In this case, the Federal Circuit determined that in its nearly 35-year history, it had not established the legal standard for demonstrating standing in an appeal from a final agency action. The underlying dispute arose from an appeal by Phigenix, Inc. ("Phigenix") of the Patent Trial and Appeal Board (PTAB) decision that the challenged claims of U.S. Patent No. 8,337,856 (the "'856 patent"), which is assigned to ImmunoGen, Inc. ("ImmunoGen"), were not obvious in view of the prior art. Genentech Inc. ("Genentech") has an exclusive license to the '856 patent, which Genentech uses to produce the drug Kadcyla®TM. Phigenix, a research company that focuses on the use of therapeutics designed to fight cancer, does not manufacture any products, but has an intellectual property portfolio that includes U.S. Patent No. 8,080,534 (the "'534 patent"), which Phigenix claims is infringed by Genetech based on its activities related to Kadcyla®TM. After Genentech refused to take a license to the '534 patent, Phigenix filed a petition for an inter partes review ("IPR") against ImmunoGen's '856 patent. After Phigenix appealed the PTAB's decision on its IPR petition, ImmunoGen filed a motion to dismiss claiming that Phigenix lacks standing to appeal the PTAB's decision.
Phigenix, the party seeking judicial review, bears the burden to establish standing. To prove standing, Phigenix must establish that (1) it suffered an injury in fact, (2) the injury is fairly traceable to challenged conduct of ImmunoGen, and (3) the injury is likely to be redressed by a favorable judicial outcome. First, the Federal Circuit addressed threshold issues of the burden of production, evidence to meet that burden, and when the evidence must be produced in cases where the appellant seeks review of final agency actions and its standing is challenged. The appellant's burden of production is the same as a plaintiff moving for summary judgment in district court. An appellant is permitted to supplement the administrative record with arguments, affidavits or other evidence to demonstrate its standing, if the appellant's standing is not self-evident (i.e., the appellant is not "an object of the action (or forgone action) at issue."). Sierra Club v. EPA, 292 F.3d 895, 900 (D.C. Cir. 2002) (quoting Lujan v. Defs. Of Wildlife, 504 U.S. 555, 561-62 (1992)). Finally, if there is no evidence on the record to support standing, the appellant must provide evidence establishing its standing at the earliest possible opportunity because standing involves threshold questions over the court's authority to hear the dispute.
The Federal Circuit held that Phigenix did not have standing to appeal the PTAB decision in federal court because it failed to establish that it suffered an injury. Phigenix asserted that although it does not face the risk of infringing the '856 patent, it has suffered actual economic injury because the '856 patent increases competition between Phigenix and ImmunoGen for licensing revenue. The Federal Circuit held that the documents and declarations Phigenix relied on to support its claim are insufficient to show injury in fact because they are merely a conclusory statement about a hypothetical licensing injury and do not establish that Phigenix ever licensed the '534 patent to anyone, let alone to entities that obtained licenses to ImmunoGen's '856 patent. Phigenix's remaining arguments that it suffered an injury based on the estoppel effect of the PTAB's decision and the violation of its procedural right to seek an appeal under 35 U.S.C. § 141 (c) were also denied. Thus, Phigenix's appeal of the PTAB's decision was dismissed.
Phigenix, Inc. v. ImmunoGen, Inc., No. 2016-1544 (Fed. Cir. Jan. 9, 2017).
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