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Developments in Drug Labels as “Prior Art” at PTAB - Intellectual Property News

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Intellectual Property News

Posted on: Dec 4, 2019

By John Bishop, Cohen Garelick & Glazier PC

Historically, parties challenging patents covering pharmaceuticals and biologics often used drug product labels as prior art before PTAB. However, recent decisions in Celltrion, Inc. v. Biogen, Inc. and Mylan Pharmaceuticals Inc. v. Boehringer Ingelheim International GMBH demonstrate that a date printed on a drug label with no other evidence supporting that date is insufficient to demonstrate that the label was publicly available as of the printed date.

In this regard, the Federal Circuit has previously reasoned that “whether a reference is a ‘printed publication’ is a ‘case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.’” Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347, 1356 (Fed. Cir. 2018) (quoting In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)). Nevertheless, best practices would suggest that petitioners check noted publications such as a pharmacopeia or the Physicians’ Desk Reference for a prior art entry for the drug label of interest and/or look for archived versions of the drug label of interest using internet archiving websites to support a public availability argument.

Source: Aziz Burgy & Christopher Gallo,, November 13, 2019.

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