Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-15-01499/USCOURTS-ca13-15-01499-0/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 

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United States Court of Appeals 

for the Federal Circuit ______________________ 

AMGEN INC., AMGEN MANUFACTURING 

LIMITED,

Plaintiffs-Appellants

v.

SANDOZ INC.,

Defendant-Appellee

______________________ 

2015-1499

______________________ 

Appeal from the United States District Court for the 

Northern District of California in No. 3:14-cv-04741-RS, 

Judge Richard Seeborg.

______________________ 

Decided: July 21, 2015

______________________ 

NICHOLAS P. GROOMBRIDGE, Paul, Weiss, Rifkind, 

Wharton & Garrison LLP, New York, NY, argued for 

plaintiffs-appellants. Also represented by ERIC ALAN 

STONE, JENNIFER H. WU, JENNIFER GORDON, PETER 

SANDEL, MICHAEL T. WU, ARIELLE K. LINSEY; WENDY A.

WHITEFORD, LOIS M. KWASIGROCH, KIMBERLIN L. MORLEY, 

Amgen Inc., Thousand Oaks, CA; VERNON M. WINTERS,

ALEXANDER DAVID BAXTER, Sidley Austin LLP, San Francisco, CA. 

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2 AMGEN INC. v. SANDOZ INC. 

DEANNE MAYNARD, Morrison & Foerster LLP, Washington, DC, argued for defendant-appellee. Also represented by JOSEPH R. PALMORE, MARC A. HEARRON; RACHEL 

KREVANS, San Francisco, CA; JULIE PARK, San Diego, CA. 

MICHAEL A. MORIN, Latham & Watkins LLP, Washington, DC, for amicus curiae AbbVie Inc. Also represented by DAVID PENN FRAZIER, GREGORY G. GARRE, MELISSA 

ARBUS SHERRY, CASEY L. DWYER, ROBERT J. GAJARSA.

GREGORY DISKANT, Patterson Belknap Webb & Tyler 

LLP, New York, NY, for amicus curiae Janssen Biotech, 

Inc. Also represented by IRENA ROYZMAN; DIANNE B.

ELDERKIN, BARBARA MULLIN, Akin Gump, Strauss, Hauer 

& Feld, LLP, Philadelphia, PA. 

LISA BARONS PENSABENE, O’Melveny & Myers LLP, 

New York, NY, for amicus curiae Biotechnology Industry 

Organization. Also represented by FILKO PRUGO. 

CARLOS T. ANGULO, Zuckerman Spaeder LLP, Washington, DC, for amicus curiae Generic Pharmaceutical 

Association. 

CHARLES B. KLEIN, Winston & Strawn LLP, Washington, DC, for amici curiae Hospira, Inc., Celltrion 

Healthcare Co., Ltd., Celltrion, Inc. Also represented by 

ANDREW C. NICHOLS; SAMUEL S. PARK, Chicago, IL; PETER 

E. PERKOWSKI, Los Angeles, CA.

______________________ 

Before NEWMAN, LOURIE, and CHEN, Circuit Judges. 

Opinion for the court filed by Circuit Judge LOURIE. 

Opinion concurring in part, dissenting in part filed by 

Circuit Judge NEWMAN. 

Opinion dissenting in part filed by Circuit Judge CHEN.

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AMGEN INC. v. SANDOZ INC. 3

LOURIE, Circuit Judge. 

This appeal presents issues of first impression relating to the Biologics Price Competition and Innovation Act 

of 2009 (“BPCIA”), Pub. L. No. 111-148, §§ 7001–7003, 

124 Stat. 119, 804–21 (2010). Amgen Inc. and Amgen 

Manufacturing Ltd. (collectively, “Amgen”) appeal from 

the decision of the United States District Court for the 

Northern District of California (1) dismissing Amgen’s 

state law claims of unfair competition and conversion 

with prejudice because Sandoz Inc. (“Sandoz”) did not 

violate the information-disclosure and notice-ofcommercial-marketing provisions of the BPCIA, respectively codified at 42 U.S.C. § 262(l)(2)(A) and (l)(8)(A); 

(2) granting judgment on the pleadings to Sandoz on its 

counterclaims seeking a declaratory judgment that it 

correctly interpreted the BPCIA; and (3) denying Amgen’s 

motion for a preliminary injunction based on its state law 

claims. Amgen Inc. v. Sandoz Inc., No. 14-cv-04741, 2015 

WL 1264756 (N.D. Cal. Mar. 19, 2015) (“Opinion”). 

For the reasons stated below, we affirm the dismissal 

of Amgen’s state law claims of unfair competition and 

conversion, vacate the judgment on Sandoz’s counterclaims and direct the district court to enter judgment 

consistent with our interpretation of the BPCIA, and 

remand for further proceedings consistent with this 

opinion. 

A. BACKGROUND

I. 

In 2010, as part of the Patient Protection and Affordable Care Act, Congress enacted the BPCIA,1 which 

1 Winston Churchill once described Russia as “a 

riddle wrapped in a mystery inside an enigma.” Winston 

Churchill, The Russian Enigma (BBC radio broadcast 

 

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4 AMGEN INC. v. SANDOZ INC. 

established an abbreviated pathway for regulatory approval of follow-on biological products that are “highly 

similar” to a previously approved product (“reference 

product”). Pub. L. No. 111-148, §§ 7001–7003, 124 Stat. 

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.). Congress established such “a biosimilar 

pathway balancing innovation and consumer interests.” 

BPCIA, Pub. L. No. 111-148, § 7001(b), 124 Stat. at 804.

The BPCIA has certain similarities in its goals and 

procedures to the Drug Price Competition and Patent 

Term Restoration Act of 1984 (the Hatch-Waxman Act), 

Pub. L. No. 98-417, 98 Stat. 1585 (1984), but it has several obvious differences. We note this as a matter of historical interest, but otherwise do not comment on those 

similarities and differences.

Traditionally, the Food and Drug Administration 

(“FDA”) approves a biological product for commercial 

marketing by granting a biologics license under 42 U.S.C. 

§ 262(a). An applicant filing a biologics license application (“BLA”) typically provides clinical data to demonstrate the safety and efficacy of its product. In contrast, 

under the abbreviated pathway created by the BPCIA, 

codified at 42 U.S.C. § 262(k), an applicant filing an 

abbreviated biologics license application (“aBLA” or 

“subsection (k) application”) instead submits information 

to demonstrate that its product is “biosimilar” to or “interchangeable” with a previously approved reference 

product, together with “publicly-available information

regarding the [FDA]’s previous determination that the 

reference product is safe, pure, and potent.” 42 U.S.C. 

Oct. 1, 1939), available at http://www.churchill-societylondon.org.uk/RusnEnig.html. That is this statute. In 

these opinions, we do our best to unravel the riddle, solve 

the mystery, and comprehend the enigma.

 

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AMGEN INC. v. SANDOZ INC. 5

§ 262(k)(2)–(5); see also id. § 262(i). The BPCIA thus

permits a biosimilar applicant to rely in part on the 

approved license of a reference product. 

To balance innovation and price competition, Congress enacted the BPCIA to provide a four-year and a 

twelve-year exclusivity period to a reference product, both 

beginning on the date of first licensure of the reference 

product. Specifically, a subsection (k) application “may 

not be submitted to the Secretary until the date that is 

4 years after the date on which the reference product was 

first licensed under subsection (a),” id. § 262(k)(7)(B), and 

approval of a subsection (k) application “may not be made 

effective by the Secretary until the date that is 12 years 

after the date on which the reference product was first 

licensed under subsection (a),” id. § 262(k)(7)(A). Thus, a 

sponsor of an approved reference product (the “reference 

product sponsor” or “RPS”) receives up to twelve years of 

exclusivity against follow-on products, regardless of 

patent protection. 

Moreover, the BPCIA established a patent-disputeresolution regime by amending Titles 28, 35, and 42 of the 

United States Code. The BPCIA amended the Patent Act

to create an artificial “act of infringement” and to allow 

infringement suits based on a biosimilar application prior 

to FDA approval and prior to marketing of the biological 

product. See 35 U.S.C. § 271(e)(2)(C), (e)(4), (e)(6). The 

BPCIA also established a unique and elaborate process

for information exchange between the biosimilar applicant and the RPS to resolve patent disputes. See 42 

U.S.C. § 262(l).

Under that process, codified at 42 U.S.C. § 262(l), the

biosimilar applicant grants the RPS confidential access to 

its aBLA and the manufacturing information regarding

the biosimilar product no later than 20 days after the 

FDA accepts its application for review. Id. § 262(l)(1)–(2). 

The parties then exchange lists of patents for which they 

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6 AMGEN INC. v. SANDOZ INC. 

believe a claim of patent infringement could reasonably be 

asserted by the RPS, as well as their respective positions 

on infringement, validity, and enforceability of those 

patents. Id. § 262(l)(3). Following that exchange, which 

could take up to six months, the parties negotiate to 

formulate a list of patents (“listed patents”) that would be 

the subject of an immediate infringement action, id. 

§ 262(l)(4)–(5), and the RPS then sues the biosimilar 

applicant within 30 days, id. § 262(l)(6). That information 

exchange and negotiation thus contemplates an immediate infringement action brought by the RPS based only on 

listed patents. 

Subsection 262(l) also provides that the applicant give

notice of commercial marketing to the RPS at least 180 

days prior to commercial marketing of its product licensed 

under subsection (k), which then allows the RPS a period

of time to seek a preliminary injunction based on patents 

that the parties initially identified during information 

exchange but were not selected for the immediate infringement action, as well as any newly issued or licensed 

patents (collectively, “non-listed patents”). Id. § 262(l)(7)–

(8). 

Subsection 262(l) additionally provides, in paragraph 

(l)(9)(A), that if the applicant discloses the information 

“required under paragraph (2)(A),” then neither the RPS 

nor the applicant may bring a declaratory judgment 

action based on the non-listed patents prior to the date on 

which the RPS receives the notice of commercial marketing under paragraph (l)(8)(A). Id. § 262(l)(9)(A). Paragraphs (l)(9)(B) and (l)(9)(C), however, permit the RPS, 

but not the applicant, to seek declaratory relief in the 

event that the applicant fails to comply with certain 

provisions of subsection (l). Id. § 262(l)(9)(B)–(C).

II. 

Amgen has marketed filgrastim under the brand 

name Neupogen® (“Neupogen”) since 1991. In May 2014, 

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AMGEN INC. v. SANDOZ INC. 7

Sandoz filed an aBLA, seeking FDA approval of a biosimilar filgrastim product, for which Neupogen is the reference product. On July 7, 2014, Sandoz received 

notification from the FDA that it had accepted Sandoz’s

application for review.

On July 8, 2014, Sandoz notified Amgen that it had 

filed a biosimilar application referencing Neupogen; that 

it believed that the application would be approved in 

“Q1/2 of 2015”; and that it intended to launch its biosimilar product immediately upon FDA approval. J.A. 1472. 

Later in July, in response to Amgen’s inquiry, Sandoz 

confirmed that the FDA had accepted its application for 

review, but Sandoz informed Amgen that it had “opted 

not to provide Amgen with Sandoz’s biosimilar application 

within 20 days of the FDA’s notification of acceptance” 

and that Amgen was entitled to sue Sandoz under 

§ 262(l)(9)(C). J.A. 1495–96. Sandoz thus did not disclose

its aBLA or its product’s manufacturing information to 

Amgen according to § 262(l)(2)(A). 

Subsequently, on March 6, 2015, the FDA approved 

Sandoz’s aBLA for all approved uses of Amgen’s 

Neupogen. Although Sandoz has maintained that it gave 

an operative notice of commercial marketing in July 2014, 

it nevertheless gave a “further notice of commercial 

marketing” to Amgen on the date of FDA approval. J.A. 

1774. Sandoz intended to launch its filgrastim product 

under the trade name Zarxio.

III. 

In October 2014, Amgen sued Sandoz in the Northern 

District of California, asserting claims of (1) unfair competition for unlawful business practices under California 

Business & Professions Code § 17200 et seq. (“UCL”), 

based on two alleged violations of the BPCIA; (2) conversion for allegedly wrongful use of Amgen’s approved

license on Neupogen; and (3) infringement of Amgen’s 

U.S. Patent 6,162,427 (the “’427 patent”), which claims a 

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8 AMGEN INC. v. SANDOZ INC. 

method of using filgrastim. Amgen alleged that Sandoz 

violated the BPCIA by failing to disclose the required 

information under § 262(l)(2)(A) and by giving a premature, ineffective, notice of commercial marketing under 

§ 262(l)(8)(A) before FDA approval of its biosimilar product. Sandoz counterclaimed for a declaratory judgment 

that it correctly interpreted the BPCIA as permitting its 

actions, and that the ’427 patent was invalid and not 

infringed.

In January 2015, the parties filed cross-motions for 

judgment on the pleadings on Amgen’s state law claims 

and Sandoz’s counterclaims interpreting the BPCIA. In 

February 2015, Amgen also filed a motion for a preliminary injunction based solely on its state law claims to 

enjoin Sandoz from launching Zarxio after FDA approval. 

Also in February 2015, through discovery, Amgen obtained access to Sandoz’s biosimilar application.

On March 19, 2015, the district court granted partial 

judgment on the pleadings to Sandoz on its BPCIA counterclaims to the extent that Sandoz’s interpretation of the 

statute is consistent with the court’s interpretation. 

Specifically, the district court concluded that: (1) the 

BPCIA renders permissible a subsection (k) applicant’s 

decision not to disclose its aBLA and the manufacturing 

information to the RPS, subject only to the consequences 

set forth in 42 U.S.C. § 262(l)(9)(C); (2) such a decision 

alone does not offer a basis for the RPS to obtain injunctive relief, restitution, or damages against the applicant; 

and (3) the applicant may give notice of commercial 

marketing under § 262(l)(8)(A) before FDA approval. 

Opinion, 2015 WL 1264756, at *8, *11.

Based on its interpretation of the BPCIA, the district 

court then dismissed Amgen’s unfair competition and 

conversion claims with prejudice because it concluded 

that Sandoz did not violate the BPCIA or act unlawfully. 

Id. at *8–9. The court also denied Amgen’s motion for a 

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AMGEN INC. v. SANDOZ INC. 9

preliminary injunction based on its state law claims, 

noting that Amgen “has yet to proceed on its remaining 

claim for patent infringement.” Id. at *10.

On the parties’ joint motion, the district court entered 

final judgment as to Amgen’s unfair competition and 

conversion claims and as to Sandoz’s BPCIA counterclaims under Rule 54(b) of the Federal Rules of Civil 

Procedure. The parties’ claims and counterclaims relating 

to infringement, validity, and enforceability of the ’427 

patent remain pending at the district court.

Amgen timely appealed from the final judgment and 

from the denial of a preliminary injunction; we have 

jurisdiction under 28 U.S.C. § 1295(a)(1) and § 1292(a)(1) 

and (c)(1). 

B. DISCUSSION

We apply the procedural law of the regional circuit, 

here the Ninth Circuit, when reviewing a district court’s 

grant of a motion for judgment on the pleadings. Merck & 

Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 1320 (Fed. 

Cir. 2007). The Ninth Circuit reviews the grant of judgment on the pleadings de novo, Peterson v. California, 604 

F.3d 1166, 1169 (9th Cir. 2010), and “accept[s] all material allegations in the complaint as true and construe[s]

them in the light most favorable to [the non-moving 

party],” Turner v. Cook, 362 F.3d 1219, 1225 (9th Cir. 

2004) (third alteration in original). Issues of statutory 

interpretation are also reviewed de novo. Qantas Airways 

Ltd. v. United States, 62 F.3d 385, 387 (Fed. Cir. 1995).

Because Amgen’s state law claims of unfair competition and conversion are premised on the proper interpretation of the BPCIA, we first interpret the relevant 

provisions of the BPCIA and then consider Amgen’s state 

law claims in light of that interpretation. 

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10 AMGEN INC. v. SANDOZ INC. 

I. 

We first consider whether the district court erred in 

concluding that a subsection (k) applicant may elect not to 

disclose its aBLA and the manufacturing information

under 42 U.S.C. § 262(l)(2)(A), subject only to the consequences set forth in § 262(l)(9)(C). Paragraph (l)(2)(A)

provides that: 

Not later than 20 days after the Secretary notifies 

the subsection (k) applicant that the application 

has been accepted for review, the subsection (k) 

applicant shall provide to the reference product 

sponsor a copy of the application submitted to the 

Secretary under subsection (k), and such other information that describes the process or processes 

used to manufacture the biological product that is 

the subject of such application . . . . 

42 U.S.C. § 262(l)(2)(A) (emphasis added). Paragraph 

(l)(9)(C) provides that:

If a subsection (k) applicant fails to provide the 

application and information required under paragraph (2)(A), the reference product sponsor, but 

not the subsection (k) applicant, may bring an action under section 2201 of Title 28, for a declaration of infringement, validity, or enforceability of 

any patent that claims the biological product or a 

use of the biological product.

Id. § 262(l)(9)(C) (emphases added). Additionally, 35 

U.S.C. § 271(e)(2)(C)(ii), as amended by the BPCIA, 

provides that: 

It shall be an act of infringement to submit . . . if 

the applicant for the application fails to provide 

the application and information required under 

section 351(l)(2)(A) of such Act, an application 

seeking approval of a biological product for a paCase: 15-1499 Document: 116-2 Page: 10 Filed: 07/21/2015
AMGEN INC. v. SANDOZ INC. 11

tent that could be identified pursuant to section 

351(l)(3)(A)(i) of such Act . . . .

35 U.S.C. § 271(e)(2)(C)(ii) (emphasis added).2

Amgen argues that the language “shall provide” in 

paragraph (l)(2)(A) suggests that the information disclosure is mandatory, not merely permissible. Amgen contends that other provisions of the BPCIA refer to the

information as “required” under paragraph (l)(2)(A) and 

also refer to non-disclosure as a failure to comply with the 

Act. Amgen argues that, by refusing to provide the required information, a subsection (k) applicant unlawfully 

evades the detection of process patent infringement and 

avoids an immediate infringement action under 

§ 262(l)(6). Amgen also argues that paragraph (l)(9)(C) is 

merely a limitation on declaratory judgment action, not a 

remedy, let alone the exclusive remedy, for noncompliance

with paragraph (l)(2)(A). 

Sandoz responds that the “shall” provision in paragraph (l)(2)(A) is only a condition precedent to engaging in 

the information-exchange process of paragraphs (l)(3) 

through (l)(6), not a mandatory requirement in all circumstances. Sandoz contends that this interpretation is 

consistent with the use of “shall” in paragraph (l)(6), 

which provides that the RPS “shall” file an infringement 

suit. Sandoz notes that this use of “shall” cannot mean 

that the RPS violates the statute if it chooses not to file 

an infringement suit. Sandoz also responds that, under 

the BPCIA, if a subsection (k) applicant does not disclose 

the information under paragraph (l)(2)(A), then the sponsor may file an infringement suit under paragraph 

(l)(9)(C) and obtain the information in discovery, which 

Amgen has done. Sandoz also contends that it did not act 

2 Section 351(l)(2)(A) of the Public Health Act corresponds to 42 U.S.C. § 262(l)(2)(A).

 

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12 AMGEN INC. v. SANDOZ INC. 

unlawfully by taking a path expressly contemplated by 

Congress and the BPCIA.

We conclude that, read in isolation, the “shall” provision in paragraph (l)(2)(A) appears to mean that a subsection (k) applicant is required to disclose its aBLA and 

manufacturing information to the RPS by the deadline

specified in the statute. Indeed, the BPCIA refers to such 

information as “required” in other provisions. See 42 

U.S.C. § 262(l)(1)(B)(i), (l)(9)(A), (l)(9)(C); 35 U.S.C. 

§ 271(e)(2)(C)(ii). Particularly, paragraph (l)(1)(B)(i) 

provides that “[w]hen” a subsection (k) applicant submits 

an aBLA to the FDA, “such applicant shall provide . . . 

confidential access to the information required to be 

produced pursuant to paragraph (2) and any other information that the subsection (k) applicant determines, in its 

sole discretion, to be appropriate” (emphases added). 

Thus, under the plain language of paragraph (l)(1)(B)(i), 

when an applicant chooses the abbreviated pathway for 

regulatory approval of its biosimilar product, it is required to disclose its aBLA and manufacturing information to the RPS no later than 20 days after the FDA’s 

notification of acceptance, but not when the “when” criterion is not met. 

Such a reading of “shall” in paragraph (l)(2)(A) is supported by the use of “may” in paragraph (l)(2)(B), which 

provides that a subsection (k) applicant “may” provide 

additional information requested by the RPS by the 

statutory deadline. Paragraph (l)(2)’s use of “shall” in 

juxtaposition with “may” in the adjacent provision would 

appear to indicate that “shall” signals a requirement. 

However, the “shall” provision in paragraph (l)(2)(A) 

cannot be read in isolation. In other provisions, the 

BPCIA explicitly contemplates that a subsection (k) 

applicant might fail to disclose the required information 

by the statutory deadline. It specifically sets forth the 

consequence for such failure: the RPS may bring an 

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AMGEN INC. v. SANDOZ INC. 13

infringement action under 42 U.S.C. § 262(l)(9)(C) and 35 

U.S.C. § 271(e)(2)(C)(ii). Those latter provisions indicate 

that “shall” in paragraph (l)(2)(A) does not mean “must.” 

And the BPCIA has no other provision that grants a 

procedural right to compel compliance with the disclosure 

requirement of paragraph (l)(2)(A). 

Under 35 U.S.C. § 271(e)(2)(C)(ii), filing a subsection 

(k) application and failing to disclose the required information under paragraph (l)(2)(A) is an artificial “act of 

infringement” of “a patent that could be identified” pursuant to paragraph (l)(3)(A)(i). 42 U.S.C. § 262(l)(9)(C) 

further provides that “[i]f a subsection (k) applicant fails 

to provide the application and information required under 

paragraph (2)(A),” then the RPS, but not the subsection 

(k) applicant, may bring a declaratory judgment action on 

“any patent that claims the biological product or a use of 

the biological product.”3 As a direct consequence of failing 

to comply with paragraph (l)(2)(A), paragraph (l)(9)(C)

bars the subsection (k) applicant from bringing a declara3 While it is true that 42 U.S.C. § 262(l)(9)(C) premises the declaration judgment action on “any patent that 

claims the biological product or a use of the biological 

product” (emphasis added), which does not appear to 

include process patents, 35 U.S.C. § 271(e)(2)(C)(ii) does 

contemplate an infringement action based on “a patent 

that could be identified pursuant to [paragraph] 

(l)(3)(A)(i)” (emphasis added), which does not exclude 

process patents. Section 271(e)(2)(C)(ii) allows the RPS to 

assert process patents, “if the [subsection (k)] applicant 

. . . fails to provide the application and information” and 

“the purpose of [the subsection (k)] submission is to obtain 

approval . . . to engage in the commercial manufacture, 

use, or sale of 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).

 

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14 AMGEN INC. v. SANDOZ INC. 

tory judgment action on patents that claim the biological 

product or its use. 

Notably, both 42 U.S.C. § 262(l)(9)(C) and 35 U.S.C. 

§ 271(e)(2)(C)(ii) are premised on a claim of patent infringement, and the BPCIA does not specify any nonpatent-based remedies for a failure to comply with paragraph (l)(2)(A). Once the RPS brings an infringement suit 

under those two provisions, it can access the required 

information through discovery.4 

Importantly, mandating compliance with paragraph 

(l)(2)(A) in all circumstances would render paragraph 

(l)(9)(C) and 35 U.S.C. § 271(e)(2)(C)(ii) superfluous, and 

statutes are to be interpreted if possible to avoid rendering any provision superfluous. Marx v. Gen. Revenue 

Corp., 568 U.S. __, 133 S. Ct. 1166, 1178 (2013) (“[T]he 

canon against surplusage is strongest when an interpretation would render superfluous another part of the same 

statutory scheme.”); TRW Inc. v. Andrews, 534 U.S. 19, 31 

(2001) (“It is a cardinal principle of statutory construction 

that a statute ought, upon the whole, to be so construed 

that, if it can be prevented, no clause, sentence, or word 

shall be superfluous, void, or insignificant.” (internal 

quotation marks omitted)). 

Moreover, 35 U.S.C. § 271(e)(4) provides “the only

remedies which may be granted by a court for an act of 

infringement described in paragraph (2)” (emphasis 

added). Under § 271(e)(2)(C)(ii), filing a subsection (k) 

application and failing to provide the required infor4 In addition, we note the existence of a rebuttable 

presumption in actions alleging infringement of a process 

patent under 35 U.S.C. § 271(g) relating to importation of 

products made abroad by a patented process. See, e.g., 

Creative Compounds, LLC v. Starmark Labs., 651 F.3d 

1303, 1314 (Fed. Cir. 2011) (citing 35 U.S.C. § 295).

 

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AMGEN INC. v. SANDOZ INC. 15

mation under paragraph (l)(2)(A) is such an act of infringement. Here, Amgen alleged that Sandoz violated 

the BPCIA, but the alleged violation is precisely an act of 

infringement under § 271(e)(2)(C)(ii), for which § 271(e)(4) 

provides the “only remedies.”

We therefore conclude that, even though under paragraph (l)(2)(A), when read in isolation, a subsection (k) 

applicant would be required to disclose its aBLA and the 

manufacturing information to the RPS by the statutory 

deadline, we ultimately conclude that 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 as those being based on a claim of patent 

infringement. Because Sandoz took a path expressly 

contemplated by the BPCIA, it did not violate the BPCIA

by not disclosing its aBLA and the manufacturing information by the statutory deadline. 

II. 

We next consider whether the district court erred in 

concluding that a subsection (k) applicant may satisfy its 

obligation to give notice of commercial marketing under 

42 U.S.C. § 262(l)(8)(A) by doing so before the FDA licenses its product. Paragraph (l)(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).” Id. § 262(l)(8)(A)

(emphases added).

a.

Amgen argues that a subsection (k) applicant may 

give notice of commercial marketing only after it has a 

“biological product licensed under subsection (k),” meaning only after the FDA has licensed the biosimilar product. Amgen notes that elsewhere subsection (l) refers to 

the biosimilar product as “the biological product that is 

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16 AMGEN INC. v. SANDOZ INC. 

the subject of ” the application, which supports its interpretation of “licensed” in paragraph (l)(8)(A). Amgen 

explains that giving notice after FDA licensure provides 

time for the RPS to seek a preliminary injunction and to 

resolve patent disputes in a timely fashion. Amgen 

contends that allowing the applicant to give notice before 

FDA licensure is irreconcilable with the statute’s text and 

purpose.

Sandoz responds that the plain terms of the notice 

provision are satisfied when an applicant provides notice 

at least 180 days before it commercially markets its 

product. According to Sandoz, the word “licensed” only 

means that, at the time of commercial marketing, the 

product must be licensed, but it does not limit the timing 

of the notice, which can be given before FDA licensure. 

Sandoz also argues that Amgen’s construction of the 

notice provision would transform it into an automatic, 

additional, six-month bar against marketing of every 

licensed biosimilar product, which improperly extends the 

twelve-year exclusivity period under § 262(k)(7)(A). 

We agree with Amgen that, under paragraph (l)(8)(A), 

a subsection (k) applicant may only give effective notice of 

commercial marketing after the FDA has licensed its 

product. The statutory language compels such an interpretation. It means that notice, to be effective under this 

statute, must be given only after the product is licensed 

by the FDA.

In subsection (l), only paragraph (l)(8)(A) refers to the 

product as “the biological product licensed under subsection (k).” In other provisions of subsection (l), the statute

refers to the product as “the biological product that is the 

subject of ” the application, even when discussing its 

commercial marketing. E.g., 42 U.S.C. § 262(l)(3)(B)(ii)(I), 

(l)(3)(C); id. § 262(l)(1)(D), (l)(2)(A), (l)(3)(A)(i), (l)(3)(B)(i), 

(l)(7)(B). If Congress intended paragraph (l)(8)(A) to 

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AMGEN INC. v. SANDOZ INC. 17

permit effective notice before the product is licensed, it 

would have used the “subject of ” language.

While it is true that only a licensed product may be 

commercially marketed, it does not follow that whenever 

the future commercial marketing of a yet-to-be licensed 

product is discussed, it is the “licensed” product. It is not

yet “the licensed product.” Congress could have used the 

phrase “the biological product that is the subject of ” the 

application in paragraph (l)(8)(A), as it did in other provisions, but it did not do so. See, e.g., Russello v. United 

States, 464 U.S. 16, 23 (1983). 

We believe that Congress intended the notice to follow 

licensure, at which time the product, its therapeutic uses, 

and its manufacturing processes are fixed. When a subsection (k) applicant files its aBLA, it likely does not know 

for certain when, or if, it will obtain FDA licensure. The 

FDA could request changes to the product during the 

review process, or it could approve some but not all 

sought-for uses. Giving notice after FDA licensure, once 

the scope of the approved license is known and the marketing of the proposed biosimilar product is imminent, 

allows the RPS to effectively determine whether, and on 

which patents, to seek a preliminary injunction from the 

court. 

Requiring that a product be licensed before notice of 

commercial marketing ensures the existence of a fully 

crystallized controversy regarding the need for injunctive 

relief. It 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. If a notice of commercial marketing could be given at 

any time before FDA licensure, the RPS would be left to 

guess the scope of the approved license and when commercial marketing would actually begin. Indeed, filing an 

aBLA only suggests that a subsection (k) applicant inCase: 15-1499 Document: 116-2 Page: 17 Filed: 07/21/2015
18 AMGEN INC. v. SANDOZ INC. 

tends to commercially market its product someday in the 

future. 

Furthermore, requiring FDA licensure before notice of 

commercial marketing does not necessarily conflict with

the twelve-year exclusivity period of § 262(k)(7)(A). It is 

true that in this case, as we decide infra, Amgen will have 

an additional 180 days of market exclusion after Sandoz’s 

effective notice date; that is because Sandoz only filed its 

aBLA 23 years after Amgen obtained FDA approval of its

Neupogen product. Amgen had more than an “extra” 180 

days, but that is apparently the way the law, business,

and the science evolved. That extra 180 days will not 

likely be the usual case, as aBLAs will often be filed 

during the 12-year exclusivity period for other products. 

A statute must be interpreted as it is enacted, not especially in light of particular, untypical facts of a given case. 

Finally, it is counterintuitive to provide that notice of 

commercial marketing be given at a time before one 

knows when, or if, the product will be approved, or licensed.

We therefore conclude that, under paragraph (l)(8)(A), 

a subsection (k) applicant may only give effective notice of 

commercial marketing after the FDA has licensed its 

product. The district court thus erred in holding that a 

notice of commercial marketing under paragraph (l)(8)(A)

may effectively be given before the biological product is 

licensed, and we therefore reverse its conclusion relating 

to its interpretation of § 262(l)(8)(A) and the date when 

Sandoz may market its product. 

b.

We next consider the consequence in this case of our 

interpretation of paragraph (l)(8)(A). Paragraph (l)(8)(A)

provides that the subsection (k) applicant “shall provide” 

notice of commercial marketing to the RPS no later than 

180 days before commercial marketing of the licensed 

product. As we have concluded, an operative notice of 

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AMGEN INC. v. SANDOZ INC. 19

commercial marketing can only be given after FDA licensure. Here, Sandoz’s notice in July 2014, the day after 

the FDA accepted its application for review, was premature and ineffective. However, the FDA approved 

Sandoz’s aBLA on March 6, 2015, and Sandoz gave a 

“further” notice of commercial marketing on that day. 

J.A. 1774. These facts are uncontested. Oral Argument 

at 35:33–56, Amgen Inc. v. Sandoz Inc., No. 2015-1499 

(Fed. Cir. June 3, 2015), available at http://www.cafc. 

uscourts.gov/oral-argument-recordings/15-1499/all. That

notice in March 2015 thus serves as the operative and 

effective notice of commercial marketing in this case.

A question exists, however, concerning whether the 

“shall” provision in paragraph (l)(8)(A) is mandatory. We 

conclude that it is. Both paragraph (l)(2)(A) and (l)(8)(A)

use the word “shall,” which presumptively signals a 

statutory requirement. See, e.g., Nat’l Ass’n of Home 

Builders v. Defenders of Wildlife, 551 U.S. 644, 661–62 

(2007); Lopez v. Davis, 531 U.S. 230, 241 (2001). As we 

have noted with respect to paragraph (l)(2)(A), however, 

the BPCIA explicitly contemplates that a subsection (k) 

applicant might fail to comply with the requirement of 

paragraph (l)(2)(A) and further specifies the consequence

for such failure in 42 U.S.C. § 262(l)(9)(C) and 35 U.S.C. 

§ 271(e)(2)(C)(ii). Because of those explicit statutory 

provisions, and to avoid construing the statute so as to 

render them superfluous, we have interpreted the BPCIA

as allowing noncompliance with paragraph (l)(2)(A), 

subject to the consequence specified in those other provisions. 

In contrast, with respect to paragraph (l)(8)(A), we do 

not find any provision in the BPCIA that contemplates, or 

specifies the consequence for, noncompliance with paragraph (l)(8)(A) here, which would be the case if Sandoz 

attempts to launch in disregard of the requirement of 

paragraph (l)(8)(A), as we have interpreted it. Sandoz 

argues that § 262(l)(9)(B) does specify the consequence for

Case: 15-1499 Document: 116-2 Page: 19 Filed: 07/21/2015
20 AMGEN INC. v. SANDOZ INC. 

noncompliance with paragraph (l)(8)(A). Paragraph 

(l)(9)(B), entitled “[s]ubsequent failure to act by subsection (k) applicant,” provides that: 

If a subsection (k) applicant fails to complete an 

action required of the subsection (k) applicant under paragraph (3)(B)(ii), paragraph (5), paragraph 

(6)(C)(i), paragraph (7), or paragraph (8)(A), the 

reference product sponsor, but not the subsection 

(k) applicant, may bring an action under section 

2201 of Title 28, for a declaration of infringement, 

validity, or enforceability of any patent included in 

the list described in paragraph (3)(A), including as 

provided under paragraph (7). 

42 U.S.C. § 262(l)(9)(B) (emphases added).

While it is true 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), it does not apply in this case, where 

Sandoz did not comply with paragraph (l)(2)(A) to begin 

with. Indeed, the consequence specified in paragraph 

(l)(9)(B) is a declaratory judgment action brought by the 

RPS based on “any patent included in the list described in 

paragraph (3)(A), including as provided under paragraph 

(7).” 42 U.S.C. § 262(l)(9)(B). Here, however, because 

Sandoz did not provide the required information to 

Amgen under paragraph (l)(2)(A), Amgen was unable to 

compile a patent list as described in paragraph (l)(3)(A) or 

paragraph (l)(7). 

Paragraph (l)(8)(A) is a standalone notice provision in 

subsection (l), and Sandoz concedes as much. Oral Argument at 39:30–52, Amgen Inc. v. Sandoz Inc., No. 2015-

1499 (Fed. Cir. June 3, 2015), available at http://www.

cafc.uscourts.gov/oral-argument-recordings/15-1499/all. 

Unlike the actions described in paragraphs (l)(3) through 

(l)(7), which all depend on, or are triggered by, the disclosure under paragraph (l)(2)(A), nothing in paragraph 

Case: 15-1499 Document: 116-2 Page: 20 Filed: 07/21/2015
AMGEN INC. v. SANDOZ INC. 21

(l)(8)(A) conditions the notice requirement on paragraph 

(l)(2)(A) or other provisions of subsection (l). Moreover, 

nothing in subsection (l) excuses the applicant from its 

obligation to give notice of commercial marketing to the 

RPS after it has chosen not to comply with paragraph 

(l)(2)(A). The purpose of paragraph (l)(8)(A) is clear: 

requiring notice of commercial marketing be given to 

allow the RPS a period of time to assess and act upon its 

patent rights. 

We therefore conclude that, where, as here, a subsection (k) applicant completely fails to provide its aBLA and 

the required manufacturing information to the RPS by 

the statutory deadline, the requirement of paragraph 

(l)(8)(A) is mandatory. Sandoz therefore may not market 

Zarxio before 180 days from March 6, 2015, i.e., September 2, 2015. 

III. 

We next consider Amgen’s unfair competition and 

conversion claims under California law. After finding 

that Sandoz did not violate the BPCIA, the district court 

dismissed Amgen’s state law claims with prejudice. We 

affirm the dismissal based on our interpretation of the 

BPCIA.5

a. 

Under Cal. Bus. & Prof. Code § 17200, “unfair competition” includes “any unlawful, unfair or fraudulent business act or practice.” Amgen’s unfair competition claim is

based solely on the “unlawful” prong, which requires a 

5 In its cross-motion for judgment on the pleadings, 

Sandoz did not argue preemption as a defense to Amgen’s 

state law claims, and thus the district court did not consider that issue. We therefore do not address preemption 

in this appeal.

 

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22 AMGEN INC. v. SANDOZ INC. 

showing that Sandoz acted unlawfully by violating another law, here, according to Amgen, the BPCIA. Davis v. 

HSBC Bank Nevada, N.A., 691 F.3d 1152, 1168 (9th Cir. 

2012); see also Farmers Ins. Exch. v. Superior Court, 826 

P.2d 730, 734 (Cal. 1992). Under California law, UCL 

remedies are not available when the underlying law 

expressly provides that the remedies in that law are 

exclusive. See Cal. Bus. & Prof. Code § 17205; Loeffler v. 

Target Corp., 324 P.3d 50, 76 (Cal. 2014).

As one basis of its unfair competition claim, Amgen 

alleges that Sandoz violated the BPCIA by failing to 

comply with § 262(l)(2)(A). As we have concluded, Sandoz 

did not violate the BPCIA by not disclosing its aBLA and 

the manufacturing information according to § 262(l)(2)(A). 

Sandoz took a path expressly contemplated by 42 U.S.C. 

§ 262(l)(9)(C) and 35 U.S.C. § 271(e)(2)(C)(ii), and 35 

U.S.C. § 271(e)(4) provides “the only remedies which may 

be granted by a court” for the alleged violation. We 

therefore affirm the dismissal of Amgen’s unfair competition claim based on the alleged violation of § 262(l)(2)(A).

b.

As another basis of its unfair competition claim, 

Amgen also asserts that Sandoz violated the BPCIA by 

giving a premature, ineffective, notice of commercial 

marketing under § 262(l)(8)(A) in July 2014, before FDA 

approval in March 2015. As indicated, under our interpretation of the BPCIA, the July 2014 notice is ineffective, 

and Sandoz gave the operative notice on March 6, 2015. 

Thus, as we have indicated, Sandoz may not market 

Zarxio before 180 days from March 6, 2015, i.e., September 2, 2015. And, as indicated below, we will extend the 

injunction pending appeal through September 2, 2015. 

Amgen’s appeal from the dismissal of its unfair competition claim based on the alleged violation of § 262(l)(8)(A) 

is therefore moot.

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AMGEN INC. v. SANDOZ INC. 23

c. 

We now turn to Amgen’s conversion claim. To sustain 

a claim for conversion under California law, Amgen must 

demonstrate: (1) its ownership or right to possession of 

the property; (2) Sandoz’s conversion by a wrongful act or 

disposition of property rights; and (3) damages. Burlesci 

v. Petersen, 80 Cal. Rptr. 2d 704, 706 (Cal. Ct. App. 1998). 

Amgen asserts that Sandoz wrongfully used Amgen’s

approved license on Neupogen by filing an aBLA referencing Neupogen but refusing to provide Amgen the benefits 

to which it is entitled under § 262(l). Sandoz responds 

that Amgen failed to show any “wrongful act” or to establish an exclusive ownership interest in the approved 

license on Neupogen to exclude Sandoz’s aBLA. 

We agree with Sandoz that Amgen failed to establish 

the requisite elements to sustain a claim of conversion 

under California law. As indicated, the BPCIA explicitly

contemplates that a subsection (k) applicant might not 

disclose its aBLA and the manufacturing information by 

the statutory deadline, and provides that the RPS may 

sue for patent infringement, which Amgen has done. 

Amgen thus failed to show a “wrongful act.”

Moreover, the BPCIA established the abbreviated 

pathway for FDA approval of follow-on biological products, allowing a subsection (k) applicant to use “publiclyavailable information” regarding the reference product in 

its application.6 42 U.S.C. § 262(k)(2). The BPCIA also

6 Amgen emphasizes in its briefs that Sandoz is 

wrongfully benefitting from Amgen’s establishment of the 

safety and efficacy of filgrastim. Be that as it may, this is 

not the first time that Congress has allowed generic 

applicants to benefit from the early work of innovators. 

See Hatch-Waxman Act, Pub. L. No. 98-417, 98 Stat. 1585 

(1984); see also Ruckelshaus v. Monsanto Co., 467 U.S. 

 

Case: 15-1499 Document: 116-2 Page: 23 Filed: 07/21/2015
24 AMGEN INC. v. SANDOZ INC. 

grants a 12-year exclusivity period to the RPS, during 

which approval of a subsection (k) application may not be 

made effective. Id. § 262(k)(7)(A). Neupogen’s 12-year 

exclusivity period has long expired. Amgen therefore fails 

to show that it has an exclusive right to possession of its 

approved license on Neupogen to sustain its claim of 

conversion under California law.

We therefore affirm the dismissal of Amgen’s unfair 

competition and conversion claims based on our interpretation of the relevant provisions of the BPCIA. 

IV. 

Amgen argues that the district court erred in denying 

its motion for a preliminary injunction based on an incorrect reading of the BPCIA and an erroneous finding that 

Amgen failed to show irreparable harm. Sandoz responds 

that Amgen’s appeal is moot because it sought an injunction only until the district court decided the parties’ crossmotions for judgment on the pleadings, which has already 

occurred. Sandoz also responds that, even if not moot, the 

district court did not abuse its discretion in denying the 

motion and did not clearly err in its factual findings. 

We agree with Sandoz that Amgen’s appeal from the 

denial of a preliminary injunction is moot. In its motion 

for a preliminary injunction, filed in the district court 

after it filed its motion for judgment on the pleadings, 

Amgen requested a preliminary injunction “until the 

Court decides the parties’ motions for judgment on the 

pleadings,” and “if the Court resolves those motions in 

Amgen’s favor, until . . . the parties have been placed in 

the position they would be in had Sandoz complied with 

the BPCIA.” Amgen Inc. v. Sandoz Inc., No. 14-cv-04741 

(N.D. Cal. Feb. 5, 2015), ECF No. 56, at 25.

986 (1984). That was a decision that Congress was entitled to make and it did so.

 

Case: 15-1499 Document: 116-2 Page: 24 Filed: 07/21/2015
AMGEN INC. v. SANDOZ INC. 25

On March 19, 2015, the district court rendered its decision on the parties’ cross-motions for judgment on the 

pleadings, deciding against Amgen on the merits and 

dismissing Amgen’s state law claims with prejudice. In 

the same order, the court also denied Amgen’s motion for 

a preliminary injunction, which was based solely on its 

state law claims. Because Amgen only requested a preliminary injunction until the district court decided the

parties’ motions for judgment on the pleadings, and the 

district court has resolved those motions against Amgen, 

Amgen’s appeal from the denial of a preliminary injunction is moot. We therefore dismiss that aspect of Amgen’s 

appeal.

V. 

After the district court granted partial judgment on 

the pleadings in favor of Sandoz and denied Amgen’s 

motion for a preliminary injunction, Amgen sought an 

injunction pending appeal, which the district court denied. Amgen then filed an emergency motion in this court 

for an injunction pending appeal. We granted the motion. 

In light of what we have decided concerning the proper 

interpretation of the contested provisions of the BPCIA, 

we accordingly order that the injunction pending appeal 

be extended through September 2, 2015. 

C. CONCLUSION

For the foregoing reasons, we affirm the dismissal of 

Amgen’s unfair competition and conversion claims, vacate 

the district court’s judgment on Sandoz’s counterclaims 

interpreting the BPCIA, and direct the district court to 

enter judgment on those counterclaims consistent with 

this opinion. We also remand for the district court to 

consider the patent infringement claim and counterclaims 

relating to the ’427 patent and any other patents properly 

brought into the district court action.

Case: 15-1499 Document: 116-2 Page: 25 Filed: 07/21/2015
26 AMGEN INC. v. SANDOZ INC. 

AFFIRMED IN PART, VACATED IN PART, 

AND REMANDED

COSTS

Each party shall bear its own costs.

Case: 15-1499 Document: 116-2 Page: 26 Filed: 07/21/2015
United States Court of Appeals 

for the Federal Circuit ______________________ 

AMGEN INC., AMGEN MANUFACTURING 

LIMITED,

Plaintiffs-Appellants

v.

SANDOZ INC.,

Defendant-Appellee

______________________ 

2015-1499

______________________ 

Appeal from the United States District Court for the 

Northern District of California in No. 3:14-cv-04741-RS, 

Judge Richard Seeborg.

______________________ 

NEWMAN, Circuit Judge, concurring in part, dissenting in 

part.

The immediate issue relates to the Biosimilar Price 

Competition and Innovation Act (BPCIA) and certain

obligations of the innovator/patentee (called the “reference product sponsor,” or “Sponsor”) and the subsection 

(k) applicant. Subsection (k) authorizes a biosimilar

applicant to use the Sponsor’s clinical safety and efficacy 

data in order to obtain FDA license approval for commercial marketing of the biosimilar product. By acting under 

subsection (k) the applicant need not obtain its own 

clinical data for its biosimilar product, and can receive 

FDA licensure by showing that “the biological product is 

Case: 15-1499 Document: 116-2 Page: 27 Filed: 07/21/2015
2 AMGEN INC. v. SANDOZ INC. 

biosimilar to a reference product,” 42 U.S.C. §262(k), and 

has the same characteristics of safety, efficacy, and purity. Id.

To facilitate identification of and resolution of any patent issues, the BPCIA requires the subsection (k) applicant to notify the Sponsor at two critical stages of FDA 

review of the subsection (k) application. I agree with the 

court that notice of issuance of the FDA license is mandatory, and that this notice starts the 180-day stay of commercial marketing, in accordance with 42 U.S.C. 

§262(l)(8)(A). Thus I join Part A, Part (B)(II), and Part 

B(V) of the court’s opinion. 

However, notice of acceptance of the filing of the subsection (k) application is also mandatory, along with the 

accompanying documentary and information exchanges 

set in the BPCIA in accordance with 42 U.S.C. 

§262(l)(2)(A). I respectfully dissent from the court’s 

holding that this activity is not required because the 

Sponsor might file an infringement suit in which it might

learn this information though discovery. 

Sandoz did not comply with either of these statutory 

requirements. These deliberate violations of the requirements of the BPCIA forfeit Sandoz’ access to the benefits 

of the BPCIA.

I 

Patent dispute resolution under the BPCIA has two 

phases. The “early phase” starts when the subsection (k) 

application is accepted by the FDA for review, and technical and patent information are then exchanged. The 

“later phase” starts when the FDA approves the biosimilar for commercial marketing. I comment only briefly on 

this later phase, for I agree, as the court holds, that 42 

U.S.C. §262(l)(8) requires that this phase of inquiry and 

dispute resolution commences when the subsection (k) 

applicant notifies the Sponsor, after the FDA license is 

Case: 15-1499 Document: 116-2 Page: 28 Filed: 07/21/2015
AMGEN INC. v. SANDOZ INC. 3

granted. My concern is that my colleagues on this panel 

do not apply, to the earlier “shall provide” words, the 

same mandatory meaning as for subsection (l)(8)(A):

§262(l)(8)(A) Notice of commercial marketing.-- 

The 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).

(Emphases added). The BPCIA explicitly states that after 

licensure and before commercial marketing the Sponsor 

may seek a preliminary injunction while the patent 

aspects are resolved: 

§262(l)(8)(B) Preliminary injunction.—After receiving the notice under subparagraph (A) and before such date of the first commercial marketing of 

such biological product, the reference product 

sponsor may seek a preliminary injunction

prohibiting the subsection (k) applicant from engaging in the commercial manufacture or sale of 

such biological product until the court decides the 

issue of patent validity, enforcement, and infringement [of any patent identified in the early 

stage or other defined proceedings.] 

(Emphasis added). Sandoz proposed to circumvent this 

provision and launch its biosimilar product immediately 

upon its FDA licensure.

I share the court’s interpretation of this statutory 

provision, which implements the purpose of the BPCIA “to 

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.” Biologics and Biosimilars: Balancing Incentives 

for Innovation: Hearing Before the Subcommittee On 

Case: 15-1499 Document: 116-2 Page: 29 Filed: 07/21/2015
4 AMGEN INC. v. SANDOZ INC. 

Courts and Competition Policy of the House Committee On 

the Judiciary, 111th Cong. 9 (July 14, 2009) (statement of 

Rep. Eshoo) (emphasis added). The BPCIA requires the 

court to give effect to the intent of Congress. See Ingersoll–Rand Co. v. McClendon, 498 U.S. 133, 138 (1990)

(“To discern Congress’ intent we examine the explicit 

statutory language and the structure and purpose of the 

statute.”)

II

The BPCIA provides for participants’ recognition of 

potential patent issues at an early stage, and requires 

that as soon as the FDA accepts the biosimilar application 

for review, the subsection (k) applicant shall notify the 

Sponsor, and exchanges of patent-related information 

shall commence. Details are set forth in 42 U.S.C. 

§262(l)(2). My colleagues hold that compliance with these 

early notice and information provisions is not mandatory. 

I cannot agree, for: “The word ‘shall’ is ordinarily the 

language of command.” Alabama v. Bozeman, 533 U.S. 

146, 153 (2001).

The purpose of subsection 262(l) is to initiate patentrelated activity, to exchange relevant information, to 

facilitate negotiations, and to expedite any litigation. 

Subsection (l)(2)(A) requires the subsection (k) applicant 

to notify the Sponsor within 20 days after the FDA accepts the subsection (k) application for review, and to 

describe the manufacturing process: 

§262(l)(2)(A) Subsection (k) application information.--Not later than 20 days after the Secretary notifies the subsection (k) applicant that the 

application has been accepted for review, the subsection (k) applicant shall provide to the reference product sponsor a copy of the application

submitted to the Secretary under subsection (k), 

and such other information that describes the 

process or processes used to manufacture 

Case: 15-1499 Document: 116-2 Page: 30 Filed: 07/21/2015
AMGEN INC. v. SANDOZ INC. 5

the biological product that is the subject of such 

application. 

(Emphases added). Sandoz did not provide this information, although it is required, and the BPCIA provides 

for confidentiality: 

§262(l)(1)(B)(i) Provision of confidential information.--When a subsection (k) applicant submits 

an application under subsection (k), such applicant shall provide to the persons described in 

clause (ii), subject to the terms of this paragraph, 

confidential access to the information required to be produced pursuant to paragraph (2) 

and any other information that the subsection (k) 

applicant determines in its sole discretion to be 

appropriate. 

(Emphases added). 

This designated exchange of information is fundamental to the BPCIA purposes of efficient resolution of patent 

issues. However, my colleagues hold that compliance by 

the applicant is not mandatory, citing §262(l)(9)(C), which 

authorizes suit by the Sponsor if the applicant does not 

provide the paragraph (2)(A) information: 

§262(l)(9)(C) Subsection (k) application not provided.--If a subsection (k) applicant fails to 

provide the application and information required 

under paragraph (2)(A), the reference product 

sponsor, but not the subsection (k) applicant, may 

bring an action under section 2201 of Title 28, for 

a declaration of infringement, validity, or enforceability of any patent that claims the biological 

product or a use of the biological product.

(Emphases added). This provision for declaratory action 

by the Sponsor is limited to “product” and “use” claims, 

and does not include manufacturing process patents, 

although the legislative record makes clear that for bioCase: 15-1499 Document: 116-2 Page: 31 Filed: 07/21/2015
6 AMGEN INC. v. SANDOZ INC. 

similars such patents may be highly material, and were 

so recognized during enactment. Amgen states that its 

patents here at issue relate primarily to manufacture.

I cannot agree that this provision excuses compliance 

by the subsection (k) applicant, even when such declaratory action is brought. Subsection (l)(9)(C) provides

declaratory jurisdiction only for product or use claims. 

Absent adequate factual support in a complaint for manufacturing method claims, declaratory jurisdiction may be 

unsupported. See Ashcroft v. Iqbal, 556 U.S. 662, 678 

(2009) (“To survive a motion to dismiss, a complaint must 

contain sufficient factual matter, accepted as true, to 

“state a claim to relief that is plausible on its face.” 

(citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 

(2007)).

The balance established in the BPCIA requires the 

statutorily identified disclosures at the threshold, in order 

both to avert and to expedite litigation. This purpose 

pervades the legislative record, as interested persons

debated which provisions would be mandatory, and which 

permissive. See, e.g., Biologics and Biosimilars: Balancing Incentives for Innovation: Hearing Before the Subcommittee on Courts and Competition Policy of the House

Committee on the Judiciary, 111th Cong. passim (2009) 

(debating the provisions of H.R. 1548, which provided for 

mandatory patent exchange, and H.R. 1427, which provided for discretionary patent exchange). Compare also S. 

623, 110th Cong. § (3)(a)(2)(k)(17)(E) (2007) (“nothing in 

this paragraph requires an applicant or prospective 

applicant to invoke the [patent notification and exchange] 

procedures set forth in this paragraph”) with S. 1695, 

110th Cong. § (2)(a)(2)(l)(2)(A) (2007) (the subsection (k) 

applicant “shall provide” application and manufacturing 

information). See Chickasaw Nation v. United States, 534 

U.S. 84, 93 (2001) (“We ordinarily will not assume that 

Congress intended ‘to enact language that it has earlier 

Case: 15-1499 Document: 116-2 Page: 32 Filed: 07/21/2015
AMGEN INC. v. SANDOZ INC. 7

discarded in favor of other language.’” (citations omitted)).

The BPCIA as enacted leaves no uncertainty as to 

which of its provisions are mandatory and which are 

permissive. For example, immediately after the “shall” 

provision of subsection (l)(2)(A), ante, subsection (l)(2)(B) 

states that a subsection (k) applicant

may provide to the reference product sponsor additional information requested by or on behalf of 

the reference product sponsor.

(Emphases added). “[W]hen the same Rule uses both 

‘may’ and ‘shall’, the normal inference is that each is used 

in its usual sense—the one act being permissive, the other 

mandatory.” Anderson v. Yungkau, 329 U.S. 482, 485 

(1947).

In United States ex rel. Siegel v. Thoman, 156 U.S. 

353, 359–60 (1895), the Court stated that when Congress 

uses the “special contradistinction” of “shall” and “may,” 

no “liberty can be taken with the plain words of the statute.” As reiterated in Sebelius v. Cloer, 133 S. Ct. 1886, 

1894 (2013), “[w]here Congress includes particular language in one section of a statute but omits it in another 

section of the same Act, it is generally presumed that 

Congress acts intentionally and purposely in the disparate inclusion or exclusion.” (alteration and internal quotation marks omitted). The BPCIA gestated during more 

than four years of study and debate. The record contains 

frequent reference to the experience of the HatchWaxman Act, as the BPCIA departed from that Act in 

seeking to “balance innovation and consumer interests” in 

the new and promising scientific era of biosimilars. 

BPCIA, Pub. L. No. 111-148, §7001(b), 124 Stat. 119, 804 

(2010). Fidelity to that balance is the judicial obligation.

The details enacted and included in the BPCIA 

demonstrate the rigor of the statute and its compromises. 

Case: 15-1499 Document: 116-2 Page: 33 Filed: 07/21/2015
8 AMGEN INC. v. SANDOZ INC. 

The BPCIA requires judicial implementation that conforms to “the design of the statute as a whole and to its 

object and policy.” Crandon v. United States, 494 U.S. 

152, 158 (1990). Subsection (k) and subsection (l) are 

components of an integrated framework; to enjoy the 

benefits of subsection (k), the biosimilar applicant is 

obligated to comply with subsection (l). Even on the 

district court’s (and my colleagues’) misplaced theory that 

subsection (l)(9)(C) excuses compliance with subsection 

(l)(2)(A), this would extend only to product and use 

claims, it does not excuse compliance as to manufacturing 

and process claims.

The BPCIA reflects an explicit balance of obligations 

and benefits. When a beneficiary of the statute withholds 

compliance with provisions enacted to benefit others, the 

withholder violates that balance. The consequences of the 

majority’s ruling are significant, for the structure of the 

BPCIA requires that the subsection (k) applicant comply 

with the information exchange provisions, as a threshold

to resolution of the Sponsor’s patent rights.1

Subsection (l)(9) provides jurisdiction in the district 

court when a subsection (k) applicant fails to comply with 

subsection (l), but it does not ratify non-compliance. 

While “a party may waive any provision, either of a 

1 The record recites the benefits of subsection (k) for 

biosimilar applicants. A study for the Congressional 

Research Service cites a Tufts report that found in 2006 

the “average cost to develop a new biotechnology product 

is $1.2 billion.” Follow-On Biologics: The Law and Intellectual Property Issues, CRS Report for Congress, Professor John Thomas, January 15, 1014, passim, n.32. The 

record explains that clinical safety and efficacy studies 

constitute the major portion of this development cost, and 

that subsection (k) authorizes the biosimilar applicant to 

rely on these data that the Sponsor provided to the FDA.

 

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AMGEN INC. v. SANDOZ INC. 9

contract or of a statute, intended for his benefit,” United 

States v. Mezzanatto, 513 U.S. 196, 201 (1995), the party 

cannot waive or disregard a provision that benefits those 

in an adverse position. The provisions of 35 U.S.C. 

§262(l)(9) function as a continuing prohibition on a party 

who fails to comply with some aspect of the patent exchange provisions. That is, subsection (l)(9)(C) prevents a 

non-compliant party from obtaining relief through a 

declaratory judgment action, while that prohibition is 

lifted as to the aggrieved party. Subsection (l)(9)(C) 

states that a “reference product sponsor, but not the 

subsection (k) applicant, may bring” a declaratory judgment action “for a declaration of infringement, validity, or 

enforceability for any patent that claims the biological 

product or use of the biological product” when a subsection (k) applicant fails to provide the information required 

under subsection (l)(2)(A).

35 U.S.C. § 271(e)(2)(C)(ii) similarly states that it 

shall be an act of infringement if the applicant fails to 

provide the information required under paragraph 

(l)(2)(A). However, this does not diminish the obligation 

set by section (l)(1)(B)(i) that the subsection (k) applicant 

“shall provide ... confidential access to the information 

required to be produced pursuant to paragraph (2).” Such 

obligation is mandatory.

Departure from the statutory obligation, to achieve 

purposes that the legislation intended to curtail, should 

not be judicially ratified. See Cannon v. Univ. of Chicago, 

441 U.S. 677, 690 (1979) (disregard of a statute is a 

wrongful act). It is not denied that Sandoz obtained the 

benefit of the Amgen data in filing under subsection (k). 

Sandoz should be required to respect its obligations, in 

fidelity to the statute. I respectfully dissent from the 

majority’s failure to require compliance with the obligations of the BPCIA.

Case: 15-1499 Document: 116-2 Page: 35 Filed: 07/21/2015
United States Court of Appeals 

for the Federal Circuit ______________________ 

AMGEN INC., AMGEN MANUFACTURING 

LIMITED,

Plaintiffs-Appellants

v.

SANDOZ INC.,

Defendant-Appellee

______________________ 

2015-1499

______________________ 

Appeal from the United States District Court for the 

Northern District of California in No. 3:14-cv-04741-RS, 

Judge Richard Seeborg.

______________________ 

CHEN, Circuit Judge, dissenting-in-part. 

I join the majority opinion except for Parts B.II.b and 

B.V. To properly interpret the BPCIA’s patent litigation 

management process described in section 262(l), I agree 

that none of subsection (l)’s provisions may be read in 

isolation. In other words, to understand the meaning of 

any one provision in § 262(l), one must first recognize how 

it interrelates with the rest of subsection (l) and the rest 

of the BPCIA. Based on this understanding, I agree that 

a subsection (k) applicant’s failure to supply the information described in (l)(2) to the reference product sponsor 

(RPS) is not a violation of the BPCIA, because the BPCIA 

itself, in (l)(9) and § 271(e)(2)(C)(ii), provides the RPS the 

Case: 15-1499 Document: 116-2 Page: 36 Filed: 07/21/2015
2 AMGEN INC. v. SANDOZ INC. 

remedial course of action in such circumstances. Contrary to the majority, however, I view this context-based 

interpretation as applying with equal force to the interpretation of (l)(8). When reading (l)(8) in the context of

subsection (l) as a whole, it becomes clear that (l)(8) is 

simply part and parcel of the integrated litigation management process contemplated in (l)(2)–(l)(7). Moreover, 

just as all the “shall” obligations set forth in (l)(3)–(l)(7) 

are contingent on the (k) applicant’s performance of the 

first “shall” step in (l)(2), this is also true of the “shall” 

notice obligation in (l)(8). What this means is when, as 

here, the (k) applicant fails to comply with (l)(2), the 

provisions in (l)(3)–(l)(8) cease to matter. In such a situation, as recognized by the majority opinion, the RPS’s 

course of action is clearly defined in (l)(9) and 

§ 271(e)(2)(C)(ii): the unfettered right to immediately 

pursue patent infringement litigation unconstrained by

any of the timing controls or limits on the number of 

patents it may assert that would result from the (l)(2)–

(l)(8) process. Based on this understanding, I do not view 

(l)(8)(A) as a “standalone provision” that provides, implicitly, the RPS a 180-day injunction beyond the express

twelve-year statutory exclusivity period. Because the 

majority opinion interprets (l)(8) differently, giving

Amgen, the RPS, an extra-statutory exclusivity windfall, I 

respectfully dissent.

I 

“It is a fundamental canon of statutory construction 

that the words of a statute must be read in their context 

and with a view to their place in the overall statutory 

scheme.” Davis v. Mich. Dep’t of Treasury, 489 U.S. 803, 

809 (1989). To that end, the Supreme Court has instructed that “statutory language cannot be construed in a 

vacuum.” Id.; see also Yates v. United States, 135 S. Ct. 

1074, 1081–82 (2015) (instructing courts to interpret 

statutory text by reference to “the specific context in 

which that language is used, and the broader context of 

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AMGEN INC. v. SANDOZ INC. 3

the statute as a whole.” (quotation marks omitted)). In 

Part B.I, the majority properly recognizes that “the ‘shall’ 

provision in paragraph (l)(2)(A) cannot be read in isolation.” Majority Op. at 12. The majority carefully examines the larger statutory context—subsection (l) and 

§ 271(e)(2)(C)(ii)—and correctly concludes that “‘shall’ in 

paragraph (l)(2)(A) does not mean ‘must.’” Majority Op. 

at 13. As the majority recognizes, nothing in the BPCIA 

grants the RPS a procedural right to compel the (k) applicant’s compliance with (l)(2)(A). In Part B.II, however, 

the majority holds that the word “shall” in (l)(8)(A) carries 

a different meaning than it does in (l)(2)(A). To reach 

that inconsistent result, the majority takes the view that 

(l)(8)(A) should be read in a vacuum, apart from the 

context and framework of subsection (l), including the 

language of (l)(8)(B). I respectfully disagree.

A 

Entitled “Patents,” § 262(l) of the BPCIA concerns one 

thing: patent litigation. Specifically, it specifies an elaborate information exchange process between the (k) applicant and the RPS that leads up to the expected patent 

infringement suit that comes during the pendency of a 

subsection (k) application. This process begins in (l)(2)(A)

with the requirement that the (k) applicant disclose to the 

RPS its biosimilar application (aBLA) and manufacturing 

process information. Compliance with subsection (l)(2)(A)

triggers a cascade of events contemplated by subsection 

(l), with each successive step reliant on the performance 

of one or more preceding steps. This intricate process

includes: the exchange of patent lists that each party 

believes the RPS has reasonable grounds to assert against 

the (k) applicant, as well as the exchange of respective

infringement, validity, and enforceability positions 

(§ 262(l)(3)); a process by which the parties may limit the 

patents in the infringement lawsuit (§ 262(l)(4)–(5)); a 

patent infringement lawsuit, filed by the RPS, limited to 

the patents listed in (l)(4) or (l)(5) (§ 262(l)(6)); a proceCase: 15-1499 Document: 116-2 Page: 38 Filed: 07/21/2015
4 AMGEN INC. v. SANDOZ INC. 

dure for updating the RPS’s previously created (l)(3) 

patent list with newly issued or licensed patents 

(§ 262(l)(7)); a requirement that the (k) applicant provide 

a 180-day notice ahead of commercial marketing thereby 

giving the RPS time to seek a preliminary injunction on 

any (l)(3) listed patents not asserted in the limited (l)(6) 

patent infringement suit (§ 262(l)(8)); and authorization 

for the RPS to file an immediate declaratory judgment 

action for patent infringement if the (k) applicant fails to 

comply with its specified obligations recited in (l)(2), 

(l)(3), (l)(5), (l)(6), (l)(7), or (l)(8) (§ 262(l)(9)(B)–(C)). 

Importantly, subsection (l) does not relate to the FDA 

approval process (for that see subsection (k)). Nor is the 

approval process contingent on any events related to a 

possible patent dispute occurring in parallel with that 

approval process. 

By enacting the provisions in subsection (l), Congress 

created a comprehensive, integrated litigation management system. These provisions also demonstrate that 

Congress anticipated the situation before us here, in 

which the (k) applicant refuses to engage in this litigation 

management process. Rather than forcing the (k) applicant, by court order or some other means, to engage in the 

subsection (l) process, or conditioning the (k) application’s 

approval on the (k) applicant fulfilling the requirements 

set forth in subsection (l), Congress instead authorized

the RPS in this situation to immediately file an infringement action. See § 262(l)(9) and 35 U.S.C. 

§ 271(e)(2)(C)(ii). 

Focusing on (l)(8), Congress accounted for the possibility (perhaps strong likelihood) of a situation in which the 

(k) applicant has received FDA approval and is on the 

verge of commercially marketing its biosimilar product

but the RPS was unable to assert all of its (l)(3) listed 

patents against the (k) applicant in the limited (l)(6) 

patent litigation. Entitled “Notice of commercial marketCase: 15-1499 Document: 116-2 Page: 39 Filed: 07/21/2015
AMGEN INC. v. SANDOZ INC. 5

ing and preliminary injunction,” (l)(8), in relevant part, is

set forth below:

8) Notice of commercial marketing and preliminary injunction 

(A) Notice of commercial marketing 

The 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). 

(B) Preliminary injunction 

After receiving the notice under subparagraph (A) 

and before such date of the first commercial marketing of such biological product, the reference 

product sponsor may seek a preliminary injunction prohibiting the subsection (k) applicant from 

engaging in the commercial manufacture or sale 

of such biological product until the court decides 

the issue of patent validity, enforcement, and infringement with respect to any patent that is— 

(i) included in the list provided by the reference 

product sponsor under paragraph (3)(A) or in 

the list provided by the subsection (k) applicant 

under paragraph (3)(B); and 

(ii) not included, as applicable, on— 

(I) the list of patents described in paragraph 

(4); or 

(II) the lists of patents described in paragraph (5)(B). 

Subsection (l)(8)(A) requires the (k) applicant to give 

the RPS at least 180 days’ notice of its intent to begin 

commercially marketing the biosimilar product. One of 

the key questions in this appeal is, “Why would Congress 

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6 AMGEN INC. v. SANDOZ INC. 

insert a 180-day commercial marketing notice provision in 

a subsection devoted to organizing patent litigation?” 

Paragraph (l)(8)(B) provides the answer. As mentioned 

above, the process in (l)(4)–(5) can result in restricting the 

(l)(6) infringement action to a subset of the RPS’s patents

identified in (l)(3). Rather than permit the (k) applicant 

to launch its biosimilar product while the RPS is blocked 

from enforcing some of its patent rights, subsection 

(l)(8)(B) addresses that problem by authorizing the RPS to

seek a preliminary injunction prohibiting commercial 

manufacture or sale based on the patents that were 

excluded from the (l)(6) action. Thus, the entirety of (l)(8), 

including (l)(8)(A)’s notice provision, serves to ensure that 

an RPS will be able to assert all relevant patents before 

the (k) applicant launches its biosimilar product. Amgen 

confirmed this understanding of (l)(8)’s purpose at oral 

argument. Oral Argument at 20:10–20:05, Amgen, Inc. v. 

Sandoz Inc., No. 2015-1499 (Fed. Cir. June 3, 2015), 

available at http://www.cafc.uscourts.gov/oral-argumentrecordings/15-1499/all. 

Given the purpose of (l)(8) and its express assumption 

that the parties have already performed the steps in (l)(3), 

and (l)(4)–(l)(5), the most logical conclusion when reading 

(l)(8) in context is that (l)(8)’s vitality is predicated on the 

performance of the preceding steps in subsection (l)’s 

litigation management process. Without first engaging in 

these procedures, (l)(8) lacks meaning. Similarly, for 

example, the statutory requirement in (l)(3) for the parties to exchange detailed positions on infringement and 

validity for the patents listed under (l)(3) no longer applies if the (k) applicant fails to comply with (l)(2). Paragraph (l)(8)’s interdependency on the preceding steps in 

subsection (l) is further reinforced by (l)(7)’s crossreference to (l)(8). Paragraph (l)(7), which sets forth a 

process for the RPS to update its (l)(3) patent list with 

any newly issued or licensed patents, states that any such 

patents “shall be subject to paragraph (8).” 42 U.S.C. 

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AMGEN INC. v. SANDOZ INC. 7

§ 262(l)(7)(B). The interwoven structure of subsection (l) 

indicates that Congress viewed the procedures of (l)(8) as 

inseverable from the preceding steps in (l). 

The majority, on the other hand, views (l)(8)(A) as a 

standalone notice provision that is not excused when the 

(k) applicant fails to comply with (l)(2).1 Yet, no one 

disputes that the requirements of (l)(3) through (l)(7) are 

certainly excused in such a case. I recognize that (l)(8)(A), 

unlike (l)(3) through (l)(7), is not expressly conditioned on 

the earlier steps. I cannot, however, read (l)(8)(A) in 

complete isolation from (l)(8)(B), which does reference, 

and is predicated on the performance of, (l)(3) and (l)(4)–

(l)(5). Thus, (l)(8) does not serve as a standalone provision; it is part and parcel to, and contingent upon, the 

preceding steps in the (l)(2)–(l)(8) litigation management 

regime. The most persuasive reading of subsection (l) as 

a whole is that Congress provided two paths to resolve 

patent disputes: (1) the intricate route expressed in (l)(2)–

(l)(8); and (2) the immediate, more flexible route provided 

in (l)(9), should the (k) applicant falter on any of its obligations recited in (l)(2)–(l)(8). 

B 

The majority is also concerned with the absence of an 

express consequence for noncompliance with (l)(8)(A) in 

situations in which the (k) applicant does not comply with 

(l)(2). I agree with the majority that the remedy in 

1 The majority states that Sandoz “concedes” that 

(l)(8)(A) is a standalone notice provision, citing to the oral 

argument. I understand Sandoz’s position as accepting 

that (l)(8)(A) as a standalone provision is one possible 

interpretation. Oral Argument at 39:30–40:30, Amgen 

Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. June 3, 

2015), available at http://www.cafc.uscourts.gov/oralargument-recordings/15-1499/all.

 

Case: 15-1499 Document: 116-2 Page: 42 Filed: 07/21/2015
8 AMGEN INC. v. SANDOZ INC. 

(l)(9)(B) does not provide relief in this scenario because 

the RPS’s right to pursue additional patent litigation at 

this stage under (l)(9)(B) is contingent on using the patents that have been “included in the list described in 

paragraph (3)(A).” If a (k) applicant never carries out 

(l)(2), the RPS will never create an (l)(3) patent list. Such 

a failure to adhere to (l)(2) would defeat the RPS’s opportunity to invoke (l)(9)(B) if the (k) applicant refuses to 

comply with (l)(8)(A)’s notice provision. 

Contrary to the majority’s conclusion, however, the 

absence of such a remedial provision in (l)(9)(B) confirms

that Congress deemed any additional remedy to be unnecessary. Congress created the fallback provision of 

(l)(9)(C) for just these circumstances. An RPS does not 

need the remedy in (l)(9)(B) because (l)(9)(C) and 

§ 271(e)(2)(C)(ii) already grant the right to file, immediately, an unrestricted patent infringement action when 

the (k) applicant fails to comply with (l)(2). At this point, 

the RPS possesses the statutory right to seek a preliminary injunction for any of its patents that “could be identified pursuant to section [262](l)(3)(A)(i).” 35 U.S.C. 

§ 271(e)(2)(C)(ii). It therefore would have been superfluous for Congress to provide the RPS with authorization to 

initiate an additional, redundant infringement action 

under (l)(9)(B)2 if the (k) applicant later does not comply 

2 It is worth examining (l)(9)(B) closely for it shows 

how Congress understood the (l)(8) notice provision to be 

one part of the entire subsection (l) litigation management process. Under (l)(9)(B), if a (k) applicant fails to 

comply with any of its obligations recited in “paragraph 

(3)(B)(ii), paragraph (5), paragraph (6)(C)(i), paragraph 

(7), or paragraph (8)(A),” the RPS may immediately bring 

an infringement action on any patent the RPS listed in 

(l)(3). 42 U.S.C. § 262(l)(9)(B) (emphasis added). By 

grouping (l)(8)(A) with (l)(3), (l)(5), (l)(6), and (l)(7), all of 

 

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AMGEN INC. v. SANDOZ INC. 9

with (l)(8)(A). Not only is compliance with (l)(8)(A) unnecessary under such a circumstance, but no additional 

remedy is needed. Thus, after Sandoz failed to perform 

the (l)(2) requirement, the only relevant provision in 

subsection (l) became (l)(9)(C) and § 271(e)(2)(C)(ii). 

C 

The practical consequence of the majority’s interpretation is that (l)(8)(A) provides an inherent right to an 

automatic 180-day injunction. The majority provides no 

basis in the statutory language to support this automatic 

injunction.3 This relief is analogous to the thirty-month 

stay of the Hatch-Waxman Act, which provides for an 

automatic stay during which the FDA cannot approve the 

ANDA unless the patent infringement suit is resolved or 

the patent expires. See 21 U.S.C. § 355(j)(5)(B)(iii). If 

Congress intended to create a 180-day automatic stay it 

understood how to do so. It could have tied FDA approval 

to the notice provision. Yet, Congress declined to link 

FDA approval to a single provision in subsection (l). At 

bottom, the majority’s view is in tension with the defined 

which are unquestionably part of the litigation management regime, and defining the scope of any infringement 

action by the patents listed in (l)(3), Congress evidenced 

that (l)(8)(A) is not a provision that stands apart from the 

others, but is instead part of an integrated regime with 

each part serving a common purpose. 3 The majority believes that (l)(8)(A)’s notice provision plays a necessary role, when the (k) applicant fails to 

comply with (l)(2), to provide the RPS adequate notice of

the aBLA and therefore a meaningful opportunity to 

assert its patent rights. In my view, the majority reads 

too much into (l)(8)(A) by empowering it with an injunction right in the limited circumstance when a (k) applicant fails to comply with (l)(2). 

 

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10 AMGEN INC. v. SANDOZ INC. 

purpose of (l)(8) while providing the RPS with an atextual 

180-day exclusivity windfall. 

Notably, nothing in the majority opinion suggests that 

this automatic injunction remedy would be available in 

cases where the applicant complied with (l)(2)(A) by 

providing its aBLA to the RPS, but later failed to provide 

notice under (l)(8)(A). In fact, the majority’s opinion 

creates an uncomfortable result in which the language of 

(l)(8)(A) is interpreted in two different ways, based on the 

(k) applicant’s actions. In a situation like the present 

case, the (k) applicant cannot refuse to provide the 180-

days’ notice, because under the majority’s reading, 

(l)(8)(A) authorizes an automatic entitlement to a 180 day 

injunction. But if a (k) applicant complies with all the 

requirements specified in (l)(2)–(l)(7), then the (k) applicant may still refuse to comply with the 180-day notice 

provision. In this scenario, there would be no automatic 

injunction because (l)(9)(B) provides the RPS with the 

authorization to immediately file suit on any patent it 

listed under (l)(3). Thus, in one scenario, (l)(8)(A) provides a 180-day injunction, but in the second scenario it 

does not. While the result in the latter scenario comes 

from the plain language of the statute, not so with the 

former. Nothing in the statute supports this peculiar 

outcome. As explained above, in my view, the better 

reading of (l)(8) is that it does not apply, just as (l)(3)–

(l)(7) do not apply, when the (k) applicant fails to comply 

with (l)(2).

II 

To be sure, (l)(8)(A) is an integral part of the procedures for managing patent litigation that arises as a 

result of a party filing an aBLA. Nevertheless, (l)(8)(A) is 

simply one piece of subsection (l)’s integrated patent 

dispute puzzle that ceases to matter, just like all the other 

pieces preceding (l)(8) cease to matter, once the (k) applicant fails to comply with (l)(2). I do not find support in 

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AMGEN INC. v. SANDOZ INC. 11

the statutory language to create an automatic 180-day 

injunction. Just as “shall” in (l)(2) does not mean “must,” 

the same is true for the “shall” provision in (l)(8)(A), once 

it is read in context with the entirety of subsection (l). 

As the majority opinion recognizes, this case requires 

us to “unravel the riddle, solve the mystery, and comprehend the enigma” that is the BPCIA. Majority Op. at 3 

n.1. To fulfill our judicial obligation “to say what the law 

is,” we must choose from a series of imperfect choices. In 

my view, the most coherent interpretation of (l)(8)(A) that 

is consistent with the rest of the BPCIA is the one I have 

described above. For these reasons, I respectfully dissent 

from the majority’s holding that (l)(8) is a standalone 

provision with an inherent right to a 180-day injunction. 

Accordingly, I would dissolve the injunction pending 

appeal.

Case: 15-1499 Document: 116-2 Page: 46 Filed: 07/21/2015