The Federal Circuit continued its explication of the standing issue for unsuccessful petitioners in inter partes review (see "Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp. (Fed. Cir. 2020)") in Pfizer Inc. v. Chugai Pharmaceuticals Co.
The case arose over IPRs initiated by Pfizer against Chugai's U.S. Patent Nos. 7,332,289 and 7,927,815. The patents were directed to protein purification methods that removed nucleic acid (DNA) contaminants. Pfizer successfully petitioned, but the Patent Trial and Appeal Board (PTAB) in a Final Written Decision held that the challenger had not proved any of the '289 (1-8 and 13) or '815 (1-7, 12, and 13) claims had been improvidently granted.
The Federal Circuit dismissed Pfizer's appeal based on lack of Article III standing, in an opinion by Judge Bryson, joined by Chief Judge Prost and Judge Dyk. The opinion sets forth the uneven playing field in IPRs, where anyone (but the patent holder) has standing to file a petition to initiate an IPR (even if the challenger fails to have Article III standing), citing JTEKT Corp. v. GKN Auto. LTD., 898 F.3d 1217, 1219 (Fed. Cir. 2018), and Fisher & Paykel Healthcare Ltd. v. ResMed Ltd., 789 F. App'x 877, 878 (Fed. Cir. 2019). However, an unsuccessful challenger, as Pfizer here, must satisfy the requirements for Article III standing in order to be able to bring an appeal, the court relying on JTEKT Corp. and Consumer Watchdog v. Wisconsin Alumni Research Foundation.
The opinion sets forth the requirements for standing: that the putative appellant 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," citing Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016). The panel notes, however, that Congress can accord a procedural right to appeal an administrative agency decision, and in those cases "certain requirements of standing—namely immediacy and redressability, as well as prudential aspects that are not part of Article III—may be relaxed," citing, via Consumer Watchdog, Massachusetts v. EPA, 549 U.S. 497, 517–18 (2007).
Regardless, however, "[a] party invoking federal jurisdiction must have 'a personal stake in the outcome'" in order to meet the injury in fact requirement, the opinion citing (again via Consumer Watchdog), City of Los Angeles v. Lyons, 461 U.S. 95, 101 (1983). Important to the panel's decision, this personal interest must exist "at all stages of review," inter alia at the time an appeal is brought and an adjudication commences under Vanda Pharm. Inc. v. W. Ward Pharm. Int'l Ltd., 887 F.3d 1117, 1125 (Fed. Cir. 2018), and Momenta Pharm., Inc. v. Bristol-Myers Squibb Co., 915 F.3d 764, 770 (Fed. Cir. 2019). And where an appellant is not currently practicing activities that could raise infringement liability, standing can still be had if the party shows "that it has concrete plans for future activity that creates a substantial risk of future infringement or would likely cause the patentee to assert a claim of infringement," citing JTEKT. Finally, with regard to the legal requirements for establishing standing, the party seeking judicial review bears the burden, citing Phigenix, Inc. v. Immunogen, Inc.
In this case, the Court held that Pfizer had not met this burden. Pfizer argued that its required "concrete and particularized injury-in-fact" was its "purported" launch of the rituximab biosimilar Ruxience®. Relevant to this appeal, Pfizer asserted that Genentech, owner of the rituximab biologic drug, was a wholly-owned subsidiary of the Roche Group and F. Hoffman LaRoche Ltd. was the majority owner of patent holder Chugai. Pfizer had obtained a license from Genentech to sell its biosimilar to rituximab from Genentech in a settlement agreement, to which Chugai was not a party; accordingly, Pfizer did not get a license to Chugai's '289 or '815 patents as part of the settlement agreement.
The panel was satisfied that Pfizer had raised the possibility of litigation under the challenged patents, but the Court notes that Pfizer had not included in any of its pleadings when the risk of infringement liability had arisen. Pfizer filed a notice of appeal on January 30, 2019, according to the Court, but "the only evidence of standing that Pfizer has provided to this court relates to events that occurred much later in 2019" (citing specifically FDA approval of the biosimilar in July 2019 and an announcement by Pfizer in October that it would begin selling the drug in January 2020). Because, inter alia, Pfizer could not have begun selling its product before FDA approval in July, it could not have established (because it did not yet exist) an injury-in-fact when the appeal was filed in January. Moreover, the panel faults Pfizer for failing to "offer[] evidence that would allow us to evaluate whether it practices or intends to practice the patented methods in the course of making its biosimilar product."
Assertions at oral argument by Pfizer's counsel that it was "self-evident to the parties" which product was at issue were unavailing, the opinion stating that "[i]t is not self-evident to the court, however, that there was standing at the outset of the appeal, or even later." It being Pfizer's burden to establish standing, this bald assertion did not pass muster. Pfizer relied on the e-mail address (rituximabIPR@win-ston.com), somewhat incredibly, for it quantum of self-evidence and on Chugai's use of Genentech's e-mail address on its IPR papers that its rituximab biosimilar was at issue. Whatever significance this may have had for the parties, the Court states that it does not "tell the court anything useful about Pfizer's plans for its biosimilar, Ruxience®, as of the beginning of 2019, when this appeal began." Almost as an aside, the opinion also states that these e-mail addresses do not "establish with sufficient likelihood that the processes used to prepare Pfizer's product would infringe Chugai's patents."
Finally, the opinion addresses Pfizer's alleged harm by application of the IPR estoppel provisions of 35 U.S.C. § 315(e). The Court rejected these on the grounds that the provisions cannot amount to injury-in-fact when the Court has no evidence that Pfizer "was or is engaged in any activity that would give rise to a possible infringement suit," citing AVX Corp. v. Presidio Components, Inc., 923 F.3d 1357, 1362–63 (Fed. Cir. 2019); Gen. Elec. Co. v. United Techs. Corp., 928 F.3d 1349, 1355 (Fed. Cir. 2019); and Argentum Pharm. v. Novartis Pharm. Corp., Case No. 2018-2273 (Fed. Cir. 2020).
The Court having found no standing, it dismissed the appeal.
Pfizer Inc. v. Chugai Pharmaceuticals Co. (Fed. Cir. 2020)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Bryson and Dyk
Opinion by Circuit Judge Bryson
