![]() Instead, the court found the evidence showed Bayer’s marketing plans were changed because of the timing of FDA approval of other indications. First, the court agreed with Watson that Bayer had not provided any data that the filing of Watson’s ANDA would lead to lost revenues or that Bayer’s changes to its marketing plans for Natazia was due to Watson’s ANDA. In analyzing irreparable harm, the court found Bayer’s arguments speculative. While the court found that the balance of hardships and public interest slightly favored Bayer, the court denied the permanent injunction because Bayer did not establish irreparable harm or that the remedies available at law would be inadequate. Instead, the court applied the eBay factors, finding Bayer failed to create a record to justify a permanent injunction. In denying Bayer’s request, the court first dispensed with the notion that all patentees prevailing in an ANDA case are entitled to a permanent injunction. 271(e)(1) or to allow Watson to conduct all research and pre-commercialization activity that could precede launching its generic product. 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. 28, 2016) (Stark, J.).Īfter 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. ![]() Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent InjunctionĪpplying 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. ![]()
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