Amgen Inc. v. Apotex Inc. , 827 F.3d 1052 ( 2016 )

United States Court of Appeals
for the Federal Circuit
______________________
AMGEN INC., AMGEN MANUFACTURING
LIMITED,
Plaintiffs-Appellees
v.
APOTEX INC., APOTEX CORP.,
Defendants-Appellants
______________________
2016-1308
______________________
Appeal from the United States District Court for the
Southern District of Florida in No. 0:15-cv-61631-JIC,
Judge James I. Cohn.
______________________
Decided: July 5, 2016
______________________
NICHOLAS P. GROOMBRIDGE, Paul, Weiss, Rifkind,
Wharton & Garrison LLP, New York, NY, argued for
plaintiffs-appellees. Also represented by ERIC ALAN
STONE, CATHERINE NYARADY, JENNIFER GORDON, PETER
SANDEL, JENNIFER H. WU, STEPHEN ACCURSIO
MANISCALCO; WENDY A. WHITEFORD, LOIS M.
KWASIGROCH, KIMBERLIN L. MORLEY, Amgen Inc., Thou-
sand Oaks, CA; JOHN F. O’SULLIVAN, ALLEN P. PEGG,
JASON STERNBERG, Hogan Lovells US LLP, Miami, FL.
2 AMGEN INC. v. APOTEX INC.
KERRY BRENDAN MCTIGUE, Cozen O’Connor, Wash-
ington, DC, argued for defendants-appellants. Also repre-
sented by AARON S. LUKAS, WILLIAM BLAKE COBLENTZ,
BARRY P. GOLOB, DONALD R. MCPHAIL; JOHN
CHRISTOPHER ROZENDAAL, DAVID CHARLES FREDERICK,
MILES SWEET, Kellogg, Huber, Hansen, Todd, Evans &
Figel, PLLC, Washington, DC.
CARLOS T. ANGULO, Zuckerman Spaeder LLP, Wash-
ington, DC, for amicus curiae Biosimilars Council.
WILLIAM A. RAKOCZY, Rakoczy Molino Mazzochi Siwik
LLP, Chicago, IL, for amicus curiae Mylan Inc. Also
represented by LARA E. FITZSIMMONS.
CHARLES B. KLEIN, Winston & Strawn LLP, Washing-
ton, DC, for amici curiae Hospira, Inc., Celltrion
Healthcare Co., Ltd., Celltrion, Inc. Also represented by
STEFFEN NATHANAEL JOHNSON, ANDREW CURTIS NICHOLS;
SAMUEL S. PARK, DAN HOANG, Chicago, IL.
GREGORY DISKANT, Patterson Belknap Webb & Tyler
LLP, New York, NY, for amicus curiae Janssen Biotech,
Inc. Also represented by IRENA ROYZMAN, ARON RUSSELL
FISCHER.
LISA BARONS PENSABENE, O’Melveny & Myers LLP,
New York, NY, for amicus curiae Biotechnology Innova-
tion Organization. Also represented by FILKO PRUGO,
DANIEL BENJAMIN O’BOYLE; DEANNA MARIE RICE, Wash-
ington, DC.
______________________
Before WALLACH, BRYSON, and TARANTO, Circuit Judges.
TARANTO, Circuit Judge.
This appeal involves an action brought by Amgen Inc.
and Amgen Manufacturing Limited (collectively Amgen)
AMGEN INC. v. APOTEX INC. 3
against Apotex Inc. and Apotex Corp. (collectively Apotex)
under the Biologics Price Competition and Innovation Act
of 2009 (Biologics Act or BPCIA). Apotex has an applica-
tion pending with the Food and Drug Administration,
filed under the Biologics Act, that seeks permission to
begin marketing a product allegedly “biosimilar” to
Amgen’s FDA-approved Neulasta®. For such an appli-
cant, the Biologics Act lays out a step-by-step process for
exchanging information and channeling litigation about
patents relevant to the application. Apotex and Amgen
proceeded several steps into that process, leading to the
present suit in which Amgen alleges that Apotex’s pro-
posed marketing would infringe an Amgen patent.
This appeal, however, does not involve the merits of
the infringement allegations. Rather, it involves Amgen’s
motion for a preliminary injunction concerning what will
happen if and when the FDA licenses Apotex’s proposed
biosimilar product. Amgen sought a preliminary injunc-
tion to enforce a provision of the Biologics Act that re-
quires a biosimilar-product applicant to give notice 180
days before commercially marketing its FDA-licensed
product, 42 U.S.C. § 262(l)(8)(A). We held in Amgen Inc.
v. Sandoz Inc., 794 F.3d 1347, 1357–58 (Fed. Cir. 2015),
among other things, that the 180-day period runs from
post-licensure notice. Here, the district court, agreeing
with Amgen, preliminarily enjoined Apotex from entering
the market unless it has given Amgen notice after receiv-
ing the requested FDA license and then waited 180 days.
We affirm. In Amgen v. Sandoz, we held that the
commercial-marketing provision is mandatory, with the
180-day period beginning only upon post-licensure notice,
and that an injunction was proper to enforce the provision
against Sandoz, a biosimilar-product applicant that had
entirely skipped the statutory process of information
exchange and patent-litigation channeling. Apotex ar-
gues that a different result is required here—that the
commercial-marketing provision is not mandatory and
4 AMGEN INC. v. APOTEX INC.
may not be enforced by an injunction—because it, unlike
Sandoz, did launch the statutory process for exchanging
patent information and channeling patent litigation. We
reject the asserted distinction. We hold that the commer-
cial-marketing provision is mandatory and enforceable by
injunction even for an applicant in Apotex’s position.
BACKGROUND
Amgen markets FDA-approved Neulasta®, whose ac-
tive ingredient is pegfilgrastim, a human-engineered
protein that, in patients undergoing chemotherapy, can
stimulate the production of neutrophils (a type of white
blood cell) and thereby decrease the incidence of infection.
Amgen received a biologics license from the FDA for
Neulasta® in 2002 pursuant to 42 U.S.C. § 262(a). In
2014, Apotex filed an application for an FDA license to
market a biosimilar version of Neulasta®, invoking the
“abbreviated pathway for regulatory approval of follow-on
biological products that are ‘highly similar’ to a previously
approved product (‘reference product’),” as described in
Amgen v. Sandoz, 794 F.3d at 1351. Congress created
that route to FDA licensure in the Biologics Act in 2010.
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.
Apotex’s application is pending.
A
When Amgen obtained its license, it had to show that
its biological product, Neulasta®, was “safe, pure, and
potent.” 42 U.S.C. § 262(a)(2)(C)(i)(I). The Biologics Act
authorizes enterprises like Apotex to gain approval, after
a time, for a product sufficiently similar to the “reference
product,” without repeating all of the work of the pioneer,
the “reference product sponsor” (defined at id.
§ 262(l)(1)(A)). Under § 262(k), an applicant may obtain a
license by demonstrating, among other things, that its
product is “biosimilar” to a reference product. In so doing,
AMGEN INC. v. APOTEX INC. 5
it may use publicly available information about the refer-
ence product’s safety, purity, and potency to support its
application. Id. § 262(k)(2)(A)(i), (iii). For the purpose of
“balancing innovation and consumer interests,” Pub. L.
No. 111-148, § 7001(b), 124 Stat. at 804, Congress pre-
scribed that a biosimilar-product application under
§ 262(k) “may not be submitted” until four years after the
reference product was first licensed under § 262(a) and
that a biosimilar-product license “may not be made effec-
tive” until twelve years after the reference product was
first licensed. 42 U.S.C. § 262(k)(7)(A), (B).
1
Of particular relevance here, the Biologics Act con-
tains a detailed, multi-part subsection, § 262(l), that is
focused in various ways on potential patent disputes
between the reference product sponsor and biosimilar-
product applicant. That subsection by its terms provides
for two stages of litigation—one under paragraph (6), the
other under paragraph (8). In this opinion, we will often
refer to paragraphs and subparagraphs within that
subsection without repeating the “§ 262(l)”; unless other-
wise made clear, any such short-hand references are to
that subsection. We also will usually call the § 262(k)
applicant simply the “applicant.”
The § 262(l) provisions of principal present signifi-
cance are as follows. Under (2)(A), within 20 days after
the FDA notifies the applicant that its application has
been accepted for review, the applicant is to give notice to
the reference product sponsor by providing the application
as well as information describing the manufacturing
process. § 262(l)(2)(A). Under (3)(A), within 60 days of
receiving that notice, the reference product sponsor is to
provide a list of patents that could reasonably be asserted
against the applicant and specify which it would be pre-
pared to license to the applicant. § 262(l)(3)(A). Under
(3)(B), within 60 days after receiving that list, the appli-
6 AMGEN INC. v. APOTEX INC.
cant is to respond with a detailed statement identifying
why each patent on the reference product sponsor’s list is
invalid, unenforceable, or not infringed, or declaring that
it does not intend to commercially market the biosimilar
product before a particular patent expires, and also
addressing the reference product sponsor’s statement of
readiness to license. § 262(l)(3)(B)(ii), (iii). The applicant,
in its response, may also provide its own list of patents
that it believes could reasonably be asserted against it.
§ 262(l)(3)(B)(i). Under (3)(C), then, within 60 days of
receiving the applicant’s (3)(B) response, the reference
product sponsor is to provide a detailed reply regarding
those patents on its (3)(A) list as to which the applicant
has asserted non-infringement, invalidity, or unenforcea-
bility. § 262(l)(3)(C).
While the reference product sponsor may later sup-
plement its (3)(A) list under paragraph (7), it is the origi-
nal lists under (3) that form the basis of the next steps in
the process leading to immediate litigation under para-
graph (6). Those steps begin with paragraph (4), which
requires that the reference product sponsor and the
applicant enter into good-faith negotiations over which of
the patents listed under (3) will be the subject of an
immediate patent-infringement action. § 262(l)(4)(A). If
the parties reach agreement, (6)(A) provides that the
reference product sponsor must bring an action for in-
fringement on all such patents within 30 days.
§ 262(l)(6)(A); see 35 U.S.C. § 271(e)(2)(C)(i). The appli-
cant must then notify the FDA. § 262(l)(6)(C).
If the parties do not reach agreement within 15 days
of starting their negotiation, (4)(B) directs the parties to
paragraph (5) for the process that determines the scope of
immediate litigation. § 262(l)(4)(B). That process gives
the applicant a scope-limiting ability, based on an ex-
change of lists of patents to be litigated. The applicant
tells the reference product sponsor how many patents will
be on the applicant’s list; that number caps how many
AMGEN INC. v. APOTEX INC. 7
patents the reference product sponsor may list, except
that if the applicant lists none, the reference product
sponsor may list one; and the two sides exchange lists.
§ 262(l)(5). Within 30 days, under (6)(B), the reference
product sponsor must sue for infringement on precisely
those patents that appear on the combined lists.
§ 262(l)(6)(B). And the applicant must notify the FDA.
§ 262(l)(6)(C). Notably, the immediate litigation is limited
to a single patent if the applicant lists no patents, no
matter how many patents the reference product sponsor
designated in (3)(A) as reasonably assertable against the
making, selling, etc., of the proposed biosimilar product.
§ 262(l)(5)(B)(ii)(II).
Given the deadlines set in § 262(l), and the time
commonly taken for FDA review, we may assume that the
early litigation under paragraph (6) will be initiated
before the FDA licenses the applicant’s biosimilar prod-
uct. But the Biologics Act—having provided for a narrow-
ing of the scope of the paragraph (6) litigation, including
by allowing the applicant to exclude potentially meritori-
ous patents from that litigation—provides, in paragraph
(8), for a second stage of patent litigation.
Paragraph (8) does so by first requiring, in (8)(A), that
the applicant give the reference product sponsor notice at
least 180 days before commercially marketing its “li-
censed” product. § 262(l)(8)(A). We held in Amgen v.
Sandoz that the notice starting the 180-day clock must
follow, not precede, the licensure. 794 F.3d at 1357–58.
(8)(B) then declares that, after receiving the (8)(A) post-
licensure notice but before the applicant’s commercial
marketing begins, the reference product sponsor may seek
a preliminary injunction based on any patent within
either of two classes. The first class, expressly described
in (8)(B), consists of the patents that appeared on any of
the original paragraph (3) lists, minus patents that were
the subject of paragraph (6) litigation (by agreement
under (4) or by the narrowing process under (5)).
8 AMGEN INC. v. APOTEX INC.
§ 262(l)(8)(B). The second class consists of certain patents
that were issued to or exclusively licensed by the refer-
ence product sponsor after it gave the applicant its (3)(A)
list. As to those patents, paragraph (7) prescribes an
information exchange and states that they “shall be
subject to paragraph (8),” § 262(l)(7)—which evidently
means that patents within (7) are to be treated as falling
under (8)(B). For this second-stage litigation, (8)(C)
requires that the parties reasonably cooperate to expedite
new discovery needed in connection with the preliminary-
injunction motion. § 262(l)(8)(C).
Paragraph (9) of § 262(l) reinforces the just-described
channeling of litigation and provides incentives for the
applicant to proceed in those channels. It does so by
addressing when declaratory-judgment actions are or are
not available in certain circumstances—in (9)(C), as to
applicants that simply bypass the process of information
exchange that begins with (2)(A); and in (9)(A) and (B), as
to applicants that begin but do not complete the process.
(9)(C) addresses an applicant that does not even pro-
vide the first-step notice under (2)(A). For such an appli-
cant, the reference product sponsor, but not the applicant,
may bring an action under 28 U.S.C. § 2201 for a declara-
tory judgment of “infringement, validity, or enforceability
of any patent that claims the biological product or a use of
the biological product.” § 262(l)(9)(C). The subject of such
action is not limited by reference to any patent lists.
(9)(A) and (B) together address an applicant that does
provide the (2)(A) notice. (9)(A) protects the two-stage
litigation scheme under paragraphs (6) and (8): it declares
that neither side may bring a declaratory-judgment action
relating to any patent described in (8)(B) for the second-
stage litigation until after the (post-licensure) 180-day
notice of commercial marketing under (8)(A) is received.
AMGEN INC. v. APOTEX INC. 9
§ 262(l)(9)(A). 1 Then, (9)(B) reinforces the applicant’s
incentives to complete the orderly process: it specifies that
the (9)(A) bar on declaratory-judgment actions is lifted for
the reference product sponsor, but not for the applicant, if
an applicant that has given the (2)(A) notice “fails to
complete an action required” of the applicant at specified
steps past the (2)(A) step. The specified applicant duties
are those prescribed by paragraph (3)(B)(ii) (responding to
the reference product sponsor’s (3)(A) list); by paragraph
(5) (furnishing lists defining the first-stage litigation in
the absence of agreement); by paragraph (6)(C)(i) (notify-
ing the FDA of the first-stage litigation); by paragraph (7)
(responding to the reference product sponsor’s update of
its (3)(A) list); and by paragraph (8)(A) (providing a 180-
day notice before commercial marketing of the licensed
product). A failure of the applicant at any of those stages
lifts the (9)(A) bar on the reference product sponsor,
allowing it to bring a declaratory-judgment action on any
patent on its (3)(A) list as supplemented under (7).
§ 262(l)(9)(B).
2
Besides setting out the foregoing regime, the Biologics
Act amended the infringement provision of the Patent
Act, 35 U.S.C. § 271, in a way that is tied to that regime.
See Pub. L. No. 111-148, § 7002(c)(1), 124 Stat. at 815–16.
As amended, 35 U.S.C. § 271(e)(2) provides that, in two
circumstances, it is “an act of infringement” for a person
“to submit” “an application seeking approval of a biologi-
cal product” if the purpose is to obtain approval “to en-
gage in the commercial manufacture, use, or sale of
1 The Declaratory Judgment Act, 28 U.S.C.
§ 2201(b), states: “For limitations on actions brought with
respect to drug patents see” 21 U.S.C. §§ 355, 360b and 42
U.S.C. § 262. The Biologics Act added the § 262 reference.
See Pub. L. No. 111-148, § 7002(c)(2), 124 Stat. at 816.
10 AMGEN INC. v. APOTEX INC.
a . . . biological product claimed in a patent or the use of
which is claimed in a patent before the expiration of such
patent.” 35 U.S.C. § 271(e)(2)(C)(i), (ii). The two circum-
stances involve, respectively, an applicant that has
launched the Biologics Act information-exchange process
we have described and an applicant that has not.
Specifically, one circumstance is when the patent “is
identified in the list of patents described in” paragraph
(3), “including as provided under” paragraph (7), of the
Biologics Act’s patent provisions described above. 35
U.S.C. § 271(e)(2)(C)(i). Filing the biosimilar application
is an act of infringement of patents that the reference
product sponsor has listed through the Biologics Act’s
prescribed processes, which occurs only when the appli-
cant has provided the (2)(A) notice. The other circum-
stance involves an applicant that “fails to provide the
application and information required” under (2)(A). In
that case, filing the biosimilar application is an act of
infringement as to a patent that “could be identified
pursuant to” (3)(A), i.e., a patent that the reference prod-
uct sponsor could identify as one it believes “could reason-
ably be asserted” with respect to the biosimilar product at
issue. 35 U.S.C. § 271(e)(2)(C)(ii).
35 U.S.C. § 271(e)(4) addresses remedies for such in-
fringements. Subparagraphs (B) and (C) authorize in-
junctions and damages, and subparagraph (D) states that
“the court shall order a permanent injunction” against
infringement of a patent in certain cases decided in the
Biologics Act’s first-stage (paragraph (6)) litigation. 35
U.S.C. § 271(e)(4)(D). Section 271(e)(4) adds that those
remedies “are the only remedies which may be granted by
a court for an act of infringement described in paragraph
(2),” except for attorney’s fees. 35 U.S.C. § 271(e)(4).
35 U.S.C. § 271(e)(6), however, then limits the just-
described remedies in two ways evidently designed to
reinforce the reference product sponsor’s incentives to
AMGEN INC. v. APOTEX INC. 11
follow the distinctive Biologics Act’s patent process where
the applicant has launched that process. First: If the
reference product sponsor is late in bringing the first-
stage infringement action under § 262(l)’s paragraph (6),
i.e., does so more than 30 days after the scope of that
litigation has been determined under (4) or (5), the only
remedy the reference product sponsor can get in that
action is a reasonable royalty. 35 U.S.C. § 271(e)(6)(A),
(B). 2 Second: If a patent that the reference product spon-
sor should have included on its (3)(A) list or its (7) sup-
plement “was not timely included,” then the owner of that
patent may not sue for infringement under 35 U.S.C.
§ 271 with respect to the biological product at issue. 35
U.S.C. § 271(e)(6)(C).
B
In October 2014, Apotex filed a biologics license appli-
cation with the FDA under 42 U.S.C. § 262(k), listing
Amgen’s Neulasta® as the reference product, and the
FDA accepted Apotex’s application for review on Decem-
ber 15, 2014. On December 31, 2014, Apotex provided
Amgen a copy of the application and information detailing
Apotex’s pegfilgrastim manufacturing process, complying
with § 262(l)’s paragraph (2)(A). Amgen provided Apotex
its (3)(A) list on February 27, 2015, identifying three
patents, and Apotex provided its (3)(B) patent-specific
response on April 17, 2015. In that response, Apotex
certified that it did not intend to begin commercial mar-
keting before two of the patents had expired and, as to the
remaining patent, described bases for asserting non-
infringement and invalidity. The same day, Apotex sent a
letter to Amgen stating that it was thereby providing
2 The same restriction applies if the reference prod-
uct sponsor timely brought a paragraph (6) action that
“was dismissed without prejudice or was not prosecuted to
judgment in good faith.” 35 U.S.C. § 271(e)(6)(A)(ii)(II).
12 AMGEN INC. v. APOTEX INC.
notice of future commercial marketing pursuant to (8)(A),
though Apotex lacked (as it still lacks) an FDA license.
On June 16, 2015, Amgen furnished Apotex its (3)(C)
reply regarding validity and infringement. The parties
then negotiated under (4) and agreed to an immediate
action under (6)(A) for infringement of the two then-
extant patents; Amgen filed that action on August 6,
2015; and when one of the patents expired in October
2015, that action became about only one patent, U.S.
Patent No. 8,952,138.
C
Just before that action was filed, this court decided
Amgen v. Sandoz. The court held first that a biosimilar-
product applicant cannot be compelled to provide notice of
FDA review under (2)(A) and that an infringement suit
under 35 U.S.C. § 271(e)(2) is the reference product spon-
sor’s remedy if the applicant does not provide such notice.
The court stressed that 35 U.S.C. § 271(e)(2)(c)(ii) de-
clares precisely that conduct—filing an application and
failing to give the (2)(A) notice—to constitute an in-
fringement (of a patent that could have been listed under
(3)(A)) and that § 271(e)(4) declares the monetary and
injunctive remedies in a suit for that infringement to be
the exclusive remedies for that conduct. 794 F.3d at
1354–57.
The court next addressed the (8)(A) requirement of a
180-day notice of commercial marketing. The court held
that the (8)(A) notice must be a notice given after FDA
licensure of the biosimilar product, not before, and that
pre-licensure notices are of no legal effect for purposes of
(8)(A). Id. at 1358. It explained that the statutory 180-
day period runs from licensure, “at which time the prod-
uct, its therapeutic uses, and its manufacturing processes
are fixed” by licensure. Id. The purpose, the court ex-
plained, is to “provide[ ] a defined statutory window
during which the court and the parties can fairly assess
AMGEN INC. v. APOTEX INC. 13
the parties’ rights prior to the launch of the biosimilar
product,” the alternative being a rush in decision-making
about requesting or issuing a preliminary injunction. Id.;
see id. at 1360 (“The purpose of [(8)(A)] is clear: requiring
notice of commercial marketing be given to allow the
[reference product sponsor] a period of time to assess and
act upon its patent rights.”).
The court then concluded that (8)(A) is “mandatory”:
“A question exists . . . concerning whether the ‘shall’
provision in [(8)(A)] is mandatory. We conclude that it is.”
Id. at 1359. The court added that (8)(A) is “a standalone
notice provision,” not dependent on the earlier infor-
mation-exchange provisions. Id. at 1359–60. And for the
case before it, involving an applicant (Sandoz) that did not
provide notice of FDA review under (2)(A), and hence did
not come under (9)(B), there could be no basis for finding
the declaratory-judgment action referred to in (9)(B) to be
the exclusive remedy for an (8)(A) violation. Id. On that
basis, the court held it appropriate to enjoin commercial
marketing until 180 days after the post-licensure notice.
Id. at 1362.
D
In the present case, Amgen filed a motion in October
2015 asking the district court to issue a preliminary
injunction that would require Apotex to provide an (8)(A)
notice if and when it receives a license and to delay any
commercial marketing for 180 days from that notice. The
parties stipulated that Amgen will be irreparably harmed
if Apotex enters the market without giving the requested
180 days’ notice, the balance of the hardships favors
Amgen, and the public interest favors the issuance of an
injunction. The decision whether to grant the prelimi-
nary-injunction motion, therefore, turned on Amgen’s
likelihood of success on the legal question presented:
whether the (8)(A) notice requirement is a mandatory one
enforceable by injunction as to an applicant (such as
14 AMGEN INC. v. APOTEX INC.
Apotex) that, unlike Sandoz in Amgen v. Sandoz, gave the
(2)(A) notice to launch the information-exchange process
leading to the paragraph (6) infringement suit. Notably,
there is no dispute that Apotex’s pre-licensure April 2015
notice is of no effect under (8)(A) as construed in Amgen v.
Sandoz.
The district court agreed with Amgen and granted a
preliminary injunction. The court noted that “[t]he
[BPCIA] is intended to provide an orderly process for
evaluating patent claims in the context of biosimilar
products.” J.A. 6. In particular, the (8)(A) notice-of-
commercial-marketing requirement “‘provides a defined
statutory window during which the court and the parties
can fairly assess the parties’ rights prior to the launch of
the biosimilar product.’” Id. (quoting Amgen v. Sandoz,
794 F.3d at 1358). The court concluded: “That defined
statutory window exists for all biosimilar products that
obtain FDA licenses, regardless of whether the subsection
(k) applicant complies with § 262(l)(2).” Id. The court
disagreed with Apotex’s contention that this conclusion
should be rejected in order to avoid adding 180 days to
§ 262(k)(7)’s 12-year exclusivity period for reference
product sponsors. J.A. 7. The court also disagreed with
Apotex’s contention that paragraph (9) establishes that
the exclusive remedy for failure to provide the (8)(A)
notice of commercial marketing is a declaratory judgment
on the patent-law merits of the patents at issue, no mat-
ter how rushed the litigation of those issues might be
without the 180 days’ notice. Id.
Apotex appeals the district court’s grant of a prelimi-
nary injunction. We have jurisdiction under 28 U.S.C.
§ 1292(a)(1) and (c)(1).
AMGEN INC. v. APOTEX INC. 15
DISCUSSION
We review a district court’s grant of a preliminary in-
junction for abuse of discretion, which may be established
when a district court’s decision is based on an error of
law. Endo Pharm. Inc. v. Actavis, Inc., 746 F.3d 1371,
1373–74 (Fed. Cir. 2014); U.S. Commodity Futures Trad-
ing Comm’n v. Hunter Wise Commodities, LLC, 749 F.3d
967, 973 (11th Cir. 2014). Here, the district court’s grant
of an injunction rested on its interpretation of a statute, a
question of law we review de novo. Sanofi-Synthelabo v.
Apotex, Inc., 470 F.3d 1368, 1374 (Fed. Cir. 2006). We
agree with the district court: that Apotex gave a (2)(A)
notice provides only a factual distinction, not a legally
material distinction, between its situation and that of
Sandoz in Amgen v. Sandoz. The (8)(A) requirement of
180 days’ post-licensure notice before commercial market-
ing, we conclude, is a mandatory one enforceable by
injunction whether or not a (2)(A) notice was given.
Paragraph (8)(A) provides that “[t]he subsection (k)
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).” § 262(l)(8)(A) (emphasis added).
The word “shall” generally indicates that the directive is
mandatory. See Nat’l Ass’n of Home Builders v. Defs. of
Wildlife, 551 U.S. 644, 661–62 (2007); Lopez v. Davis, 531
U.S. 230, 241 (2001); Lexecon Inc. v. Milberg Weiss Ber-
shad Hynes & Lerach, 523 U.S. 26, 35 (1998). We ruled in
Amgen v. Sandoz that this language is, indeed, “mandato-
ry,” and we did not say that it was mandatory only in no-
(2)(A)-notice circumstances. 794 F.3d at 1359.
The language of (8)(A) is categorical in the sense rele-
vant here. It contains no words that make the applicabil-
ity of its notice rule turn on whether the applicant took
the earlier step of giving the (2)(A) notice that begins the
§ 262(l) information-exchange process. And in Amgen v.
16 AMGEN INC. v. APOTEX INC.
Sandoz we stated that (8)(A) was “a standalone notice
provision” not dependent on the information-exchange
processes that begin with (2)(A). Id. at 1359–60.
There also is no other statutory language that effec-
tively compels a treatment of (8)(A) as non-mandatory,
contrary to the usual meaning of its “shall” terms. In this
respect, (8)(A) differs materially from (2)(A). For (2)(A),
as this court explained in Amgen v. Sandoz, the language
of 35 U.S.C. § 271(e)(2) & (4) forces (2)(A)’s “shall” not to
be a term of enforceable compulsory obligation. Section
271(e)(2)(C)(ii) declares to be an act of infringement the
filing of a biosimilar-product application coupled to a
failure to give the (2)(A) notice, and § 271(e)(4) declares
that the patent-merits infringement suit, with specified
damages and injunctive relief, is the exclusive remedy for
that combination. Compelling the applicant to provide
the (2)(A) notice would go beyond that remedy, thus
contradicting the congressional command that the in-
fringement remedies of § 271(e)(4) are “‘the only remedies
which may be granted by a court for an act of infringe-
ment described in [§ 271(e)(2)].’” Amgen v. Sandoz, 794
F.3d at 1356 (quoting § 271(e)(4); emphasis added by
Amgen v. Sandoz). For (8)(A), in contrast, as Amgen v.
Sandoz necessarily recognized in finding it “mandatory,”
there is no comparable textual source of a contradiction
that would be created by following the usual mandatory-
character interpretation.
Amgen v. Sandoz likewise disposes of Apotex’s argu-
ment that giving (8)(A) its plain meaning would effective-
ly extend, by six months, the 12-year exclusivity period
given to a reference product sponsor by § 262(k)(7). See
794 F.3d at 1358. Notably, § 262(k)(7) by its terms estab-
lishes the 12-year date only as an earliest date, not a
latest date, on which a biosimilar license can take effect.
Even when entry is delayed under (8)(A) to what amounts
to 12 years plus 180 days after the reference product
AMGEN INC. v. APOTEX INC. 17
sponsor’s licensure, the result is consistent with
§ 262(k)(7).
Moreover, it is implicit in the Biologics Act that any
such delay beyond 12 years should occur less and less as
time goes by. Doubtless, there will be some exclusivity
periods beyond 12 years in the early years of the Biologics
Act, as biosimilars are introduced for reference products
licensed well before the Act was adopted in 2010. But as
time passes, more and more of the reference products will
be newer, and a biosimilar-product applicant, entitled to
file an application a mere four years after licensure of the
reference product, § 262(k)(7)(B), can seek approval long
before the 12-year exclusivity period is up. See Amgen v.
Sandoz, 794 F.3d at 1358 (the “extra 180 days will not
likely be the usual case, as [biosimilar-product applica-
tions] will often be filed during the 12-year exclusivity
period”). In such circumstances, we have been pointed to
no reason that the FDA may not issue a license before the
11.5-year mark and deem the license to take effect on the
12-year date—a possibility suggested by § 262(k)(7)(A)’s
language about when the FDA approval may “be made
effective.” And we read (8)(A) as allowing the 180-day
notice of commercial marketing to be sent as soon as the
license issues, even if it is not yet effective, because it is at
the time of the license that “the product, its therapeutic
uses, and its manufacturing processes are fixed.” Id. at
1358.
In any event, the established and evident purpose of
(8)(A) covers applicants that file (2)(A) notices as well as
those that do not. As this court explained in Amgen v.
Sandoz, the purpose is to ensure that, starting from when
the applicant’s product, uses, and processes are fixed by
the license, the necessary decision-making regarding
further patent litigation is not conducted under time
pressure that will impair its fairness and accuracy. Id. at
1358, 1360. At the least, the reference product sponsor
needs time to make a decision about seeking relief based
18 AMGEN INC. v. APOTEX INC.
on yet-to-be litigated patents, and a district court needs
time for litigants to prepare their cases, in a complicated
area, to provide a reliable basis for judgment. While that
may not be true in every single case, Congress clearly
made a categorical fixed-period judgment in (8)(A)—as it
did elsewhere in the Biologics Act—and we have ex-
plained that the “statute must be interpreted as it is
enacted, not especially in light of particular, untypical
facts of a given case.” Id. at 1358.
That litigation-focused purpose extends to applicants
that launch and pursue the information-exchange process
of § 262(l). For those applicants as for others, the final
biosimilar product cannot be known with certainty until
the FDA license issues. Moreover, as we have described,
§ 262(l) affirmatively contemplates two stages of litigation
(under paragraphs (6) and (8)), and it contemplates that
the first stage of litigation may omit patents the reference
product sponsor has good grounds to assert, whether
patents already in the hands of the reference product
sponsor or patents newly in its hands under paragraph
(7). It gives the applicant substantial authority to force
such a limitation on the scope of the first-stage litigation. 3
3 Such applicant control is part of the design. See
Assessing the Impact of a Safe and Equitable Biosimilar
Policy in the United States: Hearing Before the Subcomm.
on Health of the H. Comm. on Energy & Commerce, 110th
Cong. 119 (2007) (statement of Bruce Downey, chairman
of the Generic Pharmaceutical Ass’n and CEO of Barr
Pharmaceuticals, Inc.) (“a biological patent system should
provide a mechanism for litigating only those patent
disputes that the generic company believes would delay
its launch”); Biologics and Biosimilars: Balancing Incen-
tives for Innovation: Hearing Before the Subcomm. on
Courts & Competition Policy of the H. Comm. on the
Judiciary, 111th Cong. 209–10 (2009) (statement of
AMGEN INC. v. APOTEX INC. 19
And it provides for the reference product sponsor to “seek
a preliminary injunction” after the licensure and (8)(A)
notice. See § 262(l)(8)(B). The 180-day period gives the
reference product sponsor time to assess its infringement
position for the final FDA-approved product as to yet-to-
be-litigated patents. And if there is such litigation, it
gives the parties and the district court the time for adju-
dicating such matters without the reliability-reducing
rush that would attend requests for relief against imme-
diate market entry that could cause irreparable injury.
This is evident on the face of § 262(l). And the Biolog-
ics Act’s legislative history confirms the aim to avoid the
uncertainties and deficiencies associated with a process in
which requests for temporary restraining orders and
preliminary injunctions are presented and adjudicated on
Teresa Stanek Rea, President of the American Intellectu-
al Property Law Ass’n) (“Under H.R. 1427, pre-launch
litigation of any patent is entirely within the control of
the follow-on applicant . . . .”); Michael P. Dougherty, The
New Follow-on-Biologics Law: A Section by Section Analy-
sis of the Patent Litigation Provisions in the Biologics
Price Competition and Innovation Act of 2009, 65 Food &
Drug L.J. 231, 238 (2010) (“a significant feature of the
Biologics Act” is that “it allows the applicant to limit
litigation at this early stage of the application process to
one patent”); Krista Hessler Carver, Jeffrey Elikan, &
Erica Lietzan, An Unofficial Legislative History of the
Biologics Price Competition and Innovation Act of 2009,
65 Food & Drug L.J. 671, 816 (2010) (“the BPCIA may
operate to prevent patentees from asserting the relevant
patents during the initial phase of litigation because the
biosimilar applicant dictates how many patents can be
asserted in the first instance”).
20 AMGEN INC. v. APOTEX INC.
short notice. See, e.g., Biologics and Biosimilars: Balanc-
ing Incentives for Innovation: Hearing Before the Sub-
comm. on Courts & Competition Policy of the H. Comm. on
the Judiciary, 111th Cong. 201–02 (2009) (statement of
Teresa Stanek Rea, President of the American Intellectu-
al Property Law Ass’n) (without a pre-launch patent-
dispute mechanism, “patent disputes in this area would
strain the federal judiciary by requiring—in preliminary
injunction proceedings—resolution of the complex legal
and scientific questions involved with each biosimilar
product launch . . . in a pressurized context and without
the benefit of a complete evidentiary record”); id. at 80
(statement of Jeffrey Kushan, on behalf of the Biotechnol-
ogy Industry Organization) (“forcing patent disputes to
commence only after a biosimilar has been placed on the
market . . . will raise the prospect that a court will not
enforce the exclusive rights of the patent by issuing an
injunction preventing the continued marketing of the
biosimilar”); id. at 9 (statement of Rep. Anna Eshoo) (“[A]
simple, streamlined patent resolution process . . . will
help ensure that litigation surrounding relevant patents
will be resolved expeditiously and prior to the launch of
the biosimilar product, providing certainty to the appli-
cant, the reference product manufacturer, and the public
at large.”); Emerging Health Care Issues: Follow-On
Biologic Drug Competition: Hearing Before the Subcomm.
on Health of the H. Comm. on Energy & Commerce, 111th
Cong. 17–18 (2009) (statement of Rep. Marsha Black-
burn); Assessing the Impact of a Safe and Equitable
Biosimilar Policy in the United States: Hearing Before the
Subcomm. on Health of the H. Comm. on Energy & Com-
merce, 110th Cong. 85 (2007) (statement of Dr. David
Schenkein, Vice President, Clinical Hematology/Oncology,
Genentech, Inc.); see also An Unofficial Legislative Histo-
ry of the Biologics Price Competition and Innovation Act of
2009, 65 Food & Drug L.J. at 798–800.
AMGEN INC. v. APOTEX INC. 21
Apotex’s final argument is that paragraph (9) of
§ 262(l) makes a declaratory-judgment action, discussed
in (9)(B), the exclusive remedy for violations of (8)(A). We
reject that contention.
Apotex has not asserted that (8)(A) creates no private-
ly enforceable right, even when asserted as part of an
infringement action concerning patent rights whose fair
and unhurried adjudication (8)(A) is designed to protect.
Nor has it identified any statutory commitment to a
government agency of responsibility or authority to en-
force or to seek to enforce the (8)(A) command. Instead,
Apotex suggests that the only remedy for an applicant’s
unilateral denial to the reference product sponsor of the
180-day period for post-licensure litigation decision-
making is a declaratory-judgment action on a patent—
which (9)(B) permits if the applicant “fails to complete”
any one of several steps, including the giving of the (8)(A)
notice. § 262(l)(9)(B).
We cannot infer such an exclusive-remedy conclusion
from paragraph (9). The Supreme Court long ago ruled
that the federal courts’ “equitable jurisdiction is not to be
denied or limited in the absence of a clear and valid
legislative command,” whether “in so many words, or by a
necessary and inescapable inference.” Porter v. Warner
Holding Co., 328 U.S. 395, 398 (1946); see Mitchell v.
Robert DeMario Jewelry, Inc., 361 U.S. 288, 291 (1960);
United States v. Oakland Cannabis Buyers’ Coop., 532
U.S. 483, 496 (2001). Under that standard, or indeed
under a straightforward understanding of paragraph (9)
as it relates to (8)(A), we do not find that paragraph (9)
establishes that a declaratory-judgment action is the sole
remedy for violating (8)(A).
Apotex cannot point to any text providing for exclusiv-
ity. Nothing in paragraph (9) declares the exclusivity of
the declaratory-judgment actions to which it refers—
either in (9)(B) as it applies to an (8)(A) violation or more
22 AMGEN INC. v. APOTEX INC.
generally. (9)(A) bars certain declaratory-judgment
actions, and (9)(B) & (C) state only that, in certain cir-
cumstances, the reference product sponsor “may bring”
such an action. § 262(l)(9)(B), (C). There is no language
that excludes other remedies for the conduct described.
Apotex’s argument is therefore for an implied exclu-
sivity of declaratory-judgment remedies. But it is clear
that there is no such exclusivity implied by paragraph (9)
generally. Most notably, when (9)(C) says that a declara-
tory-judgment action may be brought under 28 U.S.C.
§ 2201 if an applicant does not give the (2)(A) notice, see
§ 262(l)(9)(C), it plainly does not imply exclusivity of that
remedy: as Amgen v. Sandoz confirms, (9)(C) does not
exclude the monetary and injunctive infringement reme-
dies expressly authorized by 35 U.S.C. § 271(e)(4) for
what is, after all, an infringement under § 271(e)(2). See
Amgen v. Sandoz, 794 F.3d at 1357 (“when a subsection
(k) applicant fails the disclosure requirement, 42 U.S.C.
§ 262(l)(9)(C) and 35 U.S.C. § 271(e) expressly provide the
only remedies”) (emphases added); id. at 1359 (same).
Nor has Apotex shown that (9)(B), when it applies, implic-
itly negates 35 U.S.C. § 271(e)(4)’s provision of damages
and injunctive remedies (if otherwise appropriate and not
curtailed by 35 U.S.C. § 271(e)(6)) for an application that
is deemed by 35 U.S.C. § 271(e)(2)(C)(i) to be an infringe-
ment of a patent on a list under § 262(l)(3) (necessarily
after a (2)(A) notice). 4 Against this generally non-
4 We need not explore how the timing of actions for
such Title 35 remedies is affected by § 262(l). We make
the narrower point that (9)(B) does not make declaratory
judgments exclusive and thereby wipe out the remedies
expressly provided for in 35 U.S.C. § 271(e)(4). We need
not say to what extent, if at all, a similar point applies to
remedies provided for in, e.g., 35 U.S.C. §§ 283, 284 for
activities, such as actual or imminent market entry, that
AMGEN INC. v. APOTEX INC. 23
exclusive character of the paragraph (9) declaratory-
judgment remedy, it would be surprising to infer exclusiv-
ity of that remedy specifically for an (8)(A) violation.
This court did not declare otherwise when it said in
Amgen v. Sandoz “that paragraph (l)(9)(B) specifies the
consequence for a subsequent failure to comply with
paragraph (l)(8)(A) after the applicant has complied with
paragraph (l)(2)(A).” 794 F.3d at 1359. We read that
statement to mean only that, when there is noncompli-
ance with (8)(A), the consequence for the (9)(A) bar on
declaratory judgments is specified by (9)(B). That under-
standing reflects the express, limited language of (9)(B)
and its evident connection to (9)(A). The court in Amgen
v. Sandoz thus did not establish that the full remedial
consequence of (8)(A) noncompliance is a declaratory-
judgment action on the merits of the patents.
Such an exclusivity conclusion regarding (8)(A) would,
in fact, make little sense. In the ordinary case, a declara-
tory-judgment action would not actually enforce the
categorical “standalone,” “mandatory” (8)(A) notice right,
which would not be the subject of a declaratory-judgment
patent-merits action. 794 F.3d at 1359–60. A declarato-
ry-judgment action on the patent merits in the ordinary
case would not serve (8)(A)’s essential purpose or, there-
fore, be a meaningful remedy for the (8)(A) violation.
In particular, relegating a reference product sponsor
to a patent-merits declaratory-judgment action would
introduce the very problem of rushed decision-making as
to the patent merits that it is (8)(A)’s purpose to avoid.
Noncompliance with (8)(A) means either entering the
market without giving a post-licensure notice or giving a
notice but then jumping the gun and entering the market
might be infringements under portions of 35 U.S.C. § 271
other than subsection (e)(2).
24 AMGEN INC. v. APOTEX INC.
before 180 days have passed. In either event, a reference
product sponsor is likely not to know that the applicant
will fail to provide the actual 180-day commercial-
marketing notice required by (8)(A) until the applicant
begins commercial marketing or, at least, declares that it
may begin such marketing at any moment. The reference
product sponsor will have to race to court for immediate
relief to avoid irreparable harm from market entry, and
the parties and the court, in dealing with a request for a
temporary restraining order or a preliminary injunction,
will engage in precisely the hurried motion practice that
(8)(A) is designed to replace by ensuring a defined amount
of time for pre-launch litigation. (9)(B) as a “remedy” is so
gross a mismatch for the (8)(A) right that it cannot fairly
be treated, in the absence of any statutory language so
stating, as the exclusive remedy for (8)(A)’s violation.
The mention of (8)(A) in (9)(B) seems to play a limited
role in the provision, whose primary purpose is to provide
an incentive for an applicant to fulfill its obligations along
§ 262(l)’s litigation-channeling path once it starts on the
path by giving a (2)(A) notice. (9)(A) bars specified de-
claratory-judgment actions until the (8)(A) notice is
received, and without a further direction from Congress,
that bar would by its terms last precisely until the (8)(A)
notice is received. But Congress did go further in (9)(B),
by identifying several earlier points in time at which the
(9)(A) bar is lifted, for the reference product sponsor, if the
applicant “fails to complete” any of the specified actions
the applicant is obliged to take in the process designed to
lead up to and end with the (8)(A) notice. With respect to
the other actions listed in (9)(B)—namely, those required
by (3)(B)(ii), (5), (6)(C)(i), and (7)—the bar is lifted earlier
than otherwise would be implicit in (9)(A). With respect
to a failure to complete an action required by (8)(A), it
appears that (9)(B) also goes beyond what is implicit in
(9)(A) by authorizing a declaratory judgment as to an
applicant that sends an (8)(A) notice (which upon receipt
AMGEN INC. v. APOTEX INC. 25
brings the (9)(A) bar to an end by (9)(A)’s terms) but then
enters the market before 180 days have passed—which
may be a “fail[ure] to complete” an action required by
(8)(A). But even if (9)(B) does not have that application, it
would still make sense for (8)(A) to be included in the
(9)(B) list solely for completeness, to bring the chronologi-
cal list of (9)(A)-bar-lifting actions to its end point. It is
hardly an unfamiliar role for a statutory provision to
make explicit what otherwise would be implicit; such a
provision is not superfluous. See, e.g., Ali v. Fed. Bureau
of Prisons, 552 U.S. 214, 226 (2008); Fort Stewart Sch. v.
Fed. Labor Relations Auth., 495 U.S. 641, 646 (1990).
Apotex would infer an outsize consequence from the
mere modesty of the role played by (9)(B)’s mention of
(8)(A). Apotex’s proposed inference from (9)(B) would
implicitly make (8)(A) neither mandatory nor standalone,
despite (8)(A)’s language, and would reintroduce the very
problems of rushed litigation—over patents the applicant
is empowered to prevent being litigated earlier—that
(8)(A) was enacted to avoid. The inference that Congress
rendered unavailable direct injunctive enforcement of
(8)(A)’s plain terms is unwarranted.
We conclude that an applicant must provide a refer-
ence product sponsor with 180 days’ post-licensure notice
before commercial marketing begins, regardless of wheth-
er the applicant provided the (2)(A) notice of FDA review.
Because the parties here stipulated to the remaining
preliminary-injunction factors, see eBay Inc. v. Mer-
cExchange, L.L.C., 547 U.S. 388, 394 (2006), we affirm the
district court’s grant of a preliminary injunction without
addressing those factors.
CONCLUSION
For the foregoing reasons, we affirm the district
court’s grant of a preliminary injunction.
AFFIRMED