United States Court of Appeals 

for the Federal Circuit ______________________

BIODELIVERY SCIENCES INTERNATIONAL, INC.,

Appellant

v.

AQUESTIVE THERAPEUTICS, INC., FKA 

MONOSOL RX, LLC,

Appellee

______________________

2019-1643, 2019-1644, 2019-1645

______________________

Appeals from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board in Nos. IPR2015-

00165, IPR2015-00168, and IPR2015-00169.

______________________

ON PETITION FOR REHEARING EN BANC

______________________

KIA LYNN FREEMAN, McCarter & English, LLP, Boston, 

MA, filed a petition for rehearing en banc for appellant. 

Also represented by THOMAS F. FOLEY, WYLEY SAYRE 

PROCTOR.

 JOHN LLOYD ABRAMIC, Steptoe & Johnson, LLP, Chicago, IL, filed a response to the petition for appellee. Also 

represented by JAMIE LUCIA, San Francisco, CA; 

KATHERINE DOROTHY CAPPAERT, Washington, DC.

______________________
2 BIODELIVERY SCIS. INT’L v. AQUESTIVE THERAPEUTICS, INC.

Before PROST, Chief Judge, NEWMAN, LOURIE, DYK, 

MOORE, O’MALLEY, REYNA, WALLACH, TARANTO, CHEN, 

and HUGHES, Circuit Judges.

∗

NEWMAN, Circuit Judge, dissents from the denial of the 

petition for rehearing en banc.

PER CURIAM.

O R D E R

Appellant BioDelivery Sciences International, Inc.

filed a petition for rehearing en banc. A response to the 

petition was invited by the court and filed by appellee 

Aquestive Therapeutics, Inc. The petition for rehearing

and response were first referred to the panel, and thereafter, to the circuit judges who are in regular active service. 

A poll was requested, taken, and failed. 

Upon consideration thereof,

IT IS ORDERED THAT:

The petition for panel rehearing is denied.

The petition for rehearing en banc is denied.

The mandate of the court will be issued on January 21, 

2020.

 FOR THE COURT

January 13, 2020 /s/ Peter R. Marksteiner

 Date Peter R. Marksteiner

 Clerk of Court

 

∗ Circuit Judge Stoll did not participate.
United States Court of Appeals 

for the Federal Circuit ______________________

BIODELIVERY SCIENCES INTERNATIONAL, INC.,

Appellant

v.

AQUESTIVE THERAPEUTICS, INC., FKA 

MONOSOL RX, LLC,

Appellee

______________________

2019-1643, 2019-1644, 2019-1645

______________________

Appeals from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board in Nos. IPR2015-

00165, IPR2015-00168, IPR2015-00169.

______________________

NEWMAN, Circuit Judge, dissenting from denial of the petition for rehearing en banc.

The court has declined to rehear this appeal en banc. I 

write because of the significance of the balance of agency

and judicial authority, and the rules of procedural law in 

the administrative state.

The issue arises from the response of the Patent Trial 

and Appeal Board to the Federal Circuit’s mandate and order to apply the Supreme Court’s decision in SAS Institute

Inc. v. Iancu, 138 S. Ct. 1348 (2018). In SAS Institute the 

Supreme Court held that 35 U.S.C. § 318(a) requires that

in an inter partes review the PTAB must decide all of the 

claims and grounds challenged in the petition. Id. at 1354–
2 BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC.

58. Since the PTAB had not met this requirement for these 

cases, our Remand Order instructed:

The Court held that if the Director institutes review proceedings, the PTAB review must proceed 

“in accordance with or in conformance to the petition,” including “ ‘each claim challenged’ and ‘the 

grounds on which the challenge to each claim is 

based.’ ”

BioDelivery Sciences Int’l, Inc. v. Aquestive Therapeutics, 

Inc., 898 F.3d 1205, 1207 (Fed. Cir. 2018) (“Remand Order”) (quoting SAS Institute, 138 S. Ct. at 1355–56).

The PTAB did not comply with the Remand Order, 

stating that it would be inefficient and expensive to include 

the additional claims and grounds:

Because the overwhelming majority of unpatentability grounds presented by Petitioner fail to meet 

the standard for institution of inter partes review, 

we find that instituting trial as to those grounds at 

this time is neither in the interest of the efficient 

administration of the Office, nor in the interest of 

securing an inexpensive resolution of this proceeding.

BioDelivery Sciences Int’l, Inc. v. Aquestive Therapeutics, 

Inc., No. IPR2015-00165, 2019 WL 494351, at *3 (P.T.A.B. 

Feb. 7, 2019) (“Decision on Remand”).1

Instead of complying with the Remand Order, the 

PTAB withdrew all of its past actions as to these proceedings, although past actions were not the subject of the remand. Neither this court’s order nor the Supreme Court’s 

 

1 This is a consolidated appeal of the PTAB’s three 

separate decisions in IPR2015-00165, IPR2015-00168, and 

IPR2015-00169; citations to IPR 2015-00165 apply to all 

three PTAB decisions.
BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC. 3

ruling in SAS Institute related to aspects that had already 

been decided. Nonetheless, my colleagues hold that the 

PTAB is not required to comply with the court’s Remand

Order, and further hold that this non-compliance is not reviewable. This action raises critical issues of agency authority, judicial responsibility, and the constitutional plan.

DISCUSSION

For U.S. Patent No. 8,765,167, BioDelivery Sciences 

International, Inc. (“BioDelivery”)’s petition requested inter partes review of claims 1, 4, 6–9, 11, 12, 26, 27, 32, 38, 

44, 51, 58, 65, 72, 82, 109, and 125–127, citing seven prior 

art grounds of anticipation or obviousness. BioDelivery 

Sciences Int’l, Inc. v. Monosol RX, LLC, No. IPR2015-

00165, 2015 WL 2452905, at *1–2 (P.T.A.B. May 20, 2015). 

On May 20, 2015 the PTAB instituted the IPR on most, but 

not all of the challenged claims, and on one of the prior art 

grounds. Id. at *18. The PTAB received briefing and argument and held trial, and ruled by Final Written Decision 

that claims 1, 4, 11, 12, 26, 27, 44, 51, 58, 65, 72, 82, and 

125–127 are patentable. BioDelivery Sciences Int’l, Inc. v. 

Monosol RX, LLC, No. IPR2015-00165, 2016 WL 

11447939, at *14 (P.T.A.B. Mar. 24, 2016).

BioDelivery appealed, and we received briefing and argument. The Supreme Court then decided SAS Institute,

stating that “Congress’s prescribed policy here is clear: the 

petitioner in an inter partes review is entitled to a decision 

on all the claims it has challenged.” 138 S. Ct. at 1358. On 

BioDelivery’s motion, we directed the PTAB “to implement 

the Court’s decision in SAS.” Remand Order at 1210.

The PTAB did not comply with the Remand Order. Instead, the PTAB asked the parties for advice, and received 

directly opposing positions. The PTAB decided to “modify 

[its] Decision to Institute and instead deny the Petition in 

its entirety, thereby terminating [the] proceeding.” Decision on Remand at *1. The PTAB “ORDERED that Petitioner’s request for inter partes review of claims 1, 4, 6–9, 
4 BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC. 

11, 12, 26, 27, 32, 38, 44, 51, 58, 65, 72, 82, 125–127 of the 

’167 patent is denied and no inter partes review is instituted.” Id. at *12. 

The court now ratifies that action. However, the America Invents Act does not include agency authority to disregard the mandate, instead the Federal Circuit’s “mandate 

and opinion . . . shall govern the further proceedings in the 

case:” 

35 U.S.C. § 144. The United States Court of Appeals for the Federal Circuit shall review the decision from which an appeal is taken on the record 

before the Patent and Trademark Office. Upon its 

determination the court shall issue to the Director 

its mandate and opinion, which shall be entered of 

record in the Patent and Trademark Office and 

shall govern the further proceedings in the case.

Appellate courts may remand for further proceedings, “as 

may be just under the circumstances:” 

28 U.S.C. § 2106. The Supreme Court or any other 

court of appellate jurisdiction may . . . remand the 

cause and direct the entry of such appropriate judgment, decree, or order, or require such further proceedings to be had as may be just under the 

circumstances.

The further proceedings here relate to implementing SAS 

Institute as to the additional claims and grounds. The remand did not include review of the decision to institute 

these IPRs. 

My concern is with the PTAB’s position that it need not 

follow the court’s Remand Order, for reasons of efficiency 

and expense. Such agency authority cannot be discerned 

in the America Invents Act, and contravenes decades of 

constitutional jurisprudence. E.g., Chi. & S. Air Lines, Inc. 

v. Waterman S.S. Corp., 333 U.S. 103, 113 (1948):
BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC. 5

Judgments, within the powers vested in courts by 

the Judiciary Article of the Constitution, may not 

lawfully be revised, overturned or refused faith and 

credit by another Department of Government.

See also Plaut v. Spendthrift Farm, Inc., 514 U.S. 211, 218 

(1995) (“Congress cannot vest review of the decisions of Article III courts in officials of the Executive Branch.”).

In SAS Institute the Court reiterated that “the duty of 

an administrative agency is to follow its commands as written, not to supplant those commands with others it may 

prefer.” 138 S. Ct. at 1355. See City of Cleveland v. Fed. 

Power Comm’n, 561 F.2d 344, 346 (D.C. Cir. 1977) (footnotes omitted):

The decision of a federal appellate court establishes 

the law binding further action in the litigation by 

another body subject to its authority. . . . These 

principles, so familiar in operation within the hierarchy of judicial benches, indulge no exception for 

reviews of administrative agencies.

Judicial authority may be manifested in orders on remand. 

See Mefford v. Gardner, 383 F.2d 748, 758 (6th Cir. 1967):

[O]n the remand of a case after appeal, it is the 

duty of the lower court, or the agency from which 

appeal is taken, to comply with the mandate of the 

court and to obey the directions therein without 

variation . . . . 

The Administrative Procedure Act “directs courts to set 

aside agency action ‘not in accordance with law’ or ‘in excess of statutory jurisdiction, authority, or limitations.’” 

SAS Institute, 138 S. Ct. at 1359 (quoting 5 U.S.C. 

§§ 706(2)(A),(C)). Agency action is bound by the mandate 

rule:

The mandate rule . . . dictates that ‘an inferior 

court has no power or authority to deviate from the 
6 BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC.

mandate issued by an appellate court.’ Once a 

question has been considered and decided by an appellate court, the issue may not be reconsidered at 

any subsequent stage of the litigation, save on appeal.

Banks v. United States, 741 F.3d 1268, 1276 (Fed. Cir. 

2014) (citation omitted) (quoting Briggs v. Pa. R. Co., 334 

U.S. 304, 306 (1948)). These premises are beyond debate.

The PTAB has elsewhere recognized its obligation to 

comply with a judicial mandate, stating: “As an initial matter, we recognize that we are bound by the mandate on 

matters that the mandate addressed.” Zodiac Pool Sys., 

Inc. v. Aqua Prods., Inc., No. IPR2013-00159, 2019 WL 

548667, at *9 (P.T.A.B. Feb. 11, 2019). 

The PTAB acknowledged an Office SAS Guidance on

how to proceed following the decision in SAS Institute. The 

Office SAS Guidance states: “for pending trials in which a 

panel has instituted trial only on some of the challenges 

raised in the petition . . . the panel may issue an order supplementing the institution decision to institute on all challenges raised in the petition.”2 “[T]he Office SAS Guidance 

is to be interpreted with the weight of Office policy as precluding termination of a partially instituted proceeding in 

response to SAS Institute.” ESET, LLC v. Finjan, Inc., No. 

IPR2017-01738, 2018 WL 3854167, at *4 (P.T.A.B. Aug. 10, 

2018). Here, the PTAB mentioned the Office SAS Guidance but did not follow it, stating that it applies only to 

“pending trials” and does not apply to judicial remands. 

Decision on Remand at *4.

 

2 Guidance on the Impact of SAS on AIA Trial Proceedings, U.S. Patent & Trademark Office (Apr. 26, 2018), 

https://www.uspto.gov/patents-application-process/patenttrial-and-appeal-board/trials/guidance-impact-sas-aiatrial (“Office SAS Guidance”).
BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC. 7

Thus the PTAB departed from not only the letter but 

also the spirit of the Remand Order. However, the “letter 

and spirit” of a mandate control actions on remand. See 

SUFI Network Servs., Inc. v. United States, 817 F.3d 773, 

779 (Fed. Cir. 2016) (“[B]oth the letter and the spirit of the 

mandate must be considered.”); Laitram Corp. v. NEC 

Corp., 115 F.3d 947, 951 (Fed. Cir. 1997) (“[A]ctions on remand should not be inconsistent with either the letter or 

the spirit of the mandate.”).

The panel herein held that this PTAB action is not reviewable. I repeat, the court’s Remand Order was not for 

review of the PTAB’s “institution” decisions; the Remand 

Order was to review additional claims and grounds. See

St. Jude Med., Cardiology Div., Inc. v. Volcano Corp., 749 

F.3d 1373, 1375 (Fed. Cir. 2014) (“The statute separates 

the Director’s decision to ‘institute’ the review, § 314, on 

one hand, from the Board’s ‘conduct’ of the review ‘instituted’ by the Director, § 316(c), and the Board’s subsequent 

‘written decision,’ § 318, on the other.”) The legislative record contains no contemplation of a PTAB procedure 

whereby, after full PTAB trial and decision and appeal to 

the Federal Circuit, the PTAB could annul the appeal and 

remove the entire action and decisions and procedure from 

history, insulated from review.

The Supreme Court has observed that “the agency 

bears a ‘heavy burden’ in attempting to show that Congress 

‘prohibit [ed] all judicial review’ of the agency’s compliance 

with a legislative mandate.” Mach Mining, LLC v. EEOC, 

575 U.S. 480, 486 (2015) (alteration in original) (quoting 

Dunlop v. Bachowski, 421 U.S. 560, 567 (1975)). In SAS 

Institute the Court reiterated that “nothing in 

§ 314(d) . . . withdraws our power to ensure that an inter 

partes review proceeds in accordance with the law’s demands” and “everything in the statute before us confirms 

that SAS is entitled to a final written decision addressing 

all of the claims it has challenged.” 138 S. Ct. at 1359. The 

PTAB’s refusal to comply with our Remand Order to
8 BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC.

implement the Supreme Court’s ruling warrants en banc

attention.

Of further concern is the PTAB’s contravention of the 

purpose of the America Invents Act, to provide agency expertise to resolution of patentability issues. See H.R. Rep. 

No. 112–98, pt. 1, at 48 (2011) (“[T]he purpose of the [postgrant review proceedings is to] provid[e] quick and cost effective alternatives to litigation.”); 157 Cong. Rec. S1352 

(daily ed. Mar. 8, 2011) (statement of Sen. Udall) (“These 

proceedings are intended to serve as a less-expensive alternative to courtroom litigation and provide additional access 

to the expertise of the Patent Office on questions of patentability.”). On this background, the PTAB’s explanation of 

agency efficiency and cost is curious, as litigation cost was 

a primary concern of the America Invents Act.

In the interest of achieving a viable and effective administrative process, and the nation’s critical need for an 

effective system of innovation law and practice, the PTAB’s 

action is seriously flawed. From my colleagues’ inaction, I 

respectfully dissent.