Mylan Labs. Ltd. v. Janssen Pharm., N.V., 21-1071 (Fed. Cir. March 12, 2021
In Mylan, the Federal Circuit held that it does not have jurisdiction to hear a direct appeal of the Patent Trial and Appeal Board’s discretionary decision to deny a petition for inter partes review for reasons that do not turn on the merits of the petition. A court may review such decisions through a writ of mandamus, but the court is unlikely to grant such a petition unless the petition identifies a clear and indisputable right to relief or state a colorable claim for constitutional relief.
Janssen Pharmaceuticals owns a patent directed to a method of treating patients for schizophrenia and schizoaffective disorder using long acting injectable paliperidone palmitate formulations. In 2019, Janssen filed a suit against Mylan Laboratories in district court for infringing that patent. Less than six months later, Mylan petitioned for IPR. The Board, acting under its discretionary authority, denied institution of IPR in view of two co-pending district court actions: the suit against Mylan and another suit against Teva Pharmaceuticals USA, Inc. Mylan appealed the denial of an IPR institution to the Federal Circuit both directly and through a writ of mandamus. Mylan Laboratories claimed, (i) the Board’s use of six non-statutory Fintiv factors to decide whether to use its discretionary power to deny a petition was contrary to congressional intent, and (ii) the Board’s decision to deny instituting the IPR in view of the co-pending Teva cases undermined Mylan’s constitutional and other due process rights since Mylan was not a party to that suit.
The court first addressed whether it had jurisdiction over Mylan’s direct appeal. The IPR statute provides that the Board’s institution decision is non-appealable. The Supreme Court has carved out exceptions to the appeal bar where the appeal is directed to a Constitutional right, or to claims that the Board exceeded its statutory grant of jurisdiction. However, neither of those exceptions applied in this case. Because the Board’s decision to deny Mylan’s petition under its discretionary authority was germane to the Board’s institution decision, the Federal Circuit did not have jurisdiction to hear Mylan’s direct appeal
The court then considered Mylan’s arguments to determine whether Mylan had identified a clear and indisputable right to mandamus relief. The Supreme Court previously established that the Director is permitted, but never required, to institute an IPR. Thus, at least under the appropriate circumstances, the Board may exercise its discretion to deny an otherwise meritorious petition. Mylan failed to identify a clear and indisputable right to relief since there was no right to institution of an IPR. The Court also found that Mylan failed to state a colorable claim for constitutional relief for either procedural due process or substantive due process, noting that Mylan was free to litigate the patent claims’ validity in its own district court case.
Key Takeaway
Federal Court has no direct jurisdiction to review PTAB’s institution decisions. While it is possible to use a writ of mandamus for the Federal Circuit to review the institution denial of an IPR, the Federal Court is unlikely to grant such a writ.
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