United Therapeutics Corporation v. Liquidia Technologies, Inc.
AdministrativeLaw Patent
Whether the IPR statute and SAS require the Federal Circuit to review de novo, or only for an abuse of discretion, the PTO's reliance on new grounds and new printed publications—not raised in the initial petition— when deciding to cancel patent claims
QUESTIONS PRESENTED Under 35 U.S.C. § 312, a petition for inter partes review (IPR) of a patent must “identif[y]” “with particularity” the “srounds on which the challenge to each [patent] claim is based” and include “copies” of the “printed publications that the petitioner relies upon” in support of each ground. Those grounds and printed publications “define the contours of the proceeding” “from institution through to conclusion.” SAS Inst., Inc. v. Iancu, 188 S. Ct. 1348, 1855, 1357 (2018). Thus, § 312 bars the Patent and Trademark Office (PTO) or parties from injecting new issues or new printed publications into the statutorily-defined proceeding. The Federal Circuit has taken inconsistent and irreconcilable stances on the standard of review over the PTO’s reliance on new arguments never presented in an IPR petition—some panels applying de novo review and others deferring to the agency’s discretion. In the decision below, the court opted for maximum deference, allowing duly issued patent claims to be canceled based on theories absent from the petition and publications never identified in the petition or introduced into evidence. According to the court, the PTO may decide IPR challenges based on new arguments or references so long as they are “not inconsistent with” the initial petition. The questions presented are: 1. Whether the IPR statute and SAS require the Federal Circuit to review de novo, or only for an abuse of discretion, the PTO’s reliance on new grounds and new printed publications—not raised in the initial petition— when deciding to cancel patent claims. 2. Whether, if § 312 is deemed ambiguous, the Court should overrule Chevron. ii CORPORATE DISCLOSURE Petitioner United Therapeutics Corporation discloses that it has no parent corporation and that BlackRock Inc., collectively through different BlackRock entities, may own 10% or more of its stock.