Court Opinion

ID: 2681554
Source: CourtListenerOpinion
Date Created: 2014-07-01 16:00:38.355607+00
Date Added: 2024-06-11T12:02:24.286093
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
                ______________________

    ABBVIE DEUTSCHLAND GMBH & CO., KG,
    ABBVIE BIORESEARCH CENTER, INC., AND
       ABBVIE BIOTECHNOLOGY, LTD.,
              Plaintiffs-Appellants,

                           v.

           JANSSEN BIOTECH, INC. AND
           CENTOCOR BIOLOGICS, LLC,
               Defendants-Appellees.

             -----------------------

             JANSSEN BIOTECH, INC.,
                 Plaintiff–Appellee,

                           v.

    ABBVIE DEUTSCHLAND GMBH & CO., KG,
              Defendant-Appellant.
             ______________________

                   2013-1338, -1346
                ______________________

    Appeals from the United States District Court for the
District of Massachusetts in Nos. 09-CV-11340-FDS, 10-
CV-40003-FDS, and 10-CV-40004-FDS, Judge F. Dennis
Saylor, IV.
2   ABBVIE DEUTSCHLAND GMBH & CO.   v. JANSSEN BIOTECH, INC.

                  ______________________

                   Decided: July 1, 2014
                  ______________________

    WILLIAM F. LEE, Wilmer Cutler Pickering Hale and
Dorr LLP, of Boston, Massachusetts, argued for appel-
lants. With him on the brief were ROBERT J. GUNTHER,
JR., JANE M. LOVE, and VIOLETTA WATSON, of New York,
New York; WILLIAM G. MCELWAIN, THOMAS G. SAUNDERS,
RACHEL L. WEINER, and MATTHEW GUARNIERI, of Wash-
ington, DC; and ARTHUR W. COVIELLO, of Palo Alto, Cali-
fornia. Of counsel was MARK C. FLEMING, of Boston,
Massachusetts.

    DIANNE B. ELDERKIN, Akin Gump Strauss Hauer &
Feld LLP, of Philadelphia, Pennsylvania, argued for
appellees. With her on the brief were BARBARA L.
MULLIN, STEVEN D. MASLOWSKI, ANGELA VERRECCHIO, and
MATTHEW A. PEARSON; and EMILY C. JOHNSON, of Wash-
ington, DC.

     JAMES J. KELLEY, Eli Lilly and Company, of Indianap-
olis, Indiana, for amicus curiae Eli Lilly and Company.
With him on the brief were TED J. EBERSOLE, ALEXANDER
WILSON, and SANJAY JIVRAJ. On the brief for amicus
curiae Pfizer Inc. was JEFFREY J. OELKE, White and Case
LLP, of New York, New York.

   OSKAR LIIVAK, Cornell Law School, of Ithaca, New
York, for amicus curiae Professor Oskar Liivak.
                 ______________________

    Before LOURIE, O’MALLEY, and CHEN, Circuit Judges.
    Opinion for the court filed by Circuit Judge LOURIE.
    Concurring opinion filed by Circuit Judge O’MALLEY.
ABBVIE DEUTSCHLAND GMBH & CO.    v. JANSSEN BIOTECH, INC.   3

LOURIE, Circuit Judge.
    AbbVie Deutschland GmbH & Co., KG, AbbVie Biore-
search Center, Inc., and AbbVie Biotechnology Ltd. (for-
merly Abbott, collectively “AbbVie”) appeal from the final
judgments of the United States District Court for the
District of Massachusetts in a patent infringement action
and a patent interference action. In the infringement
action, patent owner AbbVie sued Janssen Biotech, Inc.
and Centocor Biologics, LLC (collectively “Centocor”) for
infringement of claims 29, 30, and 32 and claim 64 as
depending from claim 29 of U.S. Patent 6,914,128 (the
“’128 patent”) and claim 11 as depending from claim 2 of
U.S. Patent 7,504,485 (the “’485 patent”) (collectively “the
asserted claims”). 1 In the interference action, Centocor
sought the district court’s review under 35 U.S.C. § 146
(2006) of the decisions of the United States Patent and
Trademark Office (“PTO”) Board of Patent Appeals and
Interferences (the “Board”) in an interference between
U.S. Patent Application 10/912,994 (the “’994 applica-
tion”) owned by Centocor and AbbVie’s ’128 patent, in
which the Board awarded priority to AbbVie and held
that the contested claims in the ’128 patent were not
invalid for obviousness. 2
    After a trial on validity in the infringement action, the
jury determined that all of the asserted claims were
invalid on the grounds of written description, enablement,
and obviousness. The district court denied AbbVie’s post-

    1    Claims 11 and 64 are multiply-dependent from
other claims that are not at issue in these appeals.
    2    35 U.S.C. § 146 has been amended by the Leahy-
Smith American Invents Act (“AIA”), Pub. L. No. 112-29,
§§ 3, 9, 125 Stat. 284, 290–91, 316, which was enacted on
September 16, 2011. We refer to the pre-AIA version of
the statute because the interference action was filed
before the enactment date of the AIA.
4   ABBVIE DEUTSCHLAND GMBH & CO.   v. JANSSEN BIOTECH, INC.

trial motions for judgment as a matter of law (“JMOL”),
and in the alternative, for a new trial, and entered judg-
ments of invalidity in both the infringement and the
interference actions.
    In these consolidated appeals, AbbVie challenges the
district court’s denial of: (1) its motion for summary
judgment, in which the district court held that Centocor
was not collaterally estopped from raising invalidity
defenses in the infringement action after the interference
proceeding at the PTO; (2) its motion for JMOL on the
issues of written description and enablement; and (3) its
motion for a new trial for alleged errors in the court’s
evidentiary rulings and jury instructions. See Abbott
GmbH & Co. v. Centocor Ortho Biotech, Inc., 870 F. Supp.
2d 206 (D. Mass. 2012) (summary judgment order); Abbott
GmbH & Co. v. Centocor Ortho Biotech, Inc., 971 F. Supp.
2d 171 (D. Mass. 2013) (order denying JMOL); Abbott
GmbH & Co. v. Centocor Ortho Biotech, Inc., No. 09-
11340, ECF No. 542 (D. Mass. Mar. 14, 2013) (bench
ruling denying new trial).
    We conclude that because the interference action un-
der § 146 was pending at the district court, the Board’s
decision lacked the requisite finality for purposes of
collateral estoppel. We also hold that record evidence
sufficiently supported the jury verdict that the asserted
claims lacked adequate written description under 35
U.S.C. § 112, ¶ 1 (2006). 3 We further find no reversible

    3    Paragraph 1 of 35 U.S.C. § 112 was replaced with
newly designated § 112(a) by § 4(c) of the AIA and § 4(e)
of the AIA makes those changes applicable “to any patent
application that is filed on or after” September 16, 2012.
Pub. L. No. 112-29, § 4, 125 Stat. at 296–97. Because the
applications resulting in the patents at issue in this case
were filed before that date, we refer to the pre-AIA ver-
sion of § 112.
ABBVIE DEUTSCHLAND GMBH & CO.   v. JANSSEN BIOTECH, INC.   5

error in the contested evidentiary rulings and jury in-
structions relating to the issue of written description
sufficient to warrant a new trial. Because all of the
asserted claims are invalid for failing to satisfy the writ-
ten description requirement, we need not address
AbbVie’s validity arguments concerning enablement or its
procedural challenges to the district court’s obviousness
judgments. We therefore affirm the judgments of invalid-
ity in both the infringement and the interference actions.
                       BACKGROUND
     The technology in these appeals involves antibodies
that are useful for treating diseases. An antibody is a
protein that binds to a foreign substance, called an anti-
gen, to facilitate its removal from the body. The portion of
the antigen that binds to the antibody is called the
epitope. Each antibody consists of four chains of amino
acids, two identical heavy chains and two identical light
chains, which are folded into a three-dimensional struc-
ture. Each of the heavy and light chains consists of a
constant region and a variable region. The variable
region is the portion of the antibody in its three-
dimensional structure that binds to the antigen and each
variable region has three complementarity determining
regions (“CDRs”) that interact closely with the epitope of
the antigen. Among human antibodies, the variable
region of the heavy chains can be divided into seven
families: VH1 to VH7; and the variable region of the light
chains can be divided into two classes: Kappa and Lamb-
da. The binding affinity of an antibody to an antigen can
be measured by koff, the rate at which the antigen dissoci-
ates from the antibody after binding, wherein a smaller
koff value represents a tighter binding.
    AbbVie owns the ’128 and ’485 patents, directed to ful-
ly human antibodies that bind to and neutralize the
activity of human interleukin 12 (“IL-12”). IL-12 is a
signaling protein secreted by the human body, the over-
6   ABBVIE DEUTSCHLAND GMBH & CO.   v. JANSSEN BIOTECH, INC.

production of which can cause psoriasis and rheumatoid
arthritis. Because the human body does not typically
make antibodies to neutralize its own proteins, it does not
produce IL-12 antibodies naturally. Antibodies from a
non-human species often lack the desirable safety profile
of a drug because non-human antibodies can cause ad-
verse immune reactions in human patients. Researchers
therefore sought to genetically engineer fully human IL-
12 antibodies that are derived from human DNA and thus
less likely to trigger an immune response.
    The techniques that could be used to develop a fully
human IL-12 antibody have included phage display and
transgenic mice. AbbVie developed its IL-12 antibodies
using phage display, which involved creating a large
library of human DNA fragments and screening for those
fragments that encoded an antibody fragment with IL-12
binding affinity. AbbVie identified a lead through screen-
ing that it named “Joe-9”, which had the ability to bind to
and neutralize the activity of IL-12, albeit with low affini-
ty. ’128 patent col. 104 ll. 23–29. In order to improve IL-
12 affinity, AbbVie introduced mutations to the CDRs of
Joe-9 and identified an improved antibody that it named
“Y61”. Id. col. 104 l. 39–col. 107 l. 6. AbbVie then used
site-directed mutagenesis to alter individual amino acids
at selected positions in Y61 and generated additional
antibodies, among which an antibody that it named
“J695” showed a significant increase in IL-12 binding and
neutralizing activity. Id. col. 108 ll. 14–65.
     The ’128 and ’485 patents share the same written de-
scription and both claim priority from a provisional appli-
cation filed in 1999. The patents describe the amino acid
sequence of about 300 antibodies having a range of IL-12
binding affinities. Id. fig. 1A–2H, col. 95–102. Joe-9, the
initial lead, has VH3 type heavy chains and Lambda type
light chains. Id. col. 104 ll. 33–35. Because the IL-12
antibodies described in the patents were all derived from
Joe-9, they all have VH3 type heavy chains and Lambda
ABBVIE DEUTSCHLAND GMBH & CO.      v. JANSSEN BIOTECH, INC.   7

type light chains. J.A. 7547–52. The described antibodies
share a 90% or more amino acid sequence similarity in
the variable regions. Id. And over 200 of those antibodies
were generated by site-directed mutagenesis of Y61 and
thus differ from Y61 by only one amino acid and share a
99.5% sequence similarity in the variable regions. ’128
patent fig. 2A–2H; J.A. 7008.
    The ’128 and ’485 patents also teach that “the amino
acid sequence identity within the entire VH3 family is
high,” which “results in certain amino acid residues being
present at key sites in the CDR and framework regions of
the VH chain,” and thus that “other VH3 family members
could also be used to generate antibodies that bind to
human IL-12.” ’128 patent col. 41 ll. 15–17, 27–31, 54–57.
The patents similarly teach that “other Vλ1 [Lambda 1]
family members may also be used to generate antibodies
that bind to human IL-12.” Id. col. 42 ll. 5–8. The pa-
tents, however, do not describe any IL-12 antibody having
heavy chains outside of the VH3 family or light chains
outside of the Lambda family. J.A. 7549.
     The claims of the ’128 and ’485 patents at issue in
these appeals define the claimed antibodies by their
function, i.e., IL-12 binding and neutralizing characteris-
tics, rather than by structure. Claim 29 of the ’128 patent
is representative and reads as follows:
    29. A neutralizing isolated human antibody, or
    antigen-binding portion thereof that binds to hu-
    man IL-12 and disassociates from human IL-12
    with a koff rate constant of 1x10-2 s-1 or less, as de-
    termined by surface plasmon resonance.
’128 patent col. 386 ll. 55–59. Claims 30 and 32 likewise
require the koff rates to be 1x10-4 s-1 or less and 1x10-3 s-1
or less, respectively. Id. col. 386 ll. 60–63, col. 387 ll. 1–4.
Claim 64 is directed to a pharmaceutical composition
comprising the functionally claimed antibody. Id. col. 389
ll. 1–4. Claim 11 of the ’485 patent similarly defines the
8   ABBVIE DEUTSCHLAND GMBH & CO.   v. JANSSEN BIOTECH, INC.

claimed antibody by its IL-12 binding profile. ’485 patent
col. 381 ll. 33–40, col. 382 ll. 40–44.
    Centocor developed its human IL-12 neutralizing an-
tibody drug marketed under the brand name Stelara®
(“Stelara”) using the transgenic mice technology, which
involved mice that are genetically modified with human
antibody genes and capable of producing human antibod-
ies when exposed to an antigen such as IL-12. Stelara
has VH5 type heavy chains, not VH3, and Kappa type light
chains, not Lambda, and about 50% sequence similarity
in the variable regions as compared to the Joe-9 antibod-
ies described in the ’128 and ’485 patents, which is signifi-
cantly lower than the 90% sequence similarity shared
among the Joe-9 antibodies. J.A. 14958. The U.S. Food
and Drug Administration approved Stelara in 2009.
Abbott, 870 F. Supp. 2d at 218.
     Centocor filed the ’994 application directed to human
IL-12 antibodies, which claimed priority from two provi-
sional applications filed in 2000, and provoked an inter-
ference with the ’128 patent on December 12, 2007. Id.
Claims 1–15, 27–40, and 50–64 of the ’128 patent corre-
spond to the sole count of the interference. Although
Centocor indicated at an early stage of the interference
that it intended to challenge the validity of the ’128
claims on the grounds of written description, enablement,
definiteness, and obviousness, Centocor only filed invalid-
ity motions on the issue of obviousness. Centocor also
filed motions on the priority issue. On August 6, 2009,
the Board awarded priority to AbbVie, held that the ’128
patent claims were not invalid for obviousness, and there-
fore entered judgment in favor of AbbVie. Centocor, Inc.
v. Abbott GmbH & Co., Interference No. 105,592, Paper
No. 417, 418, 419 (B.P.A.I. Aug. 6, 2009) (priority deci-
sion, nonobviousness decision, and judgment, respective-
ly).
ABBVIE DEUTSCHLAND GMBH & CO.    v. JANSSEN BIOTECH, INC.   9

    On August 10, 2009, AbbVie filed an infringement ac-
tion against Centocor in the district court for the District
of Massachusetts, asserting that Stelara infringed the
’128 and ’485 patents. Abbott, 870 F. Supp. 2d at 218.
Shortly thereafter, on August 28, 2009, Centocor filed two
actions in the district court for the District of Columbia,
seeking judicial review of the Board’s interference deci-
sions under § 146 and seeking a declaratory judgment of
noninfringement and invalidity of the ’128 and ’485
patents. Id. Centocor’s two actions were transferred to
Massachusetts, where the district court consolidated the
declaratory judgment action with the infringement action
for all purposes and consolidated the interference action
with the infringement action for purposes of discovery.
Id.
    AbbVie moved for summary judgment that Centocor
was collaterally estopped from challenging the validity of
the ’128 patent in the infringement action because Cento-
cor had failed to invalidate the ’128 patent claims in the
interference proceeding at the PTO. The district court
denied the motion, reasoning that the Board’s decisions
were not final for purposes of collateral estoppel in view of
the pending § 146 action. Id. at 223. The court also
decided to proceed with the infringement action first in
order to preserve Centocor’s right to a jury trial. Id. at
226.
    After construing the claims, the court entered sum-
mary judgment that Centocor infringed claims 29, 32, and
64 of the ’128 patent and claim 11 of the ’485 patent. Id.
at 249. The parties then stipulated that claim 30 of the
’128 patent was also infringed. Abbott GmbH & Co. v.
Centocor Ortho Biotech, Inc., No. 09-11340, ECF No. 400
(D. Mass. Aug. 10, 2012). AbbVie also stipulated that it
would only assert those five claims in the infringement
action and Centocor stipulated that it would not seek
review of the PTO’s nonobviousness ruling with respect to
other claims of the ’128 patent that were at issue in the
10 ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC.

interference action. Abbott GmbH & Co. v. Centocor
Ortho Biotech, Inc., No. 09-11340, ECF No. 454 (D. Mass.
Sept. 7, 2012).
    The validity of the asserted claims was tried before a
jury in the infringement action. The district court exclud-
ed evidence of the PTO interference proceeding under
Federal Rule of Evidence 403. J.A. 323, 6421–22, 6467–
69, 6780–81. The court allowed AbbVie’s expert, Dr.
Marks, to testify that the PTO had considered the issues
of written description, enablement, and obviousness and
concluded that the asserted claims met those require-
ments before it granted the patents. Id. at 7260–63, 7284.
The court, however, precluded Dr. Marks from testifying
in detail about the reasoning of the PTO or prosecution
arguments considered by the PTO. Id. at 7281–86.
    Centocor raised four invalidity defenses on the bases
of written description, enablement, obviousness, and
anticipation by prior invention. To support its invalidity
challenges under § 112, Centocor presented evidence
seeking to establish that the antibodies described in
AbbVie’s patents were not representative of other mem-
bers of the functionally claimed genus, which included
Stelara. Centocor presented expert testimony that the
antibodies described in the patents were structurally
similar, but that they differed from Stelara in many
respects, set out below:
12 ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC.

    At the close of the jury trial, the district court in-
structed the jury that Centocor had the burden of proving
invalidity by clear and convincing evidence. Id. at 349.
Regarding evidence that was presented at trial but not
considered by the PTO, the court instructed the jury, over
AbbVie’s objection, that:
    You should consider whether that additional in-
    formation would have been “material” to the
    PTO’s decision to grant the patents. Information
    is “material” if there is a substantial likelihood
    that a reasonable patent examiner would consider
    it important in deciding whether to allow the ap-
    plication to issue as a patent. . . . If the PTO did
    not have all the material information before it
    when it made its decision as to a particular claim,
    Centocor’s burden may be easier to meet. That is
    particularly true if the additional information was
    not only material, but would have carried signifi-
    cant weight had it been considered by the PTO.
    But if the additional information was not materi-
    al, or it would not have carried significant weight,
    Centocor’s burden may be more difficult to meet.
Id. at 350.
    The jury found in AbbVie’s favor on the issue of antic-
ipation, but determined that each of the asserted claims
was invalid for lack of an adequate written description,
lack of enablement, and obviousness. Abbott GmbH & Co.
v. Centocor Ortho Biotech, Inc., No. 09-11340, ECF No.
492 (D. Mass. Sept. 25, 2012). AbbVie moved for JMOL
challenging the invalidity verdict on all of those grounds
on which it lost, and in the alternative, for a new trial for
alleged errors in the court’s evidentiary rulings and jury
instructions. The court denied both motions and entered
judgment based on the jury verdict in the infringement
action. Abbott, 971 F. Supp. 2d at 180–81, 186; Abbott,
ECF No. 542, at 4. Because the jury found the asserted
ABBVIE DEUTSCHLAND GMBH & CO.    v. JANSSEN BIOTECH, INC. 13

claims invalid under the clear and convincing evidence
standard and because the § 146 action permitted a lower
burden for proving invalidity, the court also entered
judgment of invalidity in the § 146 action, reversing the
Board’s nonobviousness ruling on claims 29, 30, and 32
and claim 64 as depending from claim 29 of the ’128
patent. Abbott, ECF No. 542, at 4.
   AbbVie timely appealed and we have jurisdiction pur-
suant to 28 U.S.C. § 1295(a)(1) and (a)(4)(C).
                        DISCUSSION
    In patent appeals, we apply the law of the regional
circuit “to which district court appeals normally lie,
unless the issue pertains to or is unique to patent law.”
Molins PLC v. Quigg, 837 F.2d 1064, 1066 (Fed. Cir.
1988). Accordingly, we apply the law of the regional
circuit in which the district court sits, here, the First
Circuit, in reviewing the grant or denial of a motion for
summary judgment, the denial of a motion for JMOL or
for a new trial, and challenges to a district court’s eviden-
tiary rulings and jury instructions. See Bd. of Trs. of
Leland Stanford Junior Univ. v. Roche Molecular Sys.,
Inc., 583 F.3d 832, 839 (Fed. Cir. 2009) (grant or denial of
summary judgment), aff’d, 131 S. Ct. 2188 (2011); Voda v.
Cordis Corp., 536 F.3d 1311, 1328 (Fed. Cir. 2008) (jury
instructions); Riverwood Int’l Corp. v. R.A. Jones & Co.,
324 F.3d 1346, 1352 (Fed. Cir. 2003) (denial of motion for
JMOL or for a new trial); Advanced Cardiovascular Sys.,
Inc. v. Medtronic, Inc., 265 F.3d 1294, 1308 (Fed. Cir.
2001) (evidentiary rulings and denial of motion for a new
trial).
    Moreover, we review the application of general collat-
eral estoppel principles under the law of the regional
circuit in which the district court sits. Pharmacia &
Upjohn Co. v. Mylan Pharm., Inc., 170 F.3d 1373, 1381
n.4 (Fed. Cir. 1999). “However, for any aspects that may
have special or unique application to patent cases, Feder-
14 ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC.

al Circuit precedent is applicable.” Aspex Eyewear, Inc. v.
Zenni Optical Inc., 713 F.3d 1377, 1380 (Fed. Cir. 2013).
                 I. COLLATERAL ESTOPPEL
    The First Circuit reviews the denial of a motion for
summary judgment de novo. OneBeacon Am. Ins. Co. v.
Commercial Union Assur. Co. of Can., 684 F.3d 237, 241
(1st Cir. 2012). In addition, the application of the doc-
trine of collateral estoppel is a question of law reviewed de
novo. Manganella v. Evanston Ins. Co., 700 F.3d 585, 590
(1st Cir. 2012). A party seeking to invoke the doctrine of
collateral estoppel must establish that:
    (1) the issue sought to be precluded in the later
    action is the same as that involved in the earlier
    action; (2) the issue was actually litigated; (3) the
    issue was determined by a valid and binding final
    judgment; and (4) the determination of the issue
    was essential to the judgment.
Ramallo Bros. Printing, Inc. v. El Dia, Inc., 490 F.3d 86,
90 (1st Cir. 2007).
    AbbVie argues that Centocor’s invalidity defenses as
to the ’128 patent should not have been tried to the jury
because of the preclusive effect of the Board’s prior judg-
ment. AbbVie contends that although the § 146 action
was a hybrid proceeding in which Centocor could present
new evidence, it remained a proceeding to review the
Board’s decision and thus was akin to an appeal. AbbVie
therefore maintains that the pending § 146 action did not
impair the finality of the Board’s judgment. AbbVie also
asserts that Centocor provoked the interference and had a
full and fair opportunity to litigate in the forum of its
choice and that the Board’s procedures did not unduly
constrain Centocor from developing its case.
    Centocor responds that the Board’s decision was not a
final judgment because it was the subject of Centocor’s
timely filed § 146 action, in which Centocor was permitted
ABBVIE DEUTSCHLAND GMBH & CO.    v. JANSSEN BIOTECH, INC. 15

to and did present new evidence. Centocor maintains that
it did not have a full and fair opportunity to litigate in the
interference proceeding because PTO regulations limited
the nature and extent of discovery and the type of evi-
dence that could be presented to the Board. Centocor also
argues that AbbVie waived its collateral estoppel argu-
ment under First Circuit law because AbbVie did not
renew it in the post-verdict JMOL motion.
    We agree with Centocor that the Board’s judgment
was not a final judgment for purposes of collateral estop-
pel because the interference action under § 146 was still
pending at the district court. Accordingly, we need not
decide whether AbbVie waived the issue for appeal under
First Circuit law.
    Section 146 of the patent statute provides, in part,
that “[a]ny party to an interference dissatisfied with the
decision of the [Board] on the interference, may have
remedy by civil action, if commenced within such time
after such decision, not less than sixty days” and that “the
record in the [PTO] shall be admitted on motion of either
party upon the terms and conditions as to costs, expenses,
and the further cross-examination of the witnesses as the
court imposes, without prejudice to the right of the parties
to take further testimony.” 35 U.S.C. § 146 (emphasis
added). Thus, a party seeking review of a decision of the
Board under § 146 may “shor[e] up evidentiary gaps” in
the agency record by presenting live testimony, which
could not be presented to the PTO. Agilent Techs., Inc. v.
Affymetrix, Inc., 567 F.3d 1366, 1380 (Fed. Cir. 2009).
When additional evidence is presented, the district court
makes a de novo finding of facts in light of the new evi-
dence, “while treating the record before the Board when
offered by a party as if it was originally taken and pro-
duced in the district court.” Winner Int’l Royalty Corp. v.
Wang, 202 F.3d 1340, 1347 (Fed. Cir. 2000) (internal
quotation marks omitted); see also Streck, Inc. v. Research
& Diagnostic Sys., Inc., 659 F.3d 1186, 1196 (Fed. Cir.
16 ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC.

2011) (“The purpose of § 146 is to bring to bear, upon the
contested issues . . . , the procedures and rules of federal
litigation.”); Rexam Indus. Corp. v. Eastman Kodak Co.,
182 F.3d 1366, 1370 (Fed. Cir. 1999) (A § 146 action “is
derivative of the interference conducted in the PTO.”);
Estée Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 592 (Fed.
Cir. 1997) (“Section 146 actions have been described as a
hybrid of an appeal and a trial de novo.”).
     The patent statute provides alternative paths for judi-
cial review of an interference decision of the Board. A
party to an interference dissatisfied with a Board decision
may file a direct appeal to this court pursuant to 35
U.S.C. § 141 (2006). 4 Unlike a § 146 action, a direct
appeal under § 141 is based solely on the agency record
and reviewed under the standard established by the
Administrative Procedure Act and is therefore more akin
to a traditional appeal from a district court decision.
Streck, 659 F.3d at 1190. The statute, however, provides
that such a direct appeal “shall be dismissed if any ad-
verse party to such interference, within twenty days after
the appellant has filed notice of appeal . . . files notice
with the Director that the party elects to have all further
proceedings conducted as provided in section 146.” 35
U.S.C. § 141. Consequently, the statutory election proce-
dure allows a party to elect further proceedings under
§ 146, in which it could reopen and supplement the factu-
al record at the district court, even when a direct appeal is
filed first by another party.
   As indicated, when a party elects to seek review of a
Board decision under § 146, the factual record remains
open with respect to the issues contested at the PTO.
Because a district court can make a de novo determina-

    4   35 U.S.C. § 141 has been amended by the AIA,
Pub. L. No. 112-29, § 7, 125 Stat. at 314. We refer to the
pre-AIA version of the statute.
ABBVIE DEUTSCHLAND GMBH & CO.   v. JANSSEN BIOTECH, INC. 17

tion of facts upon the submission of new evidence, a Board
decision that is reviewed under § 146 is not a “binding
final judgment” to preclude a losing party from litigating
the same or related issues in a parallel proceeding.
Whether a Board’s interference decision that is on appeal
under § 141 can have collateral estoppel effect on issues
raised in a co-pending litigation is another question, one
we need not address here. Here, Centocor initiated the
§ 146 action at the district court within the statutorily
prescribed time period and was thus entitled to present
new evidence at least with respect to the issues of priority
and obviousness in the underlying interference action.
The factual record in the interference action was therefore
open as to those issues, subject to a de novo determination
by the district court. Consequently, the Board’s priority
and nonobviousness decisions lacked the requisite finality
for purposes of collateral estoppel.
    We therefore hold that Centocor was not collaterally
estopped from raising invalidity defenses in the infringe-
ment action.
18 ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC.

                 II. WRITTEN DESCRIPTION 5
    The First Circuit reviews the denial of a motion for
JMOL de novo, applying the same standard as the district
court. Interstate Litho Corp. v. Brown, 255 F.3d 19, 27
(1st Cir. 2001). JMOL is appropriate when “a reasonable
jury would not have a legally sufficient evidentiary basis
to find for the party on that issue.” Fed. R. Civ. P.
50(a)(1). Applying First Circuit law, we consider the
evidence presented to the jury and all reasonable infer-

    5    AbbVie did not substantively challenge the dis-
trict court’s holding of obviousness of the asserted claims.
It might therefore be concluded that we could affirm that
court’s obviousness holding and proceed no further.
However, as an “inferior” court, we are well-advised to
review more than one issue raised before us on appeal,
lest higher authority find error in any basis for a more
limited review. Cardinal Chem. Co. v. Morton Int’l, Inc.,
508 U.S. 83, 97–98 (1993) (“[T]he Federal Circuit is not a
court of last resort. . . . [Its] decision to rely on one of two
possible alternative grounds (noninfringement rather
than invalidity) did not strip it of power to decide the
second question, particularly when its decree was subject
to review by this Court.” (emphasis in original)); see also
Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683
F.3d 1356 (Fed. Cir. 2012) (affirming invalidity based on
anticipation and obviousness); Verizon Servs. Corp. v. Cox
Fibernet Va., Inc., 602 F.3d 1325 (Fed. Cir. 2010) (same);
Union Pac. Res. Co. v. Chesapeake Energy Corp., 236 F.3d
684 (Fed. Cir. 2001) (affirming invalidity based on indefi-
niteness and lack of enablement). Because the written
description issue constituted the principal basis of
AbbVie’s appeal to this court, we proceed to consider the
written description issue rather than affirm merely on
any procedural defect or omission relating to the obvious-
ness issue.
ABBVIE DEUTSCHLAND GMBH & CO.   v. JANSSEN BIOTECH, INC. 19

ences that may be drawn therefrom in the light most
favorable to the jury verdict. Osorio v. One World Techs.,
Inc., 659 F.3d 81, 84 (1st Cir. 2011). We will only reverse
the district court’s denial of JMOL “if the facts and infer-
ences point so strongly and overwhelmingly in favor of the
movant that a reasonable jury could not have reached a
verdict against that party.” Id. (citation and internal
quotation marks omitted).
    Whether a patent claim is supported by an adequate
written description is a question of fact, and we review a
jury’s factual determination relating to compliance with
the written description requirement for substantial evi-
dence. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1355 (Fed. Cir. 2010) (en banc). Furthermore,
patents are presumed to be valid, and overcoming this
presumption requires clear and convincing evidence. 35
U.S.C. § 282; Microsoft Corp. v. i4i Ltd., 131 S. Ct. 2238,
2243 (2011); Ariad, 598 F.3d at 1354.
     AbbVie argues that each of the asserted claims is lim-
ited to a small genus of antibodies that are rare and
difficult to obtain and that its patents describe a repre-
sentative number of antibodies commensurate with the
scope of the claims. AbbVie maintains that the disclosed
antibodies reflect the variation of the entire genus be-
cause they cover the full range of the claimed feature, the
koff rate. AbbVie also asserts that it disclosed the amino
acid sequence of all known species covered by the claims
except for Stelara and that its patents were not required
to provide individual written description of an infringing
product. AbbVie argues that Centocor incorrectly seeks to
distinguish Stelara on the basis of unclaimed structural
features that are legally irrelevant and have no correla-
tion to the claimed koff rate. AbbVie maintains that even
if the structural variations are relevant at all, AbbVie’s
patents disclose a variety of amino acid sequences of the
CDRs of its antibodies.
20 ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC.

    Centocor responds that the jury verdict of invalidity
for inadequate written description is supported by sub-
stantial evidence. Centocor maintains that AbbVie’s
patent disclosure is limited to a family of closely related,
structurally similar antibodies that are all derived from
Joe-9, whereas AbbVie’s functionally defined claims cover
antibodies having widely varying structures including
Stelara. Centocor therefore argues that the antibodies
disclosed in AbbVie’s patents are not representative of the
entire genus. Centocor also responds that AbbVie’s
argument that structural differences are legally irrele-
vant is contrary to the law of written description. Cento-
cor contends that the functional requirement of the
claims, i.e., the koff rate, is dependent on the structure of
the antibody and that AbbVie’s evidence purporting to
show the disclosure of representative species is irrelevant.
    We agree with Centocor that substantial evidence
supports the jury verdict that the asserted claims are
invalid for lack of an adequate written description. The
written description requirement has long been part of our
patent law. It is provided for in the statute, and drafters
of patent applications know that they must describe their
inventions as well as disclose how to enable their use.
This court en banc held in Ariad that the written descrip-
tion requirement is separate from the enablement re-
quirement. Ariad, 598 F.3d at 1344. We also explained
that the requirement for an adequate written description
serves a different purpose from that of the claims. Id. at
1347 (“Claims define and circumscribe, the written de-
scription discloses and teaches.”).
    The essence of the written description requirement is
that a patent applicant, as part of the bargain with the
public, must describe his or her invention so that the
public will know what it is and that he or she has truly
made the claimed invention. See Festo Corp. v. Shoketsu
Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 736 (2002)
(“The[] requirements must be satisfied before issuance of
ABBVIE DEUTSCHLAND GMBH & CO.     v. JANSSEN BIOTECH, INC. 21

the patent, for exclusive patent rights are given in ex-
change for disclosing the invention to the public. What is
claimed by the patent application must be the same as
what is disclosed in the specification . . . .” (internal
citations omitted)); O’Reilly v. Morse, 56 U.S. 62, 120–21
(1853) (“The evil is the same if he claims more than he
has invented, although no other person has invented it
before him. He prevents others from attempting to im-
prove upon the manner and process which he has de-
scribed in his specification and may deter the public from
using it.”).
     We have explained that “requiring a written descrip-
tion of the invention plays a vital role in curtailing claims
. . . that have not been invented, and thus cannot be
described.” Ariad, 598 F.3d at 1352. “[T]he purpose of
the written description requirement is to ‘ensure that the
scope of the right to exclude, as set forth in the claims,
does not overreach the scope of the inventor’s contribution
to the field of art as described in the patent specification.’”
Id. at 1353–54 (quoting Univ. of Rochester v. G.D. Searle
& Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). We have held
that the written description requirement with respect to
particularly claimed subject matter is met if the specifica-
tion shows that the stated inventor has in fact invented
what is claimed, that he had possession of it. Vas-Cath
Inc. v. Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir.
1991). We have stated that possession is shown by disclo-
sure in the patent. Ariad, 598 F.3d at 1351 (“[T]he hall-
mark of written description is disclosure . . . the test
requires an objective inquiry into the four corners of the
specification from the perspective of a person of ordinary
skill in the art.”).
    One particular question regarding the written de-
scription requirement has been raised when a genus is
claimed but the specification only describes a part of that
genus that is insufficient to constitute a description of the
genus. In Regents of the University of California v. Eli
22 ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC.

Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), we held
that a genus of mammalian insulin DNA was not sup-
ported by a description of rat insulin DNA. Without
doubt, rats are different from other mammals, including
humans. A description of one does not describe or show
that one has invented the whole genus of mammals.
Whether the written description requirement for a genus
is met by a particular disclosure depends upon the facts.
Ariad, 598 F.3d at 1351. This case presents such a ques-
tion. The jury found that the requirement was not met,
and we agree.
     “For generic claims, we have set forth a number of
factors for evaluating the adequacy of the disclosure,
including ‘the existing knowledge in the particular field,
the extent and content of the prior art, the maturity of the
science or technology, [and] the predictability of the
aspect at issue.’” Id. (quoting Capon v. Eshhar, 418 F.3d
1349, 1359 (Fed. Cir. 2005)). When a patent claims a
genus using functional language to define a desired
result, “the specification must demonstrate that the
applicant has made a generic invention that achieves the
claimed result and do so by showing that the applicant
has invented species sufficient to support a claim to the
functionally-defined genus.” Id. at 1349. We have held
that “a sufficient description of a genus . . . requires the
disclosure of either a representative number of species
falling within the scope of the genus or structural features
common to the members of the genus so that one of skill
in the art can ‘visualize or recognize’ the members of the
genus.” Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568–
69).
    Here, the claimed invention is a class of fully human
antibodies that are defined by their high affinity and
neutralizing activity to human IL-12, a known antigen.
AbbVie’s expert conceded that the ’128 and ’485 patents
do not disclose structural features common to the mem-
bers of the claimed genus. J.A. 7430–31. The question
ABBVIE DEUTSCHLAND GMBH & CO.    v. JANSSEN BIOTECH, INC. 23

therefore is whether the patents sufficiently otherwise
describe representative species to support the entire
genus.
     One factor in considering the question is how large a
genus is involved and what species of the genus are
described in the patent. If the genus is not large or, even
if it is, the specification discloses species representing the
genus throughout its scope, the requirement may be met.
On the other hand, analogizing the genus to a plot of land,
if the disclosed species only abide in a corner of the genus,
one has not described the genus sufficiently to show that
the inventor invented, or had possession of, the genus. He
only described a portion of it. That is the case here.
     It is important not to take the analogy of a plot of land
too far in thinking of written description issues because,
even if one builds a house only in one corner of the plot,
one may still own the whole plot. One describes a plot of
land by its furthest coordinates, in effect drawing a pe-
rimeter fence around it. That may be akin to the function
of patent claims to particularly point out and distinctly
circumscribe the outer boundaries of a claimed invention.
With the written description of a genus, however, merely
drawing a fence around a perceived genus is not a de-
scription of the genus. One needs to show that one has
truly invented the genus, i.e., that one has conceived and
described sufficient representative species encompassing
the breadth of the genus. Otherwise, one has only a
research plan, leaving it to others to explore the unknown
contours of the claimed genus. See Ariad, 598 F.3d at
1353 (The written description requirement guards against
claims that “merely recite a description of the problem to
be solved while claiming all solutions to it and . . . cover
any compound later actually invented and determined to
fall within the claim’s functional boundaries.”).
    Here, the jury heard ample evidence that AbbVie’s pa-
tents only describe one type of structurally similar anti-
24 ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC.

bodies and that those antibodies are not representative of
the full variety or scope of the genus. Abbott, 971 F.
Supp. 2d at 176–77. All of the antibodies described in
AbbVie’s patents were derived from Joe-9 and have VH3
type heavy chains and Lambda type light chains. Alt-
hough the described antibodies have different amino acid
sequences at the CDRs, they share 90% or more sequence
similarity in the variable regions and over 200 of those
antibodies differ from Y61 by only one amino acid. The
patents describe that other VH3/Lambda antibodies may
be modified to attain IL-12 binding affinity. However, the
patents do not describe any example, or even the possibil-
ity, of fully human IL-12 antibodies having heavy and
light chains other than the VH3 and Lambda types.
    In contrast, Centocor’s Stelara, which falls within the
scope of the claimed genus, differs considerably from the
Joe-9 antibodies described in AbbVie’s patents. Stelara
has VH5 type heavy chains and Kappa type light chains.
The variable regions of Stelara only share a 50% sequence
similarity with the Joe-9 antibodies, which is far lower
than the 90% sequence similarity shared among the Joe-9
antibodies described in AbbVie’s patents. Centocor’s
expert testified that antibodies with 80% sequence simi-
larity to J695 could bind to completely different antigens,
J.A. 6496–97, thus illustrating the significant structural
differences between Stelara and the Joe-9 antibodies and
the unpredictability of the field of invention. Centocor
also presented evidence of other differences between
Stelara and the Joe-9 antibodies, such as CDR length and
epitope binding site. J.A. 14958.
    Because each of the asserted claims encompasses both
the Joe-9 antibodies and the allegedly infringing Stelara,
the claimed genus covers structurally diverse antibodies.
The ’128 and ’485 patents, however, only describe species
of structurally similar antibodies that were derived from
Joe-9. Although the number of the described species
appears high quantitatively, the described species are all
ABBVIE DEUTSCHLAND GMBH & CO.   v. JANSSEN BIOTECH, INC. 25

of the similar type and do not qualitatively represent
other types of antibodies encompassed by the genus. See
Ariad, 598 F.3d at 1351 (“[No] bright-line rules govern[]
the number of species that must be disclosed to describe a
genus claim, as this number necessarily changes with
each invention, and it changes with progress in a field.”).
     It is true that AbbVie’s patents need not describe the
allegedly infringing Stelara in exact terms. Eli Lilly, 119
F.3d at 1568 (“[E]very species in a genus need not be
described in order that a genus meet the written descrip-
tion requirement.”). However, the patents must at least
describe some species representative of antibodies that
are structurally similar to Stelara. On review of the
record, there is no evidence to show any described anti-
body to be structurally similar to, and thus representative
of, Stelara. There is also no evidence to show whether one
of skill in the art could make predictable changes to the
described antibodies to arrive at other types of antibodies
such as Stelara.
     Instead, AbbVie argues that structural differences are
legally irrelevant and inappositely attempts to rely on the
koff rates to show representativeness. The koff rate is
merely a desired result, rather than the actual means for
achieving that result. The asserted claims are directed to
new compositions, i.e., fully human antibodies having
desired IL-12 binding characteristics. It is undisputed
that the structure of the antibody determines its antigen
binding characteristic. In order to demonstrate that it
has invented what is claimed, AbbVie’s patents must
adequately describe representative antibodies to reflect
the structural diversity of the claimed genus. See Eli
Lilly, 119 F.3d at 1568 (“[N]aming a type of material
generally known to exist, in the absence of knowledge as
to what that material consists of, is not a description of
that material.”); Fiers v. Revel, 984 F.2d 1164, 1171 (Fed.
Cir. 1993) (“Claiming all DNA[s] that achieve a result
without defining what means will do so is not in compli-
26 ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC.

ance with the description requirement; it is an attempt to
preempt the future before it has arrived.”).
    Functionally defined genus claims can be inherently
vulnerable to invalidity challenge for lack of written
description support, especially in technology fields that
are highly unpredictable, where it is difficult to establish
a correlation between structure and function for the whole
genus or to predict what would be covered by the func-
tionally claimed genus. Ariad, 598 F.3d at 1351 (“[T]he
level of detail required to satisfy the written description
requirement varies depending on the nature and scope of
the claims and on the complexity and predictability of the
relevant technology.”); see also Centocor Ortho Biotech,
Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011)
(noting the technical challenges in developing fully hu-
man antibodies of a known human protein). It is true
that functionally defined claims can meet the written
description requirement if a reasonable structure-function
correlation is established, whether by the inventor as
described in the specification or known in the art at the
time of the filing date. Enzo Biochem, Inc. v. Gen-Probe
Inc., 323 F.3d 956, 964 (Fed. Cir. 2002). However, the
record here does not indicate such an established correla-
tion. Instead, AbbVie used a trial and error approach to
modify individual amino acids in order to improve the IL-
12 binding affinity. Moreover, the ’128 and ’485 patents
do not describe any common structural features of the
claimed antibodies. The asserted claims attempt to claim
every fully human IL-12 antibody that would achieve a
desired result, i.e., high binding affinity and neutralizing
activity, and cover an antibody as different as Stelara,
whereas the patents do not describe representative exam-
ples to support the full scope of the claims.
    We therefore conclude that substantial evidence sup-
ports the jury verdict of invalidity for lack of an adequate
ABBVIE DEUTSCHLAND GMBH & CO.    v. JANSSEN BIOTECH, INC. 27

written description of the claimed genus and affirm the
district court’s denial of JMOL on that issue. 6 Conse-
quently, we need not address AbbVie’s argument regard-
ing enablement.
                      III. NEW TRIAL
    The First Circuit reviews the denial of a motion for a
new trial for an abuse of discretion. Granfield v. CSX
Transp., Inc., 597 F.3d 474, 488 (1st Cir. 2010). Chal-
lenges to a district court’s evidentiary rulings are also
reviewed under an abuse of discretion standard. Lynch v.
City of Boston, 180 F.3d 1, 15 (1st Cir. 1999). “In the
event we discern error, we must determine whether the
error was harmless.” Id. “Our inquiry is whether exclu-
sion or admission of the evidence affected plaintiff’s
substantial rights.” Id. (citation and internal quotation
marks omitted).
    Moreover, the First Circuit reviews preserved chal-
lenges to jury instructions de novo and “look to the chal-
lenged instructions in relation to the charge as a whole,
asking whether the charge in its entirety—and in the
context of the evidence—presented the relevant issues to
the jury fairly and adequately.” Sony BMG Music Entm’t
v. Tenenbaum, 660 F.3d 487, 503 (1st Cir. 2011) (internal
quotation marks omitted). “Even if the instructions were
erroneous, we reverse only if the error is determined to
have been prejudicial based on a review of the record as a
whole.” Id. (internal quotation marks omitted). “A new
trial is necessary only ‘if the error could have affected the
result of the jury’s deliberation.’” Romano v. U-Haul Int’l,
233 F.3d 655, 667 (1st Cir. 2000) (quoting Allen v. Chance
Mfg. Co., 873 F.2d 465, 469 (1st Cir. 1989)). “In making

    6  We were aided in our consideration of this issue
by amicus curiae briefs filed by Eli Lilly and Co. et al. and
Professor Oskar Liivak of Cornell Law School.
28 ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC.

that determination, we consider whether we can say ‘with
fair assurance that the judgment was likely unaffected.’”
Id. (quoting Putnam Res. v. Pateman, 958 F.2d 448, 471
(1st Cir. 1992)).
                   A. Evidentiary Rulings
     AbbVie argues that the district court’s exclusion of the
interference file history from evidence allowed Centocor to
relitigate invalidity from a clean slate. AbbVie asserts
that it was unfairly precluded from using the file history
to demonstrate that much of Centocor’s case was cumula-
tive of what the PTO had already considered, such as the
phage display prior art relevant to the obviousness de-
termination. AbbVie further argues that the district court
erred in excluding expert testimony on the detailed rea-
soning of the PTO on the issues of written description,
enablement, and obviousness during ex parte prosecution.
    Centocor responds that the district court did not
abuse its discretion in excluding certain evidence to avoid
time delay and jury confusion. Centocor argues that it
proposed that the parties stipulate to a list identifying art
references considered by the PTO for the jury, but AbbVie
never accepted that invitation. Centocor maintains that
the ex parte prosecution history was admitted into evi-
dence, but AbbVie failed to introduce witness testimony
on prior art considered by the PTO. Centocor also re-
sponds that AbbVie has not shown that its substantive
rights were so affected as to warrant a new trial.
    Because we hold that substantial evidence supported
the jury verdict of invalidity for lack of written description
support, we need only address whether the evidentiary
rulings affected AbbVie’s substantive rights concerning
that verdict. The evidence of the interference or other
proffered evidence concerning obviousness is of little
probative value to the written description determination.
The Board only decided the issues of obviousness and
anticipation by prior invention and the parties did not file
ABBVIE DEUTSCHLAND GMBH & CO.   v. JANSSEN BIOTECH, INC. 29

substantive motions on written description in the inter-
ference proceeding. Moreover, as indicated, the interfer-
ence did not collaterally estop Centocor from presenting
invalidity defenses in the infringement action and thus
the court properly excluded evidence of Centocor’s partici-
pation in the interference. We find no error in the exclu-
sion of those pieces of evidence.
    We also find no reversible error in the district court’s
exclusion of Dr. Marks’ proffered testimony on the de-
tailed reasoning of the PTO. The district court allowed
Dr. Marks to testify before the jury that “the Patent Office
in the file history considered the written description
issue” and “concluded that the written description re-
quirement was met.” J.A. 7261. When AbbVie attempted
to guide Dr. Marks through the details of the file history,
the court excluded the additional testimony. J.A. 7285.
Based on Dr. Marks’ expert report, the proffered testimo-
ny likely would summarize prosecution arguments made
to the PTO, specifically that “the claims were rejected as
being non-enabled or lacking written description by the
specification,” and that “these rejections were overcome
because the applicants pointed out that the specification
provides numerous examples of fully human antibodies
that bind IL-12 with high affinity.” J.A. 10741. In view of
the record as a whole, including the substantial evidence
of structural differences between Stelara and the Joe-9
antibodies and the fact that the jury considered the
number of structurally similar antibodies disclosed in
AbbVie’s patents, we conclude that the district court did
not abuse its discretion in excluding that additional
testimony. Kelley v. Airborne Freight Corp., 140 F.3d 335,
346 (1st Cir. 1998) (“Only rarely—and in extraordinarily
compelling circumstances—will [the First Circuit] from
the vista of a cold appellate record, reverse a district
court’s on the spot judgment, concerning the relative
weighing of probative value and prejudicial effect.” (inter-
nal quotation marks omitted)).
30 ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC.

                    B. Jury Instructions
    Finally, as a last ditch argument, AbbVie argues that
the prejudicial effect of the contested evidentiary rulings
was exacerbated by the jury instruction that new infor-
mation presented at trial that was not considered by the
PTO would make it easier for Centocor to carry its burden
of proving invalidity by clear and convincing evidence.
AbbVie weakly argues that the district court erroneously
concluded that the Supreme Court decision in Microsoft v.
i4i overruled Lindemann Maschinenfabrik GmbH v.
American Hoist & Derrick Co., 730 F.2d 1452 (Fed. Cir.
1984) and erroneously refused to instruct the jury that
the new information must be more relevant than infor-
mation considered by the PTO. AbbVie maintains that a
proper instruction would have required the jury to assess
whether Centocor made the necessary comparison, which
Centocor had failed to do. AbbVie also argues that the
district court erred in interpreting the “materially new”
phrase in Microsoft v. i4i and incorrectly instructed the
jury on “materiality” using a “reasonable examiner”
standard.
    Centocor responds that the jury instruction concern-
ing additional information presented at trial followed the
language and logic of the Microsoft v. i4i decision. Cento-
cor maintains that it was not Centocor’s burden to prove
that the new information was more material than infor-
mation considered by the PTO and that AbbVie could
have made that comparison for the jury. Centocor main-
tains that it informed the jury that the Meager article and
the J695/IL-12 crystal structure were not considered by
the PTO, which is objectively true. Centocor thus re-
sponds that even if there were a legal error in the jury
instruction, AbbVie failed to show that the purported
error resulted in any prejudice to warrant a new trial.
    Again, we need only address whether the challenged
instructions constitute reversible error with respect to the
ABBVIE DEUTSCHLAND GMBH & CO.   v. JANSSEN BIOTECH, INC. 31

jury’s written description verdict. And we conclude that
they do not. Based on a review of the record as a whole,
including the evidence presented on the issue of written
description as well as the jury instruction on burden of
proof in its entirety, we conclude that there was no preju-
dicial error to warrant a new trial on the issue of written
description.
    We previously held in American Hoist, in the context
of a validity challenge based on obviousness, that “the
clear and convincing standard may more easily be met
when such non-considered art is more pertinent than the
cited art” and that “determination of whether the patent
challenger has met its burden turns on the relationship of
the uncited art to the claimed invention.” Am. Hoist, 730
F.2d at 1459. We also held that to the extent that consid-
eration of the uncited art is material, the burden is on the
challenger to show that the uncited art is more relevant
than that cited. Id. at 1460.
    The issue of pertinence or cumulativeness of non-
considered art relative to considered art often arises in
the context of validity challenges based on anticipation or
obviousness. See, e.g., Uniroyal, Inc. v. Rudkin-Wiley
Corp., 837 F.2d 1044, 1050 (Fed. Cir. 1988) (obviousness);
Alco Standard Corp. v. TVA, 808 F.2d 1490, 1498 (Fed.
Cir. 1986) (obviousness); RCA Corp. v. Applied Digital
Data Sys., Inc., 730 F.2d 1440, 1444 (Fed. Cir. 1984)
(anticipation and obviousness). Here, because we sub-
stantively affirm the written description verdict, we need
not decide whether the district court’s refusal to give
instructions on the pertinence or cumulativeness of non-
considered art, such as the Meager article, resulted in
prejudicial error in the jury’s obviousness verdict. Like-
wise, we need not address whether Centocor failed to
carry its burden to compare the Meager article with
references considered by the PTO in order to benefit from
the greater weight given to non-considered art.
32 ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC.

    Concerning the J695/IL-12 crystal structure, which is
relevant to the jury’s written description verdict, we
conclude that the alleged errors are not sufficiently preju-
dicial to warrant a new trial. The Supreme Court stated
in Microsoft v. i4i that “if the PTO did not have all mate-
rial facts before it, its considered judgment may lose
significant force” and that “the challenger’s burden to
persuade the jury of its invalidity defense by clear and
convincing evidence may be easier to sustain.” Microsoft,
131 S. Ct. at 2251. The Court also stated that:
   When it is disputed whether the evidence pre-
   sented to the jury differs from that evaluated by
   the PTO, the jury may be instructed to consider
   that question. In either case, the jury may be in-
   structed to evaluate whether the evidence before
   it is materially new, and if so, to consider that fact
   when determining whether an invalidity defense
   has been proved by clear and convincing evidence.
Id. (emphasis added).
     The district court rephrased “materially new” in its
jury instruction as “additional information [that] would
have been ‘material’ to the PTO’s decision to grant the
patents.” J.A. 350. The district court then instructed the
jury that information is “material” if “there is a substan-
tial likelihood that a reasonable patent examiner would
consider it important in deciding whether to allow the
application to issue as a patent.” Id. The court further
instructed the jury that “if the additional information was
not material, or it would not have carried significant
weight, Centocor’s burden may be more difficult to meet.”
Id. (emphasis added). Taken as a whole, the jury instruc-
tion reasonably apprised the jury on weighing evidence
relevant to the written description issue, such as the J695
crystal structure.
    Moreover, even without the J695 crystal structure in-
formation, substantial evidence would have supported the
ABBVIE DEUTSCHLAND GMBH & CO.   v. JANSSEN BIOTECH, INC. 33

jury verdict of invalidity for inadequate written descrip-
tion. As the record shows, Centocor presented to the jury
five categories of structural differences between Stelara
and the Joe-9 antibodies described in AbbVie’s patents:
(1) sequence similarity; (2) heavy chain type; (3) light
chain type; (4) CDR length; and (5) epitope binding site.
The information on Stelara in and of itself constituted
new information not considered by the PTO, which would
have carried more weight. AbbVie’s patent specification
only describes the amino acid sequence, the heavy and
light chain types, and the CDR length of the Joe-9 anti-
bodies. Centocor also compared the J695 crystal struc-
ture with the three-dimensional structure of Stelara to
show that they bind to IL-12 at different sites. That
distinction was only one of the five distinctions made by
Centocor, the absence of which most likely would not have
affected the jury’s written description verdict. According-
ly, in view of the record as a whole, we do not discern any
reversible, prejudicial error in the jury’s written descrip-
tion verdict.
    We therefore conclude that the district court did not
abuse its discretion in denying the motion for a new trial
based on the contested evidentiary rulings and jury
instructions.
                       CONCLUSION
    For the foregoing reasons, we conclude that Centocor
was not collaterally estopped from raising invalidity
defenses in the infringement action. We also hold that
substantial evidence supports the jury verdict that the
asserted claims are invalid for lack of an adequate written
description. We further conclude that the district court
did not abuse its discretion in denying AbbVie’s motion
for a new trial with respect to the jury’s written descrip-
tion verdict. We therefore affirm the district court’s
judgments in both the infringement action and the inter-
ference action.
34 ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC.

                      AFFIRMED
  United States Court of Appeals
      for the Federal Circuit
                ______________________

    ABBVIE DEUTSCHLAND GMBH & CO., KG,
    ABBVIE BIORESEARCH CENTER, INC., AND
       ABBVIE BIOTECHNOLOGY, LTD.,
              Plaintiffs-Appellants,

                           v.

           JANSSEN BIOTECH, INC. AND
           CENTOCOR BIOLOGICS, LLC,
               Defendants-Appellees.

             -----------------------

             JANSSEN BIOTECH, INC.,
                 Plaintiff–Appellee,

                           v.

    ABBVIE DEUTSCHLAND GMBH & CO., KG,
              Defendant-Appellant.
             ______________________

                   2013-1338, -1346
                ______________________

    Appeals from the United States District Court for the
District of Massachusetts in Nos. 09-CV-11340-FDS, 10-
CV-40003-FDS, and 10-CV-40004-FDS, Judge F. Dennis
Saylor, IV.
                 ______________________
2 ABBVIE DEUTSCHLAND GMBH & CO., v. JANSSEN BIOTECH, INC.

O’MALLEY, Circuit Judge, concurring in judgment.
    I agree that Centocor was not collaterally estopped
from raising invalidity defenses in this infringement
action by virtue of the Board’s prior finding that the
relevant claims in the ’128 patent were not invalid as
obvious. I also agree that we should affirm the trial
court’s judgment invalidating the asserted claims in
the ’128 and ’485 patents. I would premise the latter
judgment on the lower court’s obviousness finding howev-
er, a finding from which AbbVie does not appeal. As
AbbVie conceded at oral argument, the validity of the
patents rests entirely on whether the jury was properly
instructed as to the parties’ respective burdens of proof.
Oral Argument at 7:12, AbbVie Deutschland GMBH & Co.
v. Janssen Biotech, Inc., 2013-1338, available at
http://oralarguments.cafc.uscourts.gov/default.aspx?fl=20
13-1338.mp3 (“We have moved for a new trial on [the
obviousness] judgment. We didn’t move for JMOL on that
judgment, but it does not mean that we didn’t move for a
new trial on that judgment. The jury instruction infected
all of the invalidity verdicts. And, that’s the distinction
we made following this court’s admonition not to just
appeal everything. The [obviousness] JMOL we thought
in fairness we couldn’t and shouldn’t appeal.” (emphasis
added)).
    In other words, because AbbVie did not appeal the
district court’s finding of obviousness, our decision on the
jury instruction issue controls the outcome of this case. If
we find no prejudicial error in the challenged jury instruc-
tion, the finding of obviousness stands and the patent is
invalid. Alternatively, if we hold that the jury instruction
is erroneous, AbbVie is entitled to a new trial on all
validity issues. I express no opinion regarding the
thoughtful written description analysis in the majority
opinion. I simply do not think it necessary or dispositive
to the outcome of this case. Nat’l Am. Ins. Co. v. United
States, 498 F.3d 1301, 1306 (Fed. Cir. 2007) (“Dicta, as
ABBVIE DEUTSCHLAND GMBH & CO.,    v. JANSSEN BIOTECH, INC.   3

defined by this court, are ‘statements made by a court
that are unnecessary to the decision in the case, and
therefore[,] not precedential . . . .’ ” (internal quotation
marks omitted) (quoting C-Steel Raritan, Inc. v. Int’l
Trade Comm’n, 357 F.3d 1294, 1307 (Fed. Cir. 2004))).
    We review the legal sufficiency of jury instructions on
an issue of patent law de novo. Bettcher Indus., Inc. v.
Bunzl USA, Inc., 661 F.3d 629, 638 (Fed. Cir. 2011). We
will order a new trial only when legal errors in the in-
struction as a whole had a prejudicial effect. Id. at 638–
39. Importantly, however, we cannot do as the majority
does and address the jury instruction error alleged only as
it applies to the written description judgment. Maj. Op.
at 30–33. AbbVie argues that the improper jury instruc-
tion “infected all of the invalidity verdicts.” Oral Argu-
ment at 7:25. It points out that the trial court placed the
challenged instruction at the start of the jury instruc-
tions, making clear that it—the only instruction regarding
the defendant’s burden of proof—applied to all of Cento-
cor’s invalidity challenges. Oral Argument at 10:50. As
AbbVie explains, moreover, the challenged portion of the
instruction pertaining to the impact of material not
previously before the PTO, was relevant to and, thus,
impacted the jury’s consideration of all four of the validity
defenses/challenges. Specifically as to written descrip-
tion, AbbVie argues that Centocor’s central argument on
the § 112 defense was “that the crystal structure of J695
was ‘additional information’ that made its burden easier
to carry.” Appellant’s Reply 29.
     About this, there is no dispute. Janssen concedes that
what the parties and majority refer to as the i4i jury
instruction applied to the § 112 issues just as much as it
did to the obviousness claim. Indeed, when asked if the
challenged jury instruction “impacts all grounds of inva-
lidity,” Janssen’s counsel responded “exactly.”         Oral
Argument at 20:09 (admitting that the i4i instruction is
“not just about 103, it’s about all the 112” issues as well).
4 ABBVIE DEUTSCHLAND GMBH & CO., v. JANSSEN BIOTECH, INC.

Because both parties agree that our evaluation of
AbbVie’s challenge to the jury instruction regarding
Centocor’s burden of proof on all of its validity challenges
is determinative of errors alleged, I would assess that jury
instruction, determine whether it is legally accurate and,
if not, whether it was prejudicial. That exercise would
resolve fully the appeal before us.
     Having conducted that exercise for both the obvious-
ness and written description judgments, I believe that
“[t]aken as a whole, the jury instruction reasonably
apprised the jury on weighing evidence relevant to” both
the written description and obviousness findings. Maj.
Op. at 32. I, thus, concur in the decision to affirm the
lower court’s judgment. Because AbbVie is not entitled to
a new trial because of a legally erroneous jury instruction,
its patents stand invalid based on the jury’s obviousness
finding.
    For these reasons, I concur in the result the majority
reaches, but not in the reasoning for doing so.