Nifedipine Antitrust Litigation, Civil Action No: 1:03-MS-223(RJL), MDL No. 1515 (D.D.C.)

Hon. Richard J. Leon, District of the District of Columbia

Class Period: December 4, 2000 – December 31, 2005

Attorneys:

Robert N. Kaplan

RKaplan@kaplanfox.com

Kaplan Fox is a court appointed co-lead counsel for the Direct Purchaser Class Plaintiffs in this case. Plaintiffs claim that Defendants, including Biovail Corporation, Elan Corporation plc, and Teva Pharmaceuticals USA, Inc., engaged in a combination or conspiracy to restrain trade in the market for the generic Adalat CC, in violation of Section 1 of the Sherman Act.

Adalat CC (whose active ingredient is nifedipine) is a branded drug, sold by Bayer, which has been approved by the FDA to treat hypertension. Biovail and Elan separately filed abbreviated new drug applications to obtain FDA approval for generic versions of the drug. Elan was the first to obtain approval for the 30 mg dosage strength, and Biovail was the first to obtain approval for the 60 mg dosage strength. Each of them also received approval to market the competing dosage strengths, but failed to bring those products to market.

Specifically, Plaintiffs allege that Defendants entered into an agreement to allocate the market for generic Adalat CC. Pursuant to this agreement, Elan, which was the first to come to market with a 30 mg product, refrained from launching its 60 mg product in competition with Biovail, and Biovail, which had the initial 60 mg product, refrained from launching its 30 mg product in competition with Elan. Teva participated in the negotiation of this agreement, and served the vital role of the exclusive distributor for all generic versions of Adalat CC, with the profits being split among Biovail, Elan and Teva. This allegedly unlawful agreement was finally unwound by the FTC in 2004, and competing generic products were thereafter brought to market, resulting in reduced prices. Plaintiffs claim that they were forced to pay non-competitive prices for 30 mg and 60 mg generic Adalat CC as a result of this anti-competitive agreement.

By Opinion and Order dated September 1, 2004, the Court upheld Plaintiffs’ Second Amended Consolidated Class Action Complaint, 335 F.Supp. 2d 6 (D.D.C. 2004). Thereafter, by Opinion dated November 21, 2007, the Court granted Plaintiffs’ motion to certify a class of direct purchasers of generic Adalat CC class certification, 246 F.R.D. 365 (D.D.C. 2007). Motions for summary judgment have been argued and are pending.