AMGEN INC., AMGEN MANUFACTURING, LIMITED, Plaintiffs-Appellants
HOSPIRA, INC. Defendant-Appellee
from the United States District Court for the District of
Delaware in No. l:15-cv-00839-RGA, Judge Richard G. Andrews.
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.
J. Meloro, Willkie Farr & Gallagher LLP, New York, NY,
argued for defendant-appellee. Also represented by Michael
Dyk, Bryson, and Chen, Circuit Judges.
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 Biologies 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
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.
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" product based on an
existing "reference" biological product already
approved under section 262(a),  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.
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(Z)(2)(A). This disclosure leads to a series of
information exchanges-described in 42 U.S.C § 262(0(3),
(0(4) and (0(5)- between the applicant and the sponsor that
"channels the parties into two phases of patent
litigation"-described in 42 U.S.C. § 262(0(6) and
(0(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 (0(3) and negotiating which of
the listed patents will be subject to immediate action under
paragraph (0(6). Id. "The second phase of
litigation, " under paragraph (0(8), "is triggered
by the applicant's notice of commercial marketing and
involves any patents that were included on the parties'
[paragraph (/)(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).
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
(/)(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
letter to Hospira dated March 31, 2015, Amgen asserted that
Hospira had failed to comply with paragraph (/)(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.
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.
their disagreement over Hospira's compliance with
paragraph (Z)(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 subject to suit.
Under paragraph (Z)(3)(A), Am gen 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(Z)(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 (/)(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. 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 ...