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Mar 15, 2021Legal
Federal Circuit Cannot Review Denial of Institution of IPR, Unless Extraordinary Circumstances Are Shown

MYLAN LABS. LTD. v. JANSSEN PHARMACEUTICA, N.V.

Before Newman, Moore, and Stoll.  Appeal from the Patent Trial and Appeal Board.

Summary: The Federal Circuit lacks jurisdiction over appeals from decisions denying institution of an IPR. However, the Federal Circuit has jurisdiction over mandamus petitions challenging decisions denying institution, but mandamus relief is an extraordinary remedy.

Janssen sued Mylan in district court for patent infringement. Mylan subsequently petitioned for IPR of the asserted patent. The Board denied institution and concluded it would be an inefficient use of resources to institute the IPR due to the quickly approaching trial dates in co-pending litigation which had substantial overlap with the issues raised in the IPR petition.  Mylan was not a party to one of the co-pending lawsuits considered by the Board.  Mylan appealed to the Federal Circuit claiming that (1) the denial of institution based on timing of a separate district court litigation to which Mylan was not a party violates Mylan’s constitutional and due-process rights; and (2) “the Board’s continued adoption and application of non-statutory institution standards through ad hoc proceedings lie in contrast to congressional intent.” Mylan further requested mandamus relief on the same grounds. Janssen moved to dismiss Mylan’s appeal for lack of jurisdiction.

The Federal Circuit reasoned that no statute grants it jurisdiction over appeals from decisions denying institution and therefore Mylan’s appeal was dismissed pursuant to 28 U.S.C. § 1295(a)(4) and 35 U.S.C. § 314(d). Specifically, 35 U.S.C. § 314(d) states “[t]he determination by the Director whether to institute an inter partes review under this section shall be final and non-appealable.” The Federal Circuit recognized the Supreme Court’s strong presumption in favor of judicial review, but maintained that § 314 bars appeal from a decision denying institution.

The Federal Circuit concluded that judicial review is available for decisions denying institution in extraordinary circumstances by petition for mandamus. The Federal Circuit reasoned that the All Writs Act is especially important when the Board denies institution because this decision defeats the Federal Circuit’s prospective jurisdiction. While the Federal Circuit determined that it had jurisdiction to consider Mylan’s request for mandamus on the merits, it ultimately denied the request for mandamus relief. Mandamus is an extraordinary remedy and the petitioner must show: (1) it has clear and indisputable legal right; (2) it does not have another adequate method for relief; and (3) the writ is appropriate under the circumstances. The Federal Circuit made clear that the Director is permitted, but never compelled to institute an IPR, and the petitioner has no right to an institution.  Mylan needed to identify a colorable constitutional claim to obtain relief – and Mylan failed to do so.  Therefore, Mylan failed to show a clear right to relief and was not granted mandamus relief.

Editor: Paul Stewart

Written by: Benjamin L. Van Adrichem & Nicole R. Townes

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