SANDOZ INC., PETITIONER
15–1039 v.
AMGEN INC., ET AL.
AMGEN INC., ET AL., PETITIONERS
15–1195 v.
SANDOZ INC.
ON WRITS OF CERTIORARI TO THE UNITED STATES COURT OF
APPEALS FOR THE FEDERAL CIRCUIT
[June 12, 2017]
JUSTICE THOMAS delivered the opinion of the Court.
These cases involve 42 U. S. C. §262(l), which was enacted
as part of the Biologics Price Competition and Innovation
Act of 2009 (BPCIA), 124 Stat. 808. The BPCIA
governs a type of drug called a biosimilar, which is a
biologic product that is highly similar to a biologic product
that has already been approved by the Food and Drug
Administration (FDA). Under §262(l), an applicant that
seeks FDA approval of a biosimilar must provide its application
materials and manufacturing information to the
manufacturer of the corresponding biologic within 20 days
of the date the FDA notifies the applicant that it has
accepted the application for review. The applicant then
must give notice to the manufacturer at least 180 days
before marketing the biosimilar commercially.
The first question presented by these cases is whether the requirement that an applicant provide its application
and manufacturing information to the manufacturer of the
biologic is enforceable by injunction. We conclude that an
injunction is not available under federal law, but we remand
for the court below to decide whether an injunction
is available under state law. The second question is
whether the applicant must give notice to the manufacturer
after, rather than before, obtaining a license from the
FDA for its biosimilar. We conclude that an applicant
may provide notice before obtaining a license.
I
The complex statutory scheme at issue in these cases
establishes processes both for obtaining FDA approval of
biosimilars and for resolving patent disputes between
manufacturers of licensed biologics and manufacturers of
biosimilars. Before turning to the questions presented, we
first explain the statutory background.
A biologic is a type of drug derived from natural, biological
sources such as animals or microorganisms. Biologics
thus differ from traditional drugs, which are typically
synthesized from chemicals. A manufacturer of a biologic
may market the drug only if the FDA has licensed it pursuant
to either of two review processes set forth in §262.
The default pathway for approval, used for new biologics,
is set forth in §262(a). Under that subsection, the FDA
may license a new biologic if, among other things, the
manufacturer demonstrates that it is “safe, pure, and
potent.” §262(a)(2)(C)(i)(I). In addition to this default
route, the statute also prescribes an alternative, abbreviated
route for FDA approval of biosimilars, which is set
——————
1FDA, What Are “Biologics” Questions and Answers (Aug. 5, 2015), http://
www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/
ucm133077.htm (as last visited June 6, 2017).
Cite as: 582 U. S. ____ (2017) in §262(k).
To obtain approval through the BPCIA’s abbreviated
process, the manufacturer of a biosimilar (applicant) does
not need to show that the product is “safe, pure, and potent.”
Instead, the applicant may piggyback on the showing
made by the manufacturer (sponsor) of a previously
licensed biologic (reference product). See §262(k)(2)(A)(iii).
An applicant must show that its product is “highly similar”
to the reference product and that there are no “clinically
meaningful differences” between the two in terms of
“safety, purity, and potency.” §§262(i)(2)(A), (B); see also
§262(k)(2)(A)(i)(I). An applicant may not submit an application
until 4 years after the reference product is first
licensed, and the FDA may not license a biosimilar until
12 years after the reference product is first licensed.
§§262(k)(7)(A), (B). As a result, the manufacturer of a new
biologic enjoys a 12-year period when its biologic may be
marketed without competition from biosimilars.
A sponsor may hold multiple patents covering the biologic,
its therapeutic uses, and the processes used to manufacture
it. Those patents may constrain an applicant’s
ability to market its biosimilar even after the expiration of
the 12-year exclusivity period contained in §262(k)(7)(A).
The BPCIA facilitates litigation during the period preceding
FDA approval so that the parties do not have to
wait until commercial marketing to resolve their patent
disputes. It enables the parties to bring infringement
actions at certain points in the application process, even if
the applicant has not yet committed an act that would
traditionally constitute patent infringement. See 35
U. S. C. §271(a) (traditionally infringing acts include
making, using, offering to sell, or selling any patented
invention within the United States without authority to do
so). Specifically, it provides that the mere submission of a biosimilar application constitutes an act of infringement.
§§271(e)(2)(C)(i), (ii). We will refer to this kind of preapproval
infringement as “artificial” infringement. Section
271(e)(4) provides remedies for artificial infringement,
including injunctive relief and damages.
The BPCIA sets forth a carefully calibrated scheme for
preparing to adjudicate, and then adjudicating, claims of
infringement. See 42 U. S. C. §262(l). When the FDA
accepts an application for review, it notifies the applicant,
who within 20 days “shall provide” to the sponsor a copy of
the application and information about how the biosimilar
is manufactured. §262(l)(2)(A). The applicant also “may
provide” the sponsor with any additional information that
it requests. §262(l)(2)(B). These disclosures enable the
sponsor to evaluate the biosimilar for possible infringement
of patents it holds on the reference product (i.e., the
corresponding biologic). §262(l)(1)(D). The information
the applicant provides is subject to strict confidentiality
rules, enforceable by injunction. See §262(l)(1)(H). The
first question presented by these cases is whether
§262(l)(2)(A)’s requirement—that the applicant provide its
application and manufacturing information to the sponsor—is
itself enforceable by injunction.
After the applicant makes the requisite disclosures, the
parties exchange information to identify relevant patents
and to flesh out the legal arguments that they might raise
in future litigation. Within 60 days of receiving the application
and manufacturing information, the sponsor “shall
provide” to the applicant “a list of patents” for which it
believes it could assert an infringement claim if a person
without a license made, used, offered to sell, sold, or imported
“the biological product that is the subject of the
[biosimilar] application.” §262(l)(3)(A)(i). The sponsor
must also identify any patents on the list that it would be
Cite as: 582 U. S. ____ (2017) willing to license. §262(l)(3)(A)(ii).
Next, within 60 days of receiving the sponsor’s list, the
applicant may provide to the sponsor a list of patents that
the applicant believes are relevant but that the sponsor
omitted from its own list, §262(l)(3)(B)(i), and “shall provide”
to the sponsor reasons why it could not be held liable
for infringing the relevant patents, §262(l)(3)(B)(ii). The
applicant may argue that the relevant patents are invalid,
unenforceable, or not infringed, or the applicant may
agree not to market the biosimilar until a particular patent
has expired. Ibid. The applicant must also respond
to the sponsor’s offers to license particular patents.
§262(l)(3)(B)(iii). Then, within 60 days of receiving the
applicant’s responses, the sponsor “shall provide” to the
applicant its own arguments concerning infringement,
enforceability, and validity as to each relevant patent.
§262(l)(3)(C).
Following this exchange, the BPCIA channels the parties
into two phases of patent litigation. In the first phase,
the parties collaborate to identify patents that they would
like to litigate immediately. The second phase is triggered
by the applicant’s notice of commercial marketing and
involves any patents that were included on the parties’
§262(l)(3) lists but not litigated in the first phase.
At the outset of the first phase, the applicant and the
sponsor must negotiate to determine which patents included
on the §262(l)(3) lists will be litigated immediately.
See §§262(l)(4)(A), (l)(6). If they cannot agree, then they
must engage in another list exchange. §262(l)(4)(B). The
applicant “shall notify” the sponsor of the number of patents
it intends to list for litigation, §262(l)(5)(A), and,
within five days, the parties “shall simultaneously exchange”
lists of the patents they would like to litigate
immediately. §262(l)(5)(B)(i). This process gives the
applicant substantial control over the scope of the first
phase of litigation: The number of patents on the sponsor’s list is limited to the number contained in the applicant’s
list, though the sponsor always has the right to list at
least one patent. §262(l)(5)(B)(ii).
The parties then proceed to litigate infringement with
respect to the patents they agreed to litigate or, if they
failed to agree, the patents contained on the lists they
simultaneously exchanged under §262(l)(5). §§262(l)(6)(A),
(B). Section 271(e)(2)(C)(i) facilitates this first phase of
litigation by making it an act of artificial infringement,
with respect to any patent included on the parties’
§262(l)(3) lists, to submit an application for a license from
the FDA. The sponsor “shall bring an action” in court
within 30 days of the date of agreement or the simultaneous
list exchange. §§262(l)(6)(A), (B). If the sponsor
brings a timely action and prevails, it may obtain a remedy
provided by §271(e)(4).
The second phase of litigation involves patents that
were included on the original §262(l)(3) lists but not litigated
in the first phase (and any patents that the sponsor
acquired after the §262(l)(3) exchange occurred and added
to the lists, see §262(l)(7)). The second phase is commenced
by the applicant’s notice of commercial marketing,
which the applicant “shall provide” to the sponsor “not
later than 180 days before the date of the first commercial
marketing of the biological product licensed under subsection
(k).” §262(l)(8)(A). The BPCIA bars any declaratory
judgment action prior to this notice. §262(l)(9)(A) (prohibiting,
in situations where the parties have complied with
each step of the BPCIA process, either the sponsor or the
applicant from seeking a “declaration of infringement,
validity, or enforceability of any patent” that was included
on the §262(l)(3) lists but not litigated in the first phase
“prior to the date notice is received under paragraph
(8)(A)”). Because the applicant (subject to certain constraints)
chooses when to begin commercial marketing and
when to give notice, it wields substantial control over the timing of the second phase of litigation. The second question
presented is whether notice is effective if an applicant
provides it prior to the FDA’s decision to license the
biosimilar.
In this second phase of litigation, either party may sue
for declaratory relief. See §262(l)(9)(A). In addition, prior
to the date of first commercial marketing, the sponsor may
“seek a preliminary injunction prohibiting the [biosimilar]
applicant from engaging in the commercial manufacture
or sale of [the biosimilar] until the court decides the issue
of patent validity, enforcement, and infringement with
respect to any patent that” was included on the §262(l)(3)
lists but not litigated in the first phase. §262(l)(8)(B).
D
If the parties comply with each step outlined in the
BPCIA, they will have the opportunity to litigate the
relevant patents before the biosimilar is marketed. To
encourage parties to comply with its procedural requirements,
the BPCIA includes various consequences for
failing to do so. Two of the BPCIA’s remedial provisions
are at issue here. Under §262(l)(9)(C), if an applicant fails
to provide its application and manufacturing information
to the sponsor—thus effectively pretermitting the entire
two-phase litigation process—then the sponsor, but not
the applicant, may immediately bring an action “for a
declaration of infringement, validity, or enforceability of
any patent that claims the biological product or a use of
the biological product.” Section 271(e)(2)(C)(ii) facilitates
this action by making it an artificial act of infringement,
with respect to any patent that could have been included
on the §262(l)(3) lists, to submit a biosimilar application.
Similarly, when an applicant provides the application and
manufacturing information but fails to complete a subsequent
step, §262(l)(9)(B) provides that the sponsor, but not
the applicant, may bring a declaratory-judgment action with respect to any patent included on the sponsor’s
§262(l)(3)(A) list of patents (as well as those it acquired
later and added to the list). As noted, it is an act of artificial
infringement, with respect to any patent on the
§262(l)(3) lists, to submit an application to the FDA. See
§271(e)(2)(C)(i).
II
These cases concern filgrastim, a biologic used to stimulate
the production of white blood cells. Amgen, the respondent
in No. 15–1039 and the petitioner in No. 15–
1195, has marketed a filgrastim product called Neupogen
since 1991 and claims to hold patents on methods of manufacturing
and using filgrastim. In May 2014, Sandoz, the
petitioner in No. 15–1039 and the respondent in No. 15–
1195, filed an application with the FDA seeking approval
to market a filgrastim biosimilar under the brand name
Zarxio, with Neupogen as the reference product. The FDA
informed Sandoz on July 7, 2014, that it had accepted the
application for review. One day later, Sandoz notified
Amgen both that it had submitted an application and that
it intended to begin marketing Zarxio immediately upon
receiving FDA approval, which it expected in the first half
of 2015. Sandoz later confirmed that it did not intend to
provide the requisite application and manufacturing
information under §262(l)(2)(A) and informed Amgen that
Amgen could sue for infringement immediately under
§262(l)(9)(C).
In October 2014, Amgen sued Sandoz for patent infringement.
Amgen also asserted two claims under California’s
unfair competition law, which prohibits “any
unlawful . . . business act or practice.” Cal. Bus. & Prof.
Code Ann. §17200 (West 2008). A “business act or practice”
is “unlawful” under the unfair competition law if it
violates a rule contained in some other state or federal
statute. Rose v. Bank of America, N. A., 57 Cal. 4th 390, 396, 304 P. 3d 181, 185 (2013). Amgen alleged that
Sandoz engaged in “unlawful” conduct when it failed to
provide its application and manufacturing information
under §262(l)(2)(A), and when it provided notice of commercial
marketing under §262(l)(8)(A) before, rather than
after, the FDA licensed its biosimilar. Amgen sought
injunctions to enforce both requirements. Sandoz counterclaimed
for declaratory judgments that the asserted patent
was invalid and not infringed and that it had not
violated the BPCIA.
While the case was pending in the District Court, the
FDA licensed Zarxio, and Sandoz provided Amgen a further
notice of commercial marketing. The District Court
subsequently granted partial judgment on the pleadings to
Sandoz on its BPCIA counterclaims and dismissed
Amgen’s unfair competition claims with prejudice. 2015
WL 1264756, *7–*9 (ND Cal., Mar. 19, 2015). After the
District Court entered final judgment as to these claims,
Amgen appealed to the Federal Circuit, which granted an
injunction pending appeal against the commercial marketing
of Zarxio.
A divided Federal Circuit affirmed in part, vacated in
part, and remanded. First, the court affirmed the dismissal
of Amgen’s state-law claim based on Sandoz’s alleged
violation of §262(l)(2)(A). It held that Sandoz did not
violate the BPCIA in failing to disclose its application and
manufacturing information. It further held that the remedies
contained in the BPCIA are the exclusive remedies
for an applicant’s failure to comply with §262(l)(2)(A). 794
F. 3d 1347, 1357, 1360 (2015).
Second, the court held that an applicant may provide
effective notice of commercial marketing only after the
FDA has licensed the biosimilar. Id., at 1358. Accordingly,
the 180-day clock began after Sandoz’s second, postlicensure
notice. The Federal Circuit further concluded
that the notice requirement is mandatory and extended its injunction pending appeal to bar Sandoz from marketing
Zarxio until 180 days after the date it provided its second
notice. Id., at 1360–1361.
We granted Sandoz’s petition for certiorari, No. 15–
1039, and Amgen’s conditional cross-petition for certiorari,
No. 15–1195, and consolidated the cases. 580 U. S. ___
(2017).
III
The first question we must answer is whether
§262(l)(2)(A)’s requirement that an applicant provide the
sponsor with its application and manufacturing information
is enforceable by an injunction under either federal
or state law.
A
We agree with the Federal Circuit that an injunction
under federal law is not available to enforce §262(l)(2)(A),
though for slightly different reasons than those provided
by the court below. The Federal Circuit held that “42
U. S. C. §262(l)(9)(C) and 35 U. S. C. §271(e) expressly
provide the only remedies” for a violation of §262(l)(2)(A),
794 F. 3d, at 1357, and neither of those provisions authorizes
a court to compel compliance with §262(l)(2)(A). In
concluding that the remedies specified in the BPCIA are
exclusive, the Federal Circuit relied primarily on
§271(e)(4), which states that it provides “‘the only remedies
which may be granted by a court for an act of [artificial]
infringement.’” Id., at 1356 (emphasis deleted).
The flaw in the Federal Circuit’s reasoning is that
Sandoz’s failure to disclose its application and manufacturing
information was not an act of artificial infringement,
and thus was not remediable under §271(e)(4).
Submitting an application constitutes an act of artificial
infringement. See §§271(e)(2)(C)(i), (ii) (“It shall be an act
of infringement to submit . . . an application seeking approval of a biological product”). Failing to disclose the
application and manufacturing information under
§262(l)(2)(A) does not.
In reaching the opposite conclusion, the Federal Circuit
relied on §271(e)(2)(C)(ii), which states that “[i]t shall be
an act of infringement to submit[,] if the applicant for the
application fails to provide the application and information
required under [§262(l)(2)(A)], an application
seeking approval of a biological product for a patent that
could be identified pursuant to [§262(l)(3)(A)(i)].” (Emphasis
added.) The court appeared to conclude, based on
the italicized language, that an applicant’s noncompliance
with §262(l)(2)(A) is an element of the act of artificial
infringement (along with the submission of the application).
794 F. 3d, at 1356. We disagree. The italicized
language merely assists in identifying which patents will
be the subject of the artificial infringement suit. It does
not define the act of artificial infringement itself.
This conclusion follows from the structure of
§271(e)(2)(C). Clause (i) of §271(e)(2)(C) defines artificial
infringement in the situation where the parties proceed
through the list exchange process and the patents subject
to suit are those contained in the §262(l)(3) lists, as supplemented
under §262(l)(7). That clause provides that it is
an act of artificial infringement to submit, “with respect to
a patent that is identified in the list of patents described in
[§262(l)(3)] (including as provided under [§262(l)(7)]), an
application seeking approval of a biological product.”
(Emphasis added.) Clause (ii) of §271(e)(2)(C), in contrast,
defines artificial infringement in the situation where an
applicant fails to disclose its application and manufacturing
information altogether and the parties never prepare
the §262(l)(3) lists. That clause provides that the submission
of the application represents an act of artificial infringement
with respect to any patent that could have
been included on the lists.
In this way, the two clauses of §271(e)(2)(C) work in
tandem. They both treat submission of the application as
the act of artificial infringement for which §271(e)(4)
provides the remedies. And they both identify the patents
subject to suit, although by different means depending on
whether the applicant disclosed its application and manufacturing
information under §262(l)(2)(A). If the applicant
made the disclosures, clause (i) applies; if it did not, clause
(ii) applies. In neither instance is the applicant’s failure to
provide its application and manufacturing information an
element of the act of artificial infringement, and in neither
instance does §271(e)(4) provide a remedy for that failure.
See Brief for Amgen Inc. et al. 66–67 (conceding both
points).
A separate provision of §262, however, does provide a
remedy for an applicant’s failure to turn over its application
and manufacturing information. When an applicant
fails to comply with §262(l)(2)(A), §262(l)(9)(C) authorizes
the sponsor, but not the applicant, to bring an immediate
declaratory-judgment action for artificial infringement as
defined in §271(e)(2)(C)(ii). Section 262(l)(9)(C) thus vests
in the sponsor the control that the applicant would otherwise
have exercised over the scope and timing of the
patent litigation. It also deprives the applicant of the
certainty that it could have obtained by bringing
a declaratory-judgment action prior to marketing its
product.
The remedy provided by §262(l)(9)(C) excludes all other
federal remedies, including injunctive relief. Where, as
here, “a statute expressly provides a remedy, courts must
be especially reluctant to provide additional remedies.”
Karahalios v. Federal Employees, 489 U. S. 527, 533
(1989). The BPCIA’s “carefully crafted and detailed enforcement
scheme provides strong evidence that Congress
did not intend to authorize other remedies that it simply
forgot to incorporate expressly.” Great-West Life & Annuity Ins. Co. v. Knudson, 534 U. S. 204, 209 (2002) (internal
quotation marks omitted). The presence of §262(l)(9)(C),
coupled with the absence of any other textually specified
remedies, indicates that Congress did not intend sponsors
to have access to injunctive relief, at least as a matter of
federal law, to enforce the disclosure requirement.
Statutory context further confirms that Congress did
not authorize courts to enforce §262(l)(2)(A) by injunction.
Section 262(l)(1)(H) provides that “the court shall consider
immediate injunctive relief to be an appropriate and necessary
remedy for any violation or threatened violation” of
the rules governing the confidentiality of information
disclosed under §262(l). We assume that Congress acted
intentionally when it provided an injunctive remedy for
breach of the confidentiality requirements but not for
breach of §262(l)(2)(A)’s disclosure requirement. Cf.
Touche Ross & Co. v. Redington, 442 U. S. 560, 572 (1979)
(“[W]hen Congress wished to provide a private damage
remedy, it knew how to do so and did so expressly”).2
Accordingly, the Federal Circuit properly declined to grant
an injunction under federal law.
B
The Federal Circuit rejected Amgen’s request for an
injunction under state law for two reasons. First, it interpreted
California’s unfair competition law not to provide a
remedy when the underlying statute specifies an “expressly
. . . exclusive” remedy. 794 F. 3d, at 1360 (citing Cal.
——————
2 In holding that §262(l)(9)(C) represents the exclusive remedy for an
applicant’s failure to provide its application and manufacturing information,
we express no view on whether a district court could take into
account an applicant’s violation of §262(l)(2)(A) (or any other BPCIA
procedural requirement) in deciding whether to grant a preliminary
injunction under 35 U. S. C. §271(e)(4)(B) or §283 against marketing
the biosimilar. See Winter v. Natural Resources Defense Council, Inc.,
555 U. S. 7, 20 (2008) (court should consider “balance of equities” in
deciding whether to grant a preliminary injunction).Bus. & Prof. Code Ann. §17205; Loeffler v. Target Corp., 58
Cal. 4th 1081, 1125–1126, 324 P. 3d 50, 76 (2014)). It
further held that §271(e)(4), by its text, “provides ‘the only
remedies’” for an applicant’s failure to disclose its application
and manufacturing information. 794 F. 3d, at 1360
(quoting §271(e)(4)). The court thus concluded that no
state remedy was available for Sandoz’s alleged violation
of §262(l)(2)(A) under the terms of California’s unfair
competition law.
This state-law holding rests on an incorrect interpretation
of federal law. As we have explained, failure to comply
with §262(l)(2)(A) is not an act of artificial infringement.
Because §271(e)(4) provides remedies only for
artificial infringement, it provides no remedy at all, much
less an “expressly . . . exclusive” one, for Sandoz’s failure
to comply with §262(l)(2)(A).
Second, the Federal Circuit held in the alternative that
Sandoz’s failure to disclose its application and manufacturing
information was not “unlawful” under California’s
unfair competition law. In the court’s view, when an
applicant declines to provide its application and manufacturing
information to the sponsor, it takes a path “expressly
contemplated by” §262(l)(9)(C) and §271(e)(2)(C)(ii) and
thus does not violate the BPCIA. 794 F. 3d, at 1357, 1360.
In their briefs before this Court, the parties frame this
issue as whether the §262(l)(2)(A) requirement is mandatory
in all circumstances, see Brief for Amgen Inc. et al.
58, or merely a condition precedent to the information
exchange process, see Reply Brief for Sandoz Inc. 33. If it
is only a condition precedent, then an applicant effectively
has the option to withhold its application and manufacturing
information and does not commit an “unlawful” act in
doing so.
We decline to resolve this particular dispute definitively
because it does not present a question of federal law. The
BPCIA, standing alone, does not require a court to decide whether §262(l)(2)(A) is mandatory or conditional; the
court need only determine whether the applicant supplied
the sponsor with the information required under
§262(l)(2)(A). If the applicant failed to provide that information,
then the sponsor, but not the applicant, could
bring an immediate declaratory-judgment action pursuant
to §262(l)(9)(C). The parties in these cases agree—as did
the Federal Circuit—that Sandoz failed to comply with
§262(l)(2)(A), thus subjecting itself to that consequence.
There is no dispute about how the federal scheme actually
works, and thus nothing for us to decide as a matter of
federal law. The mandatory or conditional nature of the
BPCIA’s requirements matters only for purposes of California’s
unfair competition law, which penalizes “unlawful”
conduct. Whether Sandoz’s conduct was “unlawful”
under the unfair competition law is a state-law question,
and the court below erred in attempting to answer that
question by referring to the BPCIA alone.
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 pre-emption defense,
see 794 F. 3d, at 1360, n. 5). The court is also of
course free to address the pre-emption question first by
assuming that a remedy under state law exists.
IV
The second question at issue in these cases is whether
an applicant must provide notice after the FDA licenses its
biosimilar, or if it may also provide effective notice before
licensure. Section 262(l)(8)(A) states that the applicant
“shall provide notice to the reference product sponsor not
later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection
(k).” The Federal Circuit held that an applicant’s
biosimilar must already be “licensed” at the time the
applicant gives notice. 794 F. 3d, at 1358.
We disagree. The applicant must give “notice” at least
180 days “before the date of the first commercial marketing.”
“[C]ommercial marketing,” in turn, must be “of
the biological product licensed under subsection (k).”
§262(l)(8)(A). Because this latter phrase modifies “commercial
marketing” rather than “notice,” “commercial
marketing” is the point in time by which the biosimilar
must be “licensed.” The statute’s use of the word “licensed”
merely reflects the fact that, on the “date of the
first commercial marketing,” the product must be “licensed.”
See §262(a)(1)(A).
Accordingly, the applicant
may provide notice either before or after receiving FDA
approval.
Statutory context confirms this interpretation. Section
262(l)(8)(A) contains a single timing requirement: The
applicant must provide notice at least 180 days prior to
marketing its biosimilar. The Federal Circuit, however,
interpreted the provision to impose two timing requirements:
The applicant must provide notice after the FDA
licenses the biosimilar and at least 180 days before the
applicant markets the biosimilar. An adjacent provision
expressly sets forth just that type of dual timing requirement.
See §262(l)(8)(B) (“After receiving notice under
subparagraph (A) and before such date of the first commercial
marketing of such biological product, the reference
product sponsor may seek a preliminary injunction” (emphasis
added)). But Congress did not use that structure in
§262(l)(8)(A). “Had Congress intended to” impose two
timing requirements in §262(l)(8)(A), “it presumably
would have done so expressly as it did in the immediately
following” subparagraph. Russello v. United States, 464
U. S. 16, 23 (1983).
We are not persuaded by Amgen’s arguments to the
contrary. Amgen points out that other provisions refer to
“‘the biological product that is the subject of ’” the application,
rather than the “ ‘biological product licensed under
subsection (k).’” Brief for Amgen Inc. et al. 28 (emphasis
added). In its view, this variation “is a strong textual
indication that §262(l)(8)(A), unlike the other provisions,
refers to a product that has already been ‘licensed’ by the
FDA.” Ibid.
Amgen’s interpretation is not necessary to harmonize
Congress’ use of the two different phrases. The provision
upon which Amgen primarily relies (and that is generally
illustrative of the other provisions it cites) requires the
applicant to explain why the sponsor’s patents are “‘invalid,
unenforceable, or will not be infringed by the commercial
marketing of the biological product that is the subject
of the subsection (k) application.’” Id., at 29–30 (quoting
§262(l)(3)(B)(ii)(I); emphasis deleted). This provision uses
the phrase “subject of the subsection (k) application”
rather than “product licensed under subsection (k)” because
the applicant can evaluate validity, enforceability,
and infringement with respect to the biosimilar only as it
exists when the applicant is conducting the evaluation,
which it does before licensure. The applicant cannot make
the same evaluation with respect to the biosimilar as it
will exist after licensure, because the biosimilar’s specifications
may change during the application process. See,
e.g., 794 F. 3d, at 1358. In contrast, nothing in
§262(l)(8)(A) turns on the precise status or characteristics
of the biosimilar application.
Amgen also advances a host of policy arguments that
prelicensure notice is undesirable. See Brief for Amgen
Inc. et al. 35–42. Sandoz and the Government, in turn,
respond with their own bevy of arguments that Amgen’s
concerns are misplaced and that prelicensure notice affirmatively
furthers Congress’ intent. See Brief for Sandoz Inc. 39–42, 56; Brief for United States as Amicus
Curiae 28–29. The plausibility of the contentions on both
sides illustrates why such disputes are appropriately
addressed to Congress, not the courts. Even if we were
persuaded that Amgen had the better of the policy arguments,
those arguments could not overcome the statute’s
plain language, which is our “primary guide” to Congress’
preferred policy. McFarland v. Scott, 512 U. S. 849, 865
(1994) (THOMAS, J., dissenting).
In sum, because Sandoz fully complied with
§262(l)(8)(A) when it first gave notice (before licensure) in
July 2014, the Federal Circuit erred in issuing a federal
injunction prohibiting Sandoz from marketing Zarxio until
180 days after licensure. Furthermore, because Amgen’s
request for state-law relief is predicated on its argument
that the BPCIA forbids prelicensure notice, its claim
under California’s unfair competition law also fails. We
accordingly reverse the Federal Circuit’s judgment as to
the notice provision.
* * *
For the foregoing reasons, the judgment of the Court of
Appeals is vacated in part and reversed in part, and the
cases are remanded for further proceedings consistent
with this opinion.
It is so ordered.
