Bayer Pharma AG v. Watson Labs., Inc.

After a ruling of patent validity and infringement, the court did not impose a permanent injunction where patentee, given its highly speculative arguments of a premature ANDA product launch, failed to show irreparable harm and lack of an adequate remedy at law.

January 23, 2017

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name:Bayer Pharma AG v. Watson Labs., Inc., 12-1726-LPS, 2016 U.S. Dist. LEXIS 179103 (D. Del. Dec. 28, 2016) (Stark, J.)

Drug Product and Patent(s)-in-Suit: Natazia® (estradiol valerate/estradiol valerate/dienogest); U.S. Patents No. 8,071,577 (“the ’577 patent”)

Nature of the Case and Issue(s) Presented: After a bench trial, the court ruled that Watson’s ANDA product would infringe Bayer’s valid ’577 patent. The parties disagreed on a form of final judgment. The parties agreed that the court must enter judgment for Bayer and against Watson. The parties further agreed that the relief the court will provide Bayer must include an order that the FDA reset the approval date of Watson’s ANDA until after the expiration of the ’577 patent. But the parties disagree whether the court should additionally enter an order enjoining Watson from infringing the patent-in-suit before it expires. Bayer sought the additional injunctive relief against Watson “because otherwise there is no Court Order preventing [Defendant] from infringing the [patent-in-suit] before it expires.” In the absence of an injunction, Bayer may “have to undertake additional, duplicative infringement litigation in order to enforce a patent that has already been found valid and infringed.” Watson responds that an injunction is discretionary, not mandatory, and that Bayer has failed to meet its burden to show it needs one in this case. Moreover, Watson reasons that a permanent injunction here would be redundant given the court’s order on the FDA. The court framed the issue as follows: “whether to limit Defendant solely to research activities that are within the Hatch-Waxman Act’s “safe harbor,” 35 U.S.C. § 271(e)(1), or whether instead to allow Defendant to engage in all research and pre-commercialization activity that could precede a launch of a generic product.” The parties briefed the dispute and the Court determined that Bayer failed to show that its requested permanent injunction was warranted.

Why Watson Prevailed: Bayer argued that it had already suffered irreparable harm because “as a direct consequence of Watson’s ANDA filing, it became economically irrational for Bayer to promote Natazia.” Bayer will suffer further irreparable harm based on speculative “illegal activity” that Watson may undertake if a permanent injunction is not in place. The court disagreed, finding that Bayer failed to show that it will suffer irreparable harm in the absence of its requested permanent injunction. The court faulted Bayer for not presenting enough evidence to support its claim that it will be irreparably harmed in the absence of an injunction. Moreover, although Bayer suggests that it has already been harmed due to changing its marketing plans for Natazia, Bayer has not proven that Watson’s ANDA filing caused those changes. Additionally, the possible necessity of future litigation with Watson is slight, and litigation costs cannot support a finding of irreparable harm.

The court also found that Bayer failed to show that the remedies available to it at law are inadequate. The costs of litigation, including any future litigation, are quantifiable and can be compensated by money damages. Also, Bayer’s fear of a “premature product launch” is unfounded given the implications that Watson would face in launching its ANDA product without FDA approval. Thus, Bayer has not demonstrated that legal remedies are inadequate.

Although the court found that Bayer succeeded in showing that the balance of harms and the public interest do support the additional requested injunction, weighing all of the pertinent considerations, the court determined that the most reasonable exercise of its discretion is to deny the requested permanent injunction.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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