Big Molecule Watch
August 22, 2018

Sandoz Responds to Show Cause Order in Adalimumab IPR Appeal

As we previously reported, Sandoz appealed the PTAB’s decision not to institute an IPR regarding AbbVie’s U.S. Patent No. 9,512,216, which relates to a method for treating moderate to severe chronic plaque psoriasis using adalimumab.  Last month, the Federal Circuit ordered Sandoz to show cause why the appeals should not be dismissed for lack of jurisdiction.

On August 8, Sandoz responded to that order, arguing that the statute that limits the appealability of inter partes review (IPR) institution decisions (35 U.S.C. § 314(d)) does not extend to decisions by the PTAB regarding the public accessibility of alleged prior art references in an IPR petition.  Sandoz further argued that the PTAB’s approach to whether drug labels — in this case, the label for AbbVie’s Humira — are publicly accessible is unlawfully arbitrary and capricious.  Today, AbbVie filed its reply brief, arguing that no statute confers jurisdiction over Sandoz’s appeal to the Federal Circuit, and that in any event the PTAB’s decisions in this regard are not arbitrary or capricious.

Stay tuned to Big Molecule Watch for further updates on Sandoz’s appeal.

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