In Re Ciprofloxacin Hydrochloride Antitrust Litigation

166 F. Supp. 2d 740, 2001 U.S. Dist. LEXIS 15386, 2001 WL 1150405
CourtDistrict Court, E.D. New York
DecidedOctober 1, 2001
DocketMDL-00-1383 (DGT)
StatusPublished
Cited by36 cases

This text of 166 F. Supp. 2d 740 (In Re Ciprofloxacin Hydrochloride Antitrust Litigation) is published on Counsel Stack Legal Research, covering District Court, E.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In Re Ciprofloxacin Hydrochloride Antitrust Litigation, 166 F. Supp. 2d 740, 2001 U.S. Dist. LEXIS 15386, 2001 WL 1150405 (E.D.N.Y. 2001).

Opinion

*742 MEMORANDUM AND ORDER

TRAGER, District Judge.

Introduction

This motion presents a difficult question of federal jurisdiction. Plaintiffs have brought multiple putative class action lawsuits in various state courts, claiming defendants violated state antitrust laws and related state statutes by agreeing to prevent competition by generic drug manufacturers in the market for the antibiotic ciprofloxacin hydrochloride. Defendants removed these cases to federal court on the grounds of federal question and diversity jurisdiction, and plaintiffs have moved to remand their cases to state court.

Before the remand motions were resolved, the actions were transferred to the Judicial Panel on Multidistrict Litigation (“JPML”), which in turn transferred the actions to this Court. Presently before the Court are plaintiffs’ motions to remand in the following eight actions: Lee v. Bayer A.G., CV-00-4731 (CA); Garber v. Bayer A.G., CV-00-4529 (CA); Patane v. Bayer A.G., CV-00-9099 (CA); Samole v. Bayer Corp., CV-00-4530 (CA); Ozarow v. Bayer Corp., CV-00-8922 (FL); Platt v. Bayer Corp., CV-01-2155 (TX); Relles v. Bayer Corp., CV-00-12453 (CA); Sandhaus v. Bayer Corp., CV-00-2527 (KS). 1 A number of courts have addressed similar *743 motions, and the overwhelming majority have found federal jurisdiction lacking. 2 Although the issue is a particularly close one, the motions to remand to state court are granted.

Background 3

Defendants Bayer A.G., a German company, 4 and its American subsidiary, Bayer Corporation, (“Bayer”) are the manufacturers of Cipro, the brand name of the widely used antibiotic, ciprofloxacin hydrochloride (“ciprofloxacin”). Ciprofloxacin, a wide-spectrum antibiotic, is prescribed for a variety of infections, and is dispensed in tablet, liquid, and intravenous forms. Ci-pro has been the best-selling antibiotic in the world for the past eight years, and is the eleventh most-prescribed drug in the United States. Bayer has earned more than $1 billion from sales of Cipro in the United States alone.

Bayer claims the active ingredient in Cipro, ciprofloxacin hydrochloride, under patent number 4,670,444 (the “' 444 pat-, ent”). The '444 patent was filed with the Patent and Trademark Office (“PTO”) on May 29, 1984, and issued to Bayer on June 2, 1987. In October 1987, Miles, Inc., then a subsidiary of Bayer and the licensee of the '444 patent, obtained FDA approval to market the drug. Since 1987, defendant Bayer has been the only producer of cipro-floxacin in the United States.

On October 27, 1991, defendant Barr Laboratories, Inc. (“Barr”), filed an “Abbreviated New Drug Application” (“ANDA”) for a generic bioequivalent version of the “pioneer” drug Cipro. An ANDA filing is governed by the Drug Price Competition and Patent Term Restoration Act of 1984, known commonly as the Hatch Waxman Act. The Act provides a simplified and shortened method of obtaining FDA approval to bring generic bioe-quivalent drugs to the marketplace. The Hatch Waxman Act also provides incentives for generic competition in pharmaceuticals by granting a 180-day period of market exclusivity to the first generic entrant on the market. See 21 U.S.C. § 855 et seq. Hatch Waxman also minimizes the time it takes for a generic drug to enter the market by permitting a new drug applicant to affirm to the FDA that the drug it seeks to market contains the same active ingredient(s) as a drug already approved and listed by the FDA, and is the listed drug’s bioequivalent. See 21 U.S.C. § 355(j). An ANDA filing incorporates the conclusions and data concerning safety and effectiveness yielded by research conducted by the pioneer drug manufacturer, thereby expediting the FDA approval process.

Along with information regarding the petitioned drug’s active ingredient(s), ef *744 fective dosage, strength, and course of 'administration, the ANDA filer is required to submit a certification regarding its conclusions about the applicability of existing patents to the generic drug. See 21 U.S.C. § 355(j)(2)(A)(vii). Specifically, and of special significance in this case, an ANDA filer may indicate it believes the patent held by the pioneer drug manufacturer is either invalid or would not be infringed by the generic, bioequivalent version for which it seeks approval. See id. If an ANDA filer certifies that the existing patent is invalid, it must notify the patent holder that it has filed an ANDA and state the factual and legal bases for its contention that the existing patent is invalid. See 21 U.S.C. § 355(j)(2)(B). The patent holder then has forty-five days upon receipt of the letter to initiate a patent infringement suit against the ANDA filer. See 21 U.S.C. § 355(j)(5)(B)(iii).

Hatch-Waxman provides that, during the ensuing patent litigation, FDA consideration and approval of the generic ANDA will be stayed for thirty months from the date the notice of non-infringement is sent, or until a final, non-appealable determination regarding the invalidity of the patent is entered, whichever date is earlier. See 21 U.S.C. § 355(j)(5)(B)(iii). The court hearing the patent case may, in its discretion, extend the stay if the litigation is not resolved within the thirty month period provided by the statute. See 21 U.S.C. § 355(j)(5)(B)(iii). It seems relatively clear, however, that if there is no resolution of the patent litigation and a stay is not granted, and the patent holder has not obtained preliminary injunctive relief, the ANDA filer may begin to market its product. In such an instance, the ANDA filer assumes the risk it might be found liable for infringing the pioneer manufacturer’s patent. As noted, Hatch Waxman further provides that the first generic manufacturer to have filed an ANDA that has gained FDA approval enjoys a 180 day period of market exclusivity from the date the applicant first sells its product or the date on which a final, non-appealable order determining the invalidity of the patent is entered, whichever is earlier. See 21 U.S.C. § 355(j)(5)(B)(iv).

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166 F. Supp. 2d 740, 2001 U.S. Dist. LEXIS 15386, 2001 WL 1150405, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-ciprofloxacin-hydrochloride-antitrust-litigation-nyed-2001.