Purdue Pharma L.p., Purdue Pharmaceuticals L.p. v. Collegium Pharmaceutical, Inc.

United States Court of Appeals
for the Federal Circuit
______________________
PURDUE PHARMA L.P., PURDUE
PHARMACEUTICALS L.P.,
Appellants
v.
COLLEGIUM PHARMACEUTICAL, INC.,
Appellee
KATHERINE K. VIDAL, UNDER SECRETARY OF
COMMERCE FOR INTELLECTUAL PROPERTY
AND DIRECTOR OF THE UNITED STATES
PATENT AND TRADEMARK OFFICE,
Intervenor
______________________
2022-1482
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. PGR2018-
00048.
______________________
Decided: November 21, 2023
______________________
J ENNIFER L. SWIZE, Jones Day, Washington, DC, ar-
gued for appellants. Also represented by G REGORY A.
CASTANIAS , J OHN R. BOULE, III; G ASPER L AROSA, J OHN
J OSEPH N ORMILE, JR., New York, NY; P ABLO D ANIEL
HENDLER , Potomac Law Group PLLC, New York, NY.
Case: 22-1482 Document: 58 Page: 1 Filed: 11/21/2023

-- 1 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 2
CHRISTOPHER A. P INAHS , Robins Kaplan LLP, Minne-
apolis, MN, argued for appellee. Also represented by
J ACOB M. H OLDREITH , BRENDA L. J OLY , EMILY T REMBLAY ;
O REN D. L ANGER, New York, NY.
F ARHEENA YASMEEN R ASHEED, Office of the Solicitor,
United States Patent and Trademark Office, Alexandria,
VA, argued for intervenor. Also represented by P ETER J.
AYERS , MAUREEN D ONOVAN Q UELER .
______________________
Before D YK, HUGHES , and STOLL , Circuit Judges.
D YK, Circuit Judge.
Purdue Pharma L.P. (“Purdue”) appeals from a judg-
ment of the Patent Trial and Appeal Board (“Board”) find-
ing claims 1–17 of U.S. Patent No. 9,693,961 (“’961 patent”)
unpatentable for lack of written description and anticipa-
tion. The Board issued its Final Written Decision after the
statutory deadline, concluding that the passing of the dead-
line did not deprive it of authority. Purdue contends the
Board lost jurisdiction once the deadline passed, and that,
if the Board did not lose jurisdiction, the Board’s decision
was incorrect. We affirm.
BACKGROUND
Purdue is the owner of the ’961 patent which issued on
July 4, 2017. The patent is titled “Pharmaceutical Formu-
lation Containing Gelling Agent” and is meant to “pre-
vent[] or deter[] the abuse of opioid analgesics by the
inclusion of at least one aversive agent in the dosage form.”
’961 patent, col. 5, ll. 54–56. Specifically, the addition of an
aversive agent “helps to prevent injection, inhalation,
and/or oral abuse by decreasing the ‘attractiveness’ of the
dosage form to a potential abuser.” Id. at col. 2, ll. 59–61.
Representative claim 1 recites:
Case: 22-1482 Document: 58 Page: 2 Filed: 11/21/2023

-- 2 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 3
1. A method of preparing an abuse deterrent con-
trolled release dosage form comprising:
combining oxycodone or a pharmaceuti-
cally acceptable salt thereof as active
agent, polyglycolyzed glycerides, a C12 to
C40 fatty acid or a mixture thereof, car-
nauba wax and beeswax, to form a homog-
enous mixture, wherein the oxycodone or
pharmaceutically acceptable salt thereof is
the sole active agent in the dosage form;
preparing particles from the homogenous
mixture; and containing the particles in a
capsule;
the abuse deterrent dosage form providing
a therapeutic effect for about 12 hours or
longer when orally administered to a hu-
man patient, and
the abuse deterrent dosage form being
abuse deterrent when subjected to tamper-
ing comprising heating at a temperature
greater than about 45° C.
Id. at col. 41, ll. 37–52.
Purdue brought suit against Collegium Pharmaceuti-
cal, Inc. (“Collegium”) for infringement of the ’961 patent
in September 2017. On March 13, 2018, Collegium peti-
tioned the Board for post grant review (“PGR”) of claims 1–
17 of the ’961 patent. The district court infringement case
proceeded in parallel to the PGR.
In the PGR, Purdue argued that the ’961 patent was
not subject to PGR as it claimed priority to an August 6,
2001, application, and applications filed before March 16,
2013, were not subject to PGR. The Board found the chal-
lenged claims eligible for PGR because the pre-America In-
vents Act (“AIA”) application to which Purdue claimed
Case: 22-1482 Document: 58 Page: 3 Filed: 11/21/2023

-- 3 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 4
priority did not contain sufficient written description sup-
port for the claimed invention, and the effective filing date
was therefore after March 16, 2013. Based on that finding,
and a finding of likely lack of sufficient written description
in the ’961 patent itself, the Board instituted PGR. Under
35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c), the Board
had one year to issue a Final Written Decision subject to a
six-month extension for “good cause.”
On September 24, 2019, Purdue filed a Notice of Bank-
ruptcy Filing and Imposition of Automatic Stay. The Board
subsequently stayed the PGR proceeding, and the parallel
district court case was also stayed.
The one-year deadline fell on October 4, 2019. Before
the deadline, on October 2, 2019, the Chief Administrative
Patent Judge found good cause to grant a six-month exten-
sion so the bankruptcy court could assess whether the au-
tomatic stay applied to PGRs. Petitioner Collegium took
the position that the Automatic Stay provision was not ap-
plicable to Board proceedings. Purdue contended that the
bankruptcy automatic stay applied to PGRs. The Board
advised that “Petitioner should seek any relief it deems ap-
propriate from the Bankruptcy Court.” J.A. 868.
Neither party sought guidance from the bankruptcy
court nor asked the bankruptcy court to lift the stay during
the six-month extension period. The April 4, 2020, ex-
tended deadline passed. On July 2, 2020, Purdue moved at
the bankruptcy court for the automatic stay to be partially
lifted so the district court case could proceed. Collegium
opposed the request and argued that if the stay were lifted
for the district court case, it should also be lifted for the
PGR proceeding. The bankruptcy court lifted the stay for
both the district court case and the PGR proceeding on Sep-
tember 1, 2020.
On September 11, 2020, Purdue filed a motion to ter-
minate the PGR proceeding, arguing the Board no longer
had the authority to issue a Final Written Decision as the
Case: 22-1482 Document: 58 Page: 4 Filed: 11/21/2023

-- 4 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 5
18-month deadline had passed. On November 19, 2021, the
Board denied Purdue’s motion, explaining that “[a]pplying
the principles from the Supreme Court cases assessing
statutes without consequences for noncompliance with
time limits, we hold that, under the circumstances of this
case, the AIA’s silence as to a consequence for timely issu-
ing a final written decision does not divest us of our author-
ity to issue our final written decision.” J.A. 78. That same
day the Board issued its Final Written Decision, finding
claims 1–17 of the ’961 patent unpatentable for lack of writ-
ten description and anticipation.1
Purdue appeals. We have jurisdiction under 28 U.S.C.
§ 1295(a)(4)(A).2
1 The anticipation finding flowed from the lack of
written description in the claimed priority application.
It is unclear why the Board took over a year after the
stay was lifted to issue its Final Written Decision. As an
intervenor in the case, the Patent and Trademark Office
(“PTO”) claims it was the result of Purdue’s late argument
that the Board lacked authority to issue a Final Written
Decision, which necessitated more briefing. Additionally,
because of the length of this PGR proceeding, there was
turnover in the panel, and two panel change orders were
issued.
2 Collegium argues that Purdue’s appeal was not
timely as it occurred more than sixty-three days after the
Board issued its Final Written Decision. We disagree that
Purdue solely sought review of the motion to terminate,
which Collegium argues is subject to a fourteen-day dead-
line pursuant to 37 C.F.R. § 42.71(d)(1). Purdue also
sought Director review of the Final Written Decision
which, contrary to Collegium’s argument, was subject to a
thirty-day deadline. This tolled Purdue’s time to appeal,
and once the Director denied review on February 7, 2022,
Purdue timely appealed on February 16, 2022.
Case: 22-1482 Document: 58 Page: 5 Filed: 11/21/2023

-- 5 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 6
D ISCUSSION
I
Purdue contends that if the Board fails to meet the
deadline established by 35 U.S.C. § 326(a)(11) and 37
C.F.R. § 42.200(c) (one year plus the six-month extension),
the Board no longer has the authority to issue a Final Writ-
ten Decision. This appears to be the only proceeding in
which the Board has failed to meet the statutory deadline,
and this is accordingly a matter of first impression. Statu-
tory interpretation is an issue of law reviewed de novo. Fa-
cebook, Inc. v. Windy City Innovations, LLC, 973 F.3d 1321,
1330 (Fed. Cir. 2020).
Section 326(a)(11) of Title 35 provides:
(a) Regulations—The Director shall prescribe regu-
lations—
. . .
(11) requiring that the final determination
in any post-grant review be issued not later
than 1 year after the date on which the Di-
rector notices the institution of a proceed-
ing under this chapter, except that the
Director may, for good cause shown, extend
the 1-year period by not more than 6
months, and may adjust the time periods in
this paragraph in the case of joinder under
section 325(c)[.]
And 37 C.F.R. § 42.200(c) provides:
(c) A post-grant review proceeding shall be admin-
istered such that pendency before the Board after
institution is normally no more than one year. The
time can be extended by up to six months for good
cause by the Chief Administrative Patent Judge, or
adjusted by the Board in the case of joinder.
Case: 22-1482 Document: 58 Page: 6 Filed: 11/21/2023

-- 6 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 7
The Supreme Court has established that “if a statute
does not specify a consequence for non-compliance with
statutory timing provisions, the federal courts will not in
the ordinary course impose their own coercive sanction.”
United States v. James Daniel Good Real Prop., 510 U.S.
43, 63 (1993); see also Nielsen v. Preap, 139 S. Ct. 954, 967
(2019); Dolan v. United States, 560 U.S. 605, 611 (2010);
Barnhart v. Peabody Coal Co., 537 U.S. 149, 159 (2003);
Regions Hosp. v. Shalala, 522 U.S. 448, 459 n.3 (1998);
United States v. Montalvo-Murillo, 495 U.S. 711, 717
(1990). We have “faithfully applied this rule of law as for-
mulated by the Supreme Court . . . that, ‘even in the face of
a statutory timing directive, when a statute does not spec-
ify the consequences of non-compliance, courts should not
assume that Congress intended that the agency lose its
power to act.’” Hitachi Home Elecs. (Am.), Inc. v. United
States, 661 F.3d 1343, 1347 (Fed. Cir. 2011) (quoting
Liesegang v. Sec’y of Veterans Affs., 312 F.3d 1368, 1376–
77 (Fed. Cir. 2002)); see also Transpacific Steel LLC v.
United States, 4 F.4th 1306, 1320–21 (Fed. Cir. 2021).
Where “the statute does not specify” the “consequences of
the missed deadline . . . [the Supreme] Court has looked to
statutory language, to the relevant context, and to what
they reveal about the purposes that a time limit is designed
to serve,” in order to determine the impact of the deadline.
Dolan, 560 U.S. at 610. The statute at issue here does not
provide consequences for non-compliance with the dead-
line.
Thus, following the Supreme Court’s rule, the Board
has authority to issue a Final Written Decision even after
the deadline proscribed in the statute has passed absent
any contrary indication in the language, structure, or leg-
islative history of the statute.
A
Purdue argues there are indications in the statutory
language that support the view that the Board loses its
Case: 22-1482 Document: 58 Page: 7 Filed: 11/21/2023

-- 7 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 8
authority to issue a Final Written Decision after the dead-
line expires.
First, Purdue argues that the use of “shall” and “requir-
ing” in section 326(a)(11) deprives the Board of authority
to issue a Final Written Decision after the deadline. Pur-
due’s argument is contrary to the Supreme Court’s decision
in Brock. In Brock, the Court held the “requirement that
the Secretary ‘shall’ take action within 120 days does not,
standing alone, divest the Secretary of jurisdiction to act
after that time.” Brock v. Pierce Cnty., 476 U.S. 253, 266
(1986). Purdue contends that Brock is distinguishable be-
cause the statute contains more than just “shall . . . stand-
ing alone,” see id., because it reads the “Director shall
prescribe regulations– . . . requiring that the final determi-
nation in any post-grant review be issued not later than 1
year.” 35 U.S.C. § 326(a)(11) (emphases added). The word
“requiring” simply is the equivalent of “shall,” and Brock
governs.
Second, Purdue, relying on French v. Edwards, 80 U.S.
506 (1871), contends that the “negative words” of “not later
than 1 year” and “by not more than 6 months” in sec-
tion 326(a)(11) show “the acts required shall not be done in
any other manner or time than that designated.” Id. at
511. But French did not involve a statutory deadline, and
in later cases, the Supreme Court has held that similar
statutory language as that involved here does not result in
a loss of authority. Barnhart, 537 U.S. at 161 (statute set
the deadline as “not later than 60 days after the enactment
date”); Dolan, 560 U.S. at 607 (statute required action “not
to exceed 90 days after sentencing”). Similarly, we have
held that a statute containing “not later than” created “tim-
ing provisions [that] are at best precatory rather than man-
datory.” Liesegang, 312 F.3d at 1371, 1377.
Third, Purdue contends the statutory language bars ac-
tion after the statutory deadline because section 326(a)(11)
is linked to the Board’s jurisdictional grant in section 6 of
Case: 22-1482 Document: 58 Page: 8 Filed: 11/21/2023

-- 8 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 9
35 U.S.C. Section 326(c) provides that “[t]he Patent Trial
and Appeal Board shall, in accordance with section 6, con-
duct each post-grant review instituted under this chapter”
(emphasis added). The Board has identified section 6 as
the source of its jurisdiction, see J.A. 3, thus Purdue argues
that when the deadline in section 326(a)(11) passes, the
Board’s jurisdiction also expires. This is not correct. The
Supreme Court has “repeatedly held that procedural rules,
including time bars, cabin a court’s power only if Congress
has ‘clearly state[d]’ as much” and “absent such a clear
statement, . . . ‘courts should treat the restriction as non-
jurisdictional.’” United States v. Wong, 575 U.S. 402, 409
(2015) (alteration in original) (quoting Sebelius v. Auburn
Reg’l Med. Ctr., 568 U.S. 145, 153 (2013)). The mere men-
tion that PGRs shall be conducted “in accordance” with sec-
tion 6 or PGRs be conducted “pursuant to” chapter 32 does
not rise to the level of a clear statement that sec-
tion 326(a)(11) is jurisdictional.
Fourth, Purdue argues that the exceptions in sec-
tion 326(a)(11) for “good cause” and “joinder” show those
are the only two limited circumstances under which the
Board may issue a Final Written Decision after the one-
year deadline.3 Purdue further argues this precludes rec-
ognizing other exceptions, relying on United States v. John-
son, 529 U.S. 53, 58 (2000). The existence of statutory
exceptions does not show that the Board is without author-
ity to act once the deadline passes. In Barnhart, the stat-
ute provided for two exceptions to the deadline and the
Court ultimately held the “[i]nitial assignment[s] made af-
ter [the deadline were] valid despite [their] untimeliness.”
3 Section 326(a)(11) provides two exceptions to the
one-year deadline. “[T]he Director may, for good cause
shown, extend the 1-year period by not more than 6
months, and may adjust the time periods in this paragraph
in the case of joinder under section 325(c).”
Case: 22-1482 Document: 58 Page: 9 Filed: 11/21/2023

-- 9 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 10
Barnhart, 537 U.S. at 152.4 The Court found that “enunci-
ation of two exceptions does not imply an exclusion of a
third,” “nor does it require the absolute finality of assign-
ments urged by the companies.” Barnhart, 537 U.S. at
170–71. Thus, exceptions to the deadline do not strip the
Board of authority to issue a Final Written Decision after
the deadline passed.
Finally, it is significant that section 328(a) mandates
that the Board issue a Final Written Decision. And other
provisions of the AIA use quite different language to bar
action after deadlines pass. Section 315(b) contains ex-
plicit language denying agency power after a time dead-
line, saying “[a]n inter partes review may not be instituted
if the petition requesting the proceeding is filed more than
1 year after the date on which the petitioner . . . is served
with a complaint alleging infringement of the patent.” (em-
phasis added); see also section 321(c) (“A petition for a post-
grant review may only be filed not later than the date that
is 9 months after the date of the grant of the patent or of
the issuance of a reissue patent” (emphasis added)). Had
Congress meant to deprive the agency of power in sec-
tion 326(a)(11), it knew how to do it, and, significantly, it
did not use language in section 326(a)(11) similar to that
used in other sections.
4 The statute in Barnhart provided that the Commis-
sioner of Social Security “shall, before October 1, 1993,” as-
sign each coal industry retiree who was eligible for benefits
under the Coal Act to an operating company to fund said
benefits. 26 U.S.C. § 9706(a); Barnhart, 537 U.S. at 152.
There were “two exceptions [to the deadline] recognizing
changes for initial error or the demise of an assignee oper-
ator.” Barnhart, 537 U.S. at 170 (referring to 26 U.S.C.
§ 9704(f)(2)).
Case: 22-1482 Document: 58 Page: 10 Filed: 11/21/2023

-- 10 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 11
B
Just as the structure of the statute does not support
denying the Board authority after the deadline, the legis-
lative history likewise does not support denying the au-
thority to act after the one-year period passes. Congress
enacted the AIA in part to replace inter partes reexamina-
tions. Congress complained that inter partes reexamina-
tions were lengthy and inefficient, often lasting three to
five years. 157 Cong. Rec. 3429 (Mar. 8, 2011). The AIA
provided for PGRs and IPRs, which were “designed to allow
parties to challenge a granted patent through a[n] expedi-
tious and less costly alternative to litigation.” Introduction
of Patent Reform Act, 153 Cong. Rec. E774 (Apr. 18, 2007).
Congress had a clear intent to make patent review expedi-
tious, which was reflected in the deadline in sec-
tion 326(a)(11). But the importance of the deadline does
not support denying authority after the deadline passes.
To the contrary, forbidding the Board to issue a Final Writ-
ten Decision after the deadline has passed would go against
Congressional intent. If the Board could not issue a Final
Written Decision, the parties would be forced to pursue the
issue in district court litigation. This is the exact opposite
of the purpose of the AIA, which is meant to create a more
efficient alternative to district court litigation. Further,
some of the work done during the PGR would be lost and
the parties would have to duplicating briefing and argu-
ments. This certainly is not the efficient process contem-
plated by the AIA.
Purdue argues that under the Board’s reading “[sec-
tion] 326(a)(11) would mean nothing more than the unde-
fined timing for reexamination that Congress disliked and
replaced.” Brief of Appellants Purdue Pharma L.P. and
Purdue Pharmaceuticals L.P. at 15. This is not accurate.
The Board may not ignore statutory deadlines. See, e.g.,
Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1426 (Fed. Cir. 1988)
(holding the Board may not indefinitely stay an ex parte
reexamination in light of parallel district court litigation
Case: 22-1482 Document: 58 Page: 11 Filed: 11/21/2023

-- 11 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 12
via the “special dispatch” standard). “[W]hen an agency is
compelled by law to act within a certain time period . . . a
court can compel the agency to act.” Norton v. Southern
Utah Wilderness All., 542 U.S. 55, 65 (2004). The appro-
priate remedy is mandamus. Telecommunications Rsch. &
Action Ctr. v. F.C.C., 750 F.2d 70, 76 (D.C. Cir. 1984);
Mylan Lab’ys Ltd. v. Janssen Pharmaceutica, N.V., 989
F.3d 1375, 1380–81 (Fed. Cir. 2021) (quoting Int’l Union,
United Mine Workers of Am. v. U.S. Dep’t of Lab., 358 F.3d
40, 43 (D.C. Cir. 2004)) (“[U]nreasonable delay of agency
action . . . ‘defeats [our] prospective jurisdiction’ . . . [t]o
protect our future jurisdiction, we have jurisdiction to re-
view [a] petition for a writ of mandamus”); In re Paralyzed
Veterans of Am., 392 F. App’x 858, 859–860 (Fed. Cir. 2010)
(non-precedential); see also 5 U.S.C. § 706(1). Contrary to
the PTO’s arguments, mandamus is available immediately
upon the deadline’s expiring, assuming that the other re-
quirements for issuance of the writ are satisfied. There is
no requirement to show unreasonable delay in the issuance
of the decision—only that the deadline has passed.
Here, Purdue had an available mandamus remedy and
simply chose not to seek to compel an earlier decision from
the Board. Failure to seek relief by mandamus does not,
however, mean a loss of the Board’s authority to act. 5
5 We do not reach the question of whether the bank-
ruptcy automatic stay applies to PGRs. This would require
interpretation of the Bankruptcy Code. The Bankruptcy
Code provides that a bankruptcy petition stays “the com-
mencement or continuation . . . of a judicial, administra-
tive, or other action or proceeding against the debtor.” 11
U.S.C. § 362(a)(1). There is an exception to the automatic
stay for “the commencement or continuation of an action or
proceeding by a governmental unit . . . to enforce such gov-
ernmental unit’s or organization’s police and regulatory
Case: 22-1482 Document: 58 Page: 12 Filed: 11/21/2023

-- 12 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 13
Despite Purdue’s numerous arguments for cabining the
Board’s authority, we conclude that the Board’s failure to
comply with the statutory deadline does not deprive it of
authority thereafter to issue a final written decision.
II
Having concluded the Board retained the authority to
act, we consider the Board’s holding that the claims lacked
written description support.6 Whether a patent claim sat-
isfies the written description requirement of 35 U.S.C.
§ 112 is a question of fact reviewed for substantial evi-
dence. Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1354
(Fed. Cir. 2015). To satisfy the written description require-
ment, the description must “clearly allow persons of ordi-
nary skill in the art to recognize that [the inventor]
invented what is claimed.” Ariad Pharm., Inc. v. Eli Lilly
& Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (al-
teration in original) (quoting Vas-Cath Inc. v. Mahurkar,
935 F.2d 1555, 1563 (Fed. Cir. 1991)). “[T]he test for suffi-
ciency is whether the disclosure of the application relied
upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of
the filing date.” Id. We have required that the specifica-
tion “provide sufficient ‘blaze marks’ to guide a reader
through the forest of disclosed possibilities toward the
claimed compound.” Novozymes A/S v. DuPont Nutrition
Biosciences APS, 723 F.3d 1336, 1346 (Fed. Cir. 2013). The
power, including the enforcement of a judgment other than
a money judgment, obtained in an action or proceeding by
the governmental unit to enforce such governmental unit’s
or organization’s police or regulatory power.” Id.
§ 362(b)(4). The question is whether this exception applies
to PTO IPR or PGR proceedings.
6 As noted earlier, there was also an anticipation
ground argued in the PGR, which was dependent on writ-
ten description in the priority application.
Case: 22-1482 Document: 58 Page: 13 Filed: 11/21/2023

-- 13 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 14
issue here is whether the ’961 specification adequately dis-
closes the claimed polyglycolyzed glycerides (“PGGs”) as an
aversive agent. The Board found the claimed formulation
was not disclosed. We conclude that substantial evidence
supports the Board’s finding.
Although the ’961 claims on their face do not require
an aversive agent, the specification makes clear that the
claims require “inclusion of at least one aversive agent” and
the parties agree that the claims require the use of an aver-
sive agent. ’961 patent, col. 5, ll. 53–56. The specification
of the ’961 patent states an aversive agent is “a bittering
agent, an irritant, a gelling agent, or combinations
thereof.” Id. at col. 4, ll. 28–29. Long lists of potential bit-
tering agents and gelling agents are provided. See id. at
col. 5, l. 64–col. 6, l. 14; col. 6, l. 64–col. 7, l. 23. Among the
extensive list of possible gelling agents, surfactants are
given as an example. Id. at col. 7, l. 11. Later in the spec-
ification, PGGs are identified as a possible surfactant “use-
ful in accordance with the present invention.” Id. at col.
28, ll. 35–41.
While the specification discloses that some surfactants
can be gelling agents and that gelling agents can satisfy
the aversive agent requirement, the parties agree that not
all surfactants are gelling agents. Oral Argument at
16:54–17:01. The specification does not say that PGGs are
gelling agents, as Purdue’s expert witness admitted. J.A.
3184 (79:9–18, 80:7–11). In fact, the only time PGGs are
mentioned in the specification, they are described as a sur-
factant, and not as a gelling agent, and surfactants gener-
ally are described as “useful in accordance with the present
invention.” ’961 patent, col. 28, ll. 36–37. In other parts of
the specification, the patent recognizes that surfactants
can be used completely separate from and in addition to the
gelling agent. Id. at col. 25, ll. 45–46 (surfactants can be
used as an “absorption enhancer”). Just because the spec-
ification states PGGs are useful for the invention does not
suggest how PGGs are gelling agents. The disclosure of the
Case: 22-1482 Document: 58 Page: 14 Filed: 11/21/2023

-- 14 of 15 --

PURDUE PHARMA L . P. v. COLLEGIUM PHARMACEUTICAL , INC. 15
application does not reasonably convey to those skilled in
the art that the inventor had possession of the claimed
drug formula containing PGGs as a gelling agent (aversive
agent). In other words, there are insufficient blaze marks.
The parties agree that the ’961 patent “has substan-
tially the same disclosures as the specification of” U.S. Pro-
visional Application No. 60/310,534 (“’534 application”) to
which Purdue claims priority. J.A. 14. The specification
for the ’961 patent does not provide adequate written de-
scription support, and neither does the ’534 application.
Because the claims do not satisfy the written description
requirement, we need not reach the issue of anticipation.
CONCLUSION
We affirm that the Board has authority to issue a Final
Written Decision after the statutory deadline has passed.
We also affirm the Board’s determination that claims 1–17
of the ’961 patent are unpatentable for lack of written de-
scription under 35 U.S.C. § 112.
AFFIRMED
Case: 22-1482 Document: 58 Page: 15 Filed: 11/21/2023

-- 15 of 15 --