Amgen Inc. v. Hospira, Inc.

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 repre-
sented 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 re-
quirements 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 adju-
dicate, and then adjudicating, claims of [patent] infringe-
ment” 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 prod-
uct already approved under section 262(a), 1 a party may
instead submit an “abbreviated” application under sub-
section (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 exchang-
es—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 notwith-
standing minor differences in clinically inactive compo-
nents” and for which “there are no clinically meaningful
differences between the biological product and the refer-
ence 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 sepa-
rately provide information concerning “the process . . .
used to manufacture the biological product”—again, as
required by the statute—but contends that such infor-
mation was disclosed in its application.
In a letter to Hospira dated March 31, 2015, Amgen
asserted that Hospira had failed to comply with para-
graph (l)(2)(A) because Hospira had failed to “fully dis-
close 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 biologi-
cal 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 para-
graph (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 cultur-
ing 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 cul-
turing 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 “essential-
ly, 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 or-
der. Hospira then moved this court to dismiss Amgen’s
appeal for lack of jurisdiction. We denied Hospira’s mo-
tion, 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. Or-
dinarily, 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 or-
der may satisfy the first two conditions of being an ap-
pealable 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 “gen-
erally denied review of pretrial discovery orders”); Quan-
tum Corp. v. Tandon Corp., 940 F.2d 642, 644 (Fed. Cir.
1991) (order compelling discovery of attorney-client com-
munications 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 immedi-
ate 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 com-
mercial marketing of the biological product by the appli-
cant. 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 statuto-
ry purpose that would be undermined by denying imme-
diate 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 Stand-
ards 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 demon-
strate 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 estab-
lished 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 infringe-
ment. Failing to disclose the application and manufactur-
ing 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 para-
graph (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 spon-
sor could also sue on a patent that “could be identified”
under paragraph (l)(3), 35 U.S.C. § 271(e)(2)(C)(ii) (em-
phasis 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 para-
graph (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 in-
fringement of the patents asserted by Amgen or any of
Hospira’s defenses or counterclaims. Amgen concedes that
“the cell-culture manufacturing information is not rele-
vant 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 pro-
cess 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 litiga-
tion 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 infor-
mation 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 infringe-
ment 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. Para-
graph (l)(3)(A) merely requires the sponsor to list patents
that it “believes . . . could reasonably be asserted.” (em-
phasis added). The statute provides no sanction for hold-
ing or asserting a mistaken belief in good faith. Moreover,
once a patent is listed by the sponsor, the BPCIA’s infor-
mation exchange further requires the applicant to “pro-
vide 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 ex-
pressly 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 infor-
mation, 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 manu-
facturing 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 particu-
larly 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 ex-
posed 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 al-
ternative 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.