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October 03, 2022

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§ 314(d) Bar Does Not Defeat Federal Circuit’s Mandamus Jurisdiction

In Mylan Laboratories Ltd. v. Janssen Pharmaceutica, N.V., No. 2021-1071 (March 12, 2021), the Federal Circuit granted Janssen’s motion to dismiss Mylan’s appeal from the Patent Trial and Appeal Board’s (PTAB) denial of inter partes review (IPR) institution.

The Federal Circuit first addressed whether it had jurisdiction over Mylan’s direct appeal. The Federal Circuit concluded that PTAB decisions denying institution of IPR are not subject to review on direct appeal. While the Federal Circuit has exclusive jurisdiction over PTAB’s final decision in an IPR, it does not have such jurisdiction over PTAB’s institution decisions under §314(d). Therefore, Mylan could not directly appeal the PTAB’s decision denying institution of its IPR.

Then, the Federal Circuit addressed whether it had jurisdiction over Mylan’s request for mandamus. A federal court can issue writs of mandamus when necessary to protect its prospective jurisdiction. The Court noted that prospective jurisdiction is triggered when a party takes a preliminary step that might lead to appellate jurisdiction in the Federal Circuit. The preliminary step of an IPR is the filing of a petition, and the Court found jurisdiction over Mylan’s request for mandamus on the merits. Mylan’s request, however, was denied for failing to show a clear right to relief.

© 2022 Finnegan, Henderson, Farabow, Garrett & Dunner, LLPNational Law Review, Volume XI, Number 88

About this Author

Law Clerk

Alexander (Zan) Newkirk’s practice encompasses patent litigation, prosecution, and client counseling in the chemical, pharmaceutical, and medical device areas. He has industry experience with pulmonary and nasal medical devices, drug formulation, and vaccine formulation development.

Zan’s litigation experience covers various aspects of trial preparation, including discovery and regular pre-trial activities. He has worked on ANDA (Abbreviated New Drug Application) litigation.

Prior to law school, Zan interned at Novavax, a vaccine development company, where he analyzed...

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Christina Ji-Hye Yang Patent Litigation Attorney Finnegan Law Firm Washington, DC

Christina Ji-Hye Yang focuses her practice on patent litigation and client counseling in the areas of biotechnology and pharmaceuticals, with particular emphasis on Abbreviated New Drug Application (ANDA) cases.

Christina is involved in all phases of litigation, including pre-litigation analysis, fact discovery, and expert discovery. She also has experience in Section 337 litigation at the International Trade Commission (ITC) and post-grant proceedings at the Patent Trials and Appeals Board (PTAB), including inter partes reviews (IPRs). Christina has also advised clients in...

Elizabeth Ferrill Patent Attorney Finnegan Law Firm

Elizabeth Ferrill is an “undisputed expert on design patents” who is “always updated and enlightening others with her deep knowledge,” “very involved in the design bar,” and “gives her clients an outstanding service” as noted in Intellectual Asset Management Patent 1000. She focuses her practice on all aspects of design patents, including prosecution, counseling, post-grant, and litigation.

Elizabeth counsels clients who hold design patents as well as those accused of infringement. She has experience with design patents related to consumer and industrial products, medical...

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