Drug product labels (also known as prescribing information) are often asserted as prior art by patent challengers, both in front of the PTAB and in district court ANDA litigation.  Before the PTAB, using such prior art requires showing that it qualifies as a “printed publication” under 35 U.S.C. §§ 102 and 311(b).  Recently, the PTAB appears to be applying greater scrutiny to the use of such prior art when cited in invalidity grounds.  The Board’s analysis in such situations “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.”  Sandoz Inc. v. AbbVie Biotechnology Ltd., IPR2018-00156, Paper 11 at *9 (June 5, 2018) (citing In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)).  A pair of recent rulings identify some of the evidentiary issues catching the eyes of PTAB panels as they consider invalidity arguments that rely on product-label prior art.

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