In Phigenix, Inc. v. ImmunoGen, Inc., Appeal No. 2016-1544, the Federal Circuit, for the first time, established the legal standard for demonstrating standing in an appeal from a final agency action. The Federal Circuit held that a party seeking to establish such standing bears the same burden of production as that of a plaintiff moving for summary judgment. When the party’s standing is not self-evident, the party must identify record evidence or, if standing was not an issue before the agency, submit additional evidence to the court at the first appropriate time.

In an inter partes review filed by Phigenix, the Board found Immunogen’s patent nonobvious. Prior to addressing obviousness, the Federal Circuit addressed ImmunoGen’s argument that Phigenix lacked standing for the appeal. The Federal Circuit set forth the following standard: The appellant bears the burden of production, as that of a plaintiff moving for summary judgment, to introduce evidence of standing. This burden may be met by identifying record evidence sufficient to support its standing, or if standing was not an issue before the agency, by submitting affidavits or other evidence. Such evidence must be submitted at the first appropriate time, usually in response to a motion to dismiss or in the opening brief.

Phigenix argued it had standing based on (1) the existence of ImmunoGen’s patent encumbering Phigenix’s licensing efforts of its own patent, (2) 35 U.S.C. § 141, the statute authorizing appeal for parties dissatisfied with a final PTAB decision, and (3) the estoppel effect of PTAB decisions under 35 U.S.C. § 315(e) adversely impacting Phigenix’s ability to provide a contractual warranty. Phigenix submitted declarations and a letter as evidence of injury in fact.

The Federal Circuit found the conclusory statements of Phigenix’s declarations and the allegations of hypothetical harm failed to meet the requirements of Fed. R. Civ. P. 56(c)(4). The Federal Circuit also held that Phigenix could not base its injury in fact upon a violation of 35 U.S.C. § 141 because it has been permitted to file its appeal, and the exercise of its right to appeal did not necessarily establish Article III standing. Further, the estoppel effect under 35 U.S.C. § 315(e) did not show injury in fact because Phigenix was “not engaged in activity that would give rise to a possible infringement suit.”