Abbott Laboratories v. Teva Pharmaceuticals USA, Inc.

432 F. Supp. 2d 408, 2006 U.S. Dist. LEXIS 33952, 2006 WL 1460077
District Court, D. Delaware·Decided May 26, 2006·No. CIV.A. 02-1512-KAJ, CIV.A. 03-120-KAJ, CIV.A. 05-340-KAJ, CIV.A. 05-360-KAJ·Published·Cited by 23 cases

Opinion

MEMORANDUM OPINION

JORDAN, District Judge.

TABLE OF CONTENTS

I. INTRODUCTION 413

II. BACKGROUND 413

*413 A. Generic Drugs and the Operation of the Hatch-Waxman Act.................414

B. Defendants’ Anticompetitive Conduct.....................................415

1. The Switch from Capsules to Tablets..................................415

2. The Switch from Original Tablets to New Tablets.......................416

C. Plaintiffs’ Legal Claims.................................................418

III. STANDARD OF REVIEW .................................................419

IV. DISCUSSION.............................................................419

A. Antitrust Liability for Product Formulation Changes.......................420

1. The Appropriate Standard...........................................420

2. Plaintiffs’ Allegations Relating to Product Innovation ...................423

3. Foreclosure from the Fenofibrate Market .............................423

4. Actions Taken to Support the Formulation Changes.....................423

B. Sham Litigation .......................................................424

1. Probable Cause for Alleging Infringement.............................425

2. Summary Judgment Opinion.........................................426

3. Inequitable Conduct................................................426

C. Allegations of an Overall Scheme to Monopolize............................428

D. Antitrust Injury.......................................................430

1. Walker Process Claims..............................................430

2. Sham Litigation Claims.............................................431

E. Allegations of Joint Conduct................. 431

1. Allegations Against Abbott..........................................431

2. Allegations Against Fournier.........................................433

F. State Law Claims......................................................433

V. CONCLUSION............................................................434

I. INTRODUCTION

These antitrust actions have been brought by various plaintiffs 1 (collectively “Plaintiffs”) against Abbott Laboratories (“Abbott”), and Fournier Industrie et Santé and Laboratoires Fournier S.A. (collectively “Fournier”). 2 Before me is the Defendants’ Consolidated Motion to Dismiss Plaintiffs’ Complaints (C.A. No. 02-1512, Docket Item [“D.I.”] 383, C.A. 02-1512, D.I. 429; C.A. 03-120, D.I. 294; C.A. 05-340, D.I. 38; C.A. 05-360, D.I. 39; the “Motion”). Jurisdiction is proper under 28 U.S.C. §§ 1331 and 1337. For the reasons that follow, I will deny the Motion.

II. BACKGROUND 3

According to Plaintiffs, Abbott and Fournier have manipulated the statutory *414 framework that regulates the market for pharmaceutical drugs in order to prevent generic substitutes for the branded drug TriCor® from having a meaningful opportunity to enter the market. (C.A. No. 02-1512, D.I. 360, Ex. A at ¶ 3.) 4 As context for those allegations, a description of the approval process for generic pharmaceutical drugs may be helpful.

A. Generic Drugs and the Operation of the Hatchr-Waxman Act

Before a pharmaceutical drug is released into the market, it must be approved by the Food and Drug Administration (“FDA”), pursuant to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (D.I. 360, Ex. A at ¶ 32.) The manufacturer of a new branded drug must submit detailed safety and efficacy data for the drug to the FDA in a New Drug Application (“NDA”). 21 U.S.C. § 355(a). The NDA must also list “the patent number and the expiration date of any patent which claims the drug ... or which claims a method of using such drug.” 21 U.S.C. § 355(b)(1). After approval, information about the branded drug, including patent information, is published by the FDA in a publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is generally called the “Orange Book,” after the color of its cover. {See D.I. 360, Ex. A at ¶ 35.)

The Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), codified at 21 U.S.C. §§ 355, 360cc and 35 U.S.C. §§ 156, 271, 282, provides a framework for the introduction of generic versions of previously approved branded drugs. Under that framework, a generic manufacturer may submit an Abbreviated New Drug Application (“ANDA”) to the FDA. 21 U.S.C. § 355(j). (D.I. 360, Ex. A at ¶ 34.) The ANDA process allows the generic manufacturer to incorporate efficacy and safety data submitted to the FDA in the NDA for a branded drug, as long as the generic drug is shown to be bioequivalent to that branded drug. 21 U.S.C. § 355(j)(2)(A). (D.I. 360, Ex. A at ¶ 34.)

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Abbott Laboratories v. Teva Pharmaceuticals USA, Inc., 432 F. Supp. 2d 408, 2006 U.S. Dist. LEXIS 33952, 2006 WL 1460077 (D. Del. 2006).

432 F. Supp. 2d 408 (Abbott Laboratories v. Teva Pharmaceuticals USA, Inc.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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