Biodelivery Sciences Intl. v. Aquestive Therapeutics, Inc. , 898 F.3d 1205 ( 2018 )

United States Court of Appeals
for the Federal Circuit
______________________
BIODELIVERY SCIENCES INTERNATIONAL, INC.,
Appellant
v.
AQUESTIVE THERAPEUTICS, INC., FKA
MONOSOL RX, LLC,
Appellee
ANDREI IANCU, UNDER SECRETARY OF
COMMERCE FOR INTELLECTUAL PROPERTY
AND DIRECTOR OF THE UNITED STATES
PATENT AND TRADEMARK OFFICE,
Intervenor
______________________
2017-1265, 2017-1266, 2017-1268
______________________
Appeals from the United States Patent and Trade-
mark Office, Patent Trial and Appeal Board in Nos.
IPR2015-00165, IPR2015-00168, IPR2015-00169.
______________________
ON MOTION
______________________
LEE CARL BROMBERG, McCarter & English, LLP, Bos-
ton, MA, argued for appellant. Also represented by ERIK
PAUL BELT, KIA LYNN FREEMAN, WYLEY SAYRE PROCTOR,
DEBORAH M. VERNON; DANIELLE L. HERRITT, Womble
Bond Dickinson (US) LLP, Boston, MA; CORA RENAE
2 BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC.
HOLT, HOWARD WARREN LEVINE, THOMAS JOHN SULLIVAN,
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP,
Washington, DC; CHARLES E. LIPSEY, Reston, VA;
JENNIFER SWAN, Palo Alto, CA.
JOHN LLOYD ABRAMIC, Steptoe & Johnson, LLP,
Chicago, IL, argued for appellee. Also represented by
CASSANDRA ADAMS, New York, NY; HAROLD FOX, JAMES
FRANCIS HIBEY, GRETCHEN P. MILLER, Washington, DC;
JAMIE LUCIA, San Francisco, CA.
MOLLY R. SILFEN, Office of the Solicitor, United States
Patent and Trademark Office, Alexandria, VA, argued for
intervenor. Also represented by THOMAS W. KRAUSE,
BENJAMIN T. HICKMAN.
______________________
Before NEWMAN, LOURIE, and REYNA, Circuit Judges.
NEWMAN, Circuit Judge.
ORDER
BioDelivery Sciences International, Inc. (“BioDeliv-
ery”) moves to remand this case to the Patent Trial and
Appeal Board to consider non-instituted claims and non-
instituted grounds in accordance with the Supreme
Court’s recent decision in SAS Institute, Inc. v. Iancu, 138
S. Ct. 1348 (2018). Aquestive Therapeutics, Inc.
(“Aquestive”) and the PTO Director, who has intervened,
oppose. Having considered the parties’ arguments and
our recent decisions interpreting SAS and requests based
thereon, we remand.
DISCUSSION
BioDelivery filed three petitions for inter partes re-
view of U.S. Patent No. 8,765,167 (“the ’167 Patent”). In
IPR2015-00165, BioDelivery challenged a total of 22
claims (1, 4, 6–9, 11, 12, 26, 27, 32, 38, 44, 51, 58, 65, 72,
BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC. 3
82, 109, and 125–127) based upon seven grounds of un-
patentability. The PTAB instituted review of 15 claims
(1, 4, 11, 12, 26, 27, 44, 51, 58, 65, 72, 82, and 125–127)
based upon less than all asserted grounds. Similarly, in
IPR2015-00168 and IPR2015-00169, the PTAB instituted
on less than all asserted grounds of unpatentability but
did institute on all challenged claims (16, 36, 42, 48, 55,
62, 69, 76, 86, 92, 122, and 123 for IPR2015-00168 and 17,
18, 30, 31, 37, 49, 56, 63, 70, 77, 80, 81, 87, 93, 110–116,
and 124 for IPR2015-00169).
The Patent Trial and Appeal Board (“PTAB”) decided
each petition separately, and issued separate final written
decisions that sustained the patentability of all instituted
claims of the ’167 Patent on all instituted grounds, and
included discussion concerning the application of collat-
eral estoppel between inter partes reexamination and
inter partes review. BioDelivery appealed the PTAB’s
three decisions to this court. Aquestive responded, and
the Director intervened to confess error as to the PTAB’s
assumption that inter partes reexamination could give
rise to collateral estoppel in inter partes review.
This court received oral argument in the three ap-
peals on February 9, 2018. On April 24, 2018, the Su-
preme Court issued its decision in SAS Institute, Inc. v.
Iancu, 138 S. Ct. 1348 (2018), explaining that in estab-
lishing inter partes review, Congress set forth “a process
in which it’s the petitioner, not the Director, who gets to
define the contours of the proceeding.” 138 S. Ct. at 1355.
The Court held that if the Director institutes review
proceedings, the PTAB review must proceed “in accord-
ance with or in conformance to the petition,” id. at 1356
(internal quotations omitted), including “‘each claim
challenged’ and ‘the grounds on which the challenge to
each claim is based,’” id. at 1355 (quoting 35 U.S.C.
§ 312(a)(3)). The Court stated: “Nothing suggests the
Director enjoys a license to depart from the petition and
institute a different inter partes review of his own design.”
4 BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC.
Id. at 1356 (emphasis in original). Thus the Court em-
phasized that “the petitioner’s petition, not the Director’s
discretion, is supposed to guide the life of the litigation,”
id., and that “the petitioner’s contentions, not the Direc-
tor’s discretion, define the scope of the litigation all the
way from institution through to conclusion,” id. at 1357.
Nine days after the Court’s SAS decision issued, Bio-
Delivery requested that this court remand the final
decision in IPR2015-00165 to consider the patentability of
the non-instituted claims. See ECF No. 88. In response,
Aquestive argued that BioDelivery had waived any SAS-
based relief for failing to raise any issue of non-instituted
claims during this appeal. See ECF No. 90. In addition,
Aquestive argued that a remand would not alter the
result on appeal. Id.
Orders in other cases began to issue from this court,
applying the Court’s decision in SAS and outlining the
contours of SAS-based requests for relief. See, e.g., Ulthe-
ra, Inc. v. DermaFocus LLC, No. 2018-1542, slip op. at 3
(Fed. Cir. May 25, 2018) (granting petitioner’s motion for
remand to the PTAB to consider non-instituted claims);
Polaris Indus. Inc. v. Arctic Cat, Inc., 724 F. App’x 948,
949 (Fed. Cir. 2018) (holding that a patent owner “may
request a remand to allow the Board to consider noninsti-
tuted claims and grounds”).
This court explained that SAS “require[s] a simple
yes-or-no institution choice respecting a petition, embrac-
ing all challenges included in the petition.” PGS Geophys-
ical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018); see
also Medtronic, Inc. v. Barry, 891 F.3d 1368, 1371 n.1
(Fed. Cir. 2018) (“[T]he statute does not permit a partial
institution leading to a partial final written decision.”).
Post-SAS cases have held that it is appropriate to remand
to the PTAB to consider non-instituted claims as well as
non-instituted grounds. See, e.g., Adidas AG v. Nike, Inc.,
No. 2018-1180, 2018 WL 3213007, at *2 (Fed. Cir. July 2,
BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC. 5
2018) (remanding for the PTAB to consider a non-
instituted ground); Broad Ocean Techs., LLC v. Nidec
Motor Corp., No. 2017-1933, 2018 WL 2979928, at *1
(Fed. Cir. June 14, 2018) (remanding after summary
affirmance instructing the PTAB to consider the non-
instituted claims); Nestle Purina PetCare Co. v. Oil-Dri
Corp. of Am., No. 2017-1744, slip op. at 3–4 (Fed. Cir.
June 11, 2018) (remanding to consider non-instituted
grounds); Baker Hughes Oilfield v. Smith Int’l, Inc., Nos.
2018-1754, -1755, slip op. at 4–5 (Fed. Cir. May 30, 2018)
(remanding to the PTAB to consider non-instituted claims
and non-instituted grounds); Ulthera, slip op. at 3 (re-
manding to the PTAB to consider non-instituted claims).
Cf. PGS Geophysical, 891 F.3d at 1359–60 (“treat[ing]
claims and grounds the same . . . without distinguishing
non-instituted claims from non-instituted grounds”).
We also declined to find that a party waived its right
to seek SAS-based relief due to failure to argue against
partial institution before the PTAB. Polaris, 724 F. App’x
at 949–50 (citing Hormel v. Helvering, 312 U.S. 552, 558–
59 (1941) (holding an exception to the waiver rule exists
in “those [cases] in which there have been judicial inter-
pretations of existing law after decision below and pend-
ing appeal—interpretations which if applied might have
materially altered the result”)); accord In re Micron Tech.,
Inc., 875 F.3d 1091, 1097 (Fed. Cir. 2017) (acknowledging
that “a sufficiently sharp change of law sometimes is a
ground for permitting a party to advance a position that it
did not advance earlier in the proceeding when the law at
the time was strongly enough against that position”);
Hilton Davis Chem. Co. v. Warner-Jenkinson Co., 114
F.3d 1161, 1164 (Fed. Cir. 1997) (holding that “[g]iven the
change in law, it would be unfair at this stage of the case
to apply Hilton Davis’ statements against it or estop it
from augmenting the record to show the reason for the
claim amendment based on other facts that may be avail-
able”).
6 BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC.
Both Aquestive and the Director argue that BioDeliv-
ery has waived its right to seek SAS-based relief for not
raising the issue (A) upon the Supreme Court agreeing to
hear SAS in May 2017, see ECF No. 93 at 2; (B) during
the pendency of the inter partes reviews, see ECF No. 92
at 4; or (C) during the briefing period in this appeal, see
id. As discussed in Polaris, however, SAS represented a
significant change in law that occurred during the pen-
dency of BioDelivery’s appeals. Polaris, 724 F. App’x at
949 (“Precedent holds that a party does not waive an
argument that arises from a significant change in law
during the pendency of an appeal.”) (collecting cases).
Indeed, we remarked that “any attempt to argue against
partial institution [prior to SAS] would have been futile
under the Board’s regulations and our precedent.” Id. at
950. It is clear that waiver does not apply in the present
case.
Aquestive and the Director also argue that BioDeliv-
ery’s motion requesting remand for consideration of non-
instituted grounds is untimely. See ECF No. 93 at 4
(“Biodelivery Sciences has waited nearly two months after
the SAS decision to seek relief—after the parties spent
the time to brief and argue the case, and more than three
months after the appeal was submitted to the panel for
decision.”); ECF No. 92 at 6 (“Even if Appellant did not
waive its arguments for a complete remand, its argument
that the appeals from all three IPRs should be terminated
and remanded is untimely.”).
Nine days after the SAS decision, BioDelivery filed its
first request for SAS-based relief from the PTAB’s institu-
tion of less than all claims in IPR2015-00165. See ECF
No. 88; see also SAS, 138 S. Ct. at 1354 (“But instead of
instituting review on all of the claims challenged in the
petition, the Director instituted review on only some
(claims 1 and 3–10) and denied review on the rest.”); id. at
1359–60 (“Because everything in the statute before us
confirms that SAS is entitled to a final written decision
BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC. 7
addressing all of the claims it has challenged and nothing
suggests we lack the power to say so, the judgment of the
Federal Circuit is reversed and the case is remanded for
further proceedings consistent with this opinion.”).
Aquestive did not, at that time, complain that this request
was untimely, nor could it have reasonably done so.
BioDelivery made its second request for SAS-based
relief soon after this court began ordering remands when
the PTAB considered less than all asserted grounds,
explaining that such requests were appropriate in view of
SAS. Compare ECF No. 91 (dated June 19, 2018), with
Polaris (issued May 30, 2018), Baker Hughes Oilfield
(issued May 30, 2018), and Nestle Purina PetCare (issued
June 11, 2018). Aquestive argues that BioDelivery should
have requested this type of relief earlier, pointing to the
PTO’s informal “guidance” memorandum dated April 26,
2018 as evidence that “in view of SAS, [the PTAB] was
going to institute on all claims and grounds of unpatenta-
bility raised in the petition.” ECF No. 92 at 6–7 (discuss-
ing Guidance on the Impact of SAS on AIA Trial
Proceedings, U.S. Patent & Trademark Office (Apr. 26,
2018), available at https://www.uspto.gov/patents-
application-process/patent-trial-and-appeal-board/trials/
guidance-impact-sas-aia-trial). The PTO’s salutary
decision concerning future action does not insulate earlier
PTAB actions from remedy.
Aquestive further argues that because the PTAB rec-
ognized SAS to require institution on all challenged
claims and all challenged grounds, BioDelivery should
have also recognized this and requested complete relief in
its May 3 filing. ECF No. 92 at 7 (discussing this court’s
statements in PGS Geophysical). We agree that SAS
requires institution on all challenged claims and all
challenged grounds. See PGS Geophysical, 891 F.3d at
1360 (“Equal treatment of claims and grounds for institu-
tion purposes has pervasive support in SAS.”). However,
even if a prior action did not appear unlawful at the time,
8 BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC.
this does not insulate it from corrective action. The
second request for SAS-based relief was not untimely
simply because BioDelivery did not predict that this court
would authorize requests for remand when the PTAB
instituted on less than all grounds as well as on all
claims. It is undisputed that BioDelivery acted promptly
after these occurrences, requesting remand within days of
this court’s first orders granting remand for the PTAB’s
failure to institute on all asserted grounds.
Aquestive also asks that if this court decides that re-
mand is appropriate, that we first decide the presently
appealed issues. However, “[a]ppellate courts have his-
torically disfavored piecemeal litigation and permitted
appeals from complete and final judgments only.” W.L.
Gore & Assocs., Inc. v. Int’l Med. Prosthetics Research
Assocs., Inc., 975 F.2d 858, 861 (Fed. Cir. 1992) (citing
Catlin v. United States, 324 U.S. 229 (1945)). The inade-
quacy of the three PTAB decisions, as established by SAS,
weighs against deciding these appeals of fewer than the
required issues. This is precisely the type of piecemeal
litigation that is historically disfavored.
Aquestive also asserts that remand would result in
prejudice “because it will negatively impact Appellee’s
ability to assert and defend its patent rights in other
venues and against other parties.” ECF No. 92 at 14.
Aquestive states that it “is actively enforcing its patents
in numerous district court litigations,” id., including two
district court actions against BioDelivery. We take note
that one of these suits was stayed (jointly) during the
inter partes reviews. See Reckitt Benckiser Pharm., Inc. v.
BioDelivery Sci. Int’l, Inc., No. 5:15-cv-00350-D (E.D.N.C.
Sept. 22, 2014), ECF Nos. 39 & 42. Whether district court
litigation is stayed for these remand procedures is within
the province of the district court. Thus, the prejudice
alleged by Aquestive does not weigh against a remand in
this case.
BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC. 9
Accordingly,
IT IS ORDERED THAT:
(1) Biodelivery’s request for remand to implement
the Court’s decision in SAS is granted in Federal
Circuit Appeal Nos. 2017-1265, 2017-1266, and
2017-1268.
(2) The PTAB’s decisions in PTAB Nos. IPR2015-
00165, IPR2015-00168, and IPR2015-00169, are
vacated.
(3) Pursuant to Federal Circuit Rule 41, this or-
der shall constitute the mandate in Appeal Nos.
2017-1265, 2017-1266, and 2017-1268.
(4) Each party shall bear its costs.
FOR THE COURT
July 31, 2018 /s/ Peter R. Marksteiner
Date Peter R. Marksteiner
Clerk of Court