United States Court of Appeals 

for the Federal Circuit ______________________ 

AMGEN INC., AMGEN MANUFACTURING, 

LIMITED,

Plaintiffs-Appellants

v.

HOSPIRA, INC.

Defendant-Appellee

______________________ 

2016-2179

______________________ 

Appeal from the United States District Court for the 

District of Delaware in No. 1:15-cv-00839-RGA, Judge 

Richard G. Andrews.

______________________ 

Decided: August 10, 2017 

______________________ 

NICHOLAS P. GROOMBRIDGE, Paul, Weiss, Rifkind, 

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

plaintiffs-appellants. Also represented by STEPHEN 

ACCURSIO MANISCALCO, ERIC ALAN STONE, JENNIFER H.

WU; KEVIN M. FLOWERS, JOHN LABBE, MATTHEW NIELSEN, 

Marshall, Gerstein & Borun LLP, Chicago, IL; THOMAS 

FRANCIS LAVERY, WENDY A. WHITEFORD, Amgen Inc., 

Thousand Oaks, CA.
2 AMGEN INC. v. HOSPIRA, INC. 

THOMAS J. MELORO, Willkie Farr & Gallagher LLP, 

New York, NY, argued for defendant-appellee. Also represented by MICHAEL JOHNSON. 

______________________ 

Before DYK, BRYSON, and CHEN, Circuit Judges.

DYK, Circuit Judge. 

Amgen Inc. (“Amgen”) appeals an order of the United 

States District Court for the District of Delaware denying 

Amgen’s motion to compel discovery from Hospira, Inc. 

(“Hospira”) in a patent infringement case governed by the

Biologics Price Competition and Innovation Act of 2009

(“BPCIA”), Pub. L. No. 111-148, 124 Stat. 119, 804 (2010)

(amending 42 U.S.C. § 262). Amgen alternatively seeks a 

writ of mandamus ordering the court to compel discovery. 

Because we lack jurisdiction over the district court’s 

order under the collateral order doctrine and find that 

Amgen fails to satisfy the prerequisites for mandamus, we 

dismiss the appeal and deny the writ. 

BACKGROUND

I 

The parties’ dispute arises from the disclosure requirements of the BPCIA, provisions that were recently 

addressed by the Supreme Court in Sandoz, Inc. v. 

Amgen, Inc., 137 S. Ct. 1664 (2017). “The BPCIA sets 

forth a carefully calibrated scheme for preparing to adjudicate, and then adjudicating, claims of [patent] infringement” resulting from the approval of “biological products” 

by the federal Food and Drug Administration (“FDA”). 

Sandoz, 137 S. Ct. at 1671. To obtain FDA approval, the 

sponsor of a new biological product must demonstrate, 

inter alia, that the new product is “safe, pure, and potent.” 

42 U.S.C. § 262(a)(2)(C)(i)(I). However, for a “biosimilar”
AMGEN INC. v. HOSPIRA, INC. 3 

product based on an existing “reference” biological product already approved under section 262(a),1 a party may 

instead submit an “abbreviated” application under subsection (k) of the statute. Sandoz, 137 S. Ct. at 1670. 

Thus, instead of having to demonstrate that its biosimilar 

is “safe, pure, and potent” to obtain FDA approval, a 

subsection (k) applicant may “piggyback on the showing 

made by the [sponsor] of a previously [approved] biologic 

(reference product).” Id.

In exchange for this abbreviated pathway to approval,

the subsection (k) applicant is subject to a number of 

obligations relevant to the sponsor’s patent rights. One of 

these obligations is to provide the sponsor with “a copy of 

the application submitted” 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).

This disclosure leads to a series of information exchanges—described in 42 U.S.C § 262(l)(3), (l)(4) and (l)(5)—

between the applicant and the sponsor that “channels the 

parties into two phases of patent litigation”—described in 

42 U.S.C. § 262(l)(6) and (l)(8). Sandoz, 137 S. Ct. at 1671. 

“In the first phase, the parties collaborate to identify 

patents that they would like to litigate immediately” by 

exchanging patent lists pursuant to paragraph (l)(3) and 

negotiating which of the listed patents will be subject to 

immediate action under paragraph (l)(6). Id. “The second 

phase of litigation,” under paragraph (l)(8), “is triggered 

 

1 A “biosimilar” product is a “biological product 

[that] is highly similar to a reference product notwithstanding minor differences in clinically inactive components” and for which “there are no clinically meaningful 

differences between the biological product and the reference product in terms of . . . safety, purity, and potency.” 

42 U.S.C. § 262(i)(2)(A)–(B). 
4 AMGEN INC. v. HOSPIRA, INC. 

by the applicant’s notice of commercial marketing and 

involves any patents that were included on the parties’ 

[paragraph (l)(3)] lists but not litigated in the first phase.” 

Id.; see also Amgen Inc. v. Apotex Inc., 827 F.3d 1052, 

1055–57 (Fed. Cir. 2016).

II

Hospira filed a subsection (k) application with the 

FDA in December 2014 seeking approval of a biosimilar of 

EPOGEN®, a biological product developed by Amgen and 

approved by the FDA under section 262(a) in 1989. In 

accordance with paragraph (l)(2)(A), Hospira provided a 

copy of its application to Amgen. Hospira did not separately provide information concerning “the process . . . 

used to manufacture the biological product”—again, as 

required by the statute—but contends that such information was disclosed in its application. 

In a letter to Hospira dated March 31, 2015, Amgen 

asserted that Hospira had failed to comply with paragraph (l)(2)(A) because Hospira had failed to “fully disclose the specific composition of the cell-culture medium 

used in the manufacture” of Hospira’s biosimilar. J.A. 

699.2 Hospira responded that the components Amgen had 

identified were “commercially-available raw materials,” 

and that Hospira had, through its application, “provided 

sufficient information concerning both its product and the 

processes used to manufacture its product.” J.A. 708.

Despite their disagreement over Hospira’s compliance 

with paragraph (l)(2)(A)—a disagreement that we do not 

resolve—the parties proceeded to the next phase of the 

BPCIA’s information exchange by identifying patents 

 

2 Amgen specifically asserted that Hospira had 

failed to disclose “the composition of the ‘MAM-PF2 

(powder),’ the ‘Trace Element Solution,’ the ‘Lipid Mix,’ or 

the ‘Antifoam C Solution.’” J.A. 699.
AMGEN INC. v. HOSPIRA, INC. 5 

subject to suit. Under paragraph (l)(3)(A), Amgen was 

obligated to “provide to [Hospira] . . . a list of patents for 

which [Amgen] believe[d] a claim of patent infringement

could reasonably be asserted . . . if a person not licensed 

by [Amgen] engaged in the making, using, offering to sell, 

selling, or importing into the United States of the biological product that [was] the subject of [Hospira’s] subsection 

(k) application.” 42 U.S.C. § 262(l)(3)(A). Amgen listed 

U.S. Patent Nos. 5,756,349, 5,856,298, and 6,632,637 (the 

’349, ’298, and ’637 patents, respectively), under paragraph (l)(3)(A). These patents relate to the biological 

product and methods of producing the biological product, 

rather than the specific cell-culture medium used during 

its manufacturing process.3 Amgen stated that without 

information regarding the cell-culture medium used by 

Hospira, “Amgen [could not] assess the reasonableness of 

asserting claims for infringement” with respect to other 

patents owned by Amgen “that claim processes for culturing cells used in manufacturing biological products.” J.A. 

702. Consistent with this position, Amgen never identified 

a cell-culture patent as part of its own BPCIA disclosures. 

Ultimately, Amgen filed suit against Hospira on the ’349 

and ’298 patents. As noted, neither of the asserted patents

is a cell-culture patent.

Relying on our statement in Amgen Inc. v. Sandoz 

Inc., 794 F.3d 1347 (Fed. Cir. 2015), rev’d in part and 

vacated in part, Sandoz, 137 S. Ct. at 1664, that a sponsor 

may seek information withheld by an applicant under 

paragraph (l)(2)(A) “through discovery,” 794 F.3d at 1356, 

Amgen sought discovery on the composition of Hospira’s

cell-culture medium in its suit on the ’349 and ’298 pa-

 

3 Claim 7 of the ’349 patent recites “the step of culturing under suitable nutrient conditions, vertebrate 

cells,” but Hospira “determined not to contest that its 

manufacturing process meets” this limitation. J.A. 997. 
6 AMGEN INC. v. HOSPIRA, INC. 

tents. Hospira refused Amgen’s discovery requests, and

Amgen ultimately filed a motion to compel discovery. The 

district court denied Amgen’s motion, stating that the 

cell-culture information sought by Amgen had “essentially, no relevance to the patents that are asserted,” J.A. 37, 

a conclusion that Amgen does not now dispute. 

Amgen appealed the district court’s interlocutory order. Hospira then moved this court to dismiss Amgen’s 

appeal for lack of jurisdiction. We denied Hospira’s motion, but asked the parties to brief “whether this court has 

jurisdiction pursuant to the collateral order doctrine or 

under the All Writs Act.” Order, Amgen, Inc. v. Hospira, 

Inc., No. 16-2179 (Fed. Cir. Aug. 12, 2016), ECF No. 16.

DISCUSSION

I 

We first address our jurisdiction over this appeal. Ordinarily, an appeal must be from a “final” judgment that 

“ends the litigation on the merits and leaves nothing for 

the court to do but execute the judgment.” Coopers &

Lybrand v. Livesay, 437 U.S. 463, 467 (1978) (quoting 

Catlin v. United States, 324 U.S. 229, 233 (1945)). The 

collateral order doctrine provides a narrow exception to 

this general rule. See Microsoft Corp. v. Baker, 137 S. Ct 

1702, 1708 n.3 (2017). “To come within the ‘small class’ of 

decisions excepted from the final-judgment rule by [the 

collateral order doctrine], the order must conclusively 

determine the disputed question, resolve an important 

issue completely separate from the merits of the action, 

and be effectively unreviewable on appeal from a final 

judgment.” Livesay, 437 U.S. at 468; Cohen v. Beneficial 

Indus. Loan Corp., 337 U.S. 541, 546 (1949).

Here, it appears that the district court’s discovery order may satisfy the first two conditions of being an appealable collateral order; the order conclusively denied 

Amgen’s motion to compel discovery, and Amgen’s enti-
AMGEN INC. v. HOSPIRA, INC. 7 

tlement to discovery is separable from the merits since 

the discovery sought is concededly not relevant to the 

asserted infringement claims. The issue is whether the 

district court’s order is “effectively unreviewable” on 

appeal from a final judgment. Livesay, 437 U.S. at 468.

As noted in Livesay, “rulings on discovery” generally 

do not qualify for the collateral order doctrine’s exception 

to the final judgment rule. Id. at 470. “[T]he rule remains 

settled that most discovery orders are not final,” and 

“courts routinely dismiss appeals from orders granting . . . 

[or] denying discovery.” 15B Charles Alan Wright & 

Arthur R. Miller § 3914.23 (2d ed. June 2017); see also, 

e.g., Mohawk Indus., Inc. v. Carpenter, 558 U.S. 100, 112

(2009) (“privilege-related disclosure orders” not subject to 

collateral appeal); Firestone Tire & Rubber Co. v. Risjord, 

449 U.S. 368, 377 (1981) (noting that the Court has “generally denied review of pretrial discovery orders”); Quantum Corp. v. Tandon Corp., 940 F.2d 642, 644 (Fed. Cir. 

1991) (order compelling discovery of attorney-client communications not subject to collateral appeal). Such orders 

are not reviewable at the interlocutory stage because they 

are reviewable from a final judgment.

Amgen nevertheless argues that the lack of immediate appeal over the particular discovery order in this case 

will render it “effectively unreviewable.” Here, Amgen 

asserts that forcing it to wait until final judgment for 

review will defeat what it asserts to be the purpose of 

paragraph (l)(2)(A)’s disclosure requirements—to enable 

the sponsor (here Amgen) to commence infringement 

litigation immediately, prior to FDA approval and commercial marketing of the biological product by the applicant. Amgen analogizes its situation to cases holding 

orders immediately appealable when those orders unseal
8 AMGEN INC. v. HOSPIRA, INC. 

confidential documents or deny claims of immunity.4

Unlike those cases, however, there is no clear-cut statutory purpose that would be undermined by denying immediate appeal. In such circumstances, Congress’s decision 

not to provide for interlocutory review simply means that 

immediate appeal is not available. See Kircher v. Putnam 

Funds Tr., 547 U.S. 633, 641 n.8 (2006) (holding that the 

bar on appellate review of district court orders remanding 

cases to state courts, 28 U.S.C. § 1447(d), applies to cases 

arising under the Securities Litigation Uniform Standards Act of 1998 in the absence of an “expressly” provided 

“clear statutory command” to the contrary). 

In sum, the lack of immediate appeal over orders 

denying discovery of paragraph (l)(2)(A) information does 

not render such orders “effectively unreviewable” or 

distinguish them from run-of-the-mill discovery disputes. 

Livesay, 437 U.S. at 468. We therefore lack jurisdiction 

over Amgen’s appeal under the collateral order doctrine.

II

Amgen alternatively contends that it is entitled to 

mandamus under the All Writs Act ordering the district 

court to compel discovery. Mandamus is a drastic remedy 

reserved for the most “extraordinary causes.” Cheney v. 

U.S. Dist. Court for D.C., 542 U.S. 367, 380 (2004). A 

 

4 See Apple Inc. v. Samsung Elecs. Co., 727 F.3d 

1214, 1220 (Fed. Cir. 2013) (orders unsealing confidential 

financial and marketing information appealable under 

collateral order doctrine); Va. Dep’t of State Police v. 

Wash. Post, 386 F.3d 567, 574 n.4 (4th Cir. 2004) (“[A]n 

order unsealing district court documents is an appealable 

collateral order . . . .”); see also P.R. Aqueduct & Sewer 

Auth. v. Metcalf & Eddy, Inc., 506 U.S. 139, 147 (1993); 

Mitchell v. Forsyth, 472 U.S. 511, 524–30 (1985); Nixon v. 

Fitzgerald, 457 U.S. 731, 742–43 (1982).
AMGEN INC. v. HOSPIRA, INC. 9 

party seeking mandamus must “have no other adequate 

means to attain the [desired] relief” and must demonstrate that its right to the writ’s issuance is “clear and 

indisputable.” Id. at 380–81. Even if these “prerequisites” 

are established, “the issuing court, in the exercise of its 

discretion, must be satisfied that the writ is appropriate 

under the circumstances.” Id. at 381.

We focus our analysis on whether Amgen has established a “clear and indisputable” right to the relief it 

seeks. Under the BPCIA, there could be five potential 

avenues available to a sponsor seeking to secure process 

information pursuant to paragraph (l)(2)(A).

First, a sponsor could try to obtain an injunction as a 

matter of federal law compelling the applicant to make 

disclosures under paragraph (l)(2)(A). But the Supreme 

Court foreclosed the availability of such a remedy in 

Sandoz. See 137 S. Ct. at 1674–75. 

Second, the sponsor could try to seek injunctive relief 

under state law. The Supreme Court expressly reserved 

this question in Sandoz, id. at 1669, 1676–77, but we 

have no occasion to opine on this issue because Amgen 

has not sought a state law remedy in this case. 

Third, the sponsor could sue the applicant for patent 

infringement flowing from the applicant’s failure to 

comply with paragraph (l)(2)(A). However, Sandoz makes 

clear that under section 271(e)(2), the applicant’s “failure 

to disclose its application and manufacturing information 

[is] not an act of artificial infringement . . . . Submitting 

an application constitutes an act of artificial infringement. Failing to disclose the application and manufacturing information under [paragraph (l)(2)(A)] does not.”

Sandoz, 137 S. Ct. at 1674 (citations omitted).

This leaves the fourth and fifth means by which the 

sponsor could coercively obtain information under paragraph (l)(2)(A). The sponsor could sue on “patents de-
10 AMGEN INC. v. HOSPIRA, INC. 

scribed in [paragraph (l)(3) of the BPCIA],” 35 U.S.C 

§ 271(e)(2)(C)(i), i.e., the “list of patents for which the . . . 

sponsor believes a claim of patent infringement could 

reasonably be asserted . . . [against] a person . . . engaged 

in the making, using, selling, offering to sell, selling, or 

importing into the United States of the biological product 

that is the subject of the subsection (k) application,” 42 

U.S.C. § 262(l)(3)(A)(i)—the fourth alternative. The sponsor could also sue on a patent that “could be identified”

under paragraph (l)(3), 35 U.S.C. § 271(e)(2)(C)(ii) (emphasis added)—the fifth alternative. See Sandoz, 137 S. 

Ct. 1674–75 (explaining clauses (i) and (ii) of section 

271(e)(2)(C)). In this case, Amgen did not list any of its 

cell-culture patents, nor did it bring suit on any of these 

patents as ones that “could be identified” under paragraph (l)(3)(A). Amgen thus declined to pursue either the 

fourth or fifth alternatives. 

Instead of bringing suit on its cell-culture patents, 

Amgen brought suit on the ’349 and ’298 patents. Access 

to information under paragraph (l)(2)(A) in a suit on a 

patent covering the biological product or a patent related 

to the biological product is governed by ordinary rules of 

litigation in federal district courts, i.e., the Federal Rules 

of Civil Procedure. The Federal Rules of Civil Procedure 

provide that discoverable information must be “relevant 

to any party’s claim or defense.” Fed. R. Civ. P. 26(b)(1).

As the district court held, the composition of Hospira’s 

cell-culture media is not relevant to any claim of infringement of the patents asserted by Amgen or any of 

Hospira’s defenses or counterclaims. Amgen concedes that 

“the cell-culture manufacturing information is not relevant to the currently asserted claims.” 

Nothing in Sandoz suggests that the BPCIA somehow 

supplants the preexisting rules of civil procedure. Our 

opinion in Amgen merely acknowledged that a sponsor 

“can access the required information through discovery,” 

794 F.3d at 1356, but our statement did not purport to 
AMGEN INC. v. HOSPIRA, INC. 11

hold that the usual rules governing discovery do not apply 

in the BPCIA context. Nor does anything in Sandoz

suggest otherwise.

Amgen argues that unless discovery of Hospira’s process is allowed, its right to sue on its cell-culture patents 

under the BPCIA will be thwarted. According to Amgen,

denying discovery of information under paragraph 

(l)(2)(A) will allow applicants to “game the system . . . [b]y 

affecting which patents are in the (l)(6) lawsuit,” i.e., the 

first phase of litigation under the BPCIA, see Sandoz, 137 

S. Ct. at 1671–72. Under Amgen’s reading of the statute, 

an applicant could effectively control the scope of litigation under the BPCIA by withholding information under 

paragraph (l)(2)(A), thereby preventing the sponsor from 

identifying and bringing suit on patents related to the

biological product that the sponsor “believes a claim of 

patent infringement could reasonably be asserted” under 

paragraph (l)(3)(A). We note that the statute penalizes 

sponsors that decline to participate in the BPCIA’s information exchanges because under 35 U.S.C. § 271(e)(6)(C), 

a sponsor that fails to list a patent that “should have been 

included in the list described in [paragraph (l)(3)(A)] . . . 

may not bring an action under this section for infringement of the patent with respect to the biological product.”

In contending that a sponsor would be unable to list a 

patent under paragraph (l)(3)(A), Amgen emphasizes that 

the sponsor must form a good-faith belief that a patent 

listed under paragraph (l)(3)(A) “could reasonably be 

asserted.” Amgen asserts that a sponsor listing a patent 

without the benefit of the applicant’s paragraph (l)(2)(A) 

disclosures would later be subject to sanctions under 

Federal Rule of Civil Procedure 11 or antitrust liability 

for asserting baseless claims of patent infringement. 
12 AMGEN INC. v. HOSPIRA, INC. 

Amgen’s argument misunderstands the statute. Paragraph (l)(3)(A) merely requires the sponsor to list patents 

that it “believes . . . could reasonably be asserted.” (emphasis added). The statute provides no sanction for holding or asserting a mistaken belief in good faith. Moreover, 

once a patent is listed by the sponsor, the BPCIA’s information exchange further requires the applicant to “provide to the . . . sponsor, with respect to each patent listed 

. . . a detailed statement that describes, on a claim by 

claim basis, the factual and legal basis of the opinion of 

the subsection (k) applicant that such patent is invalid, 

unenforceable, or will not be infringed.” 42 U.S.C. 

§ 262(l)(3)(B)(ii) (emphases added). In other words, once a 

sponsor lists a patent under paragraph (l)(3)(A), the 

applicant must once again come forward with additional 

disclosures under paragraph (l)(3)(B) that inform whether 

“a claim of patent infringement . . . could” or could not 

“reasonably be asserted.” If the applicant fails to comply 

with its obligation to respond under paragraph (l)(3)(B), 

the sponsor would have a reasonable basis for asserting a 

claim of patent infringement.

Furthermore, under Rule 11, one submits a filing “to 

the best of the person’s knowledge, information, and 

belief, formed after an inquiry reasonable under the 

circumstances.” Fed. R. Civ. P. 11(b). The rule also expressly permits factual allegations that “will likely have 

evidentiary support after a reasonable opportunity for 

further investigation or discovery.” Fed. R. Civ. P. 

11(b)(3). Thus, if a sponsor forms a belief based on an 

inquiry limited by an applicant’s withholding of information, the sponsor has still satisfied Rule 11. See, e.g., 

Hoffman-La Roche Inc. v. Invamed Inc., 213 F.3d 1359, 

1363–64 (Fed. Cir. 2000) (affirming denial of Rule 11 

sanctions where patentees unsuccessfully sought manufacturing information from defendants before suit and 

“attempted to ascertain whether the processes so used 

were infringing, but were unable to do so”); Morda v. 
AMGEN INC. v. HOSPIRA, INC. 13

Klein, 865 F.2d 782, 785–86 (6th Cir. 1989) (affirming 

denial of Rule 11 sanctions because “[i]t would be particularly difficult to fault plaintiffs for a lack of prefiling 

inquiry when, as here, defendants have refused plaintiffs 

access to material information that would bear on certain 

allegations made in the complaint”). The Supreme Court 

appears to have contemplated the filing of suit after an 

applicant fails to disclose information under paragraph 

(l)(2)(A). See Sandoz, 137 S. Ct. at 1676 (“If the applicant 

failed to provide that information, then the sponsor but 

not the applicant, could bring an immediate declaratory 

judgment action pursuant to § 262(l)(9)(C).”).

These considerations dispel the notion that Amgen

would have needed to bring suit simply based on its own 

unsupported belief. Hospira, in fact, agrees that Amgen 

could have validly listed its cell-culture patents under 

paragraph (l)(3)(A) and that Hospira would have been 

obligated to respond with “detailed statement[s]” under 

paragraph (l)(3)(B). In this scenario, Amgen would have 

had an opportunity to assess the reasonableness of its 

litigation position long before filing suit and being exposed to Rule 11 sanctions or antitrust liability. Thus, the 

reasonableness requirement of paragraph (l)(3)(A) does 

not preclude a sponsor from listing a patent for which an 

applicant has not provided information under paragraph 

(l)(2)(A).5 The denial of discovery in this case does not 

undermine the purpose of the BPCIA. 

 

5 We have no occasion here to address the fifth alternative described in section 271(e)(2)(C)(ii), that is, a 

suit on a “patent that could be identified pursuant to 

[paragraph (l)(3)(A)]” of the BPCIA, where “the applicant 

. . . fail[ed] to provide the application and information 

required under [paragraph (l)(2)(A)].” 
14 AMGEN INC. v. HOSPIRA, INC. 

The district court correctly denied Amgen’s motion to 

compel on the ground that the composition of Hospira’s 

cell-culture media was of “no relevance to the patents that 

are asserted.” J.A. 37. Amgen has not established a clear 

and indisputable right to discovery of the information it 

seeks. It therefore has not established the prerequisites 

for this court to issue a writ of mandamus. 

CONCLUSION

For the reasons stated, we dismiss Amgen’s appeal for 

lack of jurisdiction and deny Amgen’s petition for a writ of 

mandamus. 

APPEAL DISMISSED AND PETITION FOR WRIT 

OF MANDAMUS DENIED

COSTS

Each party shall bear its own costs.