Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-16-01308/USCOURTS-ca13-16-01308-0/pdf.json

Parties Involved:
Amgen Inc.
Appellee
Amgen Manufacturing Limited
Appellee
Apotex Corp.
Appellant
Apotex Inc.
Appellant

Document Text:

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., Thousand Oaks, CA; JOHN F. O’SULLIVAN, ALLEN P. PEGG, 

JASON STERNBERG, Hogan Lovells US LLP, Miami, FL.

Case: 16-1308 Document: 100-2 Page: 1 Filed: 07/05/2016
2 AMGEN INC. v. APOTEX INC.

KERRY BRENDAN MCTIGUE, Cozen O’Connor, Washington, DC, argued for defendants-appellants. Also represented 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, Washington, 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, Washington, 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 Innovation Organization. Also represented by FILKO PRUGO, 

DANIEL BENJAMIN O’BOYLE; DEANNA MARIE RICE, Washington, 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) 

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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 application 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 applicant, 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 proposed 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 injunction to enforce a provision of the Biologics Act that requires 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 receiving 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 argues that a different result is required here—that the 

commercial-marketing provision is not mandatory and 

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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 commercial-marketing provision is mandatory and enforceable by 

injunction even for an applicant in Apotex’s position.

BACKGROUND

Amgen markets FDA-approved Neulasta®, whose active 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,

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AMGEN INC. v. APOTEX INC. 5

it may use publicly available information about the reference 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 prescribed 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 effective” 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 contains a detailed, multi-part subsection, § 262(l), that is 

focused in various ways on potential patent disputes 

between the reference product sponsor and biosimilarproduct 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 otherwise 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 significance 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 prepared to license to the applicant. § 262(l)(3)(A). Under 

(3)(B), within 60 days after receiving that list, the appliCase: 16-1308 Document: 100-2 Page: 5 Filed: 07/05/2016
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 unenforceability. § 262(l)(3)(C).

While the reference product sponsor may later supplement its (3)(A) list under paragraph (7), it is the original lists under (3) that form the basis of the next steps in 

the process leading to immediate litigation under paragraph (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 infringement on all such patents within 30 days. 

§ 262(l)(6)(A); see 35 U.S.C. § 271(e)(2)(C)(i). The applicant 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 exchange 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 

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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 product. But the Biologics Act—having provided for a narrowing of the scope of the paragraph (6) litigation, including 

by allowing the applicant to exclude potentially meritorious 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 “licensed” 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) postlicensure 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)). 

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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 reference 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 preliminaryinjunction 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 provide the first-step notice under (2)(A). For such an applicant, the reference product sponsor, but not the applicant,

may bring an action under 28 U.S.C. § 2201 for a declaratory 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 secondstage litigation until after the (post-licensure) 180-day 

notice of commercial marketing under (8)(A) is received. 

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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) (notifying 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 biological product” if the purpose is to obtain approval “to engage 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.

 

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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 circumstances 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 applicant has provided the (2)(A) notice. The other circumstance 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 product sponsor could identify as one it believes “could reasonably 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 infringements. Subparagraphs (B) and (C) authorize injunctions 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 justdescribed remedies in two ways evidently designed to 

reinforce the reference product sponsor’s incentives to 

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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 firststage 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 sponsor should have included on its (3)(A) list or its (7) supplement “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 application 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 December 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 marketing before two of the patents had expired and, as to the 

remaining patent, described bases for asserting noninfringement 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 product 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).

 

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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 thenextant 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 biosimilarproduct 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 sponsor’s remedy if the applicant does not provide such notice. 

The court stressed that 35 U.S.C. § 271(e)(2)(c)(ii) declares precisely that conduct—filing an application and 

failing to give the (2)(A) notice—to constitute an infringement (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 product, its therapeutic uses, and its manufacturing processes 

are fixed” by licensure. Id. The purpose, the court explained, is to “provide[ ] a defined statutory window 

during which the court and the parties can fairly assess 

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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 information-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 preliminary-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 

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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-ofcommercial-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 matter how rushed the litigation of those issues might be 

without the 180 days’ notice. Id.

Apotex appeals the district court’s grant of a preliminary injunction. We have jurisdiction under 28 U.S.C. 

§ 1292(a)(1) and (c)(1).

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DISCUSSION

We review a district court’s grant of a preliminary injunction 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 Trading 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 marketing, 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 Bershad Hynes & Lerach, 523 U.S. 26, 35 (1998). We ruled in 

Amgen v. Sandoz that this language is, indeed, “mandatory,” 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 relevant here. It contains no words that make the applicability 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. 

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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 effectively 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 infringement remedies of § 271(e)(4) are “‘the only remedies 

which may be granted by a court for an act of infringement 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 mandatorycharacter interpretation.

Amgen v. Sandoz likewise disposes of Apotex’s argument that giving (8)(A) its plain meaning would effectively 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 establishes 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 

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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 applications] 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 

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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 explained 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 Incentives for Innovation: Hearing Before the Subcomm. on 

Courts & Competition Policy of the H. Comm. on the 

Judiciary, 111th Cong. 209–10 (2009) (statement of 

 

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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-tobe-litigated patents. And if there is such litigation, it 

gives the parties and the district court the time for adjudicating such matters without the reliability-reducing 

rush that would attend requests for relief against immediate market entry that could cause irreparable injury.

This is evident on the face of § 262(l). And the Biologics 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 Intellectual 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 Analysis 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”).

 

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20 AMGEN INC. v. APOTEX INC.

short notice. See, e.g., Biologics and Biosimilars: Balancing Incentives for Innovation: Hearing Before the Subcomm. 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 Intellectual Property Law Ass’n) (without a pre-launch patentdispute 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 Biotechnology 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 applicant, 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 Blackburn); 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. 85 (2007) (statement of Dr. David 

Schenkein, Vice President, Clinical Hematology/Oncology, 

Genentech, Inc.); see also An Unofficial Legislative History of the Biologics Price Competition and Innovation Act of 

2009, 65 Food & Drug L.J. at 798–800.

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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 privately 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 enforce 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 decisionmaking 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 exclusivity. 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 

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22 AMGEN INC. v. APOTEX INC.

generally. (9)(A) bars certain declaratory-judgment 

actions, and (9)(B) & (C) state only that, in certain circumstances, 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 exclusivity 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 declaratory-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 remedies 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, implicitly 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 infringement of a patent on a list under § 262(l)(3) (necessarily 

after a (2)(A) notice).4 Against this generally non4 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 

 

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AMGEN INC. v. APOTEX INC. 23

exclusive character of the paragraph (9) declaratoryjudgment remedy, it would be surprising to infer exclusivity 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 noncompliance with (8)(A), the consequence for the (9)(A) bar on 

declaratory judgments is specified by (9)(B). That understanding 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 declaratoryjudgment 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 declaratory-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 declaratory-judgment action on the patent merits in the ordinary 

case would not serve (8)(A)’s essential purpose or, therefore, 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).

 

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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 commercialmarketing 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 declaratory-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 

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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 chronological 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 reference product sponsor with 180 days’ post-licensure notice 

before commercial marketing begins, regardless of whether 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. MercExchange, 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

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