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]
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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).
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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.
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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.

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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. 
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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.

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On May 14, 2018, the Federal Circuit (Judge Linn, with Judges Reyna and Hughes) ruled on mandamus to address two important issues related to proper venue in a patent infringement case: 1) whether regional or Federal Circuit law governs the analysis of proper venue under 28 U.S.C. § 1400(b), and 2) which party bears the burden of persuasion on the issue when a defendant challenges proper venue.  The court held that Federal Circuit law applies, and the plaintiff bears the burden of persuasion.  In re: ZTE (USA) Inc., No. 2018-113 (Fed. Cir. May 14, 2018).

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