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.

Continue Reading Recent PTAB Rulings Reflect Greater Scrutiny Of Product-Label Prior Art

In a final written decision in April 2017, the PTAB found that Petitioner did not satisfy its burden of proving claims of U.S. Patent No. 8,618,135 (“the ’135 patent”) were unpatentable in part because the PTAB found a slide deck presented to business persons was not prior art.  In Coalition for Affordable Drugs VIII, LLC v. The Trustees of the University of Pennsylvania, IPR2015-01f835, Paper No. 56 (PTAB March 6, 2017) Petitioner argued that the ’135 patent was unpatentable over a combination of prior art that included a slide deck prepared by Evan Stein, M.D., Ph.D., for PPD, Inc. (“Stein”).

Stein was presented during Analyst Day at PPD, Inc. live and via webcast, and a hyperlink was distributed.  Moreover, Stein was reported in Pink Sheet, a news webpage.  In asserting Stein was prior art, Petitioner alleged Stein was “targeted to financial analysts, investors, and skilled artisans interested in drug discovery and development.”  Petitioner also asserted that the presentation was publicized for weeks, and that skilled artisans would have taken great interest in it. 
Continue Reading Presentation Directed Toward Business Persons, Rather Than Skilled Artisans, Did Not Qualify As Prior Art