Blog Big Molecule Watch April 28, 2020

Federal Circuit Finds Pfizer’s RUXIENCE Plans Insufficient to Establish Standing to Appeal IPR

On April 27, 2020, the Federal Circuit issued a non-precedential opinion ruling that Pfizer failed to establish Article III standing in a pair of IPR appeals.  At the PTAB, Pfizer had challenged the validity of Chugai’s patents (7,332,289 and 7,927,815) covering processes relevant to the manufacture of rituximab.  In support of standing to appeal the PTAB’s final written decisions to the Federal Circuit, Pfizer pointed to FDA approval of its rituximab biosimilar, Ruxience®, in July 2019 and an announcement in October 2019 that it planned to launch Ruxience® in January 2020.  The court noted that the record was insufficient to establish standing, because these events occurred after Pfizer filed its notice of appeal on January 30, 2019.  The court suggested that even if these events had occurred prior to filing its appeal, standing would not necessarily be established.  None of Pfizer’s evidence established “with sufficient likelihood that the processes used to prepare Pfizer’s product would infringe Chugai’s patents. The court will therefore not find standing based on that evidence.”  The court rejected the notion that standing was “self-evident” and highlighted that “[i]t was Pfizer’s responsibility to submit evidence to make its standing evident to the court, which it failed to do.”  Finally, the court noted that the statutory estoppel effect of 35 U.S.C. § 315(e) alone does not constitute an injury in fact to establish standing.

The post Federal Circuit Finds Pfizer’s RUXIENCE Plans Insufficient to Establish Standing to Appeal IPR appeared first on Big Molecule Watch.