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

Today the Federal Circuit (Judges Moore, Dyk, and Reyna) ruled in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc. that tribal sovereign immunity does not apply in IPR proceedings. The appeal represented the first opportunity for the Federal Circuit to address the issue of sovereign immunity in IPR proceedings. Continue Reading Federal Circuit Affirms that Tribal Sovereign Immunity Does Not Apply in IPRs

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:

Continue Reading PTAB Tech Center 1600 Round-up: Week of July 9-13, 2018

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

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. Continue Reading Federal Circuit Rules that Pre-SAS Appeals from Partially Instituted IPRs Can Proceed

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. Continue Reading PTAB Sets Forth Updated Standards for Motions to Amend

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.’ Continue Reading Hindsight Is Not 20/20: PTAB Technology Center 1600 Decision Round-Up: Week of May 28 – June 1, 2018

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:   Continue Reading PTAB Technology Center (TC) 1600 Decision Round-Up: Week of May 21-25, 2018

The Supreme Court’s recent decision in SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018), has bred considerable uncertainty about what to do with the multitude of pending inter partes review (IPR) cases that were instituted under pre-SAS standards. The adjudicators tasked with applying SAS in those cases—at the PTAB and the Federal Circuit—are now sorting through the fallout.

The PTAB reacted quickly by releasing guidance two days after SAS that outlined the agency’s initial response: (1) future institution decisions will be decided on an all-or-nothing basis as to all claims and all grounds in the petition, (2) panels presiding over pending trials that were instituted on fewer than all claims and grounds in the petition are issuing orders to supplement the institution decision and institute on all claims and grounds, and (3) panels may take further actions in individual pending cases, such as allowing supplemental briefing or extending trial deadlines, depending on factors such as the particulars of the case, the stage of proceedings, and input from the parties. The PTAB noted that it will continue to assess its response to SAS and may issue additional guidance in the future.

The Federal Circuit is likewise wrestling with SAS. Continue Reading SAS Institute v. Iancu – What Now?