Meritless Claim for Declaration of ANDA Infringement by Possible Future Drug Formulation Justifies Award of Attorney Fees under 35 U.S.C. § 285​

The court granted defendants' motion for attorney fees under 35 U.S.C. § 285 because plaintiffs' infringement claim against defendant's operative ANDA and plaintiff's claim for a declaration of infringement by possible future products were baseless. "While Plaintiffs repeatedly argued that it only alleged current patent infringement to trigger Hatch-Waxman review of 'the product that Defendant . . . will likely market if its ANDA receives final FDA approval,' the Court found that [plaintiff's] legal theory was completely unsupported by case law and ignored the existing legal safeguards against Defendants’ potential future infringing conduct. . . . [Plaintiffs] failed to allege that Defendants were engaged in any specific activities to alter their drug formulation to infringe the patents-in-suit and even acknowledged in briefing that the focus of the case was to determine through discovery how [plaintiffs] intended to proceed through the FDA approval process. Ultimately, the absence of credible allegations or evidence that [plaintiffs] would face immediate, irreparable harm absent declaratory relief, caused the Court to conclude the declaratory judgment counts were 'not ripe for adjudication.'"

Par Pharmaceutical, Inc. et al v. Luitpold Pharmaceuticals, Inc. et al, 2-16-cv-02290 (NJD April 24, 2017, Order) (Walls, USDJ)