Rituximab – USA

On Apr. 27, 2020, Federal Circuit dismissed Pfizer’s appeal for lack of standing as it failed to establish that it was suffering a cognizable injury at all stages of appeals.

Chugai Pharmaceutical Co., Ltd., owns US 7,332,289 and US 7,927,815 patents. In two inter partes review proceedings, Pfizer Inc. petitioned the Patent Trial and Appeal Board to invalidate most of the claims of the ’289 and ’815 patents. In each IPR, the Board held that Pfizer did not prove that any of the challenged claims were unpatentable.

Pfizer appealed.

During appeal, Federal Circuit said that to establish Article III standing, an appellant must show that it has “(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” “To qualify as a case fit for federal-court adjudication, ‘an actual controversy must be extant at all stages of review . . . .’” [Arizonans for Official English v. Arizona, 520 U.S. 43, 67 (1997)]. Pfizer filed its notice of appeal on January 30, 2019. Evidence of standing that Pfizer provided to the court occurred much later in 2019. Specifically, Pfizer submitted evidence that the FDA approved its rituximab biosimilar in July 2019 and that Pfizer announced at the end of October 2019 that it would begin selling the biosimilar in the USA in January 2020 as result of settlement between Pfizer & Genentech (Roche group). F. Hoffmann-La Roche Ltd is the majority owner of appellee, Chugai. But, Chugai was not a party to that settlement agreement, and Pfizer did not get a license from Chugai for the patents at issue in this appeal. Moreover, Pfizer did not cite any evidence regarding its activities or plans relating to its rituximab biosimilar before July 2019. Pfizer thus failed to supply any evidence that it was suffering from an injury in fact when this appeal began. Nor has Pfizer offered evidence that would allow court to evaluate whether it practices or intends to practice the patented methods in the course of making its biosimilar product.

Court also rejected Pfizer’s “self-evident” theory that there was “a product at issue” when the appeal began. Specifically, Pfizer listed “rituximabIPR@win-ston.com” in its petitions as its service email address for the IPR proceedings. Court said that Pfizer’s service email address and Chugai’s response do not tell the court anything useful about Pfizer’s plans for its biosimilar, Ruxience®, as of the beginning of 2019, when this appeal began. Nor does that evidence establish with sufficient likelihood that the processes used to prepare Pfizer’s product would infringe Chugai’s patents. The court therefore did not find standing based on that evidence and dismissed the appeal.