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 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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During the week of July 9, the Board issued four decisions in Technology Center 1600, three decisions denying institution of inter partes review and one Final Decision finding the challenged claims patentable. In addition to these four decisions the Board, in ABS Global, Inc. v. XY, LLC, No. IPR2017-02184, also granted Patent Owner’s request for an adverse judgement. The four decisions are as follows:

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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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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.
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On June 1, 2018, the Patent Trial and Appeal Board (“PTAB”) designated as informative its April 25, 2018 order regarding Motions to Amend.  Western Digital Corp. v. Spex Techs. Inc., IPR2018-0082, IPR2018-00084 (PTAB April 25, 2018) (Paper 13).  The PTAB’s order provides guidance to practitioners on (1) contingent motions to amend, (2) the burden of persuasion with respect to substitute claims, (3) number of substitute claims, (4) requirement that amendments respond to unpatentability grounds, (5) scope of substitute claims, (6) claim listings, (7) page limits on briefs, and (8) duty of candor.  This new order replaces MasterImage 3D, Inc. v. RealD Inc., IPR2015-00040 (PTAB July 15, 2015) (Paper 42) and Idle Free Sys. Inc. v. Bergstrom, Inc., IPR2012-00027 (June 11, 2013) (Paper 26), which the also PTAB de-designated as informative.
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At the end of a week shortened by the Memorial Day holiday, the PTAB (“Board”) issued just two decisions in Technology Center (TC) 1600 during the week of May 28.  The Pfizer decision hammers home that hindsight is not always 20/20, and there is no place for such bias in an obviousness analysis, while the shorter Roquette Freres decision serves to remind us of the old adage ‘mean what you say and say what you mean.’
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Aside from a quick termination of IPR proceedings pending settlement in Argentum Pharmaceuticals LLC v. Cipla Ltd., No. IPR2017-00807 (Decision Entered May 21, 2018), the Board entered four decisions in TC 1600 during the week of May 21, all denying institution of IPR petitions filed by Initiative for Medicines, Access & Knowledge (I-MAK), Inc. (“I-MAK”) against Gilead Pharmasset LLC. (“Gilead”).  Those decisions are as follows:  
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