WolfTracks Logo (15)

Following all of the latest IP developments in life sciences.

 

Your IPR Petition Was Denied at Institution – What Next? The Federal Circuit Provides Insights on Petitioners’ Options

Mylan v. Janssen considers a topic IPR petitioners may be concerned about when institution of their petition is denied by the PTAB – is there any way to appeal the decision? The Federal Circuit held that while there is an avenue for relief, it is reserved for “extraordinary circumstances.”

Background

Janssen sued Mylan in district court—and had separately sued Teva Pharmaceuticals in another district court action—for infringing claims of Janssen’s U.S. Patent No. 9,439,906. Mylan timely filed an IPR petition challenging the patent on obviousness grounds. The Board exercised its discretion to deny institution based on the two parallel district court litigations. Applying its six-factor Fintiv test, the Board found that the two district court actions would likely reach final judgments before the IPR would reach final written decision on overlapping issues, making it an inefficient use of resources to institute IPR.

Mylan appealed, in part arguing that because it was not a party to the litigation against Teva, denying institution based on that litigation “undermines [Mylan’s] constitutional and other due process rights.” Mylan also requested mandamus relief on the same grounds. Janssen moved to dismiss Mylan’s appeal for lack of jurisdiction.

No Direct Appellate Jurisdiction over Denial of Institution

The Federal Circuit found that it lacks jurisdiction over appeals from decisions denying institution of IPR. 28 U.S.C. § 1295(a)(4) gives the Federal Circuit exclusive jurisdiction over appeals from Board decisions with respect to IPRs, but 35 U.S.C. § 314(d) makes the Board’s “determination…whether to institute an inter partes review…final and non-appealable.” While the Supreme Court has recognized a presumption in favor of judicial review, the Federal Circuit noted that “[e]very relevant Supreme Court case involved an appeal from a final written decision—not an institution decision.” Because “no statute confers jurisdiction over appeals from decisions denying institution,” and in fact “Section 314 bars direct appeal from a decision denying institution,” the Federal Circuit found it lacked jurisdiction over Mylan’s direct appeal.

Mandamus Relief Possible, but Not Warranted Here

Despite the unavailability of a statutory direct appeal, the Federal Circuit found that “judicial review is available in extraordinary circumstances by petition for mandamus.” Filing an IPR triggers the Federal Circuit’s exclusive prospective jurisdiction over PTAB decisions. While Section 314(d) bars direct appeals from institution denials, it does not expressly bar mandamus jurisdiction, and other case law has implied that such jurisdiction exists. Thus, the Federal Circuit found it had proper jurisdiction for considering Mylan’s request for mandamus on the merits.

However, while the Federal Circuit determined it had mandamus jurisdiction, it also held that Mylan had not shown it was entitled to mandamus relief.

Mylan made multiple arguments that the Board’s institution denial was improper, including statutory arguments that the Patent Office improperly adopted the Fintiv standard through a precedential Board decision rather than notice-and-comment rulemaking, and that Fintiv unlawfully shortens the limitations period provided by statute for filing an IPR. The Federal Circuit found that Mylan lacked a “clear and indisputable right to review” whether Fintiv is compliant with the statutes. Given that mandamus is a remedy for extraordinary cases and the scope of review over institution denials is narrow, the Federal Circuit “conclude[d] that there is no reviewability of the…discretion to deny institution except for colorable constitutional claims.”

The Federal Circuit found that Mylan failed to state any colorable claim for constitutional relief. Mylan did not identify a “deprivation of life, liberty, or property” that could support an argument that the Board had violated procedural due process. While Mylan was not a party to Teva’s district court proceeding, it was a party in the other district court proceeding, and was free to litigate the validity issues in that case. Furthermore, the Federal Circuit saw no “fundamental right” for Mylan to have its IPR petition considered without reference to the Teva litigation, so there was also no colorable claim under substantive due process.

Takeaways
  • The Federal Circuit does not have jurisdiction over direct appeals from PTAB decisions denying institution, but does have mandamus jurisdiction.

  • Under mandamus jurisdiction, the Federal Circuit can consider constitutional arguments that a decision denying IPR institution violated due process, but the petitioner must show “a clear and indisputable right to relief.”

  • This case is limited to denials of institution. The Federal Circuit noted that decisions granting institution “involve a fundamentally different calculus,” and that “the Supreme Court has suggested decisions granting institution may be reviewable (to a limited extent) on direct appeal from a final written decision” reached at the end of an instituted IPR.