Immunex Corporation v. Sandoz Inc.

Case: 20-1037 Document: 97 Page: 1 Filed: 07/01/2020
United States Court of Appeals
for the Federal Circuit
______________________
IMMUNEX CORPORATION, AMGEN
MANUFACTURING, LIMITED,
Plaintiffs-Appellees
HOFFMANN-LA ROCHE INC.,
Plaintiff
v.
SANDOZ INC., SANDOZ INTERNATIONAL GMBH,
SANDOZ GMBH,
Defendants-Appellants
______________________
2020-1037
______________________
Appeal from the United States District Court for the
District of New Jersey in No. 2:16-cv-01118-CCC-MF,
Judge Claire C. Cecchi.
______________________
Decided: July 1, 2020
______________________
CONSTANTINE L. TRELA, JR., Sidley Austin LLP, Chi-
cago, IL, argued for plaintiffs-appellees. Also represented
by STEVEN J. HOROWITZ; VERNON M. WINTERS, San Fran-
cisco, CA; JOSHUA JOHN FOUGERE, JEFFREY PAUL KUSHAN,
Washington, DC; JAMES ASA HIGH, JR., Amgen Inc., South
San Francisco, CA; DREW DIAMOND, JOSEPH E. LASHER,
DENNIS J. SMITH, WENDY A. WHITEFORD, Thousand Oaks,
Case: 20-1037 Document: 97 Page: 2 Filed: 07/01/2020
2 IMMUNEX CORP. v. SANDOZ, INC.
CA.
WILLIAM M. JAY, Goodwin Procter LLP, Washington,
DC, argued for defendants-appellants. Also represented by
BRIAN TIMOTHY BURGESS; CINDY CHANG, New York, NY;
GERARD JUSTIN CEDRONE, DAVID ZIMMER, Boston, MA; DAN
HOANG, GEORGE C. LOMBARDI, MAUREEN L. RURKA, JULIA
MANO JOHNSON, Winston & Strawn LLP, Chicago, IL.
MATTHEW S. HELLMAN, Jenner & Block LLP, Washing-
ton, DC, for amicus curiae Association for Accessible Med-
icines. Also represented by ADAM G. UNIKOWSKY; YUSUF
ESAT, Chicago, IL; JEFFREY FRANCER, The Association for
Accessible Medicines, Washington, DC.
JOHN CAMERON ADKISSON, Fish & Richardson PC, Min-
neapolis, MN, for amicus curiae Samsung Bioepis Co., Ltd.
Also represented by ELIZABETH M. FLANAGAN, DEANNA
JEAN REICHEL; JONATHAN ELLIOT SINGER, San Diego, CA.
______________________
Before O’MALLEY, REYNA, and CHEN, Circuit Judges.
Opinion for the court filed by Circuit Judge O’MALLEY.
Dissenting opinion filed by Circuit Judge REYNA.
O’MALLEY, Circuit Judge.
Patent owner Hoffmann-La Roche Inc. (“Roche”), its ex-
clusive licensee Immunex Corp., and exclusive sublicensee
Amgen Manufacturing, Ltd., initiated this patent infringe-
ment suit pursuant to the Biologics Price Competition and
Innovation Act (“BPCIA”). 1 Sandoz, Inc., Sandoz
1 Immunex Corp. and Amgen Manufacturing, Ltd.
are collectively referred to as “Immunex.” Although Roche
joined the district court litigation, it did not enter an ap-
pearance in this appeal.
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IMMUNEX CORP. v. SANDOZ, INC. 3
International GmbH, and Sandoz GmbH filed abbreviated
Biologics License Application (“aBLA”) No. 761042. 2 This
action followed shortly thereafter. In the aBLA, Sandoz
sought approval to market Erelzi, a biosimilar version of
Immunex’s biologic drug, Enbrel®.
Enbrel® is covered by the patents-in-suit: U.S. Patent
Nos. 8,063,182 (“’182 patent”) and 8,163,522 (“’522 pa-
tent”). Prior to trial, Sandoz stipulated to infringement of
the asserted claims of the patents-in-suit. After a two-
week bench trial, the United States District Court for the
District of New Jersey entered final judgment for Immunex
and Roche, holding that Sandoz had failed to prove that the
asserted claims of the patents-in-suit were invalid.
Sandoz appeals from the district court’s judgment. On
appeal Sandoz argues, as it did before the district court,
that the patents-in-suit are invalid for (1) obviousness-type
double patenting; (2) failure to meet the written descrip-
tion requirement; and (3) obviousness. For the reasons dis-
cussed below, we affirm.
I. BACKGROUND
A. The Claimed Technology and Patents-in-Suit
The patents-in-suit are directed to the fusion protein
etanercept and methods of making the same. Etanercept
is the active ingredient in Immunex’s biologic drug
Enbrel®, which is primarily indicated for reducing the
signs and symptoms of moderately to severely active rheu-
matoid arthritis, an autoimmune disorder. Etanercept is
made by combining a portion of a 75 kilodalton (“kDa”) hu-
man tumor necrosis factor receptor protein with a portion
of immunoglobulin G1 (“IgG1”).
2 Sandoz, Inc., Sandoz International GmbH, and
Sandoz GmbH are collectively referred to as “Sandoz.”
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4 IMMUNEX CORP. v. SANDOZ, INC.
IgG1 is a type of antibody. Antibodies are proteins de-
ployed by the immune system to identify and neutralize
foreign objects—such as bacteria and viruses—called anti-
gens. Each antibody contains a region that binds to a por-
tion of an antigen. Through this binding mechanism, an
antibody can either neutralize the target antigen directly—
for example, by blocking the part of a virus that is essential
for the survival of the virus—or tag a microbe or an infected
cell for attack by other parts of the immune system. Like
all proteins, antibodies are made up of amino acids con-
nected to form chains called polypeptides. The polypep-
tides fold into three-dimensional structures that impart
structural and functional characteristics to the antibodies.
Structurally, each antibody (including IgG1) consists of
four chains of amino acids: two identical “heavy chains”
and two identical “light chains,” arranged in a Y-shape. All
four chains in the antibody contain two different segments:
a constant region (denoted by CH for the heavy chain con-
stant region and CL for the light chain constant region) and
a variable region (VH for the heavy chain variable region
and VL for the light chain variable region). The variable
regions are segments of the antibody that determine
whether, and how effectively, an antibody will bind to a
given antigen. The constant regions, on the other hand,
interact with other components of the immune system
through “domains”—areas of the protein that have a spe-
cific structure and can serve a specific function. The light
chain constant region consists of the CL domain. The
heavy chain constant region includes the CH1, the hinge,
CH2, and CH3 domains.
The human immune system also contains cytokines—
cell signaling proteins that effectuate a variety of immune
responses. Tumor necrosis factor (“TNF”) is one type of cy-
tokine produced in the human body. It is associated with
autoimmune inflammatory diseases such as rheumatoid
arthritis. TNF binds to TNF receptors (“TNFRs”), trans-
membrane receptors that contain three distinct regions:
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intracellular, transmembrane, and extracellular. There
are two types of TNFRs, p55 (a 55 kDa protein) and p75 (an
approximately 75 or 80 kDa protein). The extracellular re-
gion of TNFRs binds to TNF. This region can be split off to
make a soluble protein that binds to TNF, allowing for re-
moval or neutralizing of excess TNF from the body.
Etanercept—a fusion of the extracellular region of p75
and the hinge-CH2-CH3 portion of the constant region of
the IgG1 heavy chain—binds to excess TNF and neutral-
izes it. In this way, it reduces the autoimmune inflamma-
tory response in patients with rheumatoid arthritis.
The claims of the ’182 patent are directed to etanercept,
and the claims of the ’152 patent are directed to methods of
making etanercept. Both patents-in-suit claim priority to
European Patent Application No. 90116707.2 (“the EP ’707
Application”), filed on August 31, 1990, and U.S. Applica-
tion No. 07/580,013 (“the ’013 Application”), filed on Sep-
tember 10, 1990. Roche, the party that originally filed the
applications in this patent family, abandoned the ’013 Ap-
plication, but filed a continuation, U.S. Application No.
08/965,640 (“the ’640 Application”) on July 21, 1993. This
application was subject to a restriction requirement by the
United States Patent and Trademark Office (“USPTO”).
As a result of the restriction requirement, on May 19, 1995,
Roche filed two divisional applications claiming priority to
the ’640 application. These applications matured into the
’182 and ’152 patents, which issued on November 22, 2011
and April 24, 2012, respectively.
B. License Agreements Between
Immunex 3 and Roche
To understand the parties’ arguments on appeal, a
basic understanding of the historical relationship between
3 For simplicity, we refer to the licensee of the pri-
mary agreement at issue as “Immunex,” because all rights
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6 IMMUNEX CORP. v. SANDOZ, INC.
Immunex and Roche, as well as certain licenses between
them, is necessary. By 1990, both Roche and Immunex
Corp. were separately engaged in researching TNF and in-
vestigating whether targeting this molecule could provide
any therapeutic benefits. In April 1990, Roche published
the complete amino acid sequence of the p55 TNFR. In
May 1990, Immunex Corp. published an article containing
the full amino acid sequence of the p75 TNFR. And, in July
1990, Roche published the complete amino acid sequence
of p75, along with part of its encoding DNA. As noted
above, it was Roche that filed the priority application for
the patents-in-suit in 1990, as well as the applications for
the patents-in-suit in 1995.
Immunex Corp., working independently on TNFR-IgG
fusion proteins, obtained FDA approval of Enbrel® in 1998.
Almost a year later, Immunex Corp. and Roche entered
into a license (the “Immunex-Roche agreement”), effective
as of the approval date of Enbrel®, pursuant to which Im-
munex obtained a license to, inter alia, the EP ’707 Appli-
cation and the ’013 Application, and all patents that issue
from those applications. J.A. 25867. Immunex agreed to
pay Roche royalties on the sales of Enbrel®. J.A. 25876–
80.
In 2002, non-party Amgen, Inc. acquired Immunex
Corp. Subsequently, in 2004, Amgen, Inc., Immunex Corp.,
Roche, and non-party Wyeth entered into an “Accord & Sat-
isfaction” agreement concerning the same patent family.
J.A. 25836. The purpose of the agreement was “to elimi-
nate the continuing obligations to pay royalties to Roche”
pursuant to the Immunex-Roche agreement. Id.
initially granted to the original licensee, Amgen, Inc., and
its affiliates were ultimately consolidated in Immunex
Corp.
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IMMUNEX CORP. v. SANDOZ, INC. 7
Under the terms of the Accord & Satisfaction, Im-
munex has a paid-up, irrevocable, exclusive license to the
U.S. patent family for the patents-in-suit. It has the sole
right to grant sublicenses, to make, have made, use, sell,
offer for sale and import products covered by the patent
family. J.A. 25839. With respect to patent prosecution,
Immunex has the exclusive right to prosecute patent appli-
cations in the U.S. patent family. J.A. 25840. Thus, as of
2004, Immunex controlled the prosecution of the patents-
in-suit.
Under the terms of the agreement, Immunex has the
first right to rectify any suspected infringement of the li-
censed patent family at its sole expense and under its sole
control, by instituting suit or by sublicense. And, Immunex
may retain the entirety of any award of damages or lost
profits resulting from such an infringement suit. Roche is
obligated to cooperate in any such suit, including by partic-
ipating as a party to the extent required by the court in
order to bring suit. Id. Immunex also has the right to an
assignment of the patents-in-suit upon request and upon
the payment of $50,000. Id. (“If requested . . . Roche shall
execute an assignment of” the patents). 4
Under the terms of the Accord & Satisfaction, Roche is
required to cooperate with Immunex regarding prosecution
and enforcement of the patents-in-suit, including by
providing evidence and testimony in connection with any
proceeding affecting the validity of the patents-in-suit. Id.
Roche also retains the right to practice the patents for in-
ternal, non-clinical research only. In addition, Roche re-
tains the secondary right, but not obligation, to sue if
Immunex fails to rectify infringement or initiate an action
for such infringement within 180 days after written notifi-
cation by Roche. The agreement further provides that,
4 By contrast, non-party Wyeth obtained an assign-
ment of the European patents in the patent family.
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8 IMMUNEX CORP. v. SANDOZ, INC.
once Roche’s secondary right to sue is triggered, Roche
may, at its sole expense and under its sole control and di-
rection, initiate suit and may retain the entirety of any
award of damages or lost profits as a result of such suit.
J.A. 25841.
C. Procedural History
In February 2016, Immunex, together with Roche, filed
this patent infringement action against Sandoz under the
BPCIA. The district court held a two-week bench trial in
September 2018. Sandoz did not contest infringement of
the ’182 and ’522 patents. Accordingly, the only issues be-
fore the district court at trial were the validity of the as-
serted claims of the patents-in-suit. Specifically, the
district court considered whether claims 11–12 and 35–36
of the ’182 patent, and claims 3, 8, and 10 of the ’522 patent
were invalid for lack of written description and enable-
ment; obvious in light of certain asserted prior art refer-
ences; and invalid for obviousness-type double patenting.
On August 9, 2019, in a detailed opinion, the district
court issued its findings of fact and conclusions of law, hold-
ing that Sandoz had not proven that the patents-in-suit
were invalid. Immunex Corp. v. Sandoz Inc., 395 F. Supp.
3d 366, 374 (D.N.J. 2019). The court entered final judg-
ment for Immunex and Roche on October 8, 2019. Sandoz
timely appeals. We have jurisdiction pursuant to 28 U.S.C.
§ 1295(a).
II. DISCUSSION
On appeal, Sandoz argues that the patents-in-suit are
invalid for (1) obviousness-type double patenting; (2) fail-
ure to meet the written description requirement; and (3)
obviousness. We address each issue in turn.
A. Standards of Review
Following a bench trial, we review a district court’s con-
clusions of law without deference and its findings of fact for
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IMMUNEX CORP. v. SANDOZ, INC. 9
clear error. Ferring B.V. v. Watson Labs., Inc.-Fla., 764
F.3d 1401, 1406 (Fed. Cir. 2014). “A factual finding is
clearly erroneous if, despite some supporting evidence, we
are left with the definite and firm conviction that a mistake
has been made.” Id.
B. Obviousness-Type Double Patenting
Obviousness-type double patenting is a judicially-cre-
ated doctrine aimed at preventing claims in separate pa-
tents that claim obvious variants of the same subject
matter where “granting both exclusive rights would effec-
tively extend the life of patent protection.” In re Hubbell,
709 F.3d 1140, 1145 (2013) (quotations omitted); Eli Lilly
and Co. v. Barr Labs., Inc., 251 F.3d 955, 967 (Fed. Cir.
2001) (“The judicially-created doctrine of obviousness-type
double patenting . . . prohibit[s] a party from obtaining an
extension of the right to exclude through claims in a later
patent that are not patentably distinct from claims in a
commonly owned earlier patent.”). The doctrine applies to
all commonly-owned patents, even in cases where the obvi-
ous variants are invented by different inventors. In re
Longi, 759 F.2d 887, 895 (Fed. Cir. 1985). As we have pre-
viously recognized, there are two justifications for this doc-
trine: (1) to prevent timewise extension of the right to
exclude; and (2) to prevent multiple infringement suits by
different assignees. Hubbell, 709 F.3d at 1145. “[T]he ul-
timate conclusion that a patent is invalid under the doc-
trine of obviousness-type double patenting is reviewed de
novo.” Novartis Pharm. Corp. v. Breckenridge Pharm. Inc.,
909 F.3d 1355, 1361 (Fed. Cir. 2018). “[P]redicate findings
of fact” are reviewed for clear error. Eli Lilly & Co. v. Teva
Parenteral Medicines, Inc., 689 F.3d 1368, 1376 (Fed. Cir.
2012).
At trial, Sandoz asserted that the patents-in-suit are
invalid for obviousness-type double patenting over several
patents filed by Immunex Corp. in the years leading up to
and shortly after the approval of Enbrel®. The district
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10 IMMUNEX CORP. v. SANDOZ, INC.
court rejected Sandoz’s contentions, finding in favor of Im-
munex on several layers of analysis: (1) that Sandoz’s pro-
posed test for common-ownership does not apply; (2) even
if that test applies, the patents-in-suit and the asserted
double-patenting reference patents are not commonly
owned; (3) even if they are commonly owned, the two-way,
rather than the one-way test for obviousness-type double
patenting applies as to some of the double-patenting refer-
ences; and (4) the patents-in-suit are patentably distinct
from each of the asserted double patenting references. On
appeal, Sandoz limits its arguments to two patents, U.S.
Patent Nos. 7,915,225 (“Finck ’225”) and 5,605,690 (“Ja-
cobs ’690”) (collectively, the “Immunex Patents”). It con-
cedes that it must prevail at each step of the district court’s
analysis to garner a reversal of the court’s decision regard-
ing obviousness-type double patenting; losing at any one of
these steps is fatal to Sandoz’s arguments. Oral Arg. at
1:23–54, available at http://oralarguments.cafc.uscourts.g
ov/default.aspx?fl=2020-1037.mp3) (“[Counsel for Appel-
lant:] I agree that there are multiple steps that we would
ask this court to take.”).
As to the first step of the court’s analysis, in a novel
theory of common ownership, Sandoz argues that, even
though the patents-in-suit are assigned to Roche, Immunex
effectively owns both the Immunex Patents and the pa-
tents-in-suit because all substantial rights in the patents-
in-suit transferred to Immunex pursuant to the Accord &
Satisfaction. Borrowing from our 35 U.S.C. § 281 case law,
Sandoz argues that an agreement that conveys “all sub-
stantial rights” in a patent is tantamount to an assignment
of ownership. Appellants’ Br. 27–28 (citing Morrow v. Mi-
crosoft Corp., 499 F.3d 1332, 1340 (Fed. Cir. 2007)). In
Sandoz’s view, this “all substantial rights” test—to date
used only to determine who may sue for infringement as a
“patentee” pursuant to 35 U.S.C. § 281—should apply in
the obviousness-type double patenting context as well.
And, Sandoz contends, the relevant agreement here
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transferred all substantial rights in the patents-in-suit to
Immunex.
As discussed below, although we agree with Sandoz
that the “all substantial rights” test can be informative in
determining common ownership in the obviousness-type
double patenting context, we conclude that the agreement
at issue here did not transfer all substantial rights from
the assignee, Roche, to the exclusive licensee, Immunex.
Accordingly, we need not address the other layers of the
district court’s detailed analysis on obviousness-type dou-
ble patenting.
1. The All Substantial Rights Test
Under Sandoz’s theory of common ownership, if a party
is the effective patentee for purposes of the ability to bring
an infringement suit, then it is also an effective patentee
for purposes of obviousness-type double patenting. Sandoz
contends that a contrary rule would allow circumvention of
patent term limitations by simply reclassifying an assign-
ment as a license. Appellants’ Br. 28–29. And, Sandoz ar-
gues, if a party acquires all substantial rights in a patent
application, including the right to control prosecution, then
obviousness-type double patenting should apply to prohibit
issuance of claims that are not patentably distinct from
claims in patents already owned by that party. Appellants’
Reply Br. 9.
Immunex responds that common ownership-based ob-
viousness-type double patenting arises only where the rel-
evant inventions were owned by the same entity at the time
of the invention. Appellees’ Br. 36. Immunex cites to the
Manual of Patent Examining Procedure (“MPEP”), which
states that “[a]pplications or patents are ‘commonly owned’
pursuant to 35 U.S.C. 102(b)(2)(C) or pre-AIA 35 U.S.C.
103(c)(1) if they were wholly or entirely owned by the same
person(s), or organization(s)/business entity(ies), at the
time the claimed invention was filed or made, respec-
tively.” Id. at 37 (quoting MPEP § 804.03(II)). In
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12 IMMUNEX CORP. v. SANDOZ, INC.
Immunex’s view, this test applies because common owner-
ship in the obviousness-type double patenting context “ex-
ists to fill a narrow statutory gap,” created by the Patent
Law Amendments of 1984, Pub. L. No. 98-622, § 104, 98
Stat. 3383 (“the 1984 Act”). Id. at 37–38 (citing 1984 Act
(codified in 35 U.S.C. § 103(c))). Prior to the 1984 Act, Im-
munex argues, the USPTO recognized that common own-
ership-based double patenting rejections were
unnecessary, because examiners could simply use anticipa-
tion or obviousness rejections to avoid issuing multiple pa-
tents claiming the same invention or obvious variants. Id.
at 37 (citing Commissioner’s Notice on Double Patenting,
834 O.G. 1615, 1616 (Jan. 9, 1967)). But the 1984 Act pro-
hibited rejections based on prior art owned by the same
person or subject to an obligation of assignment to the same
person. Id. at 37–38 (citing 1984 Act). Immunex argues
that Congress expected double patenting to fill the gap
where the USPTO could no longer rely on §§ 102 and 103
to avoid issuing multiple patents on the same invention in
cases involving common ownership. Id. at 37–38. Accord-
ing to Immunex, the MPEP’s test for common ownership is
“narrowly tailored to close the gap created by the 1984 Act.”
Id. at 39.
We have previously rejected Immunex’s reading of the
history of the 1984 Act. See In re Longi, 759 F.2d 887, 893
(Fed. Cir. 1985). In Longi, rejecting the argument that ob-
viousness-type double patenting should not apply to com-
monly-owned applications with different inventive entities,
we ruled that such a broad proposition was inconsistent
with recent legislation, i.e., the 1984 Act. Id. We explained
that we have never endorsed the Commissioner’s Notice on
which Immunex now relies because the notice was merely
a procedural memorandum and, importantly, was incon-
sistent with many of our predecessor court’s decisions. Id.
at 894. Indeed, directly refuting Immunex’s arguments is
our express acknowledgement in Longi that common own-
ership-based obviousness-type double patenting existed
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IMMUNEX CORP. v. SANDOZ, INC. 13
even before 1984. Id. at 893; see also In re Rogers, 394 F.2d
566, 569 (C.C.P.A. 1968). Examining the very 1984 Act
that, in Immunex’s view, created a “statutory gap” that
common ownership-based obviousness-type double patent-
ing is designed to close, we said that the Act seemed “not
intended to affect the doctrine of double patenting, but
seem[ed] rather to reaffirm its viability.” Longi, 759 F.2d
at 895. Thus, we have already considered and rejected Im-
munex’s argument that common ownership-based obvious-
ness-type double patenting is a narrow gap-filling rule in
response to the 1984 Act.
Immunex’s “time of invention” test is also inconsistent
with more recent case law. For example, we have applied
common ownership-based obviousness-type double patent-
ing where a party “merged with the original assignees of”
the double-patenting references at issue. Geneva Pharm.,
Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1377, 1386
(Fed. Cir. 2003). And, although the Board of Patents Ap-
peals and Interferences (“BPAI”), predecessor to the Patent
Trial and Appeals Board, applied the MPEP definition of
“common ownership” (from the 35 U.S.C. § 103(c) context)
to double patenting cases, it expressly did not do so with
respect to the timing of the invention. Ex Parte Maurice,
No. 2005-2463, 2005 WL 4779419, at *2 (B.P.A.I. Sept. 19,
2005). In Ex Parte Maurice, while accepting that “com-
monly owned” for double patenting purposes must be read
to be consistent with common ownership in the context of
35 U.S.C. § 103(c), the BPAI clarified that “[b]y ‘consistent,’
appellants presumably mean consistent with regard to the
required interest of each co-owner, and not necessarily con-
sistent in terms of the time frame in which ownership is
considered.” Id.
We see no justification for applying Immunex’s “time of
filing” requirement in the obviousness-type double patent-
ing context. Indeed, adopting Immunex’s rule might lead
to the absurd result where, even if originally applied for by
inventors working under an obligation of future
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14 IMMUNEX CORP. v. SANDOZ, INC.
assignment to an employer, patents may not be considered
“commonly owned” because, at the “time of invention,” the
assignment had not been effectuated. Such a result would
effectively eviscerate common ownership-based obvious-
ness-type double patenting. Accordingly, we conclude that
Immunex’s “time of filing” test for common ownership does
not apply.
By contrast, Sandoz’s proposed test for common owner-
ship—determining whether a party controlling prosecution
was the “effective patentee” under the “all substantial
rights” test—appears consistent with both principles un-
derlying obviousness-type double patenting, namely, pre-
venting unjustified patent term extensions and preventing
harassment from multiple suits. Applying Sandoz’s test
would prevent an effective patentee from unjustifiably ex-
tending its patent term by using the nominal label of licen-
see. The second consideration underlying obviousness-type
double patenting—preventing harassment through multi-
ple infringement suits by different assignees asserting es-
sentially the same patented invention—also undergirds
our 35 U.S.C. § 281 jurisprudence. See Hubbell, 709 F.3d
at 1145; see also Lone Star Silicon Innovations LLC v.
Nanya Tech. Corp., 925 F.3d 1225, 1233 (Fed. Cir. 2019).
We are mindful, however, of the existing complexities
in applying the equitable doctrine of obviousness-type dou-
ble patenting and see no reason to import into this judi-
cially-created doctrine the entirety of our body of law
analyzing who is a statutory “patentee” pursuant to 35
U.S.C. § 281. We conclude only that where one of the rights
transferred is the right to prosecute the patent at issue, iden-
tification of the effective “patentee” is informative in eval-
uating whether the patents are “commonly owned” for
purposes of obviousness-type double patenting. Where, as
here, a party ultimately controls prosecution of both sets of
patents, the “all substantial rights” test aids in preventing
the unjustifiable issuance of claims that are patentably in-
distinct from claims already owned by that party. Under
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IMMUNEX CORP. v. SANDOZ, INC. 15
these circumstances, looking to the “all substantial rights”
test achieves the proper balance between deterring games-
manship in prosecution, on the one hand, and avoiding any
chilling effect on routine collaborations and licensing be-
tween parties working in the same field of research, on the
other.
2. The Accord & Satisfaction Did Not
Transfer All Substantial Rights in the
Patents-in-Suit to Immunex
We now turn to the agreement at issue, and whether,
as Sandoz argues, it is effectively an assignment because it
transferred all substantial rights in the patents-in-suit to
Immunex. “To determine whether an exclusive license is
tantamount to an assignment, we must ascertain the in-
tention of the parties to the license agreement and examine
the substance of what was granted.” Alfred E. Mann
Found. v. Cochlear Corp., 604 F.3d 1354, 1359 (2010) (al-
terations and quotations omitted); see also Vaupel Textil-
maschinen KG v. Meccanica Euro Italia S.P.A., 944 F.2d
870, 874 (Fed. Cir. 1991). The focus is on the substance of
what was granted. Id. We have recently reaffirmed that
“we examine the ‘totality’ of the agreement to determine
whether a party other than the original patentee has es-
tablished that it obtained all substantial rights in the pa-
tent.” Lone Star, 925 F.3d at 1229; Prima Tek II, LLC v.
A-Roo Co., 222 F.3d 1372 (Fed. Cir. 2000). Although we
have “never purported to establish a complete list of the
rights [that can] . . . render an exclusive licensee the owner
of a patent,” Alfred E. Mann, 604 F.3d at 1360, “we have
often focused on two salient rights: enforcement and alien-
ation,” Lone Star, 925 F.3d at 1231. Thus, we have consid-
ered factors such as the scope of the licensee’s right to
sublicense, the nature of license provisions regarding re-
version of rights, the duration of the license grant, and the
nature of any limits on the licensee’s right to assign its in-
terests in the patent.” Alfred E. Mann, 604 F.3d at 1360–
61.
Case: 20-1037 Document: 97 Page: 16 Filed: 07/01/2020
16 IMMUNEX CORP. v. SANDOZ, INC.
As a threshold matter, the parties dispute the applica-
ble standard of review. Sandoz argues that de novo review
applies to this determination, whereas Immunex main-
tains that also at issue is the district court’s factual deter-
mination of the parties’ intent, which should be reviewed
deferentially. Appellants’ Reply Br. 11–12; Appellees’ Br.
47–48. As we explained in Alfred E. Mann, the substance
of what was granted is determined by interpreting the li-
cense. 604 F.3d at 1359. Here, the contract is governed by
Delaware law, which provides that the district court’s in-
terpretation presents a question of law to be reviewed de
novo. In re Viking Pump, Inc., 148 A.3d 633, 643–44 (Del.
2016). As to the question of whether the provisions effec-
tuated a transfer of all substantial rights such that Im-
munex, not Roche, is the “patentee,” that is a legal question
we review de novo under our own law. Prima Tek, 222 F.3d
at 1377. But, to the extent determining the intention of the
parties requires evaluation of parol evidence, that “evalua-
tion presents a question of fact that we review deferen-
tially.” Alfred E. Mann, 604 F.3d at 1359.
The district court treated this as a two-part inquiry,
looking first to the parties’ intent and then to the agree-
ment provisions to determine “the substance of what was
granted.” Immunex, 395 F. Supp. 3d at 415–17. The court
found that Roche and Immunex “specifically intended for
the Accord & Satisfaction to be a license such that Roche
would remain the owner of the patents-in-suit.” Id. at 415.
It looked to “the face of the [agreement] itself,” which calls
the grant to Immunex a “license.” Id. at 416. The court
also relied on the testimony of an Amgen corporate witness
to conclude that the parties intended for the agreement to
be a license. Id.
Absent ambiguous provisions, however, there is no
need to resort to parol evidence to determine the parties’
intent. The court did not find that the Accord & Satisfac-
tion was ambiguous. Accordingly, it should not have made
any factual determinations regarding the intent of the
Case: 20-1037 Document: 97 Page: 17 Filed: 07/01/2020
IMMUNEX CORP. v. SANDOZ, INC. 17
parties as shown by witness testimony. 5 As to the fact that
the agreement is called a “license,” we have clarified that
“whether a transfer of a particular right or interest under
a patent is an assignment or a license does not depend upon
the name by which it calls itself, but upon the legal effect of
its provisions.” Lone Star, 925 F.3d at 1230 (emphasis in
original) (quoting Waterman v. Mackenzie, 138 U.S. 252,
256 (1891)). Here, it does not matter that the grant to Im-
munex was titled a “license”—what matters is the effect of
the agreement on the parties’ respective rights. Indeed, in
arguing for a deferential standard of review, Immunex
cites to no cases where we have looked beyond the contract
at issue to determine the parties’ intent. We therefore look
only to the substance of what was transferred under the
Accord & Satisfaction, which we review de novo.
Review of the 2004 Accord & Satisfaction reveals the
following: Section 3.5 of the agreement gives Immunex the
first right to rectify any suspected infringement, at Im-
munex’s sole expense and under its sole control, by insti-
tuting suit or by sublicensing the patents. J.A. 25840.
Immunex may retain the entirety of any award of damages
or lost profits as a result of such suit. Roche is required to
cooperate in any Immunex-initiated infringement suit, in-
cluding by participating as a party only to the extent re-
quired by the court in order to bring suit. But, under
Section 3.6, Roche retains the secondary right to sue if Im-
munex fails to rectify any infringement within 180 days af-
ter written request by Roche. J.A. 25841. After this 180-
day notice period, Roche may, at its sole expense and under
its sole control and direction, initiate suit. Id. Roche may
5 The dissent likewise points to witness testimony in
support of its conclusion that Roche transferred all sub-
stantial rights in the patents-in-suit to Immunex. Dissent
Op. at 5–6. We do not think the analysis in this case should
be guided by parol evidence.
Case: 20-1037 Document: 97 Page: 18 Filed: 07/01/2020
18 IMMUNEX CORP. v. SANDOZ, INC.
retain the entirety of any award of damages or lost profits
as a result of a Roche-initiated suit. Immunex further has
a duty to cooperate in such a Roche-initiated suit. Notably,
“the right to rectify infringement under . . . Section 3.6 is
solely with” Roche. Id. As to alienation rights, under Sec-
tion 11.4, neither party may assign its rights to third par-
ties without the written consent of the other. J.A. 25849.
On appeal, Sandoz argues that these provisions, taken
together, effectuated a transfer of all substantial rights
from Roche to Immunex. Sandoz points to Immunex’s
“paid-up, irrevocable, exclusive license” and “first right to
rectify any alleged infringement” on the one hand, and
Roche’s loss of control over licensing and litigation activi-
ties on the other, to argue that Roche was “stripped of any
of the traditional attributes of ownership.” Appellants’ Br.
31–32. Sandoz also contends that Immunex’s ability to
drive the prosecution of the patents is another indication
that Roche transferred all substantial rights.
Immunex responds that Roche is still the effective pa-
tentee because it retained several key rights under the Ac-
cord & Satisfaction. Immunex points to: (1) Roche’s
secondary right to sue; (2) Roche’s right to practice the pa-
tents for internal, non-clinical research; (3) Immunex’s op-
tion to convert the license into an assignment by paying an
additional consideration of $50,000; and (4) Roche’s right
to veto the assignment of Immunex’s interest under the
agreement to any unrelated party. Appellees’ Br. 49–53.
The enforcement and alienation rights under the Ac-
cord & Satisfaction make clear that Roche did not transfer
all substantial rights in the patents to Immunex. We have
explained that the nature and scope of the licensee’s right
to sue, together with the nature of the licensor’s retained
right to sue, is “[f]requently . . . the most important consid-
eration.” Alfred E. Mann, 604 F.3d at 1361. Here, alt-
hough Immunex obtained the first right to sue, Roche
retained the secondary right to sue. Like the license at
Case: 20-1037 Document: 97 Page: 19 Filed: 07/01/2020
IMMUNEX CORP. v. SANDOZ, INC. 19
issue in Alfred E. Mann, although Roche’s “right to choose
to sue an infringer does not vest until [Immunex] chooses
not to sue that infringer, [that right] is otherwise unfet-
tered.” Id. at 1362. Once Roche’s secondary right to sue
vests, the ability to rectify infringement is “solely” with
Roche, and may not pass to Immunex. After the 180-day
notice period, Roche can decide “whether or not to bring
suit, when to bring suit, where to bring suit, what claims
to assert, what damages to seek, [and] whether to seek in-
junctive relief.” Id. Retention of “such broad right[s]” is
“thoroughly inconsistent” with a conclusion that the pa-
tents-in-suit were effectively assigned to Immunex. See id.
Sandoz cites Speedplay, Inc. v. Bebop, Inc., 211 F.3d
1245 (Fed. Cir. 2000), for the proposition that Roche’s sec-
ondary right to sue is “illusory” because Immunex can “un-
dercut Roche’s ability to sue by granting a royalty-free
sublicense to an alleged infringer.” Id. at 33–35 (citing
Speedplay, 211 F.3d at 1251). In Speedplay, we concluded
that the licensor’s retained right to sue was illusory be-
cause the licensee could render that right nugatory by
granting the alleged infringer a royalty-free sublicense.
211 F.3d at 1251. Sandoz argues that, here, because the
license is fully paid-up, there are no pass-through royalties,
just like in Speedplay, rendering the secondary right to sue
illusory. But, as we have explained, “Speedplay . . . held
that a licensee’s right to grant royalty-free sublicenses to
defendants sued by the licensor rendered illusory the licen-
sor’s right to sue.” Alfred E. Mann, 604 F.3d at 1362 (em-
phasis added). That is precisely what the licensee
Immunex cannot do here: under Section 3.6 of the agree-
ment, once Roche’s secondary right to sue is triggered, Im-
munex no longer has any right to rectify any infringement
and cannot frustrate a Roche-initiated suit by granting a
royalty-free sublicense to defendants sued by Roche, and
Roche retains the entirety of any award of damages. We
reject Sandoz’s contention that Section 3.6 “does not modify
Immunex’s sublicensing rights.” Appellants’ Reply Br. 13.
Case: 20-1037 Document: 97 Page: 20 Filed: 07/01/2020
20 IMMUNEX CORP. v. SANDOZ, INC.
Thus, unlike the licensor in Speedplay, Roche’s secondary
right to sue is not illusory. 6
Roche’s right to veto any assignment of Immunex’s in-
terest in the patents-in-suit also weighs in favor of the con-
clusion that all substantial rights were not transferred. We
have previously made clear that restrictions on the ability
to transfer patent rights are inconsistent with a transfer of
all substantial rights. Lone Star, 925 F.3d at 1222–23; see
also Abbott Labs. v. Diamedix Corp., 47 F.3d 1128, 1132
(Fed. Cir. 1995). Here, under Section 11.4 of the agree-
ment, Immunex may not assign its rights in the patents-
in-suit to a third party without Roche’s written consent.
This restriction on alienation of rights is a further indica-
tion that Roche transferred less than all substantial rights
in the patents-in-suit.
We reject Sandoz’s argument—also relied upon by the
dissent—that Immunex’s ability to convert the license into
an assignment upon payment of $50,000 somehow evinces
a transfer of all substantial rights. See Appellants’ Br. 17;
Dissent Op. at 5. This option to purchase the patents-in-
6 Adopting Sandoz’s arguments, the dissent urges
that “[t]he focus of the Speedplay inquiry is whether a li-
censee can nullify a licensor’s secondary right to sue, pre-
or post-suit.” Dissent Op. at 7. But like Sandoz, the dissent
fails to account for our decision in Alfred E. Mann, where
we explained that the holding in Speedplay turned on the
licensee’s ability to frustrate a licensor-initiated suit. See
Alfred E. Mann, 604 F.3d at 1362. We also highlighted the
importance of the licensor’s ability to control litigation
“[o]nce its right to sue an infringer activates.” Id. The dis-
sent’s singular focus on Immunex’s ability to prevent
Roche’s secondary right to sue from vesting is, therefore,
misguided. The proper inquiry must account for the par-
ties’ respective rights once Roche’s secondary right to sue
activates.
Case: 20-1037 Document: 97 Page: 21 Filed: 07/01/2020
IMMUNEX CORP. v. SANDOZ, INC. 21
suit is merely one provision in the “totality of the transfer
agreement” that guides our inquiry. See Lonestar, 925 F.3d
at 1231. The Accord & Satisfaction makes clear that the
purpose of the agreement was “to eliminate the continuing
obligations to pay royalties to Roche” pursuant to the Im-
munex-Roche agreement. J.A. 25836. Under the terms of
the Accord & Satisfaction, Immunex paid Roche tens of mil-
lions of dollars as consideration. The additional considera-
tion for an outright assignment should be viewed in the
context of the entirety of the agreement. 7
Given the totality of the Accord & Satisfaction, we hold
that Roche did not transfer all substantial rights in the pa-
tents-in-suit to Immunex. As such, the Immunex Patents
and the patents-in-suit are not “commonly owned,” and ob-
viousness-type double patenting does not apply. Accord-
ingly, we decline to address Sandoz’s remaining arguments
regarding obviousness-type double patenting. 8 We thus af-
firm the district court on this point. 9
7 We are likewise unpersuaded by Sandoz’s argu-
ment that Roche cannot terminate the agreement once it
has received payment. Appellants’ Br. 17; see also Dissent
Op. at 5. This argument overlooks the fact that Immunex’s
ability to terminate the agreement is also restricted. Even
though Immunex has the right to terminate the Accord &
Satisfaction, several provisions of the agreement survive
any such termination, including § 3.6, which governs
Roche’s secondary right to sue.
8 We note, however, that contrary to the dissent’s
view that the record here demonstrates “gamesmanship in
prosecution,” Dissent Op. at 3, we see no clear error in the
district court’s finding that Immunex “acted in good faith
to diligently prosecute” the patents-in-suit. Immunex, 395
F. Supp. 3d. at 421.
9 To the extent the district court considered parol ev-
idence, we consider this harmless error.
Case: 20-1037 Document: 97 Page: 22 Filed: 07/01/2020
22 IMMUNEX CORP. v. SANDOZ, INC.
B. Written Description
“Written description is a question of fact, judged from
the perspective of one of ordinary skill in the art as of the
relevant filing date.” Falko-Gunter Falkner v. Inglis, 448
F.3d 1357, 1363 (Fed. Cir. 2006). The written description
test involves “an objective inquiry into the four corners of
the specification from the perspective of a person of ordi-
nary skill in the art. Based on that inquiry, the specifica-
tion must describe an invention understandable to that
skilled artisan and show that the inventor actually in-
vented the invention claimed.” Ariad Pharm., Inc. v. Eli
Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). As a
question of fact, written description is “to be reviewed un-
der the clearly erroneous standard.” Vas-Cath Inc. v. Ma-
hurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991).
On appeal, Sandoz argues that the district court erred
in concluding that the priority application for the patents-
in-suit disclosed possession of the claimed invention. Spe-
cifically, Sandoz argues that the priority application did
not include written description support for (1) the full-
length p75 DNA sequence; and (2) the claimed p75-IgG1
fusion protein. We disagree with Sandoz on both points.
1. The ’013 Application Disclosed
Full-Length p75
According to Sandoz, the ’013 Application described a
fusion protein based on the truncated/mutated p75 DNA
sequence disclosed in Figure 4 of the patent, not the full-
length p75 sequence used in etanercept. Appellants’ Br.
50–52. Sandoz contends that the fact that the full-length
p75 sequence was known in the prior art is of no moment
because the real issue is exactly which p75 sequence Roche
had in its possession as of the time of the filing of the pri-
ority application. Id. at 57. In Sandoz’s view, the district
court’s finding of adequate written description impermissi-
bly rests on information outside the patent.
Case: 20-1037 Document: 97 Page: 23 Filed: 07/01/2020
IMMUNEX CORP. v. SANDOZ, INC. 23
Immunex responds that sequence identification num-
bers for p75 are mentioned in the specification, and, as its
witness testified, those sequences would have led a person
of skill (“POSA”) to the complete p75 sequence using Gen-
Bank, a well-known genetic sequence database that houses
a collection of all publicly available DNA sequences. Ap-
pellees’ Br. 63–64. Immunex further points to the refer-
ence in the specification to the Smith 1990 publication,
which, in its view, would have directed a skilled artisan to
the full-length p75 sequence.
We agree with Immunex. It is well-established that a
patent specification need not re-describe known prior art
concepts. See Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed.
Cir. 2005) (“The ‘written description’ requirement must be
applied in the context of the particular invention and the
state of the knowledge.”); see also Zoltek Corp. v. United
States, 815 F.3d 1302, 1308 (Fed. Cir. 2016) (“The written
description need not include information that is already
known and available to the experienced public.”)). Operat-
ing under the guidance of these principles, the district
court properly concluded that the inventors possessed the
full-length p75 DNA sequence. The specification identifies
both p55 and p75 TNFRs. And, as the district court noted,
it “embraces allelic variants and DNA sequences resulting
from deletions, substitutions, and additions of one or more
nucleotides of the sequences provides in Figures 1 and/or
Figure 4.” Immunex, 395 F. Supp. 3d. at 382 (citing ’182
patent, 4:1–5:24). Example 6 of the specification explains
that the inventors isolated the 75 kDa full-length p75
TNFR. Id. at 385 (citing ’182 patent, 15:30–39). We see no
error in the district court’s reliance on these disclosures to
conclude that the inventors possessed full-length p75, not
just the truncated p75 disclosed in Figure 4.
Importantly, the district court also found that the p75
sequence was known to a POSA at the time of the inven-
tion. Id. According to the district court, the Smith 1990
article, referenced in the priority application, shows that a
Case: 20-1037 Document: 97 Page: 24 Filed: 07/01/2020
24 IMMUNEX CORP. v. SANDOZ, INC.
POSA would have known the entire p75 sequence at the
time of the invention. The Smith 1990 article guided a
POSA that the “entire nucleotide sequence is available
upon request and has been deposited with GenBank, acces-
sion number M32315.” Id. (citing J.A. 26980). And, the
district court pointed to a July 1990 Roche publication, the
Dembic article, which also disclosed the entire p75 amino
acid sequence. Id. The court also credited the testimony of
Immunex’s expert, who opined that a POSA would have
been encouraged from the disclosure in the priority appli-
cation to look to Smith, and therefore, the full-length p75
protein. Id. at 384. The district court also pointed to the
two C-terminus and N-terminus p75 sequences disclosed in
the specification and concluded that, in addition to Figure
4 and the reference to Smith 1990, these two disclosed se-
quences would have directed a POSA to the full p75 se-
quence at the time of the invention. Although Sandoz
criticizes this finding, the district court credited expert tes-
timony that a POSA would be led to the complete p75 se-
quence using these disclosures. Id. Thus, Sandoz’s
argument that the district court erred by looking outside
the four corners of the specification or engaged in an “obvi-
ousness-based” written description analysis is without
merit. The district court properly considered how a POSA
would understand the specification.
As to Sandoz’s arguments that later amendments show
that the Roche inventors did not have possession of the full
p75 sequence at the time of invention, the district court cor-
rectly noted that actual reduction to practice is not re-
quired to show possession. Immunex, 395 F. Supp. 3d. at
387–88. The court rejected Sandoz’s arguments that these
amendments added new matter. We see no error in these
findings.
Accordingly, we conclude that the district court did not
err in finding that the priority application disclosed and
demonstrated possession of full-length p75.
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IMMUNEX CORP. v. SANDOZ, INC. 25
2. The ’013 Application Demonstrates
Possession of the Claimed Fusion Protein
Sandoz also argues that the priority application did not
adequately demonstrate possession of the claimed p75-
IgG1 fusion protein. Sandoz repeats its arguments that the
Figure 4 truncated sequence was “preferred,” and points
out that to arrive at the claimed invention, a POSA would
have had to select the “never-referenced” full Smith se-
quence. Appellants’ Br. 58–59. Sandoz also argues that
the specification disclosed a range of immunoglobulin clas-
ses, and even if the IgG1 and exon-encoded hinge were de-
scribed as possible options, the priority application
provided no “blaze marks” that would have led a POSA to
their selection. Id. at 59. Sandoz’s primary argument is
that the district court relied on the claims themselves as
evidence of the “required blaze marks.” Id. at 60.
Immunex responds that the specification identified
four preferred fusion proteins, including the claimed p75-
IgG1 fusion protein, and that Example 11 provided the
steps required to make these fusion proteins. Appellees’
Br. 68. And Immunex points to the reference in the speci-
fication to deposited vectors, which is an adequate descrip-
tion of the precise IgG1 sequence to be used in the claimed
fusion proteins. Id. We again agree with Immunex.
Contrary to Sandoz’s arguments, the district court’s
written description analysis was not premised on the lan-
guage of the issued claims. The district court correctly
noted that the specification refers to the use of deposited
vectors that contain DNA sequences encoding the exon-de-
fined hinge-CH2-CH3 region of the human IgG1 heavy
chain. Immunex, 395 F. Supp. 3d at 386–87. And, the court
noted that Example 11 teaches how to fuse a soluble TNF-
binding fragment directly to that hinge-CH2-CH3 region.
Id. at 385 (citing ’182 patent, 9:3–8). Citing expert testi-
mony, the court concluded that Example 11 discloses this
concept with p55, and a POSA would have followed that
Case: 20-1037 Document: 97 Page: 26 Filed: 07/01/2020
26 IMMUNEX CORP. v. SANDOZ, INC.
example to create etanercept based on the claims and spec-
ification. Id. Finally, the court noted that “the IgG1 hinge-
CH2-CH3 was also known in the prior art as of August
1990.” Id. at 386.
The district court’s findings are supported by the as-
filed specification and are not based on the language of the
issued claims. First, the district court noted that the claim
language “identifies the requisite elements of the subject
invention,” but at the same time it concluded that the ex-
amples further demonstrate that the Roche inventors had
possession. Id. Second, as Immunex correctly points out,
the as-filed patent claims included claim 19, which claimed
a fusion protein of a TNF-binding protein and IgG1 or
IgG3. Appellees’ Br. 69 (citing J.A. 25129).
Accordingly, we conclude that the district court’s writ-
ten description analysis is not clearly erroneous.
C. Obviousness
Obviousness is a question of law reviewed de novo, with
underlying factual questions reviewed for clear error. Hon-
eywell Int’l, Inc. v. United States, 609 F.3d 1292, 1297 (Fed.
Cir. 2010). “The presence or absence of a motivation to
combine references in an obviousness determination is a
pure question of fact.” Novartis AG v. Torrent Pharm. Ltd.,
853 F.3d 1316, 1327 (Fed. Cir. 2017).
Sandoz appeals the district court’s obviousness analy-
sis, arguing that (1) the district court’s motivation to com-
bine analysis erroneously focused on the inventors’
subjective motivation rather than the claims’ objective
reach; and (2) the district court’s analysis regarding objec-
tive indicia of non-obviousness was legally erroneous. As
explained below, we do not find Sandoz’s arguments per-
suasive.
Case: 20-1037 Document: 97 Page: 27 Filed: 07/01/2020
IMMUNEX CORP. v. SANDOZ, INC. 27
1. Motivation to Combine
Sandoz challenges the district court’s finding that a
POSA would not have been motivated to either select p75
or to combine it with an immunoglobulin. Appellants’ Br.
62. The district court concluded that a POSA would be de-
terred from pursuing the claimed combination by concerns
of stimulating inflammation and aggregation, the opposite
effect from that needed to treat inflammatory conditions
like rheumatoid arthritis. According to Sandoz, this was
legal error because the claims are not directed to treatment
of any disease or condition, and because it was known that,
in addition to any therapeutic benefits, TNFRs and
TNFR/IgG fusion proteins were useful as diagnostic and
research tools as well. Sandoz also points out that the spec-
ification does not mention rheumatoid arthritis or contain
any data regarding treatment efficacy. Appellants’ Br. 62.
Sandoz argues that this contravenes the teachings of KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) that “neither
the particular motivation nor the avowed purpose of the
patentee controls. What matters is the objective reach of
the claim.” Id. (citing KSR, 550 U.S. at 419).
Immunex responds that it was Sandoz’s burden to
prove motivation to combine, and at trial, Sandoz focused
on these therapeutic goals as evidence of motivation to
combine. Appellees’ Br. 71–72. Immunex points to
Sandoz’s trial arguments that focused on the use of TNFR-
IgG1 fusion proteins for treatment of autoimmune disor-
ders. Id. According to Immunex, this focus on therapy
made sense, because certain asserted claims cover pharma-
ceutical compositions, not “research tools.” Id. at 73. Im-
munex argues that the district court properly focused on
the evidence presented and found that a POSA would not
have been motivated to select the components of etaner-
cept. Id. at 73–74. We agree with Immunex that the dis-
trict court’s analysis was not legally erroneous.
Case: 20-1037 Document: 97 Page: 28 Filed: 07/01/2020
28 IMMUNEX CORP. v. SANDOZ, INC.
Although Sandoz and the amici criticize the district
court’s focus on the therapeutic anti-inflammatory effect of
TNFR binding proteins, that focus was a result of the ar-
guments and evidence presented at trial and in the parties’
post-trial submissions. For example, in its post-trial brief,
Sandoz presented the dispute about motivation as limited
to the following question: “Would a person of ordinary skill
in the art in August 1990 have been motivated to construct
a fusion protein of the p75 extracellular region fused to the
hinge-CH2-CH3 of a human IgG1—i.e., etanercept?” J.A.
60195. Sandoz’s own post-trial “findings of fact” focused on
the fact that, at the time of the invention, several diseases
were associated with overactive TNF, and that there was a
tremendous interest in studying TNF activity and inhibi-
tion to provide a therapeutic benefit. J.A. 60081–84 (“To a
POSA [prior art] references provide a strong incentive to
identify TNF inhibitors that may have therapeutic use.”).
Likewise, Sandoz emphasized that a POSA would have
considered fusing soluble receptors (like the p75 extracel-
lular domain) advantageous for many reasons, including
extending the half-life of the soluble receptor to prevent it
from being rapidly lost from the patient’s blood stream into
the urine. J.A. 60084–86. Finally, Sandoz focused on the
primary asserted prior art reference (Immunex’s ’760 pa-
tent) to argue that a POSA would have been motivated to
modify the disclosures of that reference to create etaner-
cept. J.A. 60086–97.
In its post-trial submissions, Sandoz addressed the fact
that the prior art “suggests using TNF-binding proteins as
a tool in ‘diagnostic assays for TNF.’” See, e.g., J.A. 60083.
It also noted that “the asserted claims are not directed to
any specific treatment or in vivo effects and only require
the fusion protein to, at most, specifically bind TNF . . .
Such fusion protein would indisputably be useful for in
vitro testing and diagnostics at a minimum.” J.A. 60123.
And, Sandoz noted that the claims at issue do not require
any therapeutic effect. J.A. 60137–38. But these
Case: 20-1037 Document: 97 Page: 29 Filed: 07/01/2020
IMMUNEX CORP. v. SANDOZ, INC. 29
arguments were presented in response to Immunex’s argu-
ments that a POSA would be discouraged from creating a
TNFR-human IgG1 fusion protein because of concerns of
aggregation and effector functions. The focus of Sandoz’s
motivation to combine argument remained the therapeutic
benefits of the claimed invention, and it was not error for
the district court to frame its analysis accordingly.
We conclude that the district court’s analysis regarding
motivation to combine was not legally erroneous because
the treatment of illnesses that involve TNF is a stated ob-
jective of the claimed invention; the arguments at trial
were focused on therapeutic effects of the claimed inven-
tion (and not on their benefits as diagnostic and research
tools); and at least two of the asserted claims are directed
to pharmaceutical compositions. On this record, the dis-
trict court properly weighed the evidence presented and
concluded as a matter of fact that a POSA would be dis-
suaded from selecting or combining the components as
claimed. We identify no clear error in this finding.
2. Objective Indicia of Non-Obviousness
Sandoz argues that the district court incorrectly ana-
lyzed the required nexus between the claims and the objec-
tive indicia of non-obviousness, such as clinical success,
long-felt need, and failure of others. Appellants’ Br. 63–64.
Sandoz further argues that the court did not properly con-
sider evidence of simultaneous invention, as shown by ear-
lier patents claiming etanercept, including Immunex’s
Jacobs ’690 patent. Id. Sandoz’s arguments are without
merit.
As Immunex correctly argues, “there is a presumption
of nexus for objective considerations when the patentee
shows that the asserted objective evidence is tied to a spe-
cific product and that product is the invention disclosed
and claimed in the patent.” WBIP, LLC v. Kohler Co., 829
F.3d 1317, 1329 (Fed. Cir. 2016) (quotations omitted); Ap-
pellees’ Br. 75–76. Nexus is appropriately presumed in this
Case: 20-1037 Document: 97 Page: 30 Filed: 07/01/2020
30 IMMUNEX CORP. v. SANDOZ, INC.
case where the court concluded that the claims are directed
to the active ingredient in Enbrel® and its method of man-
ufacture. The district court found that there was a suffi-
cient nexus between the claimed invention and the various
objective indicia of non-obviousness. Immunex, 395 F.
Supp. 3d at 401–05. Sandoz failed to rebut the presump-
tion of nexus.
As to simultaneous invention, Immunex correctly notes
that the district court found that three of the alleged in-
stances of “simultaneous invention” were directed to differ-
ent fusion proteins, not etanercept. Id. at 407; see also
Appellees’ Br. 76. As to invention by Immunex, the court
properly noted that the “patent applications were already
pending when Immunex created etanercept in November
or December 1990. Immunex’s subsequent decision to li-
cense the Patents-in-Suit from Roche demonstrates etaner-
cept’s inventive nature and undermines an obviousness
finding.” Id. at 408. Finally, as we have discussed above,
the district court correctly concluded that the Jacobs ’690
patent does not cover etanercept, but is directed to fusion
proteins with an unmodified constant region. It also issued
from a continuation-in-part filed two years after the origi-
nal applications for the patents-in-suit. At bottom,
Sandoz’s arguments regarding objective indicia are merely
disagreements with the district court’s weighing of the ev-
idence. We see no clear error in the district court’s findings
regarding the objective indicia of non-obviousness.
III. CONCLUSION
We have considered the parties’ remaining arguments
and find them unpersuasive. For the foregoing reasons, we
affirm the district court’s judgment that Sandoz has not
shown that the patents-in-suit are invalid.
AFFIRMED
Case: 20-1037 Document: 97 Page: 31 Filed: 07/01/2020
United States Court of Appeals
for the Federal Circuit
______________________
IMMUNEX CORPORATION, AMGEN
MANUFACTURING, LIMITED,
Plaintiffs-Appellees
HOFFMANN-LA ROCHE INC.,
Plaintiff
v.
SANDOZ INC., SANDOZ INTERNATIONAL GMBH,
SANDOZ GMBH,
Defendants-Appellants
______________________
2020-1037
______________________
Appeal from the United States District Court for the
District of New Jersey in No. 2:16-cv-01118-CCC-MF,
Judge Claire C. Cecchi.
______________________
REYNA, Circuit Judge, dissenting.
The majority determines that obviousness-type double-
patenting does not apply here because appellee Immunex
is not a common owner of the patents-in-suit. The major-
ity’s common ownership determination hinges on its inter-
pretation of the 2004 Accord & Satisfaction between
Case: 20-1037 Document: 97 Page: 32 Filed: 07/01/2020
2 IMMUNEX CORP. v. SANDOZ, INC.
Roche 1, the licensor of the patents-in-suit, and Immunex,
the exclusive licensee. Because I interpret the 2004 Accord
& Satisfaction as an effective assignment of the patents-in-
suit to Immunex, I would hold that Immunex is a common
owner for obviousness-type double patenting purposes. I
would also hold that Immunex’s patents-in-suit are invalid
for obviousness-type double patenting in view of Im-
munex’s previously issued U.S. Patent No. 7,915,225 (“the
’225 patent”) under the one-way test. For this reason and
the reasons discussed below, I respectfully dissent.
I also provide additional views concerning the applica-
bility of the one-way test for ODP purposes.
I. Common Ownership
Obviousness-type double-patenting (“ODP”) is a judi-
cially created doctrine designed to prevent a party from ex-
tending its right to exclude through claims in a later-filed
patent that are patentably indistinct from claims in a com-
monly-owned earlier filed patent. In re Longi, 759 F.2d
887, 892 (Fed. Cir. 1985). A preliminary step for determin-
ing whether the doctrine of ODP applies is whether the pa-
tents at issue are commonly owned. See Eli Lilly & Co. v.
Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 2001); see also
Longi, 759 F.2d at 895. The parties dispute whether ap-
pellee Immunex is a common owner of the patents-in-suit
such that the doctrine of ODP would be triggered.
Here, the majority accepts appellant Sandoz’s novel
theory that the “all substantial rights” test from the Sec-
tion 281 context can be used to determine common owner-
ship for ODP purposes. Maj. Op. at 11. Specifically, the
majority explains that:
1 Roche was a party in the district court litigation
but has not entered its appearance in this appeal.
Case: 20-1037 Document: 97 Page: 33 Filed: 07/01/2020
IMMUNEX CORP. v. SANDOZ, INC. 3
[w]here, as here, [Immunex] ultimately controls
prosecution of both sets of patents, the “all substan-
tial rights” test aids in preventing the unjustifiable
issuance of claims that are patentably indistinct
from claims already owned by that party. Under
these circumstances, looking to the “all substantial
rights” test achieves the proper balance between
deterring gamesmanship in prosecution, on the one
hand, and avoiding any chilling effect on routine
collaborations and licensing between parties work-
ing in the same field of research, on the other.
Id. at 14–15 (emphasis added).
While I commend the majority for adopting the “all sub-
stantial rights” test, the majority’s adoption of that test
was for naught. In applying the test, the majority permits
the type of gamesmanship it sought to prevent—games-
manship in prosecution which could result in unjustified
extension of patent rights. Here, under the 2004 Accord &
Satisfaction, Roche transferred to Immunex the sole right
to control prosecution, an exclusive license, the absolute
right to exclude Roche from commercializing the claimed
inventions, the first right to sue, and the right to nullify
any Roche-initiated suit by issuing a royalty-free license.
Specifically, Immunex’s sole right to control prosecution is
significant in the ODP context, since the doctrine of ODP
is meant to prevent applicants from receiving patents that
extend the life of their existing patents. See In re Hubbell,
709 F.3d 1140, 1145 (Fed. Cir. 2013). The facts here reveal
why.
When under Roche’s control for almost ten years, the
applications from which the patents-in-suit issued did not
claim the etanercept fusion protein, but rather a different
fusion protein and a mutated version of etanercept. How-
ever, once Immunex retained control of prosecution, Im-
munex amended the applications to claim etanercept,
which Immunex itself had claimed in its own patents and
Case: 20-1037 Document: 97 Page: 34 Filed: 07/01/2020
4 IMMUNEX CORP. v. SANDOZ, INC.
which was an active ingredient in Immunex’s Enbrel®
product. Thus, thanks to its prosecution efforts, Immunex
has effectively extended to 2029 its right to exclude public
use of the etanercept fusion protein via the patents-in-suit
(which Immunex effectively owns in all material respects).
Given this backdrop, I would hold that Immunex effectively
owns the patents-in-suit for ODP purposes.
The majority, however, reasons that Roche remains the
true owner for ODP purposes because under the 2004 Ac-
cord & Satisfaction, Roche retained a secondary right to
sue and a right to veto an Immunex-initiated assignment.
See Maj. Op. at 18–20. However, as explained below,
Roche’s retained rights are illusory, and, thus, do not inter-
fere with Immunex’s control to practice and enforce the pa-
tents-in-suit.
“[L]abels given by the parties do not control” the all-sub-
stantial-rights inquiry. A123 Sys., Inc. v. Hyrdo-Quebec,
626 F.3d 1213, 1218 (Fed. Cir. 2010). Rather, the court
looks to the “substance” of the written agreement “rather
than formalities or magic words.” Lone Star Silicon Inno-
vations LLC v. Nanya Tech. Corp., 925 F.3d 1225, 1229
(Fed. Cir. 2019). Specifically, if the licensor’s only remain-
ing rights in the patents-in-suit are “illusory,” then the li-
censor has effectively transferred all substantial rights to
the licensee. See Speedplay, Inc. v. Bebop, Inc., 211 F.3d
1245, 1251 (Fed. Cir. 2000). A licensor’s right is illusory if
it “would not hinder [the licensee’s] enjoyment of the patent
rights in any meaningful way.” Id. In other words, the li-
censor’s right is illusory for ownership purposes if it does
not meaningfully interfere with the licensee’s control and
enforcement of the patents at issue. See id.
Here, Roche’s two retained rights, i.e., a secondary right
to sue and a right to veto an Immunex-initiated assign-
ment, are illusory because these rights do not prevent Im-
munex from enjoying the patents-in-suit in any meaningful
way. Id. Specifically, pursuant to the 2004 Accord &
Case: 20-1037 Document: 97 Page: 35 Filed: 07/01/2020
IMMUNEX CORP. v. SANDOZ, INC. 5
Satisfaction, Immunex can at any time nullify Roche’s
rights by ordering Roche to assign the patents-in-suit to
Immunex upon payment of $50,000. J.A. 25840. Once Im-
munex forces Roche’s hand, Roche has no choice but to as-
sign the patents-in-suit to Immunex, leaving Roche with no
rights at all. Id. (“If requested . . . Roche shall execute
an assignment of [the patents].” (emphasis added)). Roche
cannot terminate this arrangement for any reason.
J.A. 25848 (“Roche will have no right to terminate this [Ac-
cord & Satisfaction] for any reason.”). Thus, if Immunex
disagrees with Roche’s decision to initiate suit or Roche’s
decision to veto an assignment, Immunex can undo Roche’s
decisions by simply obtaining official ownership of the pa-
tents-in-suit.
Additionally, the record shows that Immunex’s pay-
ment of $50,000 to Roche does not meaningfully hinder Im-
munex’s enjoyment of the patents-in-suit but rather is a
self-executing formality. First, the evidence shows Roche
did not value its retained rights. During negotiations for
Immunex’s “license,” Roche was willing to formally assign
the patents-in-suit at no additional cost. Specifically,
Roche’s former Senior Counsel, who drafted and negotiated
the Roche-Immunex 2004 Accord & Satisfaction on behalf
of Roche, testified that “Roche wouldn’t have had a problem
if [Immunex] had asked for an assignment [and] not to
charge them the $50,000 from day one.” J.A. 28335. Yet,
Roche included the $50,000 clause at the insistence of Im-
munex. Second, that Immunex would have to pay Roche
$50,000 is not a meaningful hinderance to Immunex’s en-
joyment of the patents-in-suit. Speedplay, 211 F.3d at
1251. The record shows that $50,000 is a de minimis
amount for Immunex. Consider that Immunex paid ap-
proximately $45 million for its alleged “license.” Addition-
ally, etanercept, the fusion protein claimed by the patents-
in-suit, earned $1.9 billion in revenue in 2004, the year Im-
munex received its “license.” Thus, it is unreasonable to
Case: 20-1037 Document: 97 Page: 36 Filed: 07/01/2020
6 IMMUNEX CORP. v. SANDOZ, INC.
conclude that $50,000 represents a meaningful hinderance
to Immunex’s effective ownership over the patents-in-suit.
Roche’s secondary right to sue is rendered illusory for
an additional, separate reason. Pursuant to the 2004 Ac-
cord & Satisfaction, Roche’s “right” to commence a civil ac-
tion for infringement is subject to Immunex’s approval.
Specifically, under Section 3.6 of the 2004 Accord & Satis-
faction, Roche must notify Immunex of any infringement in
a written request. Under Sections 3.1 and 3.5, Immunex
may nullify Roche’s right to sue by issuing a royalty-free
sublicense to the alleged infringer. The sleight of hand
here is that Immunex retains full control over whether
Roche can initiate suit. To stop Roche from pursuing an
infringement action, Immunex need only issue a royalty-
free sublicense. See Speedplay, 211 F.3d at 1251 (noting
that the licensor’s secondary right to sue was “illusory” be-
cause the licensee “can render [it] nugatory by granting the
alleged infringer a royalty-free sublicense”). Thus, “[e]ven
though [Roche] retained the right to sue, that right would
not hinder [Immunex’s] enjoyment of the patent rights in
any meaningful way.” Id.
The majority reasons that Immunex’s sublicensing
right does not render Roche’s secondary right to sue illu-
sory. See Maj. Op. at 19–20. The majority’s sole reason for
concluding as much is that this case is different from
Speedplay. The majority notes that Speedplay “held that a
licensee’s right to grant royalty-free sublicenses to defend-
ants sued by the licensor rendered illusory the licensor’s
right to sue.” Id. (quoting Alfred E. Mann Found. for Sci.
Research v. Cochlear Corp., 604 F.3d 1354, 1362 (Fed. Cir.
2010)) (emphasis in majority opinion). 2 The majority
2 The majority asserts that the dissent “fails to ac-
count” for the decision in Alfred E. Mann, “where we ex-
plained that the holding in Speedplay turned on the
Case: 20-1037 Document: 97 Page: 37 Filed: 07/01/2020
IMMUNEX CORP. v. SANDOZ, INC. 7
reasons that Speedplay does not apply because Immunex
cannot issue a sublicense once Roche initiates suit, unlike
the Speedplay licensee. Id.
That the Speedplay licensee could issue a sublicense
post-suit does not render Roche’s secondary right to sue
any less illusory. The focus of the Speedplay inquiry is
whether a licensee can nullify a licensor’s secondary right
to sue, pre- or post-suit. See Speedplay, 211 F.3d at 1251
(making no distinction as to the timing of issuance of a roy-
alty-free sublicense); see also Lone Star, 925 F.3d at 1231;
AsymmetRx, Inc. v. Biocare Med., LLC, 582 F.3d 1314, 1320
(Fed. Cir. 2009); Intellectual Prop. Dev., Inc. v. TCI Cablevi-
sion of Cal., Inc., 248 F.3d 1333, 1343 (Fed. Cir. 2001).
Here, Immunex can issue a royalty-free sublicense within
180 days of receiving Roche’s written request to correct in-
fringement and can thus prevent Roche’s secondary right
to sue from even vesting. If Roche ultimately sues, it is
only because Immunex allowed Roche to do so. As in
licensee’s ability to frustrate a licensor-initiated suit.” Maj.
Op. at 20. I respectfully disagree. The majority reads Al-
fred E. Mann too narrowly. In Alfred E. Mann, we
acknowledged the Speedplay licensee’s “ability to settle li-
censor-initiated litigation by granting royalty-free subli-
censes to the accused infringers.” Alfred E. Mann, 604 F.3d
at 1361. However, like in Speedplay, we did not hold that
a secondary right to sue is rendered illusory only when a
licensee can issue a royalty-free sublicense post-suit. Ra-
ther, we explained that the illusory inquiry should be flex-
ible, looking broadly to the “nature and scope of the
licensor’s retained right to sue.” Id. Contrary to the ma-
jority opinion, the key inquiry here should be whether a li-
censee can issue a royalty-free sublicense, regardless of
whether the sublicense issued pre- or post-suit. For once
the licensee issues this unfettered sublicense, the licensee
nullifies the licensor’s secondary right to sue.
Case: 20-1037 Document: 97 Page: 38 Filed: 07/01/2020
8 IMMUNEX CORP. v. SANDOZ, INC.
Speedplay, Roche’s secondary right to sue is subject to neu-
tralization and thus illusory. Speedplay, 211 F.3d at 1251.
In sum, because Roche’s two retained rights in the pa-
tents-in-suit are illusory, I would hold that Immunex
owned the patents-in-suit for ODP purposes.
II. Additional Views
Although the majority does not reach this issue, I
briefly address the second prong to the ODP inquiry—
whether the patents-in-suit are patentably indistinct from
Immunex’s previously issued ’225 patent. Here, the dis-
trict court alternatively determined that the doctrine of
ODP does not apply because the patents-in-suit were pa-
tentably distinct from Immunex’s previously issued ’225
patent under the “two-way” test. I would hold that the dis-
trict court legally erred in applying the “two-way” test ra-
ther than the “one-way” test.
The “two-way” test is a “narrow exception to the gen-
eral rule of the one-way test,” and it is only appropriate
“where (1) a second-filed application issues prior to a first-
filed application, and (2) the PTO is solely responsible for
the delay in the issuance of the first-filed application.” In
re Janssen Biotech, Inc., 880 F.3d 1315, 1325 (Fed. Cir.
2018) (internal quotation marks omitted) (emphasis
added); see also In re Basell Poliolefine Italia S.P.A., 547
F.3d 1371, 1376 (Fed. Cir. 2008) (noting that the two-way
test is appropriate in “the unusual circumstance that the
PTO is solely responsible for the delay” (emphasis added)).
Whether the one-way test or two-way test applies is a ques-
tion of law. See In re Emert, 124 F.3d 1458, 1460 (Fed. Cir.
1997).
Here, the district court noted that both the PTO and
Roche/Immunex contributed to the delay in prosecution of
the patents-in-suit yet concluded that the PTO was “solely
responsible” for the delay. This was legal error. Our case
law is clear that if the applicant’s “actions, or inactions, had
Case: 20-1037 Document: 97 Page: 39 Filed: 07/01/2020
IMMUNEX CORP. v. SANDOZ, INC. 9
a direct effect on the prosecution,” the PTO is not “solely”
responsible for the delay, and, thus, the “two-way test . . .
does not apply.” In re Basell, 547 F.3d at 1376; see also In
re Fallaux, 564 F.3d 1313, 1316 (Fed. Cir. 2009); Eli Lilly,
251 F.3d at 968 n.7; In re Emert, 124 F.3d at 1461. Thus,
both Roche’s and Immunex’s contribution to the delay in
prosecution—mainly, their requests for extensions and
Roche’s delay in filing the etanercept claims during prose-
cution of the patents-in-suit—should have, as a matter of
law, triggered the application of the one-way test. See In
re Basell, 547 F.3d at 1376; see also Eli Lilly, 251 F.3d at
968 n.7.
There is no serious dispute that under the one-way
test—which asks whether the asserted patent claim is ob-
vious over or anticipated by the earlier-issued patent claim,
see In re Hubbell, 709 F.3d at 1149—Immunex’s patents-
in-suit are patentably indistinct from Immunex’s ’225 pa-
tent. Thus, Immunex’s patents-in-suit are invalid for ODP
in view of Immunex’s ’225 patent.
I respectfully dissent.