Federal Circuit Clarifies Injury in Fact Standing to Challenge Final Agency Decision in IPR

Federal CircuitPhigenix, Inc. v. ImmunoGen, Inc., No. 2016-1544, 2017 U.S. App. LEXIS 323 (Fed. Cir. Jan. 9, 2017)(Before Dyk, Wallach, and Hughes, J.)(Opinion for the court, Wallach, J.)(In appealing from a final IPR decision, the appellant must have standing, based on evidence of record or supplemental evidence showing an injury in fact.).

ImmunoGen licenses U.S. Patent No. 8,337,856 (the ‘856 Patent) to Genentech. Phigenix is a for-profit company aimed at developing an intellectual property portfolio focusing on molecular therapeutics designed to fight cancer. Phigenix owns U.S. Patent No. 8,080,534 (the ’534 Patent). Phigenix believes that the subject matter of ImmunoGen’s ‘856 Patent is covered by its ’534 Patent, which Phigenix sought unsuccessfully to license to Genentech. Phigenix then sought an Inter Partes Review (IPR) of the ’856 Patent. In its final written decision, the Board found that the asserted claims of the ’856 were nonobvious. Phigenix appealed.

ImmunoGen challenged Phigenix’s standing to appeal the Board’s final written decision. The Court found that Phigenix failed to establish an injury in fact necessary for standing to challenge a final agency decision. In Cuozzo v. Lee, the Supreme Court held that not every party will have Article III standing in an appeal from a final written decision. The Federal Circuit identified three factors for demonstrating standing: 1) the burden of production; 2) the evidence appellant must produce to meet that burden; and 3) when appellant must produce that evidence.

The Court concluded that the burden of production on appeal of a final agency decision is akin to that during summary judgment, e.g. by relevant affidavit testimony. The evidence to meet that burden includes self-evident and supplemental evidence. Self-evident evidence requires no evidence beyond the administrative record, which will speak for itself. On the other hand, where the appellant must provide supplemental evidence, the appellant must “either identify . . . record evidence sufficient to support its standing to seek review” or “submit additional evidence, such as by affidavit or other evidence.” Last, the Court concluded that such evidence must be produced at the earliest possible opportunity.

Applying these standards, the Court found Phigenix did not have standing. Phigenix alleged three injuries in fact: 1) it suffered an actual economic injury because the ’856 Patent increases competition between Phigenix and ImmunoGen and encumbers its licensing efforts; 2) the statutory basis for appeal established standing; and 3) the estoppel effect of the Board’s decision interferes with its ability to provide a contractual warranty.

These alleged injuries in fact were insufficient for standing purposes. First, Phigenix’s declaration submitted in favor of its alleged economic injury only provided conclusory statements and failed to establish that it had licensed the ’534 Patent to anyone, including entities that licensed ImmunoGen’s patent. Second, the existence of a statute providing for an appeal did not necessarily provide it with standing to do so. Third, the Court reemphasized that the estoppel provision does not constitute an injury in fact when the appellant is not engaged in activity “that would give rise to a possible infringement suit.” That was the case for Phigenix.

In appealing from a final IPR decision, the appellant must have standing, based on evidence of record or supplemental evidence showing an “injury in fact.” Alleged economic injury must be specific and proven, and does not arise just from statutory appeal provisions or from IPR litigation estoppel when appellant’s infringement of the challenged patent is not a potential issue.

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Joseph Robinson

Joseph Robinson has over 20 years of experience in all aspects of intellectual property law. He focuses his practice in the pharmaceutical, life sciences, biotechnology, and medical device fields. His practice encompasses litigation, including Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in a variety of patent and trademark disputes in many different jurisdictions, and has also served as appellate counsel before the Court of Appeals for the Federal Circuit. Joe also focuses on complex inter partes matters before the U.S Patent and Trademark Office, inventorship disputes, reexaminations and reissues. His experience includes numerous interferences, a particular advantage in new U.S. Patent and Trademark Office post-grant proceedings. He also counsels on patent–related U.S. Food and Drug Administration issues, including citizen petitions, Orange Book listing, and trademark issues. For more information and to contact Joe please visit his profile page at the Troutman Sanders website.

Joseph Robinson

Robert Schaffer is an intellectual property partner at Troutman Sanders. Bob applies more than 30 years of experience to IP counseling and litigation. His work includes patent procurement, strategic planning and transactional advice, due diligence investigations, district court patent cases, and Federal Circuit appeals. He regularly handles complex and high-profile domestic and international patent portfolios, intellectual property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed court cases Bob’s work includes representing and counseling client in ANDA litigations, complex patent infringement cases and appeals, and multidistrict and international cases. In disputed Patent Office matters his work includes representing and counseling clients in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For more information and to contact Bob please visit his profile page at the Troutman Sanders website.

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