Celgene Corp. v. Teva Pharms. USA, Inc. (412 F. Supp. 2d 439, 2006)

OPINION

CHESLER, District Judge.

I. INTRODUCTION

In this Hatch-Waxman Act patent infringement case, defendant Teva Pharmaceuticals USA, Inc. (“Teva”) moves pursuant to Federal Rule of Civil Procedure 12(c) for judgement on the pleadings with respect to plaintiffs Celgene Corporation, Novartis Pharmaceuticals Corporation, and Novartis Pharma AG’s (collectively “plaintiffs”) allegation of willful infringement. For the reasons that follow, Teva’s motion is GRANTED.

II. BACKGROUND

A. The Hatch-Waxman Act

The Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-99, (“FDCA”) provides that a company seeking to market a new brand-name drug must submit a New Drug Application (“NDA”). See id. § 355(b)(1). NDAs are generally lengthy applications that include information about the drug such as evidence of its safety and effectiveness, and information about the patents that cover or might cover it. Id. Before Congress passed the Hatch-Waxman Act, a generic drug manufacturer’s use of a patented drug was considered patent infringement. This was so even if such use of the patented drug was limited to testing for Food and Drug Administration (“FDA”) approval to market its generic equivalent upon expiration of the relevant patents. Accordingly, companies seeking to market generic drugs upon the expiration of patents that covered them were impeded by the cost of filing lengthy NDAs, which they could begin to prepare only upon the expiration of the brand-name drug company’s patents. The time it took generic companies to prepare the NDA and obtain FDA approval caused a de facto extension of the patent covering the brand-name drug.

Recognizing the benefit in reducing delays in FDA approval of generic drugs, and as a means to eliminate the de facto extension of the end of a patent term, Congress enacted the Hatch-Waxman Act amendments to the FDCA. The HatchWaxman Act conferred two main benefits upon generic drug manufacturers. First, it allowed them to avoid the costly NDA process by filing an Abbreviated New Drug Application (“ANDA”) which, in effect, “ ‘piggybacked]’ on the safety-and-effectiveness information that the brand-name manufacturers submitted in their NDAs.” Purepac Pharm. Co. v. Thompson, 354 F.3d 877, 879 (D.C.Cir.2004) (citing 21 U.S.C. § 355(j)(2)(A) and 21 C.F.R. § 314.94(a)(3)). Thus, among other things, an ANDA must show the proposed generic drug is chemically bioequivalent to a drug that was previously approved by the FDA. 21 U.S.C. § 365