Appeal
from the United States District Court for the Northern
District of California in No. 3:14-cv-04741-RS, Judge Richard
Seeborg.
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, 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.
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 ...