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SUPREME COURT OF THE UNITED STATES
_________________
Nos. 15–1039 and 15–1195
_________________
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), 124Stat. 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
manufac-turer 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
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.[
1]
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 forth 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.
B
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.
C
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 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 pat-ent 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 pat-ents
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 rem-edy 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 appli-cant 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 pat-ent
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.
Accord-ingly, the 180-day clock began after Sandoz’s second,
post-licensure 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 & Annu-ity 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. 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.
