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") 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.
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. ("ImmunoGen"), is the assignee of the '856 patent. ImmunoGen 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 ("ImmunoGen'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 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 ImmunoGen'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 non-obvious, Phigenix sought further review in this court.
I. Phigenix Lacks Article III Standing
Before the parties fully briefed the subject appeal, ImmunoGen filed a motion to
In its response brief, ImmunoGen argues anew that Phigenix lacks standing, Appellee's Br. 29-37, and Phigenix again opposes, Appellant's Br. 24-25 (incorporating the arguments made in Phigenix's Resp. to MTD); Appellant'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, 126 S.Ct. 1854, 164 L.Ed.2d 589 (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, 127 S.Ct. 1438, 167 L.Ed.2d 248 (2007). As the party seeking judicial review, Phigenix bears the burden of establishing that it has standing. See DaimlerChrysler, 547 U.S. at 342, 126 S.Ct. 1854.
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, ___ U.S. ___, 136 S.Ct. 1540, 1547, 194 L.Ed.2d 635 (2016); Hollingsworth v. Perry, ___ U.S. ___, 133 S.Ct. 2652, 2661, 186 L.Ed.2d 768 (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 standing" consists of "three elements." Lujan v. Defs. of Wildlife, 504 U.S. 555, 560, 112 S.Ct. 2130, 119 L.Ed.2d 351 (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."
As to the first element, "the injury-in-fact requirement 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, 112 S.Ct. 2130 (internal quotation marks and citation omitted) — a "conjectural or hypothetical" injury will not suffice, 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
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 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;
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 litigation." Lujan, 504 U.S. at 561, 112 S.Ct. 2130. Interpreting Lujan, the D.C. Circuit has held that an appellant's burden of production 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, ___ U.S. ___, 136 S.Ct. 1491, 194 L.Ed.2d 586 (2016); N. Laramie Range All. v. FERC, 733 F.3d 1030, 1034 (10th Cir. 2013); Iowa 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).
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 action) at issue.'"
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, 127 S.Ct. 1438, 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 possible opportunity.
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 Phigenix's Resp. to MTD; Appellant's Br.; Appellant's Reply, as well as put into evidence two declarations that purportedly 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 prospective licensee of the patent, or that it otherwise plans to take any action that would implicate the
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 reasonable and commonsense conclusion is that at least a portion 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 support ... a motion must be made on personal knowledge, 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 added). 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).
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 "underscores 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 portfolio" and "believes" that the '856 patent is invalid. J.A. 6446.
The Gold Declaration and the attorney letter are insufficient 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 patent, the invalidation of the '856 patent might have increased 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 the Gold Declaration and the letter as to the hypothetical licensing injury therefore do not satisfy the requirements of Rule 56(c)(4).
Phigenix's remaining arguments do not necessitate a different conclusion. Phigenix contends that it has suffered an injury in fact because 35 U.S.C. § 141(c) "provides 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 some circumstances to constitute an injury in fact,"
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 claim, a petitioner "may not request or maintain a proceeding 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
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