Phigenix, Inc. v. Immunogen, Inc.

United States Court of Appeals
for the Federal Circuit
______________________
PHIGENIX, INC.,
Appellant
v.
IMMUNOGEN, INC.,
Appellee
______________________
2016-1544
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2014-
00676.
______________________
Decided: January 9, 2017
______________________
GREGORY LAWRENCE PORTER, Andrews Kurth Kenyon
LLP, Houston, TX, argued for appellant. Also represent-
ed by ROBERT ALAN GUTKIN, PING WANG, MICHAEL YE,
Washington, DC.
ELDORA ELLISON, Sterne Kessler Goldstein & Fox,
PLLC, Washington, DC, argued for appellee. Also repre-
sented by OLGA A. PARTINGTON, PAULINE PELLETIER,
BYRON LEROY PICKARD, ERIC K. STEFFE.
______________________
Before DYK, WALLACH, and HUGHES, Circuit Judges.
2 PHIGENIX, INC. v. IMMUNOGEN, INC.
WALLACH, Circuit Judge.
Appellant Phigenix, Inc. (“Phigenix”) sought inter
partes review of U.S. Patent No. 8,337,856 (“the ’856
patent”), alleging that claims 1–8 (“the Asserted Claims”)
of the subject patent are unpatentable as obvious over
various prior art references. In its final written decision,
the U.S. Patent and Trademark Office’s (“USPTO”) Pa-
tent Trial and Appeal Board (“PTAB”) found the Asserted
Claims nonobvious. See generally Phigenix, Inc. v. Immu-
noGen, Inc., No. IPR2014-00676, 2015 WL 6550500(P.T.A.B. Oct. 27, 2015).
Phigenix appeals. We possess subject matter jurisdic-
tion pursuant to 28 U.S.C. § 1295(a)(4)(A) (2012). Be-
cause Phigenix has not offered sufficient proof
establishing that it has suffered an injury in fact, it lacks
standing to bring suit in federal court. We dismiss.
BACKGROUND
The ’856 patent generally relates to “huMab4D5
ANTI-ErbB2 antibody-maytansinoid conjugates.” ’856
patent, Title. The claimed methods of treatment purport
to combat a variety of cancers. See id. col. 4 ll. 26–42.
The subject dispute involves three principal parties,
each of whom allege to have some relation to the ’856
patent. The first party, Appellee ImmunoGen, Inc. (“Im-
munoGen”), is the assignee of the ’856 patent. Immuno-
Gen provided the second party, Genentech Inc.
(“Genentech”), with a “worldwide exclusive license” to the
subject patent, which Genentech uses to produce the drug
Kadcyla®TM (“Kadcyla”). Phigenix, Inc. v. ImmunoGen,
Inc., No. 2016-1544, Docket No. 23 at Ex. A, ¶ 3 (Fed. Cir.
Mar. 4, 2016) (ImmunoGen’s Mot. to Dismiss (“Immuno-
Gen’s MTD”)); see id. at Ex. A, ¶ 2. The third party,
Phigenix, describes itself “as a for-profit discovery stage
biotechnology, pharmaceutical, and biomedical research
company” that focuses “on the use of novel molecular
PHIGENIX, INC. v. IMMUNOGEN, INC. 3
therapeutics” designed to fight cancer. Phigenix, Inc. v.
ImmunoGen, Inc., No. 2016-1544, Docket No. 26 at Ex. 1,
¶ 4 (Fed. Cir. Mar. 14, 2016) (Phigenix’s Resp. to Immu-
noGen’s MTD (“Phigenix’s Resp. to MTD”)). Phigenix
does not manufacture any products, but purportedly “has
developed, and is developing, an extensive intellectual
property portfolio” that includes U.S. Patent No.
8,080,534 (“the ’534 patent”). Id. at Ex. 1, ¶ 5; see id. at
Ex. 1, ¶ 7. Phigenix alleges that the ’534 patent covers
Genentech’s “activities relating to Kadycla[]” and, thus,
the subject matter claimed in the ’856 patent. Id. at Ex.
1, ¶ 7; see id. at Ex. 1, ¶¶ 8–9, and Ex. 2, ¶ 14. Phigenix
alleges that it “was forced” to bring litigation in various
fora when Genentech refused its offer to license the ’534
patent. Id. at Ex. 1, ¶ 8.
In that vein, and “[t]o further its commercialization
efforts with respect to its patent portfolio,” Phigenix
sought inter partes review of the Asserted Claims of the
’856 patent. Id. at Ex. 1, ¶ 10. When the PTAB found the
Asserted Claims nonobvious, Phigenix sought further
review in this court.
DISCUSSION
I. Phigenix Lacks Article III Standing
Before the parties fully briefed the subject appeal,
ImmunoGen filed a motion to dismiss, asserting that
Phigenix lacked standing to appeal the PTAB’s Final
Written Decision. See generally ImmunoGen’s MTD.
Phigenix opposed. See generally Phigenix’s Resp. to MTD.
A single judge of this court denied the Motion, “deem[ing]
it the better course for the parties to address the standing
issue in their briefs.” Phigenix, Inc. v. ImmunoGen, Inc.,
No. 2016-1544 (Fed. Cir. Apr. 20, 2016) (order denying
ImmunoGen’s MTD).
In its response brief, ImmunoGen argues anew that
Phigenix lacks standing, Appellee’s Br. 29–37, and Phige-
4 PHIGENIX, INC. v. IMMUNOGEN, INC.
nix again opposes, Appellant’s Br. 24–25 (incorporating
the arguments made in Phigenix’s Resp. to MTD); Appel-
lant’s Reply 3–16. “We have an obligation to assure
ourselves of litigants’ standing under Article III” of the
Constitution, DaimlerChrysler Corp. v. Cuno, 547 U.S.
332, 340 (2006) (internal quotation marks and citation
omitted), including when a party appeals from a final
agency action, see Massachusetts v. EPA, 549 U.S. 497,
505–06, 516–26 (2007). As the party seeking judicial
review, Phigenix bears the burden of establishing that it
has standing. See DaimlerChrysler, 547 U.S. at 342.
A. General Article III Standing Requirements
“Standing to sue is a doctrine rooted in the traditional
understanding of a case or controversy” required by
Article III. Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547
(2016); Hollingsworth v. Perry, 133 S. Ct. 2652, 2661
(2013) (explaining that Article III discusses the powers
granted to the Judicial Branch and, inter alia, “confines
the judicial power of federal courts to deciding actual
‘Cases’ or ‘Controversies’” (quoting U.S. Const. art. III,
§ 2)). “[T]he irreducible constitutional minimum of stand-
ing” consists of “three elements.” Lujan v. Defs. of Wild-
life, 504 U.S. 555, 560 (1992). An appellant “must have
(1) suffered an injury in fact, (2) that is fairly traceable to
the challenged conduct of the [appellee], (3) that is likely
to be redressed by a favorable judicial decision.” 1 Spokeo,
136 S. Ct. at 1547 (citations omitted).
1 We recite the standing framework using the des-
ignations “appellant” and “appellee,” rather than “plain-
tiff” and “defendant,” because we are the court of first
instance in an appeal challenging the PTAB’s final writ-
ten decision in an inter parties review. 35 U.S.C. § 141(c)
(2012) (“A party to an inter partes review . . . who is
dissatisfied with the final written decision of the
PHIGENIX, INC. v. IMMUNOGEN, INC. 5
As to the first element, “the injury-in-fact require-
ment requires [an appellant] to allege an injury that is
both concrete and particularized.” Id. at 1545 (internal
quotation marks and citation omitted). To constitute a
“concrete” injury, the harm must “actually exist,” id. at
1548 (citation omitted), or appear “imminent,” Lujan, 504
U.S. at 560 (internal quotation marks and citation omit-
ted)—a “conjectural or hypothetical” injury will not suf-
fice, id. (internal quotation marks and citation omitted).
And an injury is “particularized” if it affects an appellant
“in a personal and individual way.” Spokeo, 136 S. Ct. at
1548 (internal quotation marks and citation omitted).
“[A]lthough Article III standing is not necessarily a
requirement to appear before an administrative agency,”
Consumer Watchdog v. Wis. Alumni Research Found., 753
F.3d 1258, 1261 (Fed. Cir. 2014) (citation omitted), an
appellant must nevertheless supply the requisite proof of
an injury in fact when it seeks review of an agency’s final
action in a federal court, 2 see Massachusetts, 549 U.S. at
517 (explaining that, when a party appeals from a final
agency action, it must demonstrate that it suffers an
injury “that is either actual or imminent” (quoting Lujan,
504 U.S. at 560–61)). Indeed, the Supreme Court has
recognized that not every party will have Article III
standing in an appeal from a PTAB final written decision.
See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131,
2143–44 (2016) (explaining that, although a party that
[PTAB] . . . may appeal the [PTAB]’s decision only to
the . . . Federal Circuit.”).
2 An appellant’s obligation to establish an injury in
fact remains firm even though it need not “‘meet[] all the
normal standards for redressability and immediacy’”
when, as here, a statute provides the appellant with a
right to appeal. Massachusetts, 549 U.S. at 517–18 (quot-
ing Lujan, 504 U.S. at 572 n.7).
6 PHIGENIX, INC. v. IMMUNOGEN, INC.
initiated an inter partes review “need not have a concrete
stake in the outcome,” it “may lack constitutional stand-
ing” to sue in federal court).
B. The Legal Requirements to Demonstrate Standing in
an Appeal from a Final Agency Action
In the nearly thirty-five years since the court’s incep-
tion, we have not established the legal standard for
demonstrating standing in an appeal from a final agency
action. This standard must identify the burden of produc-
tion; 3 the evidence an appellant must produce to meet
that burden; and when an appellant must produce that
evidence. We discuss each item in turn.
As to the burden of production, the Supreme Court
has held that each element is “an indispensable part of”
an appellant’s case and “must be supported in the same
way as any other matter on which the [appellant] bears
the burden of proof, i.e., with the manner and degree of
evidence required at the successive stages of the litiga-
tion.” Lujan, 504 U.S. at 561. Interpreting Lujan, the
D.C. Circuit has held that an appellant’s burden of pro-
duction is “the same as that of a plaintiff moving for
summary judgment in the district court.” Sierra Club v.
EPA, 292 F.3d 895, 899 (D.C. Cir. 2002) (citation omitted).
At least four of our sister circuits have adopted the D.C.
Circuit’s standard, see Sierra Club v. EPA, 793 F.3d 656,
662–663 (6th Cir. 2015), cert. denied sub nom., Ohio v.
Sierra Club, 136 S. Ct. 1491 (2016); N. Laramie Range
All. v. FERC, 733 F.3d 1030, 1034 (10th Cir. 2013); Iowa
3“Burden of production” means “[a] party’s duty to
introduce enough evidence on an issue to have the issue
decided by the fact-finder, rather than decided against the
party in a peremptory ruling such as a summary judg-
ment or a directed verdict.” Burden of Production, Black’s
Law Dictionary (10th ed. 2014).
PHIGENIX, INC. v. IMMUNOGEN, INC. 7
League of Cities v. EPA, 711 F.3d 844, 869–70 (8th Cir.
2013); Citizens Against Ruining the Env’t v. EPA, 535
F.3d 670, 675 (7th Cir. 2008), and two others appear to
have followed it, see Ass’n of Pub. Agency Customers v.
Bonneville Power Admin., 733 F.3d 939, 971 n.7 (9th Cir.
2013) (Alarcón, J., dissenting) (explaining that the Ninth
Circuit has appeared to follow, but not expressly adopted,
the burden of production standard articulated in Sierra
Club, 292 F.3d 895); Manufactured Hous. Inst. v. EPA,
467 F.3d 391, 398 (4th Cir. 2006) (similar). 4 Our review
of Lujan and the Supreme Court’s subsequent decisions
leads us to conclude that the summary judgment burden
of production applies in cases where an appellant seeks
review of a final agency action and its standing comes into
doubt. See Lujan, 504 U.S. at 561 (explaining that a
party challenging government action may demonstrate its
standing, inter alia, “at the summary judgment stage”);
see also Massachusetts, 549 U.S. at 521–23 (relying upon
evidence typically produced at the summary judgment
stage (i.e., affidavits and declarations) to find that a party
possessed standing in an appeal from a final agency
action).
Having established the relevant burden of production,
we turn to what evidence will meet the burden. The D.C.
Circuit has held that, in some cases, an appellant’s
“standing to seek review of administrative action is self-
evident; no evidence outside the administrative record is
necessary for the court to be sure of it.” Sierra Club, 292
F.3d at 899–900. Self-evident standing typically arises
when an appellant “is ‘an object of the action (or forgone
4 The First, Second, Third, Fifth, and Eleventh Cir-
cuits do not appear to have addressed the precise issue
before us.
8 PHIGENIX, INC. v. IMMUNOGEN, INC.
action) at issue.’” 5 Id. at 900 (quoting Lujan, 504 U.S. at561–62). “When the [appellant]’s standing is not self-
evident, however, the [appellant] must supplement the
record to the extent necessary to explain and substantiate
its entitlement to judicial review.” Id. In so doing, an
appellant may submit “arguments and any affidavits or
other evidence” to demonstrate its standing. Id. Taken
together, an 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.” Id. at
899 (internal quotation marks and citation omitted).
Finally, we must determine when an appellant should
produce the evidence establishing its standing. Because
standing involves threshold questions over a court’s
authority to hear a dispute, see Massachusetts, 549 U.S.
at 505, an appellant must identify the relevant evidence
demonstrating its standing “at the first appropriate” time,
whether in response to a motion to dismiss or in the
opening brief, Sierra Club, 292 F.3d at 900; see id at 901.
Imposing on an appellant the dual obligations of produc-
ing the evidence and producing the evidence early in the
litigation comports with the reality that such evidence is
“necessarily peculiar to” the appellant and “ordinarily
within its possession.” Id. at 901. Thus, if there is no
record evidence to support standing, the appellant must
produce such evidence at the appellate level at the earli-
est possible opportunity.
5 “[W]hen the [appellant] is not himself the object of
the government action or inaction he challenges, standing
is not precluded, but it is ordinarily substantially more
difficult to establish.” Lujan, 504 U.S. at 562 (internal
quotation marks and citations omitted).
PHIGENIX, INC. v. IMMUNOGEN, INC. 9
C. Phigenix Has Not Demonstrated Injury in Fact
Having identified the operative standards, we turn to
the question of Phigenix’s standing. Phigenix has argued
its standing in several submissions, see generally Phige-
nix’s Resp. to MTD; Appellant’s Br.; Appellant’s Reply, as
well as put into evidence two declarations that purported-
ly demonstrate its standing, see Phigenix’s Resp. to MTD
at Ex. 1 (“Donald Decl.”) and Ex. 2 (“Gold Decl.”). In these
documents, Phigenix does not contend that it faces risk of
infringing the ’856 patent, that it is an actual or prospec-
tive licensee of the patent, or that it otherwise plans to
take any action that would implicate the patent. See
generally Phigenix’s Resp. to MTD; Appellant’s Br.; Appel-
lant’s Reply. Instead, Phigenix asserts that it has suf-
fered an actual economic injury because the ’856 patent
increases competition between itself and ImmunoGen, see
Phigenix’s Resp. to MTD at 6, and “‘[i]ncreased competi-
tion represents a cognizable Article III injury,’” id. (quot-
ing Liquid Carbonic Indus. Corp. v. FERC, 29 F.3d 697,
701 (D.C. Cir. 1994)).
Phigenix argues that “[t]he existence of ImmunoGen’s
’856 patent has . . . encumber[ed] Phigenix’s licensing
efforts while ImmunoGen receives millions of dollars in
licensing revenue.” Id. at 9; see id. at 9–10 (citing Gold
Decl. at ¶¶ 10, 15). Phigenix contends “[t]he most reason-
able and commonsense conclusion is that at least a por-
tion of that licensing revenue would inure to Phigenix if
the ’856 patent were invalidated.” Appellant’s Reply 9–
10. Phigenix does not substantiate these arguments with
record evidence developed before the PTAB. See generally
Phigenix’s Resp. to MTD; Appellant’s Br.; Appellant’s
Reply. Instead, Phigenix relies principally upon the
declarations accompanying its response to ImmunoGen’s
Motion to Dismiss and another non-record document.
Rule 56(c)(4) explains that a “declaration used to sup-
port . . . a motion must be made on personal knowledge,
10 PHIGENIX, INC. v. IMMUNOGEN, INC.
set out facts that would be admissible in evidence, and
show that the . . . declarant is competent to testify on the
matters stated.” Fed. R. Civ. P. 56(c)(4) (emphasis add-
ed). A “conclusion[] of law” in a declaration “cannot be
utilized [i]n a summary-judgment motion.” 10B Charles
Alan Wright & Arthur R. Miller, Fed. Prac. & Proc. § 2738
(4th ed. 2016) (internal quotation marks and footnotes
omitted); accord F.R.C. Int’l, Inc. v. United States, 278
F.3d 641, 643 (6th Cir. 2002); Schubert v. Nissan Motor
Corp. in U.S.A., 148 F.3d 25, 30–31 (1st Cir. 1998); Or-
thopedic & Sports Injury Clinic v. Wang Labs., Inc., 922
F.2d 220, 224 (5th Cir. 1991); Barfield v. Orange Cty., 911
F.2d 644, 650 (11th Cir. 1990); Toro Co. v. Krouse, Kern &
Co., 827 F.2d 155, 162 n.3 (7th Cir. 1987).
Phigenix’s documents do not have such supporting
facts. As stated above, Phigenix relies upon the Gold
Declaration to argue that “[t]he existence of ImmunoGen’s
’856 patent has . . . encumber[ed] Phigenix’s licensing
efforts.” Phigenix’s Resp. to MTD at 9; see id. at 9–10
(citing Gold Decl. at ¶¶ 10, 15). Phigenix also alleges that
a letter highlighting concerns over the ’856 patent’s
validity that its attorney sent to ImmunoGen “under-
scores the actual, concrete controversy” between the
parties. Appellant’s Br. 25. In that letter, counsel stated
that Phigenix “believes that it has a strong patent portfo-
lio” and “believes” that the ’856 patent is invalid. J.A.
6446.
The Gold Declaration and the attorney letter are in-
sufficient to demonstrate injury in fact. It is possible
that, if Phigenix had licensed the ’534 patent to the same
parties to which ImmunoGen had licensed the ’856 pa-
tent, the invalidation of the ’856 patent might have in-
creased Phigenix’s revenues. However, there is simply no
allegation here that Phigenix has ever licensed the ’534
patent to anyone, much less that it licensed the ’534
patent to entities that have obtained licenses to the
ImmunoGen ’856 patent. The conclusory statements in
PHIGENIX, INC. v. IMMUNOGEN, INC. 11
the Gold Declaration and the letter as to the hypothetical
licensing injury therefore do not satisfy the requirements
of Rule 56(c)(4). 6 See Lujan v. Nat’l Wildlife Fed’n, 497
U.S. 871, 888 (1990) (explaining that “[t]he object” of Rule
56 “is not to replace conclusory allegations of the com-
plaint or answer with conclusory allegations of an affida-
vit”).
Phigenix’s remaining arguments do not necessitate a
different conclusion. Phigenix contends that it has suf-
fered an injury in fact because 35 U.S.C. § 141(c) “pro-
vides a statutory basis for appeal,” Phigenix’s Resp. to
MTD at 16, and Spokeo recognizes that “[t]he violation of
a procedural right granted by statute can be sufficient in
6 Several aspects of the Declarations submitted by
Phigenix also fail to lay the requisite foundation to be
“admissible in evidence,” as Rule 56(c)(4) requires. See
10B Charles Alan Wright & Arthur R. Miller, Fed. Prac.
& Proc. § 2738 (4th ed. 2016) (explaining that “the rules of
evidence and their exceptions determine what allegations
the affidavit may contain” (footnote omitted)); see also
Fed. R. Evid. 901(a) (“To satisfy the requirement of au-
thenticating or identifying an item of evidence, the propo-
nent must produce evidence sufficient to support a finding
that the item is what the proponent claims it is.”). For
example, Dr. Carlton D. Donald testified that “Phigenix
and Genentech had multiple discussions
through . . . telephone conversations concerning the
Phigenix technology and its patent portfolio,” Donald
Decl. at ¶ 8; however, Dr. Donald does not establish that
(1) a particular number was dialed; (2) the number dialed
was “assigned at the time” to Genentech; or (3) “the call
related to business reasonably transacted over the tele-
phone,” Fed. R. Evid. 901(b)(6).
12 PHIGENIX, INC. v. IMMUNOGEN, INC.
some circumstances to constitute an injury in fact,” 7
Appellant’s Reply 16 (emphasis added) (quoting 136 S. Ct.
at 1549). In relevant part, § 141(c) provides that “[a]
party to an inter partes review . . . who is dissatisfied
with the final written decision of the [PTAB] . . . may
appeal the [PTAB]’s decision” to this court. Phigenix
cannot base its injury in fact upon a violation of § 141(c)
because it has been permitted to file its appeal, and the
exercise of its right to appeal does not necessarily estab-
lish that it possesses Article III standing. See Raines v.
Byrd, 521 U.S. 811, 820 n.3 (1997) (“Congress cannot
erase Article III’s standing requirements by statutorily
granting the right to sue to [an appellant] who could not
otherwise have standing.” (citation omitted)). As the
Supreme Court has observed, statutorily “broadening the
categories of injury that may be alleged in support of
standing is a different matter from abandoning the re-
quirement that the party seeking review must himself
have suffered an injury.” Sierra Club v. Morton, 405 U.S.
727, 738 (1972); accord Massachusetts, 549 U.S. at 516–17
(discussing the need for injury in fact to pursue appeal
from a final agency action); Lujan, 504 U.S. at 578 (same).
Finally, Phigenix asserts an injury in fact based on 35
U.S.C. § 315(e), arguing that “the estoppel effect of the
[PTAB]’s decision adversely impacts Phigenix’s ability to
provide a contractual warranty.” Appellant’s Reply 11
(capitalization modified). If the PTAB issues a final
written decision in an inter partes review on a patent
7 To the extent Phigenix alleges that Spokeo over-
ruled the Supreme Court’s prior decisions on standing,
that argument ignores governing law. See Hohn v. United
States, 524 U.S. 236, 252–53 (1998) (“Our decisions re-
main binding precedent until we see fit to reconsider
them, regardless of whether subsequent cases have raised
doubts about their continuing vitality.” (citation omitted)).
PHIGENIX, INC. v. IMMUNOGEN, INC. 13
claim, a petitioner “may not request or maintain a pro-
ceeding before” the USPTO, the U.S. International Trade
Commission, or a federal district court “with respect to
that claim on any ground that the petitioner raised or
reasonably could have raised during that inter partes
review.” 35 U.S.C. § 315(e)(1); see id. § 315(e)(2). In
Consumer Watchdog, we explained that a similar estoppel
provision “do[es] not constitute an injury in fact” when, as
here, the appellant “is not engaged in any activity that
would give rise to a possible infringement suit.” 753 F.3d
at 1262 (citation omitted). We see no reason to reach a
different conclusion on the facts before us.
CONCLUSION
Because Phigenix has not substantiated its alleged in-
jury in fact, it lacks standing to appeal the PTAB’s Final
Written Decision affirming the patentability of the As-
serted Claims of the ’856 patent. We have considered
Phigenix’s remaining arguments to the contrary and find
them unpersuasive. Accordingly, Phigenix’s appeal is
DISMISSED