ANDA Update - March 2017 Volume 3, Number 1

McDermott Will & Emery
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Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction -

Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) -

Applying the eBay factors to Plaintiff Bayer's request for permanent injunction, the US District Court for the District of Delaware denied the request because Bayer failed to establish irreparable harm and that the remedies at law were inadequate. Bayer Pharma AG, et al. v. Watson Laboratories, Inc., Case No. 12-cv-1726, (D. Del. Dec. 28, 2016) (Stark, J.).

After finding Bayer's patent not invalid and infringed by defendant Watson's proposed generic of Natazia®, a combination estrogen/progestin oral contraceptive, the parties agreed to enter an order resetting the US Food and Drug Administration (FDA) approval date of Watson's abbreviated new drug application (ANDA) until after expiration of Bayer's patent, but disputed whether the court should enter a permanent injunction against Watson. The court framed the dispute as whether to limit Watson's activities following its finding of infringement to only those within the "safe harbor" of 35 U.S.C. 271(e)(1) or to allow Watson to conduct all research and pre-commercialization activity that could precede launching its generic product.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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