KING DRUG CO. OF FLORENCE, INC. v. Cephalon, Inc.

702 F. Supp. 2d 514, 2010 U.S. Dist. LEXIS 29905, 2010 WL 1221793
CourtDistrict Court, E.D. Pennsylvania
DecidedMarch 29, 2010
DocketCivil Action 2:06-cv-1797, 2:06-cv-1833, 2:06-cv-2768, 2:08-cv-2141
StatusPublished
Cited by9 cases

This text of 702 F. Supp. 2d 514 (KING DRUG CO. OF FLORENCE, INC. v. Cephalon, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
KING DRUG CO. OF FLORENCE, INC. v. Cephalon, Inc., 702 F. Supp. 2d 514, 2010 U.S. Dist. LEXIS 29905, 2010 WL 1221793 (E.D. Pa. 2010).

Opinion

MEMORANDUM OPINION

GOLDBERG, District Judge.

Currently pending are Defendants’ motions to dismiss the antitrust complaints filed by numerous parties. 1 The issue raised in these motions is whether Plain *518 tiffs have pled sufficient antitrust allegations pursuant to the Sherman Antitrust Act,15 U.S.C. §§ 1, 2, to survive Defendants’ motions to dismiss. The answer to this question necessitates a somewhat protracted review of divergent precedent regarding the appropriate framework to apply in analyzing what is commonly referred to as a “reverse payment settlement.” These settlements are typically entered into as a result of patent litigation between a brand name drug manufacturer and generic drug manufacturers. The multi-party antitrust litigation before the Court stems from four (4) such reverse payment settlements consummated in late 2005 and early 2006, regarding the drug Provigil®. 2 The agreements at issue were between the pharmaceutical company Cephalon, Inc., and several generic drug manufacturers (hereinafter “the Generic Defendants”), all of whom are Defendants in the cases before this Court. Plaintiffs generally allege that these agreements constitute an unlawful restraint of trade. For the reasons detailed below, except for selected counts brought under several state statutes, Defendants’ motions will be denied.

1. BACKGROUND

A. Structure of the Litigation and Parties

Sixteen (16) separate cases, many of which are class actions, commenced as a result of the patent litigation settlements noted above. These cases are now collectively referred to as the In re Modafinil litigation and were consolidated into four (4) subcategories pursuant to FED. R. CIV. P. 42(a). These subcategories are: The King Drug Direct Purchaser Class Action; The Vista Healthplan End Payor Class Action; The Apotex Litigation; and The F.T.C. Litigation. A brief description of the Plaintiffs in each of the four (4) cases is as follows:

All direct purchaser proposed class action cases were consolidated into King Drug Co. of Florence, Inc., et al. v. Cephalon, Inc., et al., 2:06-cv-1797. 3 The Plaintiffs in these cases are companies who directly purchased Provigil® from Cephalon for re-distribution. The end payor proposed class action cases were consolidated into Vista Healthplan, Inc., et al. v. Cephalon, Inc., et al., 2:06-cv-1833. 4 This *519 group of Plaintiffs includes individuals who indirectly purchased Provigil® and companies who paid for those purchases. The third case involves a generic drug manufacturer, Apotex, who has raised non-infringement and. patent invalidity allegations, as well as antitrust claims in Apotex, Inc. v. Cephalon, Inc., et al., 2:06-cv-2768, 2010 WL 678104. 5 Finally, the Federal Trade Commission (hereinafter “F.T.C.”) has brought Sherman Act claims in Fed. Trade Comm’n v. Cephalon, Inc., 2:08-cv-2141.

The Defendants in each of these cases are the parties who entered into four (4) reverse settlement agreements: Cephalon and the Generic Defendants-Barr Laboratories, Inc.; Mylan Laboratories, Inc.; Teva Pharmaceutical Industries, Ltd., and Teva Pharmaceuticals USA, Inc.; and Ranbaxy Laboratories, Ltd., and Ranbaxy Pharmaceuticals, Inc.

B. Procedural History-In re Modafinil Litigation

The In re Modafinil litigation commenced when The King Direct Purchaser Class Action was filed on April 27, 2006, in the Eastern District of Pennsylvania. The Vista Healthplan End Payor Class Action was filed three (3) days later on May 1, 2006, followed by The Apotex Litigation on June 26, 2006. Nine (9) other related cases were filed later in 2006 and 2007. The F.T.C. Litigation was filed on February 13, 2008, in the United States District Court for the District of Columbia and subsequently transferred to this Court on April 28, 2008. 6

On April 28, 2009, all of the cases referenced above were re-assigned to the undersigned. At that time, eighteen (18) separate motions were pending, including the motions to dismiss at issue, which were denied without prejudice. The filing of amended consolidated complaints then followed as did Cephalon and the Generic Defendants’ filing of consolidated motions to dismiss which are currently before the Court. 7

C. The Drug at Issue

The U.S. Food and Drug Administration (hereinafter “FDA”) approved Cephalon’s New Drug Application (hereinafter “NDA”) No. 20-717 for Provigil® on December 24,1998. Provigil® is a prescription drug used to promote wakefulness in adults with sleep disorders such as shift work disorder, obstructive sleep apnea and narcolepsy. Modafinil, the main pharmacological component of Provigil®, is á psychostimulant that enhances wakefulness and vigilance. Modafinil is an acetamide that is prescribed in 100 mg and 200 mg tablets and has the efficacy and side effects similar to amphetamines and methylphenidates (e.g., Ritalin®), but those drugs are not reasonably interchangeable with Provigil®. Cephalon’s sales of Provigil® exceeded $420 million in 2004,$500 million in 2005, $690 million in 2006,$800 million in 2007, and $920 million in 2008. (See Apotex Second Am. Compl., ¶¶ 20, 39-40, 75.)

D. Statutory and Regulatory Framework-The Hatch-Waxman Act

The circuit court cases that are reviewed later in this Opinion provide an extensive *520 analysis of the statutory and regulatory framework of the Hatch-Waxman Act. Consequently, we will not re-plow the same ground here, but rather summarize portions of the Act that are pertinent to the issues currently before the Court.

Typically, through the submission of a NDA a pharmaceutical company must obtain approval from the FDA to market a prescription drug. This application details all safety and efficacy studies, the components in the drug, the methods used in “the manufacture, process and packaging” of the drug, and any patents issued on the composition or methods of using the drug. 21 U.S.C. § 355(b)(1). The FDA publishes the patent information in the “Approved Drug Products with Therapeutic Equivalence Evaluations,” otherwise known as the “Orange Book.” See FDA Electronic Orange Book (Jan. 2010), http://www.fda. gov/cder/ob/.

Prior to 1984, a generic drug company also had to undertake its own costly studies regarding the efficacy and safety of a drug and file its own NDA. See Schering-Plough Corp. v. Fed. Trade Comm’n,

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702 F. Supp. 2d 514, 2010 U.S. Dist. LEXIS 29905, 2010 WL 1221793, Counsel Stack Legal Research, https://law.counselstack.com/opinion/king-drug-co-of-florence-inc-v-cephalon-inc-paed-2010.