In Phigenix v. Immunogen, the CAFC discusses the "injury in fact" requirement for standing in appeals from USPTO decisions
Overview of the case:
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”) Patent
Trial and Appeal Board (“PTAB”) found the Asserted
Claims nonobvious. See generally Phigenix, Inc. v. ImmunoGen,
Inc., No. IPR2014-00676, 2015 WL 6550500
(P.T.A.B. Oct. 27, 2015).
Phigenix appeals. We possess subject matter jurisdiction
pursuant to 28 U.S.C. § 1295(a)(4)(A) (2012). Because
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.
Briefing on a standing issue was requested:
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
It was foreseeable that the WARF/stem cell case would be
“[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)).
Footnote 2 states:
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 (quoting
Lujan, 504 U.S. at 572 n.7).
In the Phigenix case the CAFC noted past omissions:
In the nearly thirty-five years since the court’s inception,
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 production;
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.
Footnote 3 states: “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 judgment
or a directed verdict.” BurdBurden of Production, Black’s
Law Dictionary (10th ed. 2014).
**As to the concept of "self-evident standing"
Self-evident standing typically arises
when an appellant “is ‘an object of the action (or forgone
action) at issue.’”5 Id. at 900 (quoting Lujan, 504 U.S. at
561–62). “When the [appellant]’s standing is not selfevident,
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).
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 producing
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 earliest
Phigenix does not contend that it faces risk of
infringing the ’856 patent, that it is an actual or prospective
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.; Appellant’s
Reply. Instead, Phigenix asserts that it has suffered
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 competition
represents a cognizable Article III injury,’” id. (quoting
Liquid Carbonic Indus. Corp. v. FERC, 29 F.3d 697,
701 (D.C. Cir. 1994)).
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); Orthopedic
& 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).
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 complaint
or answer with conclusory allegations of an affidavit”).
One should note footnote 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 authenticating
or identifying an item of evidence, the proponent
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 telephone,”
Fed. R. Evid. 901(b)(6).
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 establish
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 requirement
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).
Footnote 7 is also of interest:
To the extent Phigenix alleges that Spokeo overruled
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 remain
binding precedent until we see fit to reconsider
them, regardless of whether subsequent cases have raised
doubts about their continuing vitality.” (citation omitted)).
The WARF/stem cell case is referenced before the "conclusion":
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.
Because Phigenix has not substantiated its alleged injury
in fact, it lacks standing to appeal the PTAB’s Final
Written Decision affirming the patentability of the Asserted
Claims of the ’856 patent. We have considered
Phigenix’s remaining arguments to the contrary and find
them unpersuasive. Accordingly, Phigenix’s appeal is
The outcome of this case is relevant to potential appeals
of IPRs of Kyle Bass in the pharma area.