The US Court of Appeals for the Federal Circuit concluded that while it did not have jurisdiction to consider the direct appeal of a Patent Trial & Appeal Board decision denying institution, it could review the decision under its mandamus jurisdiction. Mylan Laboratories Ltd. v. Janssen Pharmaceutica, N.V., Case No. 20-1071 (Fed. Cir. Mar. 12, 2021) (Moore, J.)

In 2019, Janssen sued Mylan in district court for infringement of one patent. Less than six months later, Mylan petitioned the Board for inter partes review (IPR) of that patent. Opposing institution, Janssen argued that the IPR would be an inefficient use of Board resources because of two co-pending district court actions (one involving Mylan and one involving a third party) that implicated the same validity issues as the IPR petition. Janssen also argued that those district court actions would likely reach final judgment before any IPR final decision. The Board agreed with Janssen. Mylan appealed and also requested mandamus relief.

On appeal, Mylan argued that the Board’s determination to deny institution based on the timing of a separate district court action that did not involve Mylan undermined constitutional and due process rights.

Before addressing the merits of the appeal, the Federal Circuit addressed two jurisdictional questions: whether it had jurisdiction over Mylan’s direct appeal and whether it had jurisdiction over the mandamus request. As to the first question, the Court relied on its decision in St Jude Medical v. Volcano, finding that decisions denying institution are not subject to review on direct appeal. As to the second question, the Court concluded that judicial review was available in extraordinary circumstances, and particularly in situations involving denial of petitions. The Court stated that “[t]o protect our future jurisdiction, we have jurisdiction to review any petition for a writ of mandamus denying institution of an IPR.”

Having found that it had jurisdiction, the Federal Circuit turned to the merits. The Court explained that when a mandamus petition challenges a decision denying institution, it will be especially difficult to satisfy the requirements for mandamus because the relevant statute bestows the Board with significant discretion. The Court concluded that there is no reviewability of a Board denial of institution except for colorable constitutional claims. The Court found that Mylan lacked a clear and indisputable right to relief and also failed to state a colorable claim for constitutional relief since it did not identify a deprivation of “life, liberty or property” necessary to a procedural due process claim. The Court also found that there were no substantive due process claims since there is no fundamental right to have the Board consider whether to institute on an IPR petition based only upon co-pending litigation to which petitioner is a party. The Court thus denied Mylan’s petition.