AbbVie Inc. v. Mathilda & Terrance Kennedy Institute of Rheumatology Trust

United States Court of Appeals
for the Federal Circuit
______________________
ABBVIE INC. AND
ABBVIE BIOTECHNOLOGY LIMITED,
Plaintiffs-Appellees,
v.
THE MATHILDA AND TERENCE KENNEDY
INSTITUTE OF RHEUMATOLOGY TRUST,
Defendant-Appellant.
______________________
2013-1545
______________________
Appeal from the United States District Court for the
Southern District of New York in No. 11-CV-2541, Judge
Paul A. Crotty.
______________________
Decided: August 21, 2014
______________________
MARK A. PERRY, Gibson, Dunn & Crutcher LLP, of
Washington, DC, argued for defendant-appellant. With
him on the brief were WAYNE M. BARSKY and TIMOTHY P.
BEST, of Los Angeles, California. Of counsel on the brief
were JOHN P. WHITE, NORMAN H. ZIVIN and ROBERT T.
MALDONADO, Cooper & Dunham LLP, of New York, New
York.
MICHAEL A. MORIN, Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP, of Washington, DC, argued for
2 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
plaintiffs-appellees. With him on the brief were DAVID P.
FRAZIER, CASEY L. DWYER and CORA R. HOLT.
______________________
Before DYK, WALLACH, and CHEN, Circuit Judges.
DYK, Circuit Judge.
The Mathilda and Terrance Kennedy Institute of
Rheumatology Trust (Kennedy) owns U.S. Patent Nos.
7,846,442 (the ’442 patent) and 6,270,766 (the ’766 pa-
tent). Both patents are directed towards methods of
treating rheumatoid arthritis by co-administering two
drugs. AbbVie, Inc. and AbbVie Biotechnology Ltd. (collec-
tively, AbbVie) are licensees of the ’766 patent but not the
’442 patent. In 2011, AbbVie sued Kennedy in the South-
ern District of New York for a declaratory judgment that
the ’442 patent was invalid under the doctrine of obvious-
ness-type double patenting because the ’442 patent was
not patentably distinct from the ’766 patent. We agree
with AbbVie that the ’442 patent would have been obvious
in light of the ’766 patent. Accordingly, we affirm the
district court’s finding of invalidity.
BACKGROUND
Rheumatoid arthritis is an autoimmune disease that
causes painful joint inflammation. If left untreated, this
disease can result in bone destruction and lead to poten-
tially life-threatening complications. Although there is no
cure for rheumatoid arthritis, scientists have developed a
number of treatments that help abate this disease. The
patents at issue in this appeal cover a very popular and
effective treatment for rheumatoid arthritis: combination
therapy of a disease-modifying antirheumatic drug and an
antibody.
Kennedy secured two patents on this combination
therapy—the ’766 and ’442 patents. The first (the ’766
patent) expired on October 8, 2012, while the second (the
ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 3
’422 patent) does not expire until August 21, 2018. The
question here is whether the ’442 patent is invalid for
obviousness-type double patenting. Some background of
the two patents is essential to understanding the double
patenting issue.
Prior to the advent of this combination therapy, pa-
tients were treated with disease-modifying antirheumatic
drugs, such as methotrexate. However, in the 1980s,
researchers began to study the use of antibodies in the
treatment of rheumatoid arthritis. Antibodies are the
proteins that the immune system uses to identify and
neutralize foreign bodies such as viruses and bacteria.
During this period, the named inventors of the ’766 and
’422 patents discovered that a protein called Tumor
Necrosis Factor Alpha (TNFα) is partially responsible for
the inflammation rheumatoid arthritis causes. This
discovery led the inventors to research antibodies that
block the TNFα protein. In September 1994, the inventors
began a study of rheumatoid arthritis patients whose
disease had not responded completely to treatment with
methotrexate. The inventors gave those patients an anti-
TNFα antibody, either alone or in combination with
methotrexate treatment. This study, known as the T-14
study, formed the basis of the ’766 and ’442 patents and
demonstrated the utility of the method claimed in the
patents. The T-14 study revealed that rheumatoid arthri-
tis patients better responded to anti-TNFα antibodies
when they were administered in conjunction with metho-
trexate as compared to the response observed when either
of the drugs was administered alone.
Titled “Anti-TNF Antibodies and Methotrexate in the
Treatment of Arthritis and Crohn’s Disease,” the ’766
patent application was filed on August 1, 1996, and
claimed priority to a date of October 8, 1992. The specifi-
cation clarifies that the invention
4 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
is also based on the unexpected and dramatic dis-
covery that a multiple dose regimen of . . . an [an-
ti-TNF] antibody, when administered adjunctively
with methotrexate to an individual suffering from
a TNF-mediated disease[,] produces a highly ben-
eficial or synergistic clinical response for a signifi-
cantly longer duration compared to that obtained
with a single or multiple dose regimen of the an-
tagonist administered alone or that obtained with
methotrexate administered alone.
’766 Patent col. 2 ll. 39-48 (emphases added).
The ’766 patent then claims a method of co-
administering the anti-TNFα antibody and methotrexate.
Independent claim 8 is representative: “A method of
treating rheumatoid arthritis in an individual in need
thereof comprising co-administering methotrexate and an
[anti-TNFα] antibody or an antigen-binding fragment
thereof to the individual, in therapeutically effective
amounts.” ’766 Patent col. 35 ll. 59-63.
Claims 9 through 14 depend, either directly or indi-
rectly, on claim 8, adding additional limitations to the
method of treating rheumatoid arthritis set forth in claim
8. ’766 Patent col. 35 l. 64 to col. 36 l. 51. For example,
claim 9 recites “[a] method of claim 8 wherein the [anti-
TNFα] antibody or antigen-binding fragment is adminis-
tered in a series of doses separated by intervals of days or
weeks.” ’766 Patent col. 35 ll. 64-67. The ’766 patent
issued on August 7, 2001, and expired on October 8, 2012.
After the issuance of the ’766 patent, the inventors ob-
tained a second patent, the ’442 patent, on the method of
treatment described therein. Although Kennedy admits
that the claims of the ’442 patent are encompassed by
those of the ’766 patent, Kennedy argued that the claims
of the ’442 patent were separately patentable.
ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 5
The ’442 patent application was filed on September
12, 2005, and claimed priority to the date the ’766 patent
was filed: August 1, 1996. The specification of the ’442
patent is identical to that of the ’766 patent. Independent
claim 1 of the ’442 patent is representative:
1. A method of treating an individual suffering
from rheumatoid arthritis whose active disease is
incompletely controlled despite already receiving
methotrexate comprising adjunctively administer-
ing with methotrexate therapy a different compo-
sition comprising an anti-human [TNFα] antibody
or a human [TNFα] binding fragment thereof to
the individual, wherein the anti-human [TNFα] or
fragment thereof (a) binds to an epitope on human
[TNFα], (b) inhibits binding of human [TNFα] to
human [TNFα] cell surface receptors and (c) is
administered at a dosage of 0.01-100 mg/kg, and
wherein such administration reduces or elimi-
nates signs and symptoms associated with rheu-
matoid arthritis.
’442 Patent col. 35 ll. 2-15. The remaining claims are
similar. Unlike the ’766 patent, which is directed towards
all “individual[s] in need” of rheumatoid arthritis treat-
ment, ’766 Patent col. 35 ll. 35-36, the ’442 patent claims
treatment of a more specific patient group: individuals
with “active disease.” ’442 Patent col. 35 l. 3. The claim
language is also different in that the ’442 patent refer-
ences “adjunctively administering” the two drugs, ’442
Patent col. 35 l. 5, whereas the ’766 patent refers to “co-
administering” the two drugs. ’766 Patent col. 35 l. 36.
The ’442 patent issued on December 7, 2010, and expires
on August 21, 2018—six years after the expiration of the
’766 patent. Both the ’766 and ’442 patents were assigned
to Kennedy.
6 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
On December 23, 2002, AbbVie 1 sought and obtained
a license to the ’766 patent. Thereafter, AbbVie obtained
FDA approval to sell Humira, an anti-TNFα antibody, for
use either alone or in combination with methotrexate to
treat rheumatoid arthritis. AbbVie paid Kennedy over
$100 million in royalties for AbbVie’s sale of Humira in
the United States. Once the ’442 patent issued in 2010,
Kennedy demanded that AbbVie secure an additional
license for that patent in order to continue sales of Humi-
ra.
Unwilling to pay further royalties for the right to sell
the same product, AbbVie filed this action in the district
court on April 13, 2011. AbbVie sought a declaratory
judgment that claims of the ’442 patent were invalid over
the ’766 patent for obviousness-type double patenting.
After a bench trial, the district court ruled that claims 1-
7, 13, 14, and 17-20 of the ’442 patent (all of the claims
that are the subject of the declaratory judgment action)
were invalid over claims 8-14 of the ’766 patent. While
Kennedy conceded that the ’766 patent encompasses the
same inventive subject matter as the ’442 patent (i.e., that
the ’766 patent is a dominant patent), Kennedy contended
that the ’442 patent was nonetheless patentable over the
’766 patent. Kennedy argued that the ’766 patent claims a
“broad genus” of methods for treating rheumatoid arthri-
tis, whereas the ’442 patent claims a “narrower species” of
those treatment methods with unexpected results. Appel-
lant’s Br. 4.
As the first step of the obviousness-type double pa-
tenting inquiry, the district court construed the claims of
the patents and rejected Kennedy’s proposed construc-
1 AbbVie was previously known as Abbott Biotech-
nology Ltd. and then AbbVie Biotechnology Ltd. For
simplicity, we refer to this party as AbbVie.
ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 7
tions of the terms “co-administering,” as it is used in the
’766 patent, and “active disease,” as it is used in the ’442
patent. Kennedy argued that the word “co-administering”
should be construed to cover not only the administration
of methotrexate and the antibody together, but also a
scenario in which a patient receives methotrexate alone,
is taken off methotrexate, and then receives the antibody
alone. The district court rejected Kennedy’s proposed
claim construction and instead construed the term “co-
administering” as follows:
a person of ordinary skill in the art would under-
stand “co-administration” . . . to encompass three
possibilities for the order of administration of the
methotrexate and anti-TNFα antibody . . . : (1)
treatment with methotrexate and antibody is
started at approximately the same time (“concom-
itantly”); (2) treatment with methotrexate is be-
gun first and treatment with antibody is then
added (“adjunctively”) to ongoing and continuing
methotrexate treatment; or (3) treatment with an-
tibody is begun first and treatment with metho-
trexate is then added (“adjunctively”) to ongoing
and continuing antibody treatment.
J.A. 85-86 ¶ 317. The court then construed the word
“adjunctively,” as it is used in the ’442 patent, “to mean a
method of administration of methotrexate and an anti-
TNFα antibody in which therapy with an anti-TNFα
antibody (or fragment thereof) is added to ongoing metho-
trexate treatment.” J.A. 91 ¶ 338. Thus, the district court
found that the ’442 patent’s “adjunctive” administration is
one of the three forms of “co-administration” covered by
the ’766 patent.
The district court also rejected Kennedy’s proposed
construction of the phrase “active disease.” Kennedy
advocated that “active disease,” as used in the ’442 pa-
tent, should be limited to particularly sick patients. The
8 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
district court rejected Kennedy’s restricted definition and
construed the term to reach all patients suffering from
rheumatoid arthritis and requiring treatment.
After construing the disputed claim terms of the ’766
and ’442 patents, the district court turned to the next step
of the obviousness-type double patenting inquiry and
compared the claims of the two patents. With respect to
the terms “co-administration” and “adjunctive,” the court
found that “[i]n light of the limited universe of treatment
methods within the genus of co-administration defined by
claims 8 through 14 of the ’766 patent, a person of ordi-
nary skill in the art would have envisaged the species of
adjunctive administration defined by claims 1 and 2 of the
’442 patent.” J.A. 93 ¶ 349. Regarding the phrase “active
disease” the court found that “a person of ordinary skill in
the art would not consider there to be a substantial differ-
ence between the patient populations identified by claim 8
of the ’766 patent and claim 1 of the ’442 patent.” J.A. 95
¶ 354. As a result, the district court found that the ’442
patent covered the exact same invention as the ’766
patent and held that asserted claims of the ’442 patent
were invalid over the asserted claims of the ’766 patent
for obviousness-type double patenting. The district court
entered a partial final judgment pursuant to Rule 54(b) in
favor of AbbVie, and Kennedy appealed. Fed. R. Civ. P.
54(b).
We have jurisdiction pursuant to 28 U.S.C. §§ 1292(c)
and 1295(a)(1). Invalidity must be proven by clear and
convincing evidence. Microsoft Corp. v. i4i Ltd. P’Ship,
131 S. Ct. 2238, 2242 (2011); McGinley v. Franklin Sports,
Inc., 262 F.3d 1339, 1349 (Fed. Cir. 2001). While the
ultimate conclusion that a patent is invalid under the
doctrine of obviousness-type double patenting is reviewed
de novo, the underlying factual determinations—
including the existence of secondary factors such as
unexpected results—are reviewed for clear error. Eli Lilly
ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 9
& Co. v. Teva Parenteral Meds., Inc., 689 F.3d 1368, 1376
(Fed. Cir. 2012). Claim construction is a question of law
that we review de novo. Lighting Ballast Control LLC v.
Philips Elecs. N. Am. Corp., 744 F.3d 1272, 1286 (Fed.
Cir. 2014) (en banc); Cybor Corp. v. FAS Techs., Inc., 138
F.3d 1448, 1454-55 (Fed. Cir. 1998) (en banc).
DISCUSSION
I
While often described as a court-created doctrine, ob-
viousness-type double patenting is grounded in the text of
the Patent Act. See In re Longi, 759 F.2d 887, 892 (Fed.
Cir. 1985); see also Boehringer Ingelheim Int’l GmbH v.
Barr Labs., Inc., 592 F.3d 1340, 1346 (Fed. Cir. 2010); Eli
Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 967 (Fed.
Cir. 2001). Section 101 reads: “Whoever invents or discov-
ers any new and useful process, machine, manufacture, or
composition of matter, . . . may obtain a patent therefor.”
35 U.S.C. § 101 (emphasis added). Thus, § 101 forbids an
individual from obtaining more than one patent on the
same invention, i.e., double patenting. As this court has
explained, “a rejection based upon double patenting of the
obviousness type” is “grounded in public policy (a policy
reflected in the patent statute).” Longi, 759 F.2d at 892(emphasis removed).
The courts have recognized this principle since the in-
ception of our patent laws. In 1819, Justice Story ex-
plained,
It cannot be, that a patentee can have in use at
the same time two valid patents for the same in-
vention; and if he can successively take out at dif-
ferent times new patents for the same invention,
he may perpetuate his exclusive right during a
century . . . . If this proceeding could obtain coun-
tenance, it would completely destroy the whole
consideration derived by the public for the grant
10 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
of the patent, [] the right to use the invention at
the expiration of the term specified in the original
grant.
Odiorne v. Amesbury Nail Factory, 18 F. Cas. 578, 579
(C.C.D. Mass. 1819). The Supreme Court has reaffirmed
the prohibition on double patenting on multiple occasions.
See Singer Mfg. Co. v. June Mfg. Co., 163 U.S. 169, 185
(1896) (“It is self-evident that on the expiration of a
patent the monopoly created by it ceases to exist, and the
right to make the thing formerly covered by the patent
becomes public property. It is upon this condition that the
patent is granted.”); Miller v. Eagle Mfg. Co., 151 U.S.
186, 197-98 (1894); Suffolk Co. v. Hayden, 70 U.S. (3
Wall.) 315, 319 (1865). As this court recently reminded,
“[t]he bar against double patenting was created to pre-
serve that bargained-for right held by the public.” Gilead
Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1212
(Fed. Cir. 2014); see also Boehringer, 592 F.3d at 1346;
Longi, 759 F.2d at 892; In re Robeson, 331 F.2d 610, 614
(CCPA 1964). The ban on double patenting ensures that
the public gets the benefit of the invention after the
original period of monopoly expires.
Despite the “longstanding” recognition of the “prohibi-
tion against double patenting,” Gilead, 753 F.3d at 1212,
Kennedy argues that the statutory and policy rationales
underlying the obviousness-type double patenting doc-
trine no longer exist and the doctrine should be discarded.
More specifically, Kennedy contends that the Uruguay
Round Agreement Act (URAA), Pub. L. 103-465, 108 Stat.
4809, effective June 8, 1995, and its implementation of a
20-year period of patent protection that runs from a
patent’s earliest claimed priority date, eliminated the
need for the obviousness-type double patenting doctrine.
Kennedy views the purpose of this doctrine narrowly:
“The ODP doctrine developed to curb abuses, made possi-
ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 11
ble by continuation practice” wherein “[n]either the Ex-
aminer nor a patent challenger could assert prior art
arising between the filing date of the continuation appli-
cation and an earlier claimed priority date.” Appellant’s
Br. 20. This practice—where “the use of continuation
applications to claim previously disclosed but unclaimed
features of an invention many years after the filing of the
original patent application,” Ricoh Co., Ltd. v. Nashua
Corp., 185 F.3d 884, No. 97-1344, slip op. at *3 n.3 (Fed.
Cir. Feb. 18, 1999)—is known as submarine patenting.
Now that the patent term is measured from the earliest
claimed priority date, as opposed to the date of issuance,
Kennedy contends that the submarine patent problem no
longer exists and that the URAA amendment vitiated the
policy basis for the doctrine of obviousness-type double
patenting.
But this argument ignores another crucial purpose of
the doctrine: It is designed to prevent an inventor from
securing a second, later expiring patent for the same
invention. See Miller, 151 U.S. at 197-98; Singer, 163 U.S.
at 185. That problem still exists. Patents claiming over-
lapping subject matter that were filed at the same time
still can have different patent terms due to examination
delays at the PTO. See 35 U.S.C. § 154(b) (patent term
adjustments); In re Berg, 140 F.3d 1428, 1430 (Fed. Cir.
1998); In re Goodman, 11 F.3d 1046, 1048-49 (Fed. Cir.
1993). So too where, as here, the applicant chooses to file
separate applications for overlapping subject matter and
to claim different priority dates for the applications, the
separate patents will have different expiration dates since
the patent term is measured from the claimed priority
date. 2 When such situations arise, the doctrine of obvi-
2 Here, Kennedy claimed a priority date of October
8, 1992 (the filing date of an earlier application), for the
12 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
ousness-type double patenting ensures that a particular
invention (and obvious variants thereof) does not receive
an undue patent term extension. See Berg, 140 F.3d at
1432, 1435; Goodman, 11 F.3d at 1052-53; In re Braat,
937 F.2d 589, 592 (Fed. Cir. 1991).
Although this court has recognized that the doctrine
of obviousness-type double patenting is less significant in
post-URAA patent disputes, we have also recognized its
continued importance. For example, in In re Fallaux, we
recognized “that the unjustified patent term extension
justification for obviousness-type double patenting” may
have “limited force in . . . many double patenting rejec-
tions today, in no small part because of the change in the
Patent Act from a patent term of seventeen years from
issuance to a term of twenty years from filing.” 564 F.3d
1313, 1318 (Fed. Cir. 2009). 3
’766 patent. For the ’442 patent, Kennedy claimed a later
priority date, August 1, 1996 (the filing date of the appli-
cation that issued as the ’766 patent), so that the ’442
patent would expire after the ’766 patent.
3 See also Boehringer, 592 F.3d at 1346 (“The doc-
trine of obviousness-type double patenting is an im-
portant check on improper extension of patent rights
through the use of divisional and continuation applica-
tions, at least for patents issued from applications filed
prior to the amendment of 35 U.S.C. § 154 to create
twenty-year terms running from the date of the earliest
related application.”); 3A Donald S. Chisum, Chisum on
Patents § 9.01 (“[T]he 1994 Uruguay Round Agreements
Act . . . alters the scenarios raising double patenting
concerns, but it does not alter the fundamental policies
against issuing multiple patents for the same claimed
invention or for obvious variations of the same inven-
tion.”).
ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 13
At the same time, the continued importance of the
doctrine of obviousness-type double patenting where two
patents have different expiration dates was recently
reaffirmed by this court in Gilead. In Gilead, we held that
a later-issued, but earlier-expiring patent could qualify as
a double patenting reference, and thus invalidate an
earlier-issued, but later expiring patent. 753 F.3d at 1217.
Because both the reference and later expiring patents in
Gilead issued after the 1995 URAA amendment, id. at
1209, Gilead implicitly assumed the continued vitality of
the obviousness-type double patenting doctrine. See id. at
1212. We now make explicit what was implicit in Gilead:
the doctrine of obviousness-type double patenting contin-
ues to apply where two patents that claim the same
invention have different expiration dates. We hold that
Kennedy is not entitled to an extra six years of monopoly
solely because it filed a separate application unless the
two inventions are patentably distinct.
II
We now turn to the question of whether the doctrine
applies here. The obviousness-type double patenting
analysis involves two steps: “First, the court ‘construes
the claim[s] in the earlier patent and the claim[s] in the
later patent and determines the differences.’ Second, the
court ‘determines whether those differences render the
claims patentably distinct.’” Sun Pharm. Indus., Ltd. v.
Eli Lilly & Co., 611 F.3d 1381, 1385 (Fed. Cir. 2010)
(alteration in original) (quoting Pfizer, Inc. v. Teva
Pharm. USA, Inc., 518 F.3d 1353, 1363 (Fed. Cir. 2008)).
“‘A later claim that is not patentably distinct from,’ i.e., ‘is
obvious over[ ] or anticipated by,’ an earlier claim is
invalid for obviousness-type double patenting.” Id. at 1385(alteration in original) (quoting Eli Lilly, 251 F.3d at 968).
14 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
A. Claim Construction
1. Co-Administration
We begin with Kennedy’s claim construction argu-
ments. Through claim construction, Kennedy attempts to
enlarge the scope of the ’766 patent while narrowing that
of the ’442 patent. First, Kennedy urges that the district
court erred in limiting the term “co-administering” 4 in the
’766 patent to three modes of administration. The district
court construed “co-administering” to mean that treat-
ment with the antibody can be: (1) started at approxi-
mately the same time as treatment with methotrexate
(concomitant administration); (2) added after treatment
with the methotrexate has already begun (adjunctive
administration); or (3) begun first, with the methotrexate
treatment later added (adjunctive administration). Ken-
nedy argues that this definition erroneously excludes a
fourth form of co-administration: administration of the
antibody alone after discontinuing the administration of
methotrexate.
The ’766 patent’s specification confirms the correct-
ness of the district court’s claim construction. The specifi-
cation never uses the term “co-administering” to refer to
patients who only received the antibody after discontinu-
ing treatment with methotrexate. The specification makes
clear that the invention described in the claims is limited
to concomitant and adjunctive use. The specification
outlines several possible modes of co-administration:
“TNF antagonists can be administered prior to, simulta-
4 Claim 8 of the ’766 patent reads: “A method of
treating rheumatoid arthritis in an individual in need
thereof comprising co-administering methotrexate and an
[anti-TNFα] antibody or an antigen-binding fragment
thereof to the individual, in therapeutically effective
amounts.” ’766 Patent col. 35 ll. 59-63.
ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 15
neously with (in the same or different compositions) or
sequentially with the administration of methotrexate. For
example, TNF antagonists can be administered as adjunc-
tive and/or concomitant therapy to methotrexate thera-
py.” ’766 Patent col. 18 ll. 58-62. “Concomitant” therapy
involves starting the two drugs at the same time and then
continuing their administration together; “adjunctive”
therapy involves starting one of the drugs after the other
and then continuing their administration together. The
specification concludes that “[t]he present invention
relates to the discovery that tumor necrosis factor antag-
onists can be administered to patients suffering from a
TNF-mediated disease as adjunctive and/or concomitant
therapy to methotrexate therapy, with good to excellent
alleviation of the signs and symptoms of the disease.” ’766
Patent col. 4 ll. 31-36. This discussion in the specification
shows that “co-administering” encompasses treatment
with the antibody that can be started before, after, or at
the same time as treatment with methotrexate, as long as
two drugs are administered together. The specification
nowhere suggests that the invention includes administra-
tion of the antibody alone after discontinuing treatment
with methotrexate.
The specification’s discussion of the three examples it
provides similarly confirms the district court’s claim
construction. None of the examples discusses the discon-
tinuation of methotrexate as a form of co-administration
or as part of the invention. The first example describes
the T-14 study. To qualify for entry into the T-14 study,
patients must have received weekly methotrexate treat-
ment for at least six months. Upon enrollment into the
study, the patients were “stabilized” on a fixed weekly
dose of methotrexate for the first four weeks. After this
first, equalizing month, the patients were organized into
three separate groups that received three different treat-
ment regimens—three different modes of antibody admin-
16 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
istration. The week the patients began to receive the
differing treatment regimens was called “week zero”
because it marked the beginning of the trial period. The
three distinct treatment regimens, or modes of anti-body
administration, were: (1) patients who received metho-
trexate as a tablet and infusions of a placebo instead of
the anti-TNFα antibody (the “control” group), (2) patients
who received methotrexate as a tablet and infusions of the
anti-TNFα antibody throughout the trial (“MTX+” group),
and (3) patients who received a placebo tablet instead of
methotrexate and infusions of the anti-TNFα antibody
throughout the trial (the “anti-TNFα antibody alone” or
“MTX-” group). In the T-14 study, as in the specification’s
other examples, the therapy that the non-placebo, non-
control patients received was “adjunctive” co-
administration. 5 The specification discusses the MTX-
treatment group and recognized that this group manifest-
ed some limited benefits as compared to the MTX+
group, 6 but never suggests that this group received the
5 In other words, the antibody treatment was added
onto the methotrexate therapy: the patients were already
receiving methotrexate and then began taking the anti-
body in addition. None of the examples discusses a sce-
nario in which patient received “concomitant” co-
administration—where treatment with methotrexate and
the antibody are begun at the exact same time. Neverthe-
less, the specifications of the ’766 patent and ’442 patent
discuss concomitant administration of the two drugs as a
type of “co-administration.”
6 At trial, multiple experts attributed this result to
a “carry-over” effect that the patients’ prior treatment
with methotrexate caused. All the patients in the T-14
study had received weekly methotrexate for at least six
months prior to the trial and were then “stabilized” on a
ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 17
adjunctive or concomitant therapy that is within the
invention of the ’766 patent’s claims.
To the contrary, the specification of the ’766 patent
points to the outcomes experienced by the MTX+ group,
as compared to those the MTX- and control groups experi-
enced, in order to show that “co-administration” produces
“a highly beneficial or synergistic clinical response.” ’766
Patent col. 31 l. 39; see ’766 Patent col. 29 ll. 3-10. It was
only through a comparison of the MTX+ group to the
MTX- group (which the specification refers to as the group
receiving the antibody “without methotrexate,” ’766
Patent col. 29 ll. 8-9) that the specification concludes that
“treatment with a multiple dose regimen of [the antibody]
as adjunctive and/or concomitant therapy to methotrexate
therapy, in [rheumatoid arthritis] patients whose disease
is incompletely controlled by methotrexate, produces a
highly beneficial or synergistic clinical response that can
be sustained through 26 weeks.” ’766 Patent col. 31 ll. 35-
40. Put simply, the specification compares the better
outcomes that the group treated with both drugs experi-
enced to the poorer results obtained in the groups that
received no methotrexate or no antibody after week zero
to support its conclusion that “co-administration”—
administration of both drugs at the same time—is a
superior method of rheumatoid arthritis treatment. Co-
administration cannot include patients who discontinued
methotrexate as Kennedy contends.
fixed weekly dose of methotrexate for the first four weeks
of the study.
The specification does not discuss this carry-over ef-
fect or suggest that the MTX- group received a form of co-
administration. As discussed in the text, the specification
highlights the superior results that the MTX+ group
experienced in order to prove that “co-administration” is a
beneficial therapy.
18 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
Nevertheless, Kennedy argues that the principle of
claim differentiation counsels in favor of reading claim 8
to encompass embodiments where single doses of either
the antibody or methotrexate are delivered to patients.
Claim 8 reads “[a] method of treating rheumatoid arthri-
tis in an individual in need thereof comprising co-
administering methotrexate and an [anti-TNFα] antibody
or an antigen-binding fragment thereof to the individual,
in therapeutically effective amounts,” ’766 Patent col. 35
ll. 59-63, while claim 9 reads “[a] method of claim 8
wherein the [anti-TNFα] antibody or antigen-binding
fragment is administered in a series of doses separated by
intervals of days or weeks.” ’766 Patent col. 35 ll. 64-67
(emphasis added). Kennedy contends that “[a] comparison
of claim 8 to its dependent claim 9 demonstrates that the
only additional limitation is that the anti-TNFα antibody
must be administered ‘in a series of doses separated by
intervals of days or weeks.’” Appellant’s Br. 37. Kennedy
relies on this difference to support its argument that the
administration of the antibody after discontinuation of
methotrexate treatment is covered.
But claim 9 says nothing about the discontinuation of
the methotrexate. Its administration is assumed to be
ongoing with the single or multiple doses of the antibody.
The plain text of the ’766 patent’s specification and claims
supports the district court’s claim construction of “co-
administering.” See also J.A. 86-87 ¶ 319-21 (the district
court also explained that the inventors’ testimony at trial
supported this construction of the term “co-
administering”). Accordingly, the district court correctly
interpreted “co-administration.”
ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 19
2. Active Disease
Kennedy also contests the district court’s construction
of the term “active disease,” as used in the ’442 patent. 7
Kennedy contends that the ’442 patent “explicitly defines”
the term “active disease” to mean “‘the presence of six or
criteria (duration of morning stiffness ≧45 minutes; ≧6
more swollen joints plus at least three of four secondary
(ESR) ≧28 mm/hour; C-reactive protein (CRP) ≧20
tender or painful joints; erythrocyte sedimentation rate
mg/l[)].’” Appellant’s Br. 32 (quoting ’442 Patent col. 20 ll.
35-39). In support of this argument, Kennedy points to
the ’442 patent’s description of the T-14 study’s patient
population:
One hundred one (101) patients . . . who
had . . . active disease (according to the criteria of
the American College of Rheumatology) . . . were
enrolled in the trial. Active disease was defined by
the presence of six or more swollen joints plus at
morning stiffness ≧45 minutes; ≧6 tender or pain-
least three of four secondary criteria (duration of
≧28 mm/hour; C-reactive protein (CRP) ≧20 mg/l.
ful joints; erythrocyte sedimentation rate (ESR)
’442 Patent col. 20 ll. 29-39.
Kennedy relies on the prosecution history of the ’442
patent to support its desired claim construction argument.
The examiner originally rejected the ’442 patent for
indefiniteness, in part, because Kennedy did not suffi-
ciently define the term “active disease.” In its response to
7 Claim 1 of the ’442 patent states: “A method of
treating an individual suffering from rheumatoid arthritis
whose active disease is incompletely controlled despite
already receiving methotrexate . . . .” ’442 Patent col. 35 ll.
2-4.
20 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
the examiner’s rejection, Kennedy stated that “active
disease” is “defined by” the portion of the specification
quoted above referring to the T-14 study. J.A. 5955.
Thereafter, the examiner allowed the ’442 patent’s claims:
“Given that [the] claimed methods are drawn to treat-
ing . . . patients who have already failed to respond to
methotrexate or whose active disease has been incomplete-
ly controlled by previous treatment with methotrexate;
the claimed methods of treating rheumatoid arthritis . . .
due to unexpected results . . . are deemed to be an unobvi-
ous species.” J.A. 6007 (emphasis added). Kennedy argues
that this prosecution history reveals that its more specific
definition of active disease, in accordance with the defini-
tion set forth in the portion of the specification describing
the T-14 study, was critical to the examiner’s allowance of
the ’442 patent claims.
AbbVie, on the other hand, contends that the quoted
portion of the ’442 specification does not provide a single
definition of active disease, but rather sets forth two
definitions. Accordingly, AbbVie argues that the inventors
cannot be viewed as having acted as their own lexicogra-
phers. See Abbott Labs. v. Syntron Bioresearch, Inc., 334
F.3d 1343, 1355 (Fed. Cir. 2003) (“Because the specifica-
tion provides two alternative definitions for the term at
issue, the specification does not define the claim term.”).
Under such circumstances, AbbVie contends that the
standard definition of active disease—“patients with
continuing signs and symptoms of rheumatoid arthritis,”
J.A. 92 ¶ 345—should apply here. This standard defini-
tion includes individuals in need of rheumatoid arthritis
treatment, the definition used in the ’766 patent.
We assume, without deciding, that Kennedy’s pro-
posed construction of “active disease” was correct. The
consequence is the genus claimed in the ’766 patent
(treating all patients in need thereof) is broader than the
species claimed in the ’442 patent (treating patients with
ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 21
“active disease,” i.e., particularly sick patients). Thus,
assuming Kennedy’s construction of the term “active
disease” is correct, we must decide whether a patent that
claims to treat a subset of patients with more severe
rheumatoid arthritis (the ’442 patent) is an obvious
variant of a patent that claims treatment of rheumatoid
arthritis patients generally (the ’766 patent).
B. Obviousness
We thus turn to the second step of the obviousness-
type double patenting analysis: “whether the differences
in subject matter between the claims” of the ’766 and ’442
patents render their claims “patentably distinct” because
the ’442 patent applies to patients with active disease. 8
8 We note that Kennedy does not contend that un-
der the district court’s claim construction of the term “co-
administering,” the ’442 patent is patentably distinct from
the ’766 patent because it claims “adjunctive” therapy
alone. In other words, Kennedy does not contend that the
’442 patent is a separately patentable species of the ’766
patent because it only claims “adjunctive” co-
administration and not “concomitant” co-administration.
Kennedy does contend, however, that the ’442 patent
is non-obvious over the ’766 patent because the ’442
patent claims are narrower than those of the ’766 patent
in that the ’442 patent refers to a reduction in the “signs
and symptoms associated with rheumatoid arthritis.” ’442
Patent col. 35 ll. 13-15. Kennedy asserts that the reduc-
tion in both the “signs and symptoms” of the disease was
an unexpected result. At oral argument, Kennedy ex-
plained that “signs” of the disease are indicators that are
measured in the laboratory, such as inhibition of the
biological activity of TNFα, whereas “symptoms” are
observable patient outcomes, such as a renewed ability to
walk. Kennedy then argued that the claims of the ’766
patent only require a reduction in the signs of the dis-
22 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
Amgen Inc. v. F. Hoffman–La Roche Ltd, 580 F.3d 1340,
1361 (Fed. Cir. 2009); see Eli Lilly & Co., 689 F.3d at
1377; Sun, 611 F.3d at 1385. As we clarified in Eli Lilly
and Amgen, in this respect, the law of obviousness-type
double patenting looks to the law of obviousness general-
ly. As we further explained in Amgen, “[t]his part of the
obviousness-type double patenting analysis is analogous
to an obviousness analysis under 35 U.S.C. § 103.”
Amgen, 580 F.3d at 1361; Eli Lilly, 689 F.3d at 1377; see
also Longi, 759 F.2d at 896. Indeed, Kennedy admits that
“the second step of the [obviousness-type double patent-
ing] analysis is analogous to an inquiry into the obvious-
ness of a claim under 35 U.S.C. § 103.” Appellant’s Br. 44
(citing Longi, 759 F.2d at 892 n.4). Thus, if the later
expiring patent is “merely an obvious variation of an
invention disclosed and claimed in the [reference] patent,”
the later expiring patent is invalid for obviousness-type
double patenting. In re Vogel, 422 F.2d 438, 441 (CCPA
ease—inhibition of the biological activity of the TNFα
protein—whereas the T-14 study shows that the ’442
patent led to a reduction in both the signs and symptoms
of the disease.
Although the ’766 patent may not have specifically
claimed to “reduce[] or eliminate[] [the] signs and symp-
toms associated with rheumatoid arthritis,” ’442 Patent
col. 35 ll. 14-15, the ’766 patent’s specification demon-
strates that this outcome was a known result of the
patent’s claimed method. According to the ’766 patent’s
specification, “[t]he present invention is based on the
discovery that treatment of patients suffering from
[rheumatoid arthritis] with [an anti-TNF antibody] . . . as
adjunctive and/or concomitant therapy to methotrexate
therapy produces a rapid and sustained reduction in the
clinical signs and symptoms of the disease.” ’766 Patent
col. 2 ll. 33-39 (emphases added).
ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 23
1970). But “the nonclaim portion of the earlier patent
ordinarily does not qualify as prior art against the pa-
tentee.” Eli Lilly, 689 F.3d at 1379.
To be sure, obviousness is not demonstrated merely
by showing that an earlier expiring patent dominates a
later expiring patent. Nor do we think that the district
court here relied on any such principle. It is well-settled
that a narrow species can be non-obvious and patent
eligible despite a patent on its genus. See Eli Lilly & Co.
v. Bd. of Regents of Univ. of Wash., 334 F.3d 1264, 1270
(Fed. Cir. 2003); In re Kaplan, 789 F.2d 1574, 1577-78
(Fed. Cir. 1986); In re Sarett, 327 F.2d 1005, 1014 (CCPA
1964); 3A Donald S. Chisum, Chisum on Patents
§ 9.03[2][b][ii].
But not every species of a patented genus is separate-
ly patentable. First, when a “genus is so limited that a
person of ordinary skill in the art can ‘at once envisage
each member of this limited class,’ . . . a reference describ-
ing the genus anticipates every species within the genus.”
In re Gleave, 560 F.3d 1331, 1337-38 (Fed. Cir. 2009)
(quoting Eli Lilly & Co. v. Zenith Goldline Pharms., Inc.,
471 F.3d 1369, 1376 (Fed. Cir. 2006), and citing Perricone
v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir.
2005)); see also Bristol-Myers Squibb Co. v. Ben Venue
Labs., Inc., 246 F.3d 1368, 1380 (Fed. Cir. 2001) (“[T]he
disclosure of a small genus may anticipate the species of
that genus even if the species are not themselves recit-
ed.”). For example, in Pfizer, Inc. v. Apotex, Inc., we inval-
idated a patent on a species belonging to a previously
patented genus. 480 F.3d 1348, 1361 (Fed. Cir. 2007). As
we explained, “this is not the case where there are ‘nu-
merous parameters’ to try.” Id. at 1363. Because prior art
references “provide[d] ample motivation to narrow the [a
previously patented] genus of . . . pharmaceutically-
acceptable anions to a few,” id. at 1366, we concluded that
the species at issue in this case was unpatentable. Id. at
24 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
1372. We clarified that “the outcome of this case need not
rest heavily on the size of the genus . . . disclosed by [a
prior art reference] because clear and convincing evidence
establishes that . . . one of ordinary skill in the art would
have favorably considered [the species patent at issue].”
Id. at 1363. In In re Petering, the court similarly found
that certain species claims were unpatentable over a prior
patent on their genus:
It is our opinion that one skilled in this art would,
on reading the [prior] patent, at once envisage
each member of this limited class, even though
this skilled person might not at once define in his
mind the formal boundaries of the class as we
have done here. . . . [W]e think that one with ordi-
nary skill in this art, with. . . [the reference genus
patent] before him, would also have before him
those subspecies.
301 F.2d 676, 681-82 (CCPA 1962) (emphases added).
Thus, species are unpatentable when prior art disclosures
describe the genus containing those species such that a
person of ordinary skill in the art would be able to envi-
sion every member of the class. Here, we think it is clear
that a reader of the ’766 patent could have easily envi-
sioned a species limited to sicker patients. The district
court was correct in concluding that the species of the ’442
patent was not patentably distinct from the genus of the
’766 patent.
Moreover, even if Kennedy were to show that not eve-
ry species could be envisioned from the ’766 patent’s
genus, Kennedy’s claim of non-obviousness rests on its
contention that the species has unexpected results. A
species contained in a previously patented genus may be
patentable if the species manifests unexpected properties
or produces unexpected results. For example, in Petering,
the court found that a species was patentable in spite of
prior art that claimed its genus because the species had
ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 25
unexpected properties. 301 F.2d at 683. In Pfizer, Inc. v.
Apotex, Inc., on the other hand, we concluded that Pfizer’s
patent was invalid because Pfizer “failed to prove that the
results [associated with the species patent at issue] [we]re
unexpected.” 480 F.3d at 1371. Kennedy’s claim of unex-
pected results is not supported.
In its brief, Kennedy appeared to admit that it was
only able to show that the ’442 patent manifested unex-
pected results if its desired construction of the term “co-
administering” were accepted. 9 However, at oral argu-
ment, Kennedy more broadly asserted that the ’442
patent led to the unexpected result of improving the
health of the “hardest-to-treat patients”—the patients
with “active disease.” We disagree.
To determine whether the ’442 patent is directed to a
species that yielded unexpected results, we must neces-
sarily look to the ’766 patent’s disclosures to assess what
results were expected at the time the ’766 patent applica-
tion was filed. The demonstration of utility of the ’766
patent relies on the T-14 study, the very study that Ken-
nedy now relies on to show that the ’442 patent led to
unexpected results and merits a separate patent. Indeed,
Kennedy’s definition of the term “active disease” is taken
from the T-14 study. The ’766 patent relied on the results
obtained in the T-14 study to demonstrate that a combi-
nation therapy of methotrexate and anti-TNFα antibody
improved the health of the very subset of rheumatoid
9 In its brief, Kennedy explained that “[t]he district
court refused to credit [Kennedy’s evidence of unexpected
results] principally because the court’s construction of ‘co-
administering’ eliminated the results obtained with
the . . . MTX- patients from the analysis, leaving nothing
against which to compare the results of the ’442 pa-
tent’s . . . treatment.” Appellant’s Br. 56; see also id. at 63.
26 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
arthritis patients that Kennedy now contends show that
the method of the ’442 patent led to unexpected results.
Thus, the ’442 patent merely claims the known utility of
the ’766 patent and does not claim a species with unex-
pected results.
However, Kennedy argues that the ’766 patent’s dis-
closures cannot be used to determine whether the results
of the ’442 patent were unexpected because this amounts
to treating the disclosures of the ’766 patent as prior art.
It is true that a reference patent’s specification cannot be
used as prior art in an obviousness-type double patenting
analysis. See Eli Lilly, 689 F.3d at 1378-79; Geneva
Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373,
1385 (Fed. Cir. 2003); Gen. Foods Corp. v. Studiengesell-
schaft Kohle mbH, 972 F.2d 1272, 1280 (Fed. Cir. 1992).
But, it is also well settled that we may look to a reference
patent’s disclosures of utility to determine the question of
obviousness. As our predecessor court concluded, “[i]n
considering the question [of obviousness-type double
patenting], the patent disclosure may not be used as prior
art. This does not mean that the disclosure may not be
used at all. As pointed out above, in certain instances it
may be used . . . as required to answer the . . . question
above.” Vogel, 422 F.2d at 441-42 (internal citations
omitted) (emphasis added). Similarly, in In re Basell
Poliolefine Italia S.P.A., we clarified that “[w]hile . . . it is
impermissible to treat a ‘patent disclosure as though it
were prior art’ in a double patenting inquiry, . . . the
disclosure may be used . . . to answer the question wheth-
er claims merely define an obvious variation of what is
earlier disclosed and claimed.” 547 F.3d 1371, 1378-79
(Fed. Cir. 2008) (quoting Kaplan, 789 F.2d at 1580).
We have repeatedly approved examination of the dis-
closed utility of the invention claimed in an earlier patent
to address the question of obviousness. As we explained in
Geneva Pharmaceutical, Inc. v. GlaxoSmithKline PLC,
ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 27
“[t]he [reference] patent’s claim describes a compound,
and [the reference patent’s] written description discloses a
single utility of that compound . . . . The [later expiring]
patent claims nothing more than [the reference patent’s]
disclosed utility as a method of using the [reference
patent’s] compound. Thus, the claims of the [reference
patent] and [later expiring] patents are not patentably
distinct.” 349 F.3d at 1386. 10
In Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., we
explained that a later expiring patent is not patentably
distinct from an earlier expiring patent if it merely claims
a disclosed utility of the earlier claimed invention.
The claims at issue of the [later expiring] patent
merely recite methods of administering a “thera-
peutically-effective amount” of the compositions
found in claim 5 of the [earlier expiring] pa-
tent. . . . Thus, . . . the [later expiring] patent
merely claims a particular use described in the
[earlier expiring] patent . . . . The asserted claims
of the [later expiring patent] are therefore not pa-
tentably distinct over the claims of the [earlier ex-
piring] patent.
10 In reaching this conclusion, the court confirmed
the policy rationale articulated by our predecessor court
in In re Byck:
It would shock one’s sense of justice if an inventor
could receive a patent upon a composition of mat-
ter, setting out at length in the specification the
useful purposes of such composition, manufacture
and sell it to the public, and then prevent the pub-
lic from making any beneficial use of such product
by securing patents upon each of the uses to
which it may be adapted.
48 F.2d 665, 666 (CCPA 1931).
28 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY
518 F.3d at 1363 (internal footnote omitted). There is no
meaningful distinction between examining the disclosed
utility of an earlier patent to determine the overall ques-
tion of obviousness and looking at the disclosed utility of
an earlier patent to determine whether the utility of the
later patent was unexpected at the time of the earlier
patent. Neither involves improper use of the reference
patent’s specification as prior art.
The ’442 patent does not claim a species manifesting
unexpected results. The ’442 patent would have been
obvious over the ’766 patent.
CONCLUSION
In sum, we conclude that the ’442 patent is invalid for
obviousness-type double patenting in light of the ’766
patent.
AFFIRMED
Costs to appellee.