The PTAB ruled that the Saint Regis Mohawk Tribe could not assert sovereign immunity in IPRs of patents that Allergan had assigned to the Tribe relating to Restasis®. See The Saint Regis Mohawk Tribe is not entitled to Sovereign Immunity at the PTAB. Following the PTAB’s dismissal of the Tribe’s sovereign immunity defense, the Tribe filed a notice of appeal and request to the PTAB to stay the IPR proceedings. IPR2016-01127, Paper 134 (PTAB March 8, 2018). The Tribe argued that its appeal divested the PTAB of jurisdiction. Id. at 3-7. The PTAB denied the Tribe’s motion to stay and stated that the Tribe’s interlocutory appeal does not divest the PTAB of jurisdiction, because the IPR proceedings can proceed against Allergan alone. IPR2016-01127, Paper 137 at 4 (PTAB March 22, 2018). The Tribe then filed a motion with the Federal Circuit to stay the IPR proceedings.
On March 28, 2018, the Federal Circuit granted the Tribe’s motion to stay the IPR proceedings. St. Regis Mohawk Tribe v. Mylan Pharms. Inc., No. 18-1638 slip op. at 2 (Fed. Cir. March 28, 2018). The Federal stated that “it appears that the appeals divested the Board of jurisdiction over the aspects of the case on appeal,” and noted that “the threshold issue of whether these proceedings must be terminated vests in this court, and the Board may not proceed until granted leave by this court.” Id. The stay will remain in effect at least until 1 day after oral argument in the appeal, which will occur in June 2018. Id. At that time, the Federal Circuit will issue an order indicating whether or not the IPR stay will remain in effect.
Following the Federal Circuit’s order, the PTAB issued an Order cancelling the Oral hearings and stating that no final written decision will issue until the Federal Circuit grants the PTAB leave to proceed. IPR2016-01127, Paper 139 at 2 (PTAB March 28, 2018).
The Federal Circuit’s order appears to address one question that had been previously undecided: whether the PTAB’s decisions on sovereign immunity were appealable. The Federal Circuit appears to take the position that the PTAB’s sovereign immunity decisions are appealable even absent a final written decision. This could open the door to additional appeals of various other PTAB decisions on sovereign immunity. Also, this is the first order by the Federal Circuit of an interlocutory appeal of an AIA trial at the PTAB. While the Federal Circuit relied on case law directed solely to sovereign immunity for their rationale in staying the IPRs, might it be possible for interlocutory appeals to the Federal Circuit of other issues?
The Federal Circuit’s stay also raises questions regarding PTAB procedures and timing. The Federal Circuit did not address the PTAB’s statutory timing mandate. The PTAB extended the deadline for issuing a written decision to April 6, 2018, based on the joinder of this case with IPRs filed by Teva Pharmaceuticals. IPR2016-01127, Paper 96 at 4-5 (PTAB November 3, 2017) (citing 35 U.S.C. § 316(a)(11)). The PTAB has recently reset the deadline for June 6, 2018, though the statutory basis for that extension was unclear. IPR2016-00127, Paper 132 at 4 (PTAB Feb. 23, 2018).
It will be interesting to see how the Federal Circuit decides the sovereign immunity issue, whether other parties currently in IPR will appeal the PTAB’s sovereign immunity decisions and move to stay the proceedings, and how the Federal Circuit and PTAB address statutory timing requirements for issuing a final written decision.