² the ANDA applicant must notify the patentholder, which is then given forty-five days to initiate patent infringement proceedings against the ANDA applicant, see § 355(j)(5)(B)(iii). If the patentholder timely initiates such litigation, FDA approval for the generic drug will be stayed for up to thirty months, unless the patent being litigated expires or a final determination on the patent's validity is reached at an earlier date. Id.

Against this background of information on drug approval procedures, we proceed to the facts relevant to the parties on appeal. Elan was the owner of U.S. Patent No. 5,637,320 ("the '320 patent"), which granted it the exclusive right to manufacture and sell in the United States a controlled release naproxen medication. In 1998, SkyePharma, Inc. ("SkyePharma")³ filed an ANDA application pursuant to § 355(j) to manufacture and sell a generic version of Elan's controlled release naproxen medication. In making its application, SkyePharma certified pursuant to § 355(j)(2)(A)(vii)(IV) that its activity would not constitute patent infringement. Consequently, pursuant to § 355(j)(5)(B)(iii), Elan initiated patent infringement proceedings against SkyePharma. According to Andrx's complaint, Elan and SkyePharma settled the litigation by entering into an agreement in which SkyePharma admitted to infringing the '320 patent in exchange for a license from Elan to manufacture a generic controlled release naproxen medication. Because SkyePharma was the first filing ANDA applicant, pursuant to § 355(j)(5)(B)(iv)(I), the license agreement effectively would have given SkyePharma an exclusive 180-day period to market a generic naproxen medication. According to Andrx's complaint, however, SkyePharma had no intention of marketing its generic drug and therefore would never trigger the running of the 180-day exclusivity period. Accordingly, the settlement agreement had the effect of preventing any generic competition in the controlled release naproxen market and constituted a conspiracy to restrain trade.

In addition to SkyePharma's alleged attempt to seek FDA approval for a generic controlled release naproxen medication, Andrx contends that it also sought to introduce a generic naproxen to the market. After Andrx filed notice of non-infringement as required by § 355(j)(2)(B)(ii), however, Elan filed patent infringement proceedings against Andrx. According to Andrx's complaint, Elan initiated this litigation "despite the absence of any reasonable belief that the claim might fairly be held to be valid upon adjudication." R1-3 ¶ 29, at 5. Andrx alleged that Elan could not maintain its suit because the '320 patent had not been "validly issued because of inter alia, the SCRIP publication of June 22, 1988 which advertised its controlled release naproxen in the United States more than one year prior to the filing of the application which resulted in the '320 patent." Id. ¶ 27.⁴ Moreover, Andrx alleged that "Elan's goal and intention in bringing [the infringement proceedings] was solely to . . . cause Andrx damage from the automatic administrative delay in the approval process" pursuant to § 355(j)(5)(B)(iii). Id. ¶ 29, at 5-6. In addition to these allegations, Andrx alleged that "Elan has engaged in a pattern and practice of baseless and sham litigation" against companies seeking to complete ANDAs for generic controlled release naproxen medications. Id. ¶ 26, at 5. According to Andrx, Elan sought through this behavior to preserve its monopoly over the controlled release naproxen market in the United States. Id. ¶ 39, at 7.

Based on these allegations, Andrx filed suit against Elan and SkyePharma and alleged violations of the Sherman Anti-Trust Act, 15 U.S.C. §§ 1 and 2, and the Florida antitrust laws, FLA. STAT. chs. 542.18 and 542.19. Citing the Noerr-Pennington doctrine and precedent which allowed for the licensing settlement reached by Elan and SkyePharma, the district court granted Elan's motion for judgment on the pleadings. In addition, the district court denied Andrx's motion to amend its complaint on account of Andrx's undue delay. On appeal, Andrx argues that the district court erred in dismissing with prejudice its suit against Elan because the district court misconstrued the Noerr-Pennington doctrine and its sham litigation exception. In addition, Andrx argues that the district court erred by denying its motion for leave to amend its complaint.

II. DISCUSSION

A. Judgment on the Pleadings

"We review de novo the district court's ruling on a motion for judgment on the pleadings pursuant to Federal Rule of Civil Procedure 12(c)." Horsley v. Rivera, 292 F.3d 695, 700 (11th Cir.2002). The application of the Noerr-Pennington doctrine is a question of law, and therefore also reviewed de novo. See TEC Cogeneration Inc. v. Fla. Power & Light Co., 76 F.3d 1560, 1567 (11th Cir.1996), modified in part on other grounds, 86 F.3d 1028 (11th Cir.1996) (per curiam). Judgment on the pleadings is proper when no issues of material fact exist, and the moving party is entitled to judgment as a matter of law based on the substance of the pleadings and any judicially noticed facts. See Horsley, 292 F.3d at 700.

The Sherman Anti-Trust Act provides that "[e]very contract. . . in restraint of trade or commerce among the several States, or with foreign nations, is . . . illegal." 15 U.S.C. § 1. The Act also proscribes acts which seek "to monopolize any part of the trade or commerce among the several States, or with foreign nations." 15 U.S.C. § 2.⁵ Citing the Sherman Act and the Florida antitrust statutes, Andrx alleges that Elan improperly sought to monopolize the controlled release naproxen market and prevent competition by: (1) initiating sham patent infringement litigation against Andrx; and (2) entering into a...