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.
The Patent Trial and Appeal Board issued seven decisions in TC 1600 during the week of June 11-15, 2018, including four decisions denying institution of inter partes review and three final written decisions. Summaries of the decisions follow:
SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018), established a clear rule requiring institution on all challenged claims in future IPR proceedings. But the Supreme Court’s April 24 decision created immediate uncertainty regarding the hundreds of IPRs in which the PTAB had already instituted review or issued a final written decision on fewer than all claims and all grounds presented in the petition. The Federal Circuit’s immediately apparent interest in SAS transitional issues has led to swift action—the court’s precedential decision in PGS Geophysical AS v. Iancu explains that (1) SAS requires institution on all claims and all grounds presented in a petition for IPR, (2) the Federal Circuit can exercise appellate jurisdiction in pre-SAS cases where the Board granted only partial institution, and (3) parties can waive requests for SAS-based relief on appeal. Continue Reading Federal Circuit Rules that Pre-SAS Appeals from Partially Instituted IPRs Can Proceed
Other than quickly granting Petitioner’s unopposed motion to dismiss with prejudice in Pfizer, Inc. v. Biogen, Inc., No. IPR2018-00231 (Decision Entered June 6, 2018), during the week of June 4, the Patent Trial and Appeal Board issued three decisions in TC 1600, two denying institution of IPR petitions filed by Sandoz, Inc. and Sanofi Pasteur, Inc., respectively, and one final decision finding all challenged claims unpatentable in an IPR filed by Acrux DDS Pty Ltd., joined to an IPR filed by Argentum Pharmaceuticals LLC. The decisions are as follows: Continue Reading PTAB Tech Center 1600 Round-up: Week of June 4-8, 2018
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