As we have reported in several recent posts, the PTAB often rigorously evaluates public accessibility when considering non-patent prior art.  Disputes over accessibility are often pivotal because insufficient evidence of accessibility can disqualify a reference as a “printed publication” under § 102.  The Federal Circuit recently expanded on the applicable standard for online publications in a case rooted in computer technology, but the decision provides relevant insights for life science practitioners as well. Continue Reading Federal Circuit Upholds PTAB Decision Finding Library Website’s Indexing and Search Capabilities Insufficient to Establish Public Accessibility

The Federal Circuit recently held that a product catalog distributed at a trade show was “publicly accessible,” and therefore qualified as prior art. In Nobel Biocare Services AG, v. Instradent USA, Inc., decided on September 13, 2018, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“PTAB”) finding that a catalog distributed at the International Dental Show (“IDS”) Conference in Cologne, Germany was publicly accessible. The court’s decision in Nobel hinged largely on the testimony of two declarants, one who went to the conference (Zvi Chakir), and another who Chakir gave the catalog to upon his return (Yechiam Hantman). Continue Reading Federal Circuit again finds product catalog distributed at trade show to be “publicly accessible”

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

On July 27, 2018, in GoPro, Inc., v. Contour IP Holdings LLC, the Federal Circuit overturned the Patent Trial and Appeal Board (“PTAB”) in its most recent decision on what constitutes publicly available prior art. In GoPro the Court held that a catalog distributed at a trade show open only to dealers was publicly available prior art.

Continue Reading Federal Circuit overturns PTAB: catalog distributed at a trade show found to be publicly available prior art

On July 13, 2018, in Jazz Pharms., Inc. v. Amneal Pharms., LLC, (Case Nos. 2017-1617, -1673, -1674, -1675, -1676, -1677, -2075), the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“PTAB”) holding that certain FDA advisory meeting minutes, transcripts, and slides were publicly available such that the materials constituted prior art.  We have previously discussed the PTAB’s public availability jurisprudence in Coalition for Affordable Drugs VIII, LLC v. The Trustees of the University of Pennsylvania, IPR2015-01835 where the PTAB held a presentation given to investors was not prior art.  Continue Reading FDA Advisory Committee Materials Determined to be Publicly Available Prior Art

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

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