Today, the PTO’s Patent Trial and Appeal Board (PTAB) issued a final rule related to trial proceedings under the America Invents Act.  The final rule goes into effect 30 days after publication in the Federal Register (scheduled for December 9, 2020); it makes changes to institution practice and sur-replies, and eliminates an evidentiary presumption in favor of a petitioner on certain institution-related fact issues.
Continue Reading PTAB Publishes Final Rule on Institution and Presumption in AIA Trials

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”

It has become a significant open question in inter partes review proceedings what a petitioner must do to establish a reference as a printed publication. In a decision designated Precedential on December 20, 2019 (Hulu, LLC v. Sound View Innovations, LLC, IPR2018-1039) the Patent Trial and Appeal Board (“the Board”) provided practitioners with guidance regarding “what is required for a petition to establish that an asserted reference qualifies as a ‘printed publication’ at the institution stage.” Paper 29 at 6. The decision held, inter alia, that at the institution stage the “reasonable likelihood” standard applies to printed publications, and that the inquiry, as during other stages of the proceedings, is based on the totality of the evidence. Id. at 14-17.
Continue Reading PTAB states the “reasonable likelihood” standard applies to demonstrating public accessibility at the institution stage

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

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