Phigenix, Inc. v. Immunogen, Inc.

• Citation: 121 U.S.P.Q.2d 1242,845 F.3d 1168
• Decision Date: 09 January 2017
• Docket Number: 2016-1544
• Parties: PHIGENIX, INC., Appellant v. IMMUNOGEN, INC., Appellee
• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit

845 F.3d 1168

121 U.S.P.Q.2d 1242

PHIGENIX, INC., Appellant

v.IMMUNOGEN, INC., Appellee

2016-1544

United States Court of Appeals, Federal Circuit.

Decided: January 9, 2017

Gregory Lawrence Porter , Andrews Kurth Kenyon LLP, Houston, TX, argued for appellant. Also represented by Robert Alan Gutkin, Ping Wang, Michael Ye , Washington, DC.

Eldora Ellison , Sterne Kessler Goldstein & Fox, PLLC, Washington, DC, argued for appellee. Also represented by Olga A. Partington, Pauline Pelletier, Byron Leroy Pickard, Eric K. Steffe .

Before Dyk, Wallach, and Hughes, Circuit Judges.

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.

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. ("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®™ ("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 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 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."¹ Spokeo , 136 S.Ct. at 1547 (citations omitted).

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 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, 127 S.Ct. 1438 (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, 112 S.Ct. 2130 )). 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 , ––– U.S. ––––, 136 S.Ct. 2131, 2143–44, 195 L.Ed.2d 423 (2016) (explaining that, although a party that initiated an inter partes review "need not have a concrete stake in the outcome," it "may lack constitutional standing" 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 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.

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).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, 112 S.Ct. 2130 (explaining that a party challenging government action may demonstrate its standing, inter alia, "at the summary judgment stage"); see also Massachusetts , 549...