Amgen Inc. v. Sandoz Inc. ( 2019 )

United States Court of Appeals
for the Federal Circuit
______________________
AMGEN INC., AMGEN MANUFACTURING,
LIMITED,
Plaintiffs-Appellants
v.
SANDOZ INC., SANDOZ INTERNATIONAL GMBH,
SANDOZ GMBH,
Defendants-Appellees
______________________
2018-1551
______________________
Appeal from the United States District Court for the
Northern District of California in No. 3:14-cv-04741-RS,
Judge Richard Seeborg.
------------------------------------------------------
AMGEN INC., AMGEN MANUFACTURING,
LIMITED,
Plaintiffs-Appellants
v.
SANDOZ INC., SANDOZ INTERNATIONAL GMBH,
SANDOZ GMBH, LEK PHARMACEUTICALS, D.D.,
Defendants-Appellees
______________________
2018-1552
2 AMGEN INC. v. SANDOZ INC.
______________________
Appeal from the United States District Court for the
Northern District of California in No. 3:16-cv-02581-RS,
Judge Richard Seeborg.
______________________
Decided: May 8, 2019
______________________
NICHOLAS P. GROOMBRIDGE, Paul, Weiss, Rifkind,
Wharton & Garrison LLP, New York, NY, argued for plain-
tiffs-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.
DEANNE MAYNARD, Morrison & Foerster LLP, Wash-
ington, DC, argued for defendants-appellees. Also repre-
sented by BRYAN LEITCH, BRIAN ROBERT MATSUI; ERIK
JEFFREY OLSON, ERIC C. PAI, Palo Alto, CA.
______________________
Before LOURIE, O’MALLEY, and REYNA, Circuit Judges.
LOURIE, Circuit Judge.
Amgen Inc. and Amgen Manufacturing Ltd. (collec-
tively, “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 un-
der 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
AMGEN INC. v. SANDOZ INC.
3
by Sandoz’s filgrastim biosimilar and its proposed pegfil-
grastim 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.
BACKGROUND
Amgen created and commercialized two related bio-
logic products, filgrastim (marketed as Neupogen®) and
pegfilgrastim (marketed as Neulasta®), indicated for treat-
ing neutropenia, a deficiency of white blood cells. Neutro-
penia 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 natu-
rally-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 stimu-
late neutrophil production, and Neupogen® is further indi-
cated to mobilize stem cells from the bone marrow into the
bloodstream for collection for autologous stem cell trans-
plantation.
In 2014, Sandoz submitted to the Food and Drug Ad-
ministration (“FDA”) an abbreviated Biologics License Ap-
plication (“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 pa-
tent. 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(l)(9)(C) (allowing a reference product sponsor to
4 AMGEN INC. v. SANDOZ INC.
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). 1 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 un-
der 35 U.S.C. §§ 271(e)(2)(C)(ii), (g).
In 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(l)(6)(A). Sandoz has not yet received approval for its
proposed pegfilgrastim biosimilar.
The ’878 patent discloses methods of protein purifica-
tion 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 af-
finity and non-protein affinity methods like ion exchange.
’878 patent col. 15 ll. 17–24. The ’878 patent further dis-
closes 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.
1 These cases have an extensive procedural history
concerning issues not relevant to this appeal. See Amgen
Inc. v. Sandoz Inc., 877 F.3d 1315 (Fed. Cir. 2017); Amgen
Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015), rev’d in
part, vacated in part, 137 S. Ct. 1664 (2017).
AMGEN INC. v. SANDOZ INC.
5
16 ll. 2–22. Claim 7, recited below, is directed to the use of
a non-affinity separation matrix.
7. A method of purifying a protein expressed in a
non-native limited solubility form in a non-mam-
malian expression system comprising:
(a) expressing a protein in a non-native
limited solubility form in a non-mamma-
lian 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 suppressor;
(iii) a protein stabilizer; and
(iv) a redox component;
(e) directly applying the refold solution to a
separation matrix under conditions suita-
ble for the protein to associate with the ma-
trix;
(f) washing the separation matrix; and
(g) eluting the protein from the separation
matrix, wherein the separation matrix is a
non-affinity resin selected from the group
consisting of ion exchange, mixed mode,
and a hydrophobic interaction resin.
6 AMGEN INC. v. SANDOZ INC.
The ’427 patent discloses methods of treating “diseases
requiring peripheral stem cell transplantation.” ’427 pa-
tent col. 1 ll. 9–10. Certain cancer treatments, like chemo-
therapy and radiation, can destroy stem cells, so stem cells
are often collected from a person’s bloodstream in a process
called leukapheresis and re-infused after such treatment.
The claimed invention lies in administering G-CSF before
chemotherapy to “achiev[e] a superior yield of stem cells,”
so that fewer leukaphereses are required to achieve the
stem cell transplant. Id. col. 1 ll. 58–61. Representative
claim 1 reads:
1. A method of treating a disease requiring periph-
eral stem cell transplantation in a patient in need
of such treatment, comprising
administering to the patient a hematopoi-
etic stem cell mobilizing-effective amount
of G-CSF; and
thereafter administering to the patient a
disease treating-effective amount of at
least one chemotherapeutic agent.
No other claim from either the ’427 patent or the ’878 pa-
tent is before us in this appeal.
The district court construed “disease treating-effective
amount of at least one chemotherapeutic agent” in claim 1
of the ’427 patent as limited to “[a]n amount sufficient to
treat a disease for which at least one chemotherapeutic
agent is prescribed.” Claim Construction Order, 2016 WL
4137563, at *18. The court thereby rejected Amgen’s argu-
ment that the amount must be “sufficient to enhance the
mobilization of stem cells,” id. at *6–7, regardless of its ef-
fect on the underlying disease. Amgen thereafter stipu-
lated to noninfringement of the ’427 patent contingent
upon its right to appeal from the district court’s claim con-
struction order. J.A. 49–53.
AMGEN INC. v. SANDOZ INC.
7
With respect to the ’878 patent, the district court
treated the Neupogen® and Neulasta® cases together. It
construed limitations (f) and (g) of claim 7 (the “washing”
and “eluting” steps) as separate steps and further clarified
that the eluting step “must occur after the step of ‘washing
the separation matrix.’” Claim Construction Order, 2016
WL 4137563, at *18. As construed, performing limitations
(e)–(g) of the process of claim 7 requires:
(e) applying the refold solution to a separation ma-
trix . . . ,
(f) applying a solution to remove . . . unwanted compo-
nents of the refold solution . . . while preserving [pro-
tein] binding . . .; and
(g) applying a solution that reverses the binding of the
purified protein . . . .
Id.
Since it is undisputed that Sandoz’s process only in-
volves one step—applying the refold solution to the matrix,
with no separate washing or eluting steps—the district
court granted summary judgment that neither Zarxio® nor
Sandoz’s proposed pegfilgrastim biosimilar infringes claim
7 of the ’878 patent. Decision, 295 F. Supp. 3d at 1071.
Amgen appeals. We have jurisdiction under 28 U.S.C.
§ 1295(a)(1).
DISCUSSION
We review a district court’s grant of summary judg-
ment according to the law of the regional circuit. Kaneka
Corp. v. Xiamen Kingdomway Grp. Co., 790 F.3d 1298,
1303 (Fed. Cir. 2015) (citing Halo Elecs., Inc. v. Pulse El-
ecs., Inc., 769 F.3d 1371, 1377 (Fed. Cir. 2014)). In the
Ninth Circuit, summary judgment is reviewed de novo,
Brunozzi v. Cable Commc’ns, Inc., 851 F.3d 990, 995 (9th
Cir. 2017) (citing Ctr. for Bio-Ethical Reform, Inc. v. L.A.
Cty. Sheriff Dep’t, 533 F.3d 780, 786 (9th Cir. 2008)), and
8 AMGEN INC. v. SANDOZ INC.
is appropriate when, viewing the evidence in favor of the
non-movant, there is no genuine dispute of material fact,
Zetwick v. Cty. of Yolo, 850 F.3d 436, 440 (9th Cir. 2017)
(citing United States v. JP Morgan Chase Bank Account
No. Ending 8215, 835 F.3d 1159, 1162 (9th Cir. 2016)).
Claim construction is ultimately an issue of law, which
we review de novo. Shire Dev., LLC v. Watson Pharm., Inc.,
787 F.3d 1359, 1364 (Fed. Cir. 2015). We review de novo
the district court’s findings of fact on evidence “intrinsic to
the patent (the patent claims and specification[], along
with the patent’s prosecution history),” and review for clear
error all other subsidiary findings of fact. Teva Pharm.
USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). While
infringement is a question of fact, Lucent Techs., Inc. v.
Gateway, Inc., 580 F.3d 1301, 1309 (Fed. Cir. 2009), we re-
view de novo the district court’s grant of summary judg-
ment of noninfringement, Unwired Planet, LLC v. Apple
Inc., 829 F.3d 1353, 1356 (Fed. Cir. 2016). The patentee
has the burden of proving infringement by a preponderance
of the evidence. SmithKline Diagnostics, Inc. v. Helena
Labs. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988).
I. ’878 Patent
Amgen contends that the district court misconstrued
the “washing” and “eluting” claim limitations in both its
claim construction and summary judgment decisions as re-
quiring distinct solutions added to the matrix at different
times. Instead, Amgen argues, the claims cover any num-
ber of solutions or steps as long as the functions of washing
and eluting happen in sequence, and it cites as support the
specification’s teaching that a wide variety of solutions will
work to perform the washing and eluting steps. Amgen
claims that, in Sandoz’s process, washing precedes elution
at any given point in the separation matrix; that is, wash-
ing may occur toward the bottom of the matrix at the same
time that elution occurs toward the top. Thus, Amgen ar-
gues that Sandoz’s process infringes because the claim
AMGEN INC. v. SANDOZ INC.
9
construction only generally requires that washing precede
elution.
Sandoz responds that the claim logically requires a se-
ries of steps and cites Mformation Technologies, Inc. v. Re-
search in Motion Ltd., 764 F.3d 1392, 1398–1400 (Fed. Cir.
2014), as holding that a process claim is properly limited to
a certain order of steps “‘when the claim language, as a
matter of logic or grammar, requires that the steps be per-
formed in the order written, or the specification directly or
implicitly requires’ an order of steps.” Id. at 1398 (quoting
TALtech Ltd. v. Esquel Apparel, Inc., 279 F. App’x 974, 978
(Fed. Cir. 2008)). Sandoz argues that the district court cor-
rectly concluded, in light of the specification, that the step
of applying the washing solution to the matrix must pre-
cede the step of applying the elution solution, which it
claims does not occur in its process.
We agree with Sandoz that the washing and eluting
steps of claim 7 require discrete solutions. Amgen’s argu-
ment to the contrary is, at its core, that the “washing” and
“eluting” limitations describe functions, rather than actual
process steps. See Reply Br. 14 (“[T]he claims and specifi-
cation . . . define washing and eluting as functional steps.”).
We reject this argument for two reasons. First, as in Mfor-
mation, the claim language logically requires that the pro-
cess steps, lettered (a) through (g), be performed in
sequence. For example, expressing the protein in a non-
mammalian cell (limitation (a)) obviously must occur be-
fore the step of lysing that cell (limitation (b)). There is no
indication on the face of claim 7 that the washing and elut-
ing steps are any different. Second, washing and eluting
are consistently described in the specification as separate
steps performed by different solutions. See ’878 patent col.
10 ll. 44–46 (“After the separation matrix with which the
protein has associated has been washed, the protein of in-
terest is eluted from the matrix using an appropriate solu-
tion.”), col. 10 ll. 31–34 (“The wash buffer can be of any
composition, as long as [it] . . . maintains the interaction
10 AMGEN INC. v. SANDOZ INC.
between the protein and matrix.”), col. 17 l. 46–col. 21 l. 42
(disclosing four exemplary purification methods using sep-
arate washing and eluting steps and discrete solutions).
Critically, the same conclusion would follow even if the
district court had accepted Amgen’s proposed constructions
of these limitations. Amgen requested that the washing
and eluting limitations be construed as separate process
steps, such that limitations (e)–(g) would read:
(e) applying the refold solution to a column that
contains the separation matrix . . . ,
(f) adding a solution into the column . . . to remove
materials in the refold solution that do not interact
with the separation matrix . . . ; and
(g) adding a solution into the column . . . which
[h]as the effect of reversing the interactions be-
tween the protein and the separation matrix . . . .
See Claim Construction Order, 2016 WL 4137563, at *12,
*17. Since there is no dispute that Sandoz’s current pro-
cess only uses one step and one solution, Reply Br. 9, it can-
not literally infringe claim 7. We therefore need not
further address Amgen’s argument for literal infringe-
ment. We conclude that the district court correctly con-
strued the washing and eluting limitations as separate
process steps performed by adding discrete solutions to the
separation matrix in sequence.
Amgen next argues that the district court erred by re-
jecting its argument that Sandoz’s process infringes claim
7 through the doctrine of equivalents. Amgen argues that
Sandoz’s one-step, one-solution process is insubstantially
different from the claimed three-step, three-solution pro-
cess because it “achieves the same functions (washing and
eluting), in substantially the same way (binding protein
preferentially compared to contaminants, and then raising
salt concentration to reverse protein binding) to achieve
the same result (protein purification).” Appellant Br. 52.
AMGEN INC. v. SANDOZ INC.
11
Sandoz responds that the district court properly ana-
lyzed Amgen’s argument and found that Sandoz’s one-step,
one-solution process accomplishes purification in a differ-
ent way from the claimed method and, as a result, is not
equivalent. Sandoz further argues that Amgen failed to
provide any factual support for its equivalency argument
before the district court.
We agree with Sandoz and conclude that the district
court correctly held that Sandoz’s one-step, one-solution
process does not function in the same way as the claimed
process. In essence, Amgen seeks to cover, one way or an-
other, any method of using a salt concentration gradient in
an adsorbent matrix to separate a protein of interest from
other solutes. But claim 7 is not that broad. As the district
court held, the claim recites a sequence of steps requiring
application of “refolding,” “washing,” and “eluting” solu-
tions, and our precedent prohibits us from overriding the
natural language of claim 7 to extend these limitations to
cover nearly any type of adsorbent chromatographic sepa-
ration. The doctrine of equivalents applies only in excep-
tional cases and is not “simply the second prong of every
infringement charge, regularly available to extend protec-
tion beyond the scope of the claims.” London v. Carson Pi-
rie Scott & Co., 946 F.2d 1534, 1538 (Fed. Cir. 1991); see
also Duncan Parking Techs., Inc. v. IPS Grp., Inc., 914 F.3d
1347, 1362 (Fed. Cir. 2019) (“[T]he doctrine of equivalents
cannot be used to effectively read out a claim limitation . . .
because the public has a right to rely on the language of
patent claims.” (citing Primos, Inc. v. Hunter’s Specialties,
Inc., 451 F.3d 841, 850 (Fed. Cir. 2006))). Accordingly, the
district court was correct to grant summary judgment that
Sandoz does not infringe claim 7 under the doctrine of
equivalents because its one-step, one-solution purification
process works in a substantially different way from the
claimed three-step, three-solution process.
Amgen also maintains that the district court abused its
discretion by denying Amgen’s motion for a continuance
12 AMGEN INC. v. SANDOZ INC.
under Federal Rule of Civil Procedure 56(d), which allows
a district court to deny or postpone summary judgment if
the nonmovant shows that “it cannot present facts essen-
tial to justify its opposition.” Decision, 295 F. Supp. 3d at
1070 (quoting Fed. R. Civ. P. 56(d)). It is undisputed that
Sandoz intends, at some point in the future, to modify its
purification processes for both Zarxio® and its proposed
pegfilgrastim biosimilar to accommodate the use of a dif-
ferent resin in its separation matrix, but Amgen contends
that Sandoz has neither submitted to the FDA a corre-
sponding amendment to its aBLA nor provided Amgen
with the details of that modification. Amgen argues that
judgment cannot be rendered on a technical act of infringe-
ment of a process patent under 35 U.S.C. § 271(e)(2) if a
biosimilar applicant plans to submit a modification of a rel-
evant process to the FDA but has not yet done so. Other-
wise, Amgen warns, it will be “effectively deprive[d] [of] the
ability to allege infringement in the future,” and Sandoz
will be free “to make any changes it wishes to the modified
process because it has been declared non-infringing in ad-
vance.” Appellant Br. 57.
Sandoz argues in response that it provided Amgen with
ample details regarding the modification well in advance of
summary judgment, and Amgen’s failure to diligently pur-
sue discovery bars it from using Rule 56(d) to stave off sum-
mary judgment. See Mackey v. Pioneer Nat’l Bank, 867
F.2d 520, 524 (9th Cir. 1989). Sandoz also maintains that
the details Amgen seeks are immaterial to infringement
because it will continue to use the one-step, one-solution
process that has already been held noninfringing.
We agree with Sandoz that, regarding its proposed peg-
filgrastim biosimilar, the district court did not abuse its
discretion. In Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d
1562 (Fed. Cir. 1997), we held that a proper analysis of a
technical act of infringement under § 271(e)(2) requires a
determination of whether “[w]hat is likely to be sold” will
infringe “in the conventional sense” of patent infringement.
AMGEN INC. v. SANDOZ INC.
13
Id. at 1569–70. This “hypothetical inquiry,” id. at 1569,
may be complex, given that ANDA and biosimilar appli-
cants often make changes to their applications while they
are pending, see, e.g., Ferring B.V. v. Watson Labs., Inc.-
Fla., 764 F.3d 1382, 1390 n.6 (Fed. Cir. 2014). We have
thus recognized that, while a district court cannot ignore
amendments to an ANDA or aBLA, Sunovion Pharm., Inc.
v. Teva Pharm. USA, Inc., 731 F.3d 1271, 1279–80 (Fed.
Cir. 2013), it also has a broad mandate to render a “just,
speedy, and inexpensive” decision, In re Micron Tech., Inc.,
875 F.3d 1091, 1100 (Fed. Cir. 2017) (quoting Dietz v.
Bouldin, 136 S. Ct. 1885, 1891 (2016)), based upon the evi-
dence of record, see Ferring, 764 F.3d at 1391 (holding that
a district court has discretion to consider an amended
ANDA after issuing a decision but before final judgment).
We therefore conclude that the district court was not obli-
gated to postpone summary judgment until Sandoz submit-
ted its amended pegfilgrastim aBLA.
In contrast with certain of our previous cases, the ques-
tion here is of little consequence to infringement because
Amgen has conceded that, under the claim construction we
have affirmed, there is no genuine dispute that the process
Sandoz will likely use to manufacture its proposed pegfil-
grastim biosimilar—whether it uses the current resin or
the new resin—will not infringe claim 7. J.A. 7056–57; Re-
ply Br. 23. Claim 7 does not distinguish between types of
resins. Thus, the district court did not abuse its discretion
in denying Amgen’s Rule 56(d) motion or err in granting
summary judgment of noninfringement regarding the pro-
posed pegfilgrastim biosimilar.
We further agree with Sandoz that its current process,
which it uses to manufacture Zarxio®, does not infringe
claim 7. Because Zarxio® is currently marketed, it is un-
necessary to determine “what is likely to be sold,” as is re-
quired for a technical act of infringement. Glaxo, 110 F.3d
at 1569–70. Instead, infringement turns on whether
Sandoz’s current process for manufacturing Zarxio®
14 AMGEN INC. v. SANDOZ INC.
infringes claim 7 according to conventional principles of pa-
tent infringement. See Warner-Lambert Co. v. Apotex
Corp., 316 F.3d 1348, 1365–66 (Fed. Cir. 2003) (“[T]he sub-
stantive determination [of] actual infringement [under
§ 271(e)(2)] . . . is determined by traditional patent in-
fringement analysis . . . .”). Applying those principles, the
district court granted summary judgment of noninfringe-
ment, Decision, 295 F. Supp. 3d at 1067–69, and as we con-
cluded above, the district court did not err either in
construing claim 7 or in granting summary judgment.
We also note that Amgen is not, as it alleges, left with-
out a remedy for possible future infringement if the facts
change. It may in a future action plead infringement of
claim 7 by Zarxio® or, if approved, Sandoz’s pegfilgrastim
biosimilar to the extent permitted by the Patent Act and
the principles of res judicata and collateral estoppel. See,
e.g., Bayer AG v. Biovail Corp., 279 F.3d 1340, 1349–50
(Fed. Cir. 2002) (declining to apply collateral estoppel from
previous Hatch-Waxman case when defendant’s marketed
product differed from that of the hypothetical inquiry). We
conclude that the district court did not abuse its discretion
in denying Amgen’s Rule 56(d) motion or err in granting
summary judgment of noninfringement.
II. ’427 Patent
Finally, Amgen argues that the district court miscon-
strued the limitation of “disease treating-effective amount”
of a chemotherapeutic agent in claim 1 of the ’427 patent
as “an amount sufficient to treat a disease for which at
least one chemotherapeutic agent is prescribed.” Claim
Construction Order, 2016 WL 4137563, at *6–7. Specifi-
cally, Amgen asserts that the phrase only limits the
amount of the chemotherapeutic agent administered and
that the method of claim 1 encompasses “situations where
the chemotherapeutic agent is prescribed only for stem cell
mobilization rather than treatment of an underlying dis-
ease.” Appellant Br. 63; see also Reply Br. 24.
AMGEN INC. v. SANDOZ INC.
15
Sandoz responds that Amgen’s construction would read
disease treatment out of the claim and collapse the claim’s
textual distinction between a “stem cell mobilizing-effec-
tive amount” of G-CSF and a “disease treating-effective
amount” of the chemotherapeutic agent.
We agree with Sandoz that “disease treating” requires
that the chemotherapeutic agent be administered to treat
an underlying disease. As an initial matter, the preamble
of claim 1, as construed, arguably precludes Amgen’s con-
struction. The district court construed the preamble, “[a]
method of treating a disease requiring peripheral stem cell
transplantation,” as requiring that the stem cell transplant
be incorporated as a component of a method of treating an
underlying disease, such as cancer, Claim Construction Or-
der, 2016 WL 4137563, at *5–6, and Amgen does not dis-
pute that construction on appeal. The claimed method
therefore must be performed to treat an underlying dis-
ease. As the claim itself states, the “disease treating-effec-
tive amount” of a chemotherapeutic agent does precisely
that.
Moreover, neither the claim nor the specification lends
support to Amgen’s interpretation of “disease treating-ef-
fective amount.” Amgen’s construction would broaden
claim 1 to cover administration of G-CSF and a chemother-
apeutic agent solely for the purpose of mobilizing stem
cells. Such a conclusion would require interpreting “dis-
ease treating” as “stem cell mobilizing,” but “[o]ur prece-
dent instructs that different claim terms are presumed to
have different meanings.” Helmsderfer v. Bobrick Wash-
room Equip., Inc., 527 F.3d 1379, 1382 (Fed. Cir. 2008) (cit-
ing Applied Med. Res. Corp. v. U.S. Surgical Corp., 448
F.3d 1324, 1333 n.3 (Fed. Cir. 2006)). Had Amgen simply
wanted to claim a method of mobilizing stem cells, in any
context, it could have done so. See Merck & Co., Inc. v. Teva
Pharm. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005) (“A
claim construction that gives meaning to all the terms of
the claim is preferred over one that does not do so.” (citing
16 AMGEN INC. v. SANDOZ INC.
Elekta Instrument S.A. v. O.U.R. Sci. Int’l, Inc., 214 F.3d
1302, 1307 (Fed. Cir. 2000))).
Amgen’s argument to the contrary—that not all chemo-
therapeutic agents can mobilize stem cells on their own—
cannot be maintained in view of its simultaneous conten-
tion that “disease treating” should be construed as “stem
cell mobilizing.” And while the specification is relatively
sparse, it does indicate that disease treatment refers to an
overall regimen for treating an underlying disease, which
includes, but is not limited to, a stem cell transplant. See,
e.g., ’427 patent col. 1 ll. 9–11 (“treatment of diseases . . .
e.g., in high-dosage chemotherapy or bone marrow ablation
by irradiation”), col. 1 ll. 28–29 (“the success of treatment
crucially depends on [stem cell mobilization]” (emphasis
added)), col. 1 ll. 56–58 (“the run-up to the treatment of
particular diseases, e.g., in preparing a myeloablative or
myelotoxic therapy”). In summary, we conclude that the
district court did not err in construing claim 1 of the ’427
patent.
CONCLUSION
We have considered the rest of the parties’ arguments
but find them unpersuasive. The judgment of the district
court is
AFFIRMED