AMGEN INC., AMGEN MANUFACTURING, LIMITED, Plaintiffs-Appellants
SANDOZ INC., SANDOZ INTERNATIONAL GMBH, SANDOZ GMBH, Defendants-Appellees AMGEN INC., AMGEN MANUFACTURING, LIMITED, Plaintiffs-Appellants
SANDOZ INC., SANDOZ INTERNATIONAL GMBH, SANDOZ GMBH, LEK PHARMACEUTICALS, D.D., Defendants-Appellees
from the United States District Court for the Northern
District of California in Nos. 3:14-cv-04741-RS,
3:16-cv-02581-RS, Judge Richard Seeborg.
Nicholas P. Groombridge, Paul, Weiss, Rifkind, Wharton &
Garrison LLP, New York, NY, argued for plaintiffs-appellants.
Also represented by Jennifer Gordon, Golda Lai, Stephen
Accursio Maniscalco, Peter Sandel, Eric Alan Stone, Jacob
Whitt, Jennifer H. Wu; Lois M. Kwasigroch, Kimberlin L.
Morley, Wendy A. Whiteford, Amgen Inc., Thousand Oaks, CA.
Maynard, Morrison & Foerster LLP, Washington, DC, argued
for defendants-appellees. Also represented by Bryan Leitch,
Brian Robert Matsui; Erik Jeffrey Olson, Eric C. Pai, Palo
Lourie, O'Malley, and Reyna, Circuit Judges.
Lourie, Circuit Judge.
Inc. and Amgen Manufacturing Ltd. (collectively,
"Amgen") appeal from two decisions of the United
States District Court for the Northern District of California
in two patent infringement actions brought by Amgen under the
Biologics Price Competition and Innovation Act
("BPCIA"), 42 U.S.C. § 262 (2012). The court
construed claims of U.S. Patents 6, 162, 427 (the
"'427 patent") and 8, 940, 878 (the
"'878 patent"), Amgen Inc. v. Sandoz
Inc., No. 14-CV-04741-RS, 2016 WL 4137563 (N.D. Cal.
Aug. 4, 2016) ("Claim Construction
Order"), and granted summary judgment of
noninfringement of claim 7 of the '878 patent by
Sandoz's filgrastim biosimilar and its proposed
pegfilgrastim biosimilar, Amgen Inc. v. Sandoz Inc.,
295 F.Supp.3d 1062, 1064 (N.D. Cal. 2017)
("Decision"). We conclude that the
district court correctly construed the claims and granted
summary judgment of noninfringement of claim 7. The judgment
of the district court is therefore affirmed.
created and commercialized two related biologic products,
filgrastim (marketed as Neupogen®) and
pegfilgrastim (marketed as Neulasta®),
indicated for treating neutropenia, a deficiency of white
blood cells. Neutropenia often results from exposure to
certain chemotherapeutic regimens or radiation therapy during
cancer treatment. Filgrastim is a recombinant analog of
granulocyte-colony stimulating factor ("G-CSF"), a
naturally-occurring human glycoprotein that stimulates the
production of neutrophils and stem cells and their release
into the bloodstream. Pegfilgrastim is materially identical
but much larger because it is conjugated to a polyethylene
glycol molecule, which enables long-acting administration.
Both of Amgen's products are generally indicated to
stimulate neutrophil production, and Neupogen®
is further indicated to mobilize stem cells from the bone
marrow into the bloodstream for collection for autologous
stem cell transplantation.
2014, Sandoz submitted to the Food and Drug Administration
("FDA") an abbreviated Biologics License
Application ("aBLA") to market a biosimilar
filgrastim product. While Sandoz's aBLA referenced
Neupogen®, Sandoz elected not to provide Amgen
with its aBLA or manufacturing information. In October 2014,
Amgen filed a complaint for, inter alia, a
declaratory judgment that Sandoz's proposed biosimilar
would infringe the '427 patent. See 35 U.S.C.
§ 271(e)(2)(C) (defining submission of an aBLA as an act
of patent infringement); 42 U.S.C. § 262(1)(9)(C)
(allowing a reference product sponsor to bring a declaratory
judgment action regarding "any patent that claims the
biological product or a use of the biological product"
when the biosimilar applicant does not provide its aBLA and
manufacturing information). In 2015, Sandoz received FDA
approval for its filgrastim biosimilar,
Zarxio®. After Sandoz launched
Zarxio®, Amgen amended its complaint to plead
infringement of the '878 patent under 35 U.S.C.
§§ 271(e)(2)(C)(ii), (g).
2015, Sandoz submitted an aBLA to market a bio-similar
pegfilgrastim product referencing Neulasta®.
In May 2016, Amgen filed a complaint for infringement of the
'878 patent under 35 U.S.C. § 271(e)(2)(C)(i) and 42
U.S.C. § 262(1)(6)(A). Sandoz has not yet received
approval for its proposed pegfilgrastim biosimilar.
'878 patent discloses methods of protein purification by
adsorbent chromatography, a well-known method that involves
separating the components of a solution ("the mobile
phase") based upon their chemical attraction to the
molecules or ions that comprise a stationary separation
matrix ("the stationary phase"). The '878
patent refers to several methods of chromatography, including
protein affinity and non-protein affinity methods like ion
exchange. '878 patent col. 15 ll. 17-24. The '878
patent further discloses use of a salt or pH gradient to
control the elution of the protein of interest, as well as
the preceding elution (or "washing") from the
matrix of unwanted components of a refold solution containing
the protein of interest. Id. col. 16 ll. 2-22. Claim
7, recited below, is directed to the use of a non-affinity
7. A method of purifying a protein expressed in a non-native
limited solubility form in a non-mammalian expression system
(a) expressing a protein in a non-native limited solubility
form in a non-mammalian cell;
(b) lysing a non-mammalian cell;
(c) solubilizing the expressed protein in a solubilization
solution comprising one or more of the following:
(i) a denaturant;
(ii) a reductant; and
(iii) a surfactant;
(d) forming a refold solution comprising the solubilization
solution and a refold buffer, the refold buffer comprising
one or more of the following:
(i) a denaturant;
(ii) an aggregation ...