[co-author: Nicole Prescott]*
In a recent decision, the Patent Trial and Appeals Board (“PTAB”) exercised its discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review (“IPR”) after applying the Fintiv factors, despite Petitioner’s Sotera stipulation. Cipla Limited v. Gilead Sciences, Inc., IPR2025-00033, Paper 22 (May 15, 2025).
On October 28, 2024, Cipla Limited (“Petitioner”) filed a petition requesting an IPR of Gilead Sciences, Inc.’s (“Patent Owner”) patent, U.S. Pat. No. 11,744,802 (“the ’802 patent”). The ’802 patent is directed towards a pharmaceutical formulation for treating human immunodeficiency virus (HIV), and was asserted against Cipla as part of a Hatch-Waxman litigation. Gilead Sciences, Inc. v. Lupin Ltd., Laurus Labs Ltd., and Cipla Limited, C.A. No. 22-cf-00615 (MN) (the “district court litigation”). The district court litigation also included two other defendants that did not join the IPR petition.
While Petitioner was awaiting a decision on institution, the United States Patent and Trademark Office (“USPTO”) rescinded prior interim procedures for discretionary denials in cases with parallel district court litigation. Shortly thereafter, on March 24, 2025, Chief Administrative Patent Judge Boalick’s issued new “Guidance on USPTO’s recission of ‘Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation,’” advising the PTAB on applying the Fintiv factors to determine whether discretionary denial is appropriate. Later that same week, Petitioner filed a Sotera stipulation in the district court litigation stating that it would “not seek an adjudication of ’802 Patent invalidity on any ground raised or that reasonably could have been raised in the Petition.” Notably, the other two defendants in the district court litigation did not sign the Sotera stipulation.
Accordingly, in reaching its decision to deny institution, the PTAB evaluated each of the Fintiv factors to determine “whether efficiency, fairness, and the merits support the exercise of authority to deny institution” of the IPR. The factors analyze: (1) whether the court granted a stay or evidence exists that one may be granted; (2) proximity of the court’s trial date to the PTAB’s deadline for a final decision; (3) investment in the parallel proceeding by the court and the parties; (4) overlap between issues raised in the petition and in the parallel proceeding; (5) whether the petitioner and the defendant in the parallel proceeding are the same party; and (6) other circumstances that impact the PTAB’s exercise of discretion, including the merits. The PTAB concluded that factors 2 to 6 weighed in favor of exercising discretion to deny the Petition, whereas factor 1 was neutral.
The PTAB determined that factor 2 held the most weight because the district court was expected to complete trial “well before” the PTAB’s final written decision. PTAB also devoted a significant amount of its discussion to factors 3 and 4. Factor 3 favored denial, even though the ’802 patent was added to the district court litigation over a year after the litigation began. Petitioner argued that the district court did not heavily invest in evaluating infringement of the ’802 patent because of this delay, asserting that most of the district court’s investment focused on other disputed patents. The PTAB disagreed and found that the district court heavily invested in litigation because: (1) infringement and invalidity contentions had already been served for the ’802 patent in district court, and (2) the parties in the district court litigation had completed fact discovery and began expert discovery. Factor 4 also favored denial despite Petitioner’s Sotera stipulation because the PTAB found this stipulation “hollow” since the other defendants were free to assert overlapping invalidity defenses in district court.
Overall, this decision alerts petitioners to the revival of Fintiv denials at the PTAB if there is a parallel district court proceeding. Moreover, petitioners should be reminded that under the Fintiv analysis a Sotera stipulation is not dispositive, and that proximity of a district court trial date is still a significant consideration.
*Summer Associate
