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ARTICLE · 06 MAY 2020

Generic Drug Developer Lacks Standing To Appeal Adverse IPR Ruling

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The Federal Circuit recently held a generic drug developer lacked Article III standing to appeal an adverse patentability determination by the Patent Trial and Appeal Board (PTAB) because it failed to prove...

United StatesIntellectual Property
Matthew Hartman
Matthew Hartman
Rachel J. Elsby
Rachel J. Elsby
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The Federal Circuit recently held a generic drug developer lacked Article III standing to appeal an adverse patentability determination by the Patent Trial and Appeal Board (PTAB) because it failed to prove that it suffered an injury in fact necessary to establish standing.

Apotex filed a petition for an inter partes review (IPR) challenging the validity of Novartis' U.S. Patent 9,187,405 (the '405 Patent), which generally covers methods for treating relapsing multiple sclerosis. The Board instituted proceedings and subsequently joined several other generic companies as petitioners to the proceeding, including Argentum. At the conclusion of the IPR, the Board held that the petitioners failed to show the claims were unpatentable and the petitioners appealed. Before the opening briefs were filed in the appeal, Novartis settled with all of the petitioners except Argentum. Novartis then filed a motion to dismiss the appeal on the basis that Argentum, the only

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