Request for Permanent Injunction Precluding ANDA Infringer’s Pre-Launch Commercialization Activities Denied​

Following a bench trial, the court denied plaintiffs' motion for a permanent injunction precluding infringement of its contraceptive drug patent because plaintiff failed to establish irreparable harm or inadequate remedies at law. "The parties agree . . . that the relief the Court provides Plaintiffs must include an order that the [FDA] reset the approval date of Defendant's [ANDA] until after the expiration of the [patent-in-suit. The parties disagree as to whether the Court should additionally enter an order enjoining Defendant from infringing the patent-in-suit before it expires. . . . Effectively, the parties' dispute seems to be whether to limit Defendant solely to research activities that are within the Hatch-Waxman Act's 'safe harbor,' 35 U.S.C. § 271(e)(l), or whether instead to allow Defendant to engage in all research and pre-commercialization activity that could precede a launch of a generic product. . . . [Plaintiff’s] position largely relies on a series of speculations as to ‘illegal activity’ [defendant] might undertake if the Court does not grant [plaintiff] its full requested relief, such as ‘manufacture, importation, offers to sell, or the use of its generic ANDA product’ and ‘working with and licensing with a third party for purposes of facilitating a second ANDA filing behind the veil of the third party company. . . . It is true . . . that [defendant] seeks to be a direct competitor of [plaintiffs] in the market for [plaintiff's drug product] and has committed an 'act of infringement' (albeit an 'artificial' act) by filing an ANDA. But these facts alone are insufficient to establish irreparable harm in all ANDA cases. . . . While Defendant's launch of a generic product during the life of the patent is the type of activity that could result in irreparable harm to [plaintiffs], Plaintiffs' speculation that Defendant will risk criminal sanctions by launching its generic product into the market without FDA approval strikes the Court as entirely unfounded, and FDA approval will not happen until after the expiration of the patent. Moreover, the possible necessity of future litigation with Defendants is slight, and litigation costs cannot support a finding of irreparable harm."

Bayer Pharma AG et al v. Watson Laboratories Inc., 1-12-cv-01726 (DED December 28, 2016, Order) (Stark, USDJ)