Party Who Does Not Face Infringement Risk Lacks Standing to Appeal Adverse PTAB Decision: Federal Circuit | Practical Law

Party Who Does Not Face Infringement Risk Lacks Standing to Appeal Adverse PTAB Decision: Federal Circuit | Practical Law

In Phigenix, Inc. v. Immunogen, Inc., the US Court of Appeals for the Federal Circuit held that Phigenix, Inc. lacked standing to appeal an adverse Patent Trial and Appeal Board (PTAB) decision because Phigenix did not face a risk of infringing the challenged patent.

Party Who Does Not Face Infringement Risk Lacks Standing to Appeal Adverse PTAB Decision: Federal Circuit

by Practical Law Intellectual Property & Technology
Published on 10 Jan 2017 • USA (National/Federal)
In Phigenix, Inc. v. Immunogen, Inc., the US Court of Appeals for the Federal Circuit held that Phigenix, Inc. lacked standing to appeal an adverse Patent Trial and Appeal Board (PTAB) decision because Phigenix did not face a risk of infringing the challenged patent.
On January 9, 2017, in Phigenix, Inc. v. Immunogen, Inc., the US Court of Appeals for the Federal Circuit held that a party challenging an adverse Patent Trial and Appeal Board (PTAB) decision lacked standing to appeal because the party did not show that it faced a risk of infringing the challenged patent ( (Fed. Cir. Jan. 9, 2017)).
Phigenix, Inc. is a biomedical research company that focuses on therapies to treat cancer. Phigenix does not manufacture any products, but it owns US Patent No. 8,080,534 ('534 patent), which describes methods of treating breast cancer. Immunogen, Inc. is the assignee of US Patent No. 8,337,856 ('856 patent), which concerns therapies for treating a variety of cancers. Genentech, Inc. is the exclusive licensee of the '856 patent and uses the license to produce the drug Kadcyla, which is approved for treating breast cancer.
Phigenix believed that its '534 patent covers Genentech's drug Kadcyla and therefore offered Genentech a license to the '534 patent. After Genentech refused Phigenix's license offer, Phigenix:
  • Brought suit against Genentech.
  • Filed a petition for inter partes review (IPR) of Immunogen's '856 patent with the PTAB arguing that the claims of the '856 patent would have been obvious.
The PTAB instituted an IPR of the '856 patent and eventually issued a final written decision finding the challenged claims nonobvious. After Phigenix appealed that decision to the Federal Circuit, Immunogen filed a motion to dismiss the appeal, arguing that Phigenix lacked standing. Phigenix responded that it had standing to appeal because the '856 patent impeded its efforts to license the '534 patent. Phigenix did not contend that it faced any risk of infringing the '856 patent.
The Federal Circuit held that Phigenix lacked standing to appeal the adverse PTAB written decision. The court explained that a party may bring an administrative agency action without standing, but not an appeal in federal court. The Federal Circuit said that standing to appeal requires the appellant to have suffered an injury in fact that is:
  • Actual or imminent, and not conjectural or hypothetical.
  • Particular to the appellant.
  • Relatively related to the actions of the appellee.
  • Likely to be fixed by a favorable decision.
The Federal Circuit ruled that to demonstrate standing in an appeal from a final agency decision, an appellant must:
  • Meet the burden of production required in a summary judgment action.
  • Identify evidence to support its standing either:
    • in the record; or
    • by argument or affidavit.
  • Present the evidence at the earliest opportunity.
The Federal Circuit held that Phigenix failed to show injury in fact and did not have standing because:
  • Phigenix's statements of economic injury were conclusions of law inadmissible in a summary judgment motion.
  • Phigenix's documents referred to a hypothetical competitive injury because Phigenix has not actually licensed the '534 patent to the same parties to which Immunogen licensed the '856 patent.
  • Receiving an unfavorable decision in an IPR is not a statutory basis for appeal under 35 U.S.C. § 141(c).
  • The estoppel provisions of 35 U.S.C. § 315(e) do not constitute an injury in fact because Phigenix is not engaged in any activity that would form the basis of an infringement suit.
The Federal Circuit therefore dismissed Phigenix's appeal for lack of standing.