This appeal has returned to us on remand from the Supreme Court of the United States. In their earlier appearance in this court, Amgen Inc. and Amgen Manufacturing Ltd. (collectively, “Amgen”) appealed from the decision of the United States District Court for the Northern District of California (1) granting partial judgment on the pleadings to Sandoz Inc. (“Sandoz”) on its counterclaims seeking a declaratory judgment interpreting the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), Pub. L. No. 111-148, §§ 7001–7003, 124 Stat. 119, 804–21 (2010) (codified as amended at 42 U.S.C. § 262, 35 U.S.C. § 271(e), 28 U.S.C. § 2201(b), 21 U.S.C. § 355 et seq.); (2) dismissing with prejudice Amgen’s unfair competition claims asserting unlawful business practices under California Business & Professions Code § 17200 et seq. (“UCL”) and conversion claims (collectively, the “state law claims”); and (3) denying Amgen’s motion for a preliminary injunction based on its state law claims. Amgen Inc. v. Sandoz Inc., No. 14-cv-04741, 2015 WL 1264756 (N.D. Cal. Mar. 19, 2015) (“Opinion”).
Following full briefing and oral argument, we affirmed the dismissal of Amgen’s state law claims, vacated the judgment on Sandoz’s counterclaims, directed the district court to enter judgment on those counterclaims consistent with our opinion, and remanded for further proceedings. See Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015), rev’d in part, vacated in part, 137 S. Ct. 1664 (2017).
In particular, we held that under 42 U.S.C. § 262(l)(8)(A) “a subsection (k) applicant may only give effective notice of commercial marketing after the FDA has licensed its product.” Id. at 1357. In addition, we held that the “shall” provision in paragraph (l)(2)(A) did not mean “must” and concluded that “when a subsection (k) applicant fails the disclosure requirement [of § 262(l)(8)(A)], 42 U.S.C. § 262(l)(9)(C) and 35 U.S.C. § 271(e) expressly provide the only remedies as those being based on a claim of patent infringement.” Id. at 1355–57.
Both parties petitioned for rehearing en banc, which this court denied. See Amgen Inc. v. Sandoz Inc., No. 15- 1499, slip op. (Fed. Cir. Oct. 16, 2015). Sandoz then filed a petition for a writ of certiorari in the Supreme Court presenting the following questions: “Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating Section 262(l)(8)(A) as a standalone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper.” Petition for a Writ of Certiorari at ii, Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017) (No. 15-1039).
Amgen subsequently filed a conditional cross-petition for a writ of certiorari presenting the following questions:
Is an Applicant required by 42 U.S.C. § 262(l)(2)(A) to provide the Sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the Applicant “shall provide,” and, where an Applicant fails to provide that required information, is the Sponsor’s sole recourse to commence a declaratory-judgment action under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 27l(e)(2)(C)(ii)?
Conditional Cross-Petition for a Writ of Certiorari at ii, Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017) (No. 15- 1195). The Supreme Court granted both Sandoz’s petition and Amgen’s conditional cross-petition and consolidated the cases for briefing and oral argument. Sandoz Inc. v. Amgen Inc., 137 S. Ct. 808 (2017). The United States filed a brief and argued as amicus curiae.
On June 12, 2017, the Court announced its decision. Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017). The Court held that an injunction under federal law is not available to enforce 42 U.S.C. § 262(l)(2)(A); and a biosimilar applicant may provide the notice required by 42 U.S.C. § 262(l)(8)(A) either before or after receiving FDA approval, i.e., the applicant need not defer giving notice of commercial marketing until FDA licensure of the biosimilar in order to begin the running of the 180-day clock. Id. at 1674, 1677. The Court reversed our decision in part and vacated it in part and remanded the case for further proceedings consistent with its opinion. The Court directed:
On remand, the Federal Circuit should determine whether California law would treat noncompliance with § 262(l)(2)(A) as “unlawful.” If the answer is yes, then the court should proceed to determine whether the BPCIA pre-empts any additional remedy available under state law for an applicant’s failure to comply with § 262(l)(2)(A) (and whether Sandoz has forfeited any preemption defense, see 794 F.3d, at 1360, n. 5). The court is also of course free to address the preemption question first by assuming that a remedy under state law exists. Id. at 1676–77.
Following remand, we recalled our mandate, reopened the appeal, and directed supplemental briefing on July 26, 2017. Both parties responded with supplemental briefing, which, inter alia, addressed the question whether Sandoz waived any preemption defense it had to Amgen’s state law claims.
Because Sandoz did not forfeit its preemption defense and the BPCIA preempts state law remedies for an applicant’s failure to comply with § 262(l)(2)(A), we now affirm the district court’s dismissal of Amgen’s state law claims.
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