Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC

United States Court of Appeals
for the Federal Circuit
______________________
ALLGENESIS BIOTHERAPEUTICS INC.,
Appellant
v.
CLOUDBREAK THERAPEUTICS, LLC,
Appellee
______________________
2022-1706
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2020-
01438.
______________________
Decided: November 7, 2023
______________________
D ONALD J. MIZERK, Husch Blackwell LLP, Chicago, IL,
argued for appellant. Also represented by P HILIP D.
SEGREST , J R.
N ITIKA G UPTA F IORELLA , Fish & Richardson P.C., Wil-
mington, DE, argued for appellee. Also represented by
SARAH J ACK, Minneapolis, MN.
______________________
Before M OORE, Chief Judge, STOLL and CUNNINGHAM ,
Circuit Judges.
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MOORE, Chief Judge.
Allgenesis Biotherapeutics Inc. (Allgenesis) appeals
from an inter partes review final written decision in which
the Patent Trial and Appeal Board held that Allgenesis
failed to prove claims 4 and 5 of U.S. Patent No. 10,149,820
are unpatentable. Because Allgenesis has failed to estab-
lish an injury in fact sufficient to confer standing to appeal,
we dismiss.
BACKGROUND
Cloudbreak Therapeutics, LLC (Cloudbreak) owns the
’820 patent, which discloses compositions and methods for
treating pterygium. ’820 patent at 1:19–22. Pterygium is
an eye condition in which a tumor-like growth extends from
the nasal or temporal side of the eye to the cornea. Id. at
1:26–31, 5:61–63. Historically, the only treatment option
was surgery to remove the growth. Id. at 6:36–42. This
surgery, however, provides no guarantee against tumor re-
currence. Id. Recognizing these drawbacks, the ’820 pa-
tent sought to provide a new treatment option for
pterygium—administering multikinase inhibitors1 to the
eye to inhibit specific growth factors that contribute to tu-
mor growth and hyperemia (i.e., eye redness). Id. at 6:49–
7:2, 7:19–21, 11:17–20. The patent discloses that
nintedanib in particular “may be one of the most powerful
multikinase inhibitors for reducing corneal neovasculari-
zation,” i.e., new blood vessel growth on the front part of
1 The term “multikinase inhibitor” refers to “drug
compounds (e.g., a small molecule) that reduce or inhibit
the expression or activity of two or more kinases, including,
for example, intracellular and/or cell surface protein ki-
nases.” ’820 patent at 8:28–32. Examples of multikinase
inhibitors include nintedanib, pazopanib, and sunitinib.
Id. at 8:47–56.
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the eye that is associated with hyperemia and pterygia. Id.
at 12:3–7; see also id. at 18:2–17.
Claim 4, which depends from claims 1 and 3, is repre-
sentative and recites:
1. [disclaimed] A method for reducing hyperemia
or symptoms thereof in pterygium in an affected
eye of a subject in need of such treatment, without
surgically excising a pterygium, comprising admin-
istering to the affected eye of the subject a thera-
peutically effective amount of a multikinase
inhibitor.
3. [disclaimed] The method of claim 1, wherein the
multikinase inhibitor is administered to the af-
fected eye in the form of topical ocular formulation
or ocular implant.
4. The method of claim 3, wherein the multikinase
inhibitor is nintedanib and the nintedanib is ad-
ministered to the affected eye in the form of a topi-
cal ocular formulation and is administered
topically to the affected eye.
Id. at 24:33–37, 48–54 (emphasis added).
Allgenesis petitioned for IPR of all eleven claims of the
’820 patent. After the Board instituted, Cloudbreak dis-
claimed the genus claims, i.e., claims 1–3 and 6–11, leaving
only claims 4 and 5, which more narrowly claim the use of
nintedanib.
The Board issued a final written decision holding
Allgenesis failed to show claims 4 and 5 are unpatentable.
Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics,
LLC, No. IPR2020-01438, 2022 WL 496909 (P.T.A.B. Feb.
15, 2022) (Decision). The Board first determined Allgenesis
failed to show the claims were anticipated by, or would
have been obvious over, Allgenesis’ PCT Application Publi-
cation No. WO 2016/209555 (Allgenesis’ PCT). Id. at *8–
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27. Specifically, the Board determined Allgenesis’ PCT,
which claims priority to a U.S. provisional application filed
June 22, 2015, does not qualify as prior art because claims
4 and 5 may claim priority to Cloudbreak’s U.S. Provisional
Application No. 62/172,063 (the ’063 provisional), filed
June 6, 2015. Id. In reaching this priority determination,
the Board found the ’063 provisional provides sufficient
written description support for claims 4 and 5. Id. at *12–
17.
The Board also determined Allgenesis failed to show
claims 4 and 5 would have been obvious over King2 and
Amparo.3 Id. at *27–35. The Board determined a skilled
artisan would have been motivated to combine the refer-
ences with a reasonable expectation of success. Id. at *27–
33. But it ultimately held the claims were not unpatenta-
ble in light of objective indicia of nonobviousness, namely
unexpected results. Id. at *33–35. The Board credited the
’820 patent’s description of the unexpected result that
nintedanib provides improved efficacy and has a better
safety profile compared to the closest prior art, sunitinib.
Id. (citing ’820 patent at Table 2, 11:17–24, 12:1–20, 18:2–
18).
Allgenesis appeals, challenging the Board’s finding
that the ’063 provisional provides written description sup-
port for claims 4 and 5 and its unexpected results analysis.
D ISCUSSION
We have jurisdiction to review final decisions of the
Board under 28 U.S.C. § 1295(a)(4)(A). However, Article
2 U.S. Patent Application Publication No.
2013/0012531.
3 Amparo et al., Safety and Efficacy of the Multitar-
geted Receptor Kinase Inhibitor Pazopanib in the Treat-
ment of Corneal Neovascularization, 54 I NVESTIGATIVE
O PHTHALMOLOGY & VISUAL SCI. 537–44 (2013).
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III of the U.S. Constitution limits our jurisdiction to the
adjudication of “Cases” or “Controversies.” U.S. Const. art.
III, § 2, cl. 1. To establish a case or controversy, a party
invoking federal jurisdiction must meet the “irreducible
constitutional minimum of standing.” Lujan v. Defs. of
Wildlife, 504 U.S. 555, 560 (1992). Although a party does
not need Article III standing to file an IPR petition or to
obtain a Board decision, see Cuozzo Speed Techs., LLC v.
Lee, 579 U.S. 261, 279 (2016), the party must establish Ar-
ticle III standing once it seeks review of the Board’s deci-
sion in this Court. Consumer Watchdog v. Wis. Alumni
Rsch. Found., 753 F.3d 1258, 1261 (Fed. Cir. 2014).
To meet the Article III standing requirements, an ap-
pellant must have “(1) suffered an injury in fact, (2) that is
fairly traceable to the challenged conduct of the defendant,
and (3) that is likely to be redressed by a favorable judicial
decision.” Spokeo, Inc. v. Robins, 578 U.S. 330, 338 (2016).
To establish an injury in fact, an appellant must show it
has “suffered ‘an invasion of a legally protected interest’
that is ‘concrete and particularized’ and ‘actual or immi-
nent, not conjectural or hypothetical.’” Id. at 339 (quoting
Lujan, 504 U.S. at 560). As the party seeking judicial re-
view, Allgenesis bears the burden of proving it has stand-
ing. Phigenix, Inc. v. Immunogen, Inc., 845 F.3d 1168, 1171
(Fed. Cir. 2017).
Allgenesis asserts it has standing to appeal the Board’s
decision based on (1) its potential infringement liability
and (2) the Board’s priority determination. We conclude
Allgenesis has failed to meet its burden to establish stand-
ing on either ground.
A
Allgenesis first argues it has suffered an injury in fact
based on the potential infringement liability stemming
from its development of nintedanib treatments for pteryg-
ium. Where an appellant relies on potential infringement
liability as a basis for injury in fact, “it must establish that
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it has concrete plans for future activity that creates a sub-
stantial risk of future infringement or likely cause the pa-
tentee to assert a claim of infringement.” JTEKT Corp. v.
GKN Auto. LTD., 898 F.3d 1217, 1221 (Fed. Cir. 2018). In
support of standing, Allgenesis submitted a declaration
from its Vice President of Finance, Jack Chang. J.A. 5139–
45. Mr. Chang testifies that Allgenesis has been and is
continuing to develop formulations of nintedanib for the
treatment of pterygium and “reasonably expects that
Cloudbreak will seek to enforce [the ’820 patent] against
any product brought to market.” J.A. 5144 ¶ 25; see J.A.
5140 ¶ 5. Mr. Chang, however, fails to identify any specific,
concrete plans for Allgenesis to develop a nintedanib prod-
uct that might implicate claims 4 and 5 of the ’820 patent.
Mr. Chang testifies that “Allgenesis is engaged in re-
search and clinical trials” to develop its nintedanib product
but points only to a Phase II clinical trial completed over
three years ago and a related 2020 publication. J.A. 5140–
41 ¶ 6. He does not identify any of Allgenesis’ development
activities since the completion of its Phase II trial in 2020
or its plans for future clinical development. For example,
he has not identified any plans to conduct Phase III trials4
or seek FDA approval.
4 Allgenesis asserted in its briefing and at oral argu-
ment that it plans to engage in Phase III trials. Appel-
lant’s Opening Br. at 2; Oral Arg. at 10:08–26, available at
https://oralarguments.cafc.uscourts.gov/default.aspx?fl=22
-1706_10042023.mp3. However, there is no record support
for this assertion, as Mr. Chang’s declaration makes no
mention of Phase III trials. See Phigenix, 845 F.3d at 1173
(“[A]n appellant ‘must either identify . . . record evidence
sufficient to support its standing to seek review or, if there
is none because standing was not an issue before the
agency, submit additional evidence to the court of appeals,’
such as ‘by affidavit or other evidence.’” (quoting Sierra
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Rather, Mr. Chang generically states that “Allgenesis
has not abandoned its development of nintedanib and is
continuing to devote resources to the development of this
project.” J.A. 5144 ¶ 25; see also J.A. 5141 ¶ 8 (“Allgenesis
continues to invest in and pursue this project.”); J.A. 5144
¶ 26 (describing Allgenesis’ past expenditures and the
“likely” future cost of bringing the product to market); J.A.
5145 ¶ 28 (“Allgenesis’s concrete future plans to continue
to develop and bring to market its own nintedanib treat-
ments for pterygium pose a substantial risk that Cloud-
break will sue Allgenesis in the future alleging
infringement of the ’820 patent.”). Such conclusory testi-
mony is insufficient to establish that Allgenesis has any
concrete plans to develop and bring to market a nintedanib
treatment for pterygium.
Beyond this, Allgenesis has not shown its activities will
create a substantial risk of infringement or will likely
cause Cloudbreak to assert a claim of infringement.
Allgenesis directs us to settlement conversations between
the parties relating to Allgenesis’ IPR petition. J.A. 5142–
44 ¶¶ 13–17, 19, 21–22, 24 (Chang Decl.). Mr. Chang ex-
plains “the parties were unable to reach a mutually agree-
able settlement that could remove the likelihood of
litigation for patent infringement when Allgenesis brings
its product to market.” J.A. 5144 ¶ 24. These conversa-
tions merely show that Allgenesis reached out to Cloud-
break in relation to Allgenesis’ IPR petition. J.A. 5142
¶¶ 14–15; see also Oral Arg. at 27:44–28:00. Such evidence
is insufficient to show its activities will create a substantial
risk of infringement, especially given that Allgenesis has
made no assertion that Cloudbreak has sued or threatened
to sue Allgenesis if it brings a nintedanib product to mar-
ket. See AVX Corp. v. Presidio Components, Inc., 923 F.3d
Club v. E.P.A., 292 F.3d 895, 899 (D.C. Cir. 2002)) (second
alteration in original)).
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1357, 1365 (Fed. Cir. 2019) (“[Petitioner]’s suspicion that
[Patent Owner] would assert the upheld claims against
[Petitioner] if it had a reasonable basis for doing so does
not mean that there is any reasonable basis right now.” (in-
ternal citation omitted)).
Allgenesis has failed to establish it has nonspeculative,
concrete plans for future activity that creates a substantial
risk of future infringement. We therefore conclude Allgen-
esis has failed to show an injury in fact based on potential
infringement liability.
B
Allgenesis also argues it has suffered an injury in fact
based on the Board’s priority determination. Specifically,
the Board determined claims 4 and 5 of the ’820 patent are
entitled to the June 6, 2015 priority date of the ’063 provi-
sional. Decision, 2022 WL 496909, at *27. Based on this,
the Board determined Allgenesis’ PCT, which has a later
effective filing date of June 22, 2015, is not prior art. Id. at
*27. According to Allgenesis, because claims 4 and 5 of the
’820 patent and Allgenesis’ PCT both relate to the same in-
vention (i.e., nintedanib treatments for pterygium), the
Board’s relative priority determination affects the scope
Allgenesis’ own patent rights.
Allgenesis asserts it suffered an injury in fact because
the Board’s determination will have a preclusive effect on
the scope of its pending patent application, Ser. No.
17/750,400, which claims priority to Allgenesis’ PCT. See
Oral Arg. at 7:40–54. Allgenesis has not established that
the Board’s decision will have preclusive effect. Again,
Allgenesis’ allegations of harm are not sufficiently specific
to establish any injury in fact.
We rejected a similar preclusion argument in Best Med-
ical International, Inc. v. Elekta Inc., 46 F.4th 1346 (Fed.
Cir. 2022). There, we held the patentee lacked standing to
appeal a Board decision holding a claim unpatentable
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because the patentee cancelled the claim before filing a no-
tice of appeal. Id. at 1351–52. The patentee argued that
certain “collateral estoppel effects” resulting from the
Board’s decision, including that an examiner in a related
reexamination proceeding relied on the Board’s analysis,
conferred standing. Id. at 1352. We rejected this argu-
ment, reasoning that collateral estoppel does not apply to
non-appealable judgments and the patentee thus would be
able to challenge the examiner’s findings and conclusions
in the reexamination proceeding on appeal. Id. at 1352–
53. We further explained, “the potential for collateral con-
sequences is insufficient, on its own, to confer standing.”
Id. at 1353 (internal citation and quotation marks omit-
ted).
While Best Medical involved different facts, the reason-
ing is applicable here. Collateral estoppel will not attach
to the Board’s non-appealable priority determination. See
SkyHawke Techs., LLC v. Deca Int’l Corp., 828 F.3d 1373,
1376 (Fed. Cir. 2016). If the examiner were to reach the
same priority determination during prosecution of Allgen-
esis’ pending application, Allgenesis can challenge that de-
termination in a separate appeal. Allgenesis has, based on
these quite vague allegations, failed to establish a concrete
injury.
Beyond any preclusive effect, Allgenesis argues the
Board’s determination will still have a practical impact on
the scope of its patent rights. Oral Arg. at 8:26–33, 8:58–
9:15. The problem with this argument is that Allgenesis
has failed to articulate with any specificity how the Board’s
priority determination will impact its issued patents or
pending continuation applications which claim priority to
its PCT application. Allgenesis’ argument on this point is
limited to a single paragraph containing only vague allega-
tions in its opening brief and reply brief, respectively. See
Appellant’s Opening Br. at 3–4 (“[T]he Board’s determina-
tion as to the scope of the disclosure of the ’063 provisional
and the relative priority of the ’820 patent in comparison
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to Allgenesis’s own patents and pending applications also
affects or may affect . . . Allgenesis’s patent rights and the
issued or still-pending continuation applications claiming
priority to that application.”); Appellant’s Reply Br. at 12–
13 (“The Board’s specific priority finding, in the Final Writ-
ten Decision that is the subject of this appeal, injures
Allgenesis by impairing Allgenesis’s own patent rights.”).
Allgenesis’ general and nonspecific allegations are insuffi-
cient to meet its burden of establishing standing. Under
these circumstances, Allgenesis has failed to show it has
suffered any concrete injury in fact based on the Board’s
priority determination.
CONCLUSION
For these reasons, we conclude Allgenesis has failed to
establish an injury in fact sufficient to confer Article III
standing. We dismiss the appeal and do not reach the mer-
its of the Board’s decision.
DISMISSED
COSTS
No costs.
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