Pp. 770 – 777. 427 F.3d 958, reversed and remanded. SCALIA, J., delivered the opinion of the Court, in which ROBERTS, C.J., and STEVENS,KENNEDY, SOUTER, GINSBURG, BREYER, and ALITO, JJ., joined.

Clemens v. DaimlerChrysler Corp. , 534 F.3d 1017, 1022 (9th Cir.2008) (quoting Bell Atl. Corp. v. Twombly , 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ); Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (stating that a “claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged”). Furthermore, the Federal Circuit has found the heightened pleading standard under Rule 9(b) applies to allegations of inequitable conduct, Exergen Corp. v. Wal–Mart Stores, Inc. , 575 F.3d 1312, 1326 (Fed.Cir.2009), and antitrust violations based on fraud on the U.S. Patent and Trademark Office (“PTO”), Medimmune, Inc. v. Genentech, Inc. , 427 F.3d 958, 967 (Fed.Cir.2005), overruled on other grounds , 549 U.S. 118, 127 S.Ct. 764, 166 L.Ed.2d 604 (2007). Rule 9(b) states that “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake,” and it “requires identification of the specific who, what, when, where, and how” of the alleged fraud or inequitable conduct, Exergen , 575 F.3d at 1327.

February 21, 2006.Reported below: 427 F. 3d 958.Certiorari Granted.

In addition, "[l]ike all fraud-based claims, Walker Process allegations are subject to the pleading requirements of Fed. R. Civ. P. 9(b)." MedImmune, Inc. v. Genentech, Inc., 427 F.3d 958, 967 (Fed. Cir. 2005), rev'd on other grounds, 549 U.S. 118, 127 S.Ct. 764, 166 L.Ed.2d 604 (2007). That means that the party alleging the fraud, with respect to elements not bearing on the "conditions of a person's mind," "must state with particularity the circumstances constituting fraud."

ORDER In MedImmune, Inc. v. Genentech, Inc., ___ U.S. ___, 127 S.Ct. 764, 166 L.Ed.2d 604 (2007), the Supreme Court reversed this court's decision, reported at 427 F.3d 958 (Fed. Cir. 2005), and remanded with instructions that the lower court consider the issues flowing from the Court's decision that Medimmune "was not required, insofar as Article III is concerned, to break or terminate its 1997 license agreement before seeking a declaratory judgment in federal court that the underlying patent is invalid, unenforceable, or not infringed." The Court "express[ed] no opinion on . . . the applicability of licensee estoppel under [the] circumstances" of the case at bar, id. at 769-70, and declined to affirm the dismissal of the declaratory judgment claims on discretionary grounds, the Court "leav[ing] the equitable, prudential, and policy arguments in favor of such a discretionary dismissal for the lower courts' consideration on remand."

The heightened pleading requirements of Rule 9(b) apply to causes of action for inequitable conduct, unclean hands, and Walker Process claims. See Senju Pharm., 921 F. Supp. 2d at 306 (applying Rule 9(b) standard to inequitable conduct); Cephalon, Inc. v. Slayback Pharma Ltd. Liab. Co., C.A. No. 17-1154-CFC, 2019 WL 3497105, at *1 (D. Del. Aug. 1, 2019) (applying Rule 9(b) standard to causes of action for unclean hands based on allegations of inequitable conduct); MedImmune, Inc. v. Genentech, Inc., 427 F.3d 958 (Fed. Cir. 2005), rev'd on other grounds, 549 U.S. 118 (2007) ("Like all fraud-based claims, Walker Process allegations are subject to the pleading requirements of Fed. R. Civ. P. 9(b).").

The heightened pleading requirements of Rule 9(b) apply to causes of action for inequitable conduct, unclean hands, and Walker Process claims. See Senju Pharm., 921 F. Supp. 2d at 306 (applying Rule 9(b) standard to inequitable conduct); Cephalon, Inc. v. Slayback Pharma Ltd. Liab. Co., C.A. No. 17-1154-CFC, 2019 WL 3497105, at *1 (D. Del. Aug. 1, 2019) (applying Rule 9(b) standard to causes of action for unclean hands based on allegations of inequitable conduct); MedImmune, Inc. v. Genentech, Inc., 427 F.3d 958, (Fed. Cir. 2005), rev'd on other grounds, 549 U.S. 118 (2007) ("Like all fraud-based claims, Walker Process allegations are subject to the pleading requirements of Fed. R. Civ. P. 9(b).").

Id. at 122, 127 S.Ct. 764. During litigation of the declaratory judgment action, an issue arose as to whether there was an actual controversy in light MedImmune's payment of the disputed fees. The lower courts concluded that there was no case or controversy because MedImmune's payment of the disputed fees eliminated any threat of imminent harm. MedImmune, Inc. v. Genentech, Inc. , 427 F.3d 958, 962–63 (Fed. Cir. 2005). That is, because the payments were being made, MedImmune was not at risk of being sued, being found liable for treble damages, or enjoined from making sales of the product at issue.

The Federal Circuit explained in Medimmune, Inc. v. Genentech, Inc. that "[l]ike all fraud-based claims, Walker Process allegations are subject to the pleading requirements of Fed. R. Civ. P. 9(b)." 427 F.3d 958, 967 (Fed. Cir. 2005), rev'd and remanded on other grounds, 549 U.S. 118 (2007) (citing Vess, 317 F.3d at 1103-04). Further, the Federal Circuit applies its "own law, not the law of the regional circuit, to the question of whether inequitable conduct has been pleaded with particularity under Rule 9(b)," Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1326 (Fed. Cir. 2009), because it "pertains to or is unique to patent law," Cent. Admixture Pharmacy Servs., Inc. v. Advanced Cardiac Solutions, P.C., 482 F.3d 1347, 1356 (Fed. Cir. 2007) (quotation marks omitted).

Walker Process allegations are subject to the pleading requirements of Fed. R. Civ. P. 9(b). Medimmune, Inc. v. Genentech, Inc., 427 F.3d 958, 967 (Fed. Cir. 2005), overruled on other grounds by Medimmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007). In support of its monopoly allegations, Dawgs states that Crocs and Seamans, with the assistance of defendants, "fraudulently procured patents from the U.S. Patent Office by failing to disclose proper inventorship as well as known material, invalidating prior art, and prior sales."