Court Opinion

ID: 4232357
Source: CourtListenerOpinion
Date Created: 2017-12-26 17:00:45.241738+00
Date Added: 2024-06-11T14:43:03.219449
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                ______________________

     TAKEDA PHARMACEUTICAL COMPANY
                LIMITED,
                Appellant

                           v.

             ARRAY BIOPHARMA INC.,
                      Appellee
               ______________________

                      2017-1079
                ______________________

    Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2015-
00754.
                 ______________________

             Decided: December 26, 2017
               ______________________

    STEPHEN MAEBIUS, Foley & Lardner LLP, Washing-
ton, DC, argued for appellant.

   THOMAS J. MELORO, Willkie Farr & Gallagher LLP,
New York, NY, argued for appellee. Also represented by
ALEXANDRA AWAI, MICHAEL JOHNSON.
               ______________________

Before MOORE, O’MALLEY, and WALLACH, Circuit Judges.
2                TAKEDA PHARM. CO.   v. ARRAY BIOPHARMA INC.

WALLACH, Circuit Judge.
    Appellee Array Biopharma Inc. (“Array”) sought inter
partes review of certain claims of Appellant Takeda
Pharmaceutical Company Limited’s (“Takeda”) U.S.
Patent No. 8,592,454 (“the ’454 patent”). During the
proceedings, Takeda filed a contingent motion to amend,
seeking to replace any challenged claims found to be
unpatentable with certain substitute and new claims. See
J.A. 307−39. The U.S. Patent and Trademark Office’s
Patent Trial and Appeal Board (“PTAB”) issued a final
written decision finding claims 1–7 and 12–16 of the ’454
patent unpatentable, inter alia, as anticipated. See Array
BioPharma Inc. v. Takeda Pharm. Co., IPR2015-00754,
2016 WL 8999741, at *4–13, *19 (P.T.A.B. Aug. 12, 2016).
The PTAB also denied Takeda’s Contingent Motion to
Amend, finding that, inter alia, proposed substitute
claims 26–29 (“the Asserted Claims”) lacked written
description support pursuant to 37 C.F.R. § 42.121(b)
(2015). Id. at *17–19.
    Takeda appeals. We have jurisdiction pursuant to 28
U.S.C. § 1295(a)(4)(A) (2012). We vacate and remand for
further proceedings.
                       BACKGROUND
    The ’454 patent “relates to a novel nitrogen-
containing heterocyclic compound having excellent antag-
onistic action for a tachykinin receptor and use thereof.”
’454 patent col. 1 ll. 11–13. “Tachykinin is a generic term
for a group of neuropeptides,” including “[s]ubstance P,”
“neurokinin A,” and “neurokinin B.” Id. col. 1 ll. 18–19.
These neuropeptides “are known to bind to the corre-
sponding receptors . . . that exist in a living body”: neuro-
kinin-1 (“NK1”), neurokinin-2 (“NK2”), and neurokinin-3
(“NK3”). Id. col. 1 ll. 20–23. The claimed invention
asserts to be “useful” as “an agent for the prophylaxis or
treatment of various diseases such as a lower urinary
TAKEDA PHARM. CO.   v. ARRAY BIOPHARMA INC.             3

tract disease, a digestive tract disease[,] or a central
nervous system disease.” Id. col. 12 ll. 4–7.
    The Asserted Claims were offered by Takeda during
the inter partes review as proposed substitute claims in
the event the PTAB found the original claims 13−16
unpatentable. See J.A. 314−17, 319. The Asserted
Claims include independent claims 26 and 28, from which
claims 27 and 29 depend, respectively. The Asserted
Claims recite:
   26. A method of antagonizing an NK1 receptor in
   a mammal, comprising administering an effective
   amount of a pharmaceutical composition compris-
   ing a compound represented by the formula [in
   original claim 1 1] to the mammal.
   27. The method according to claim 26, wherein the
   method further comprises administering an effec-
   tive amount of the composition to antagonize an
   NK2 receptor and/or an NK3 receptor.
   28. A method of antagonizing an NK2 receptor in
   a mammal, comprising administering an effective
   amount of a pharmaceutical composition compris-
   ing a compound represented by the formula [in
   original claim 1] to the mammal.
   29. The method according to claim 28, wherein the
   method further comprises administering an effec-

   1    Proposed, independent claims 26 and 28 do not
depend from original claim 1, but rather recite claim 1’s
formula for a particular nitrogen-containing, heterocyclic
compound in its entirety. Compare J.A. 314–17 (claims
26 and 28), with ’454 patent col. 403 ll. 12–60 (original
claim 1). For convenience, we express the compound in
proposed substitute claims 26 and 28 by reference to
original claim 1.
4                TAKEDA PHARM. CO.   v. ARRAY BIOPHARMA INC.

    tive amount of the composition to antagonize an
    NK1 receptor and/or an NK3 receptor.
J.A. 314–17. 2
                       DISCUSSION
    Takeda argues the PTAB’s rejection of the Asserted
Claims for lack of written description support was based
on “an erroneous premise,” Appellant’s Br. 13; see id. 17–
20, that “mandates reversal or remand,” id. at 21. After
stating the applicable standards, we discuss Takeda’s
arguments.
        I. Standard of Review and Legal Standard
    Pursuant to the Administrative Procedure Act, 5
U.S.C. §§ 551–559 (2012), we will only set aside the
PTAB’s denial of a motion to amend if it is “arbitrary,
capricious, an abuse of discretion, or otherwise not in
accordance with law, and set aside factual findings that
are unsupported by substantial evidence,” Microsoft Corp.
v. Proxyconn, Inc., 789 F.3d 1292, 1306 (Fed. Cir. 2015)
(internal quotation marks and citation omitted), overruled
on other grounds by Aqua Prods., Inc. v. Matal, 872 F.3d
1290 (Fed. Cir. 2017) (en banc); see 5 U.S.C. § 706. “Sub-
stantial evidence is something less than the weight of the
evidence but more than a mere scintilla of evidence,”
meaning that “[i]t is such relevant evidence as a reasona-
ble mind might accept as adequate to support a conclu-
sion.” In re NuVasive, Inc., 842 F.3d 1376, 1379–80 (Fed.
Cir. 2016) (internal quotation marks and citations omit-
ted). By regulation, “[a] motion to amend claims must

    2   The Asserted Claims are nearly identical to their
corresponding original claims but limit the pharmaceuti-
cal composition administered to an “effective amount.”
Compare J.A. 314–17 (Asserted Claims), with ’454 patent
col. 404 ll. 46–55 (original claims 13–16).
TAKEDA PHARM. CO.   v. ARRAY BIOPHARMA INC.                   5

include a claim listing . . . and set forth,” inter alia, “[t]he
support in the original disclosure of the patent for each
claim that is added or amended.” 37 C.F.R. § 42.121(b)(1).
  II. The PTAB Erred in Denying Takeda’s Contingent
  Motion to Amend with Respect to the Asserted Claims
    The PTAB, after finding that proposed substitute
claim 18 lacked written description support pursuant to
37 C.F.R. § 42.121(b), 3 Array, 2016 WL 8999741, at
*17−19, the PTAB explained that “proposed claims 19–29
depend from independent claim 18” and, thus, “are also
unsupported for at least the same reasons,” id. at *19.
This was error, as both parties acknowledge. See Appel-
lant’s Br. 13 (arguing that the PTAB’s finding was based
on “an erroneous premise”); Appellee’s Br. 15 (stating “the
rationale articulated by the [PTAB] was misplaced” and
characterizing the error as a “harmless misstatement”).
Although the PTAB is correct that proposed claims 19–25
depend from proposed claim 18, the Asserted Claims do
not. Compare J.A. 312–13 (claims 19–25), with J.A. 314–
17 (Asserted Claims). Instead, proposed claims 26 and 28
are independent claims, from which proposed claims 27
and 29 depend, respectively. See J.A. 314–17. According-
ly, the PTAB’s determination that the Asserted Claims
lack written description support is based on an error and
is not supported by substantial evidence.
    Despite this error, Array argues this court should af-
firm the PTAB on the basis that: (1) Takeda failed to
comply with the requirements of 37 C.F.R. § 42.121 for
other reasons, Appellee’s Br. 24–27; (2) the Asserted

    3   Specifically, the PTAB determined that claim 18
lacked adequate written description support in the origi-
nal disclosure, as claim 18 taught a new structure for the
compound’s “ring D,” as compared to original claim 1’s
disclosure. See Array, 2016 WL 8999741, at *17–19.
6               TAKEDA PHARM. CO.   v. ARRAY BIOPHARMA INC.

Claims are anticipated by two prior art references, id. at
27–33; and (3) the Asserted Claims are unpatentable for
lack of written description and enablement pursuant to 35
U.S.C. § 112 (2012), id. at 34–43. Typically, “[t]he agency
tribunal must make findings of relevant facts, and pre-
sent its reasoning in sufficient detail that the court may
conduct meaningful review of the agency action.” In re
Van Os, 844 F.3d 1359, 1362 (Fed. Cir. 2017) (internal
quotation marks and citation omitted). Here, the PTAB
did not provide an opinion as to any of Array’s alternative
grounds for affirmance, and therefore did not make factu-
al findings necessary for this court to conducting mean-
ingful review. See generally Array, 2016 WL 8999741. In
such a situation, where the PTAB’s “action is potentially
lawful but insufficiently or inappropriately explained, we
have consistently vacated and remanded for further
proceedings.” Van Os, 844 F.3d at 1362 (internal quota-
tion marks and citation omitted); see SEC v. Chenery
Corp., 318 U.S. 80, 94 (1943) (“[We] cannot exercise [our]
duty of review unless [we] are advised of the considera-
tions underlying the action under review.”); NuVasive,
842 F.3d at 1385 (stating that when the PTAB fails to
articulate its rationale, “judicial review cannot meaning-
fully be achieved” (internal quotation marks, brackets,
and citation omitted)). Vacating and remanding is appro-
priate here, where the PTAB provided only an erroneous
basis to reject the Asserted Claims and did not make
factual findings relevant to alternate grounds for rejec-
tion.
                       CONCLUSION
    We have considered the parties’ remaining arguments
and find them unpersuasive. Accordingly, the Final
Written Decision of the U.S. Patent and Trademark
Office’s Patent Trial and Appeal Board is
             VACATED AND REMANDED
TAKEDA PHARM. CO.   v. ARRAY BIOPHARMA INC.   7

                           COSTS
   Costs to Takeda.