Teva Pharmaceuticals USA, Inc. v. Abbott Laboratories

252 F.R.D. 213, 2008 U.S. Dist. LEXIS 63331, 2008 WL 3849696
CourtDistrict Court, D. Delaware
DecidedAugust 18, 2008
DocketCiv. Nos. 02-1512-SLR, 05-340-SLR, 05-360-SLR, 03-120-SLR
StatusPublished
Cited by7 cases

This text of 252 F.R.D. 213 (Teva Pharmaceuticals USA, Inc. v. Abbott Laboratories) is published on Counsel Stack Legal Research, covering District Court, D. Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Teva Pharmaceuticals USA, Inc. v. Abbott Laboratories, 252 F.R.D. 213, 2008 U.S. Dist. LEXIS 63331, 2008 WL 3849696 (D. Del. 2008).

Opinion

MEMORANDUM OPINION

ROBINSON, District Judge.

I. INTRODUCTION

Presently before the court is plaintiffs’ Louisiana Wholesale Drug Co., Inc. (“LWD”), Rochester Drug Co-Operative, Inc. (“RDC”) and Meijer, Inc. and Meijer Distribution, Inc. (together, “Meijer”) (collec[220]*220tively, the “direct purchaser plaintiffs” or the (“proposed DPP class”)) motion for class certification pursuant to Federal Rules of Civil Procedure 23(a) and 23(b)(3).1 (D.I. 106, D.I. 107 at 1-2) Also before the court is the indirect purchaser plaintiffs’ motion for class certification pursuant to Federal Rules of Civil Procedure 23(a), 23(b)(2) and 23(b)(3).2 (D.I.116) Defendants are Abbott Laboratories (“Abbott”) and Fournier Industrie et Sante’ and Laboratories Fournier S.A. (together, “Fournier”) (collectively, “defendants”). (D.I. 107 at 1) The direct purchaser and indirect purchaser plaintiffs assert that defendants engaged in anticompetitive conduct, (Id.) More specifically, they allege that defendants, through an overarching scheme, impeded the market entry of the generic version of TRICOR®, a brand name drug used to control levels of cholesterol and triglycerides. (See id.; Civ. No. 05-360, D.I. 24) In particular, direct and indirect purchaser plaintiffs contend that defendants manipulated the statutory framework that regulates pharmaceutical drugs to maintain monopoly power. (See id.) For the reasons that follow, the direct purchaser plaintiffs’ motion (D.I.106) is granted. The indirect purchaser plaintiffs’ motion (Civ. No. 05-360, D.I.116) is [granted in part and denied in part].3

II. BACKGROUND4

Plaintiffs assert that defendants instituted a multi-faceted scheme, which manipulated the statutory framework as set forth in the Hatch Waxman Act, to maintain a monopoly position in the market, consisting of: (1) “sham” litigations; (2) product conversions; and (3) other intentional wrongful behavior designed to further a monopoly, as discussed in more detail below.

TRICOR® is a drug that is used to reduce high-levels of low-density lipoprotein cholesterol (“LDL-C”) or “bad cholesterol,” and of triglycerides by promoting the dissolution and elimination of fat particles in the blood. (Id. at ¶ 42) TRICOR® increases levels of high-density lipoprotein cholesterol (“HDL-C”) or “good cholesterol,” and reduces LDL-C in patients with primary hypercholesterolemia (high bad cholesterol) or mixed dyslipidemia (high bad cholesterol and high triglycerides). (Id.) TRICOR® also effectively reduces triglycerides in patients with hypertriglyceridemia (high triglycerides). (Id.) The active pharmaceutical ingredient in TRI-COR® is fenofibrate. (Id.)

Fenofibrate is a fibrate.5 (Id. at ¶43) Fibrates, statins, bile acid sequestrants and niacin are categories of cholesterol-lowering drugs. (Id.) Each category has different side effects and different efficacy profiles for reducing LDL-C, raising HDL-C and lowering triglycerides. (Id.) According to plaintiffs, a cholesterol-lowering drug from one category is not reasonably interchangeable with a drug from another category; consequently, TRICOR® occupies an unique niche, defined by its efficacy in controlling levels of HDL-C, LDL-C and triglycerides. (Id. at ¶45)

[221]*221In 1997, Fournier granted Abbott an exclusive license to U.S. Patent No. 4,895,726 (the “Curtet Patent” or “the '726 patent”), which claims a formulation of fenofibrate. (Id. at ¶46) Defendants submitted separate New Drug Applications (“NDA”) for three strengths of branded fenofibrate capsules.6 (Id.) The FDA approved the TRICOR® 67 mg capsule NDA on February 9, 1998 and the TRICOR® 134 mg and 200 mg capsule NDAs on June 30, 1999. (Id.) Defendants marketed each of these capsule products (collectively, “TRICOR®-A”) shortly after receiving FDA approval and successfully sold TRICOR0-A throughout 2000 and 2001. (Id.) In connection with the TRICOR®-A fenofibrate capsules, Abbott submitted the '726 patent to the FDA for listing in the Orange Book. (Civ. No. 05-360, D.I. 24 at ¶ 49)

On December 14, 1999, Novopharm Limited (“Novopharm”), which was subsequently acquired by Teva,7 filed an Abbreviated New Drug Application (“ANDA”) with the FDA.8 (Id. at ¶ 62) Teva’s ANDA requested approval to market generic fenofibrate 67 mg capsules (the “Teva Capsule ANDA”) before the expiration of the '726 patent. (Id.) Novopharm later amended the Teva Capsule ANDA to request approval to market generic fenofibrate 134 mg and 200 mg capsules.9 (Id.) In connection with the Teva Capsule ANDA, Novopharm certified under Paragraph IV that the proposed generic fenofibrate capsule did not infringe the '726 patent. (Id.) On May 9, 2000, Impax10 also filed an ANDA for TRICOR®-A (the “Impax Capsule ANDA”), similarly seeking to market its fenofibrate capsules prior to the expiration of the '726 patent. (Id. at ¶ 63) Impax certified under Paragraph IV that its product did not infringe the '726 patent. (Id.)

On or about April 7, 2000, August 18, 2000 and March 19, 2001, respectively, defendants initiated a series of infringement actions in the United States District Court for the Northern District of Illinois against Teva, its subsidiary Novopharm, and Impax alleging that the generic manufacturers had infringed the '726 patent under 35 U.S.C. § 271(e)(2) (these three suits, collectively, referred to as the “Illinois Litigation”). (Id. at ¶ 65) These suits, under the Hatch-Waxman Act, imposed thirty-month stays on FDA approval for Teva’s and Impax’s products.11 (Id. at ¶ 66)

On March 19, 2002, the Illinois district court granted Teva’s motion for summary judgment of non-infringement and the Federal Circuit subsequently affirmed. (Id. at ¶¶ 68, 73-75) While the appeal before the Federal Circuit was pending, Teva received FDA approval to market its 67 mg, 134 mg and 200 mg capsules on April 9, 2002.12 (Id. at ¶ 76) Teva’s 134 mg and 200 mg capsules entered the market shortly thereafter.13 (Id.)

[222]*222Defendants, during the pendency of the Illinois Litigation, started to develop a tablet formulation of TRICOR®, in 54 mg and 160 mg strengths (“TRICOR®-B”). (Id. at ¶ 79) On September 4, 2001, defendants obtained FDA approval to market TRICOR®-B.14 (Id. at ¶ 80) Defendants marketed the TRI-COR®-B tablets, stressing that TRICOR®B had an additional indication for HDL effect, while TRICOR®-A had not been approved for HDL treatment. (Civ. No. 05-360, D.I. 24 at ¶ 53) According to direct purchaser plaintiffs, however, TRICOR®-B did not provide the public with a better or improved product because it contained the same drug as the earlier-approved capsules, was therapeutically equivalent, and bioequivalent to the capsules. (D.I.

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Bluebook (online)
252 F.R.D. 213, 2008 U.S. Dist. LEXIS 63331, 2008 WL 3849696, Counsel Stack Legal Research, https://law.counselstack.com/opinion/teva-pharmaceuticals-usa-inc-v-abbott-laboratories-ded-2008.