On April 7, 2020, the Patent Trial and Appeal Board (“PTAB”) designated one decision as precedential and four decisions as informative, all relating to the topic of prior-art status.  Overall, the precedential decision clarifies the different standards for establishing a reference as a printed publication in IPRs versus patent examination, and the informative decisions provide examples of factual scenarios meeting and failing to meet the “threshold showing” for printed-publication status at the IPR institution stage.  A summary of each decision is below.
Continue Reading The Threshold Showing Of Prior Art Status: PTAB’s New Precedential and Informative Decisions

Building on one of the running topics on our blog—what a Petitioner must do to demonstrate public accessibility of a printed publication (see, for example, posts from Dec. 27, 2019; Dec. 2, 2019; Nov. 13, 2018; and Sept. 25, 2018)—the Patent Trial and Appeal Board (“PTAB”) has once again addressed the issue and held that bare attorney argument cannot overcome objective evidence of a reference’s accessibility.  A summary of the institution decision in this case was published on our blog on March 5, 2019.
Continue Reading The Continued Prior Art Accessibility Saga: Beware of “Bare Attorney Argument”

As we noted previously on the blog (see here, here, here, and here), issues proving up prior art during inter partes review proceedings arise regularly at the PTAB.

Our colleagues, Miguel Bombach and Brandon White, reviewed the current state of PTAB rulings, and synthesized their findings in a short research paper, now available, entitled Inter Partes Review Practice: Challenges in Proving Up Publications as Prior Art. [PDF]
Continue Reading Challenges in Proving Up Publications as Prior Art During IPR

We wrote previously regarding Incyte Corp. v. Concert Pharms., Inc., IPR2017-01256, in which the Board reached different conclusions regarding the availability of two pieces of prior art, over a dissent by Judge Fitzpatrick.  Regarding art referred to as the Concert Backgrounder, the Board’s earlier ruling found public accessibility where the Backgrounder was 1) identified on a cached WebCite page, 2) cited in an International Search Report for a patent application, and 3) used in a law review article that cited the WebCite page.  In a new decision in the same case, the Board ruled on Petitioner’s motion for additional discovery regarding public availability of the Concert Backgrounder, granting the discovery in part.  Interestingly, the Board declined to allow discovery that it viewed as changing the Petitioner’s theory of public availability of the art.
Continue Reading Granting A Motion For Discovery, Board Bars Changes In Theory Of The Evidence

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