Amgen Inc. v. Sandoz Inc.

• Decision Date: 14 December 2017
• Docket Number: 2015-1499
• Parties: AMGEN INC., Amgen Manufacturing Limited, Plaintiffs–Appellants v. SANDOZ INC., Defendant–Appellee
• Court: U.S. Court of Appeals — Federal Circuit

877 F.3d 1315

AMGEN INC., Amgen Manufacturing Limited, Plaintiffs–Appellants

v.SANDOZ INC., Defendant–Appellee

2015-1499

United States Court of Appeals, Federal Circuit.

Decided: December 14, 2017

Nicholas P. Groombridge, Paul Weiss, Rifkind, Wharton & Garrison LLP, New York, NY, for plaintiffs-appellants. Also represented by Jennifer Gordon, Jennifer H. Wu, Arielle K. Linsey, Michael T. Wu, Peter Sandel, Eric Alan Stone ; Lois M. Kwasigroch, Wendy A. Whiteford, Kimberlin L. Morley, Amgen Inc., Thousand Oaks, CA; Vernon M. Winters, Alexander David Baxter, Sidley Austin LLP, San Francisco, CA.

Deanne Maynard, Morrison & Foerster LLP, Washington, DC, for defendant-appellee. Also represented by Marc A. Hearron, Joseph R. Palmore ; Julie Park, San Diego, CA; Erik Jeffrey Olson, Palo Alto, CA.

Michael A. Morin, Latham & Watkins LLP, Washington DC, for amicus curiae AbbVie Inc. Also represented by David Penn Frazier, Gregory G. Garre, Melissa Arbus Sherry, Casey L. Dwyer, Robert J. Gajarsa.

Gregory Diskant, Patterson Belknap Webb & Tyler LLP, New York, NY, for amicus curiae Janssen Biotech, Inc. Also represented by Irena Royzman ; Dianne B. Elderkin, Barbara Mullin, Akin, Gump, Strauss, Hauer & Feld, LLP, Philadelphia, PA.

Lisa Barons Pensabene, O'Melveny & Myers LLP, New York, NY, for amicus curiae Biotechnology Industry Organization. Also represented by Filko Prugo,

Carlos T. Angulo, Zuckerman Spaeder LLP, Washington, DC, for amicus curiae Generic Pharmaceutical Association.

Charles B. Klein, Winston & Strawn LLP, Washington, DC, for amici curiae Hospira, Inc., Celltrion Healthcare Co., Ltd, Celltrion, Inc. Also represented by Andrew Curtis Nichols, Steffen Nathanael Johnson ; Samuel S. Park, Dan Hoang, Chicago, IL.

William M. Jay, Goodwin Procter LLP, Washington, DC, for amicus curiae The Biosimilars Council. Also represented by Jaime Ann Santos ; Elaine Blais, Boston, MA.

Lowell Sturgill, Jr., Appellate Staff, Civil Division, United States Department of Justice, Washington, DC, for amicus curiae United States. Also represented by Chad A. Readler, Hashim M. Mooppan, Scott R. Mcintosh.

William A. Rakoczy, Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL, for amicus curiae Mylan Inc. Also represented by Peter James Curtin, Lara E. Fitzsimmons.

Before Newman, Lourie, and Chen, Circuit Judges.

Lourie, Circuit Judge.

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 , ––– U.S. ––––, 137 S.Ct. 1664, 198 L.Ed.2d 114 (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. , ––– U.S. ––––, 137 S.Ct. 1664, 198 L.Ed.2d 114 (2017).

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. § 271(e)(2)(C)(ii) ?

Conditional Cross–Petition for a Writ of Certiorari at ii, Sandoz Inc. v. Amgen Inc. , ––– U.S. ––––, 137 S.Ct. 1664, 198 L.Ed.2d 114 (2017). 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. , ––– U.S. ––––, 137 S.Ct. 808, 196 L.Ed.2d 594 (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. , ––– U.S. ––––, 137 S.Ct. 1664, 198 L.Ed.2d 114 (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.

BACKGROUND

In 2010, as part of the Patient Protection and Affordable Care Act, Congress enacted the BPCIA, which established an abbreviated pathway for regulatory approval of follow-on biological products that are "highly similar" to a previously approved product ("reference product"). Pub. L. No. 111–148, §§ 7001–7003, 124 Stat. at 815. Congress established such "a biosimilars pathway balancing innovation and consumer interests." BPCIA, Pub. L. No. 111–148, § 7001(b), 124 Stat. at 804.

The BPCIA has certain similarities in its goals and procedures to the Drug Price Competition and Patent Term Restoration Act of 1984 ("the Hatch–Waxman Act"), Pub. L. No. 98-417, 98 Stat. 1585 (1984), but it has several obvious differences. We note this as a matter of historical interest, but otherwise do not comment on those similarities and differences.

Under the governing statutory scheme, the Food and Drug Administration ("FDA") approves a biological product for commercial marketing by granting a biologics license under 42 U.S.C. § 262(a). An applicant filing an original biologics license application ("BLA") typically must provide clinical data to demonstrate the safety and efficacy of its product. In contrast, under the abbreviated regulatory approval pathway created by the BPCIA, codified at 42 U.S.C. § 262(k), an applicant filing an abbreviated biologics license application ("aBLA" or "biosimilar application") instead submits information to demonstrate that its product is "biosimilar" to or "interchangeable" with a previously approved reference product, together with "publicly-available information regarding the [FDA]'s previous determination that the reference product is safe, pure, and potent." Id. § 262(k)(2)–(5) ; see also id. § 262(i). The BPCIA thus permits a biosimilar applicant to rely in part on the approved license of a reference product.

To balance the goals of innovation and price competition, Congress enacted the BPCIA to provide a four-year and a twelve-year exclusivity period to a reference product, both beginning on the date of first licensure of the reference...