In a recent article, Real Parties In Interest Guidance On Who Is An RPI-And Who Is Not-In Post Grant Proceedings, linked here, Emily Greb and Maria Stubbing offer practical guidance and examine caselaw to clear some of the confusion and frustration practitioners encounter when real parties-in-interest in post-grant review proceedings before the U.S.
On June 21, 2021, the Supreme Court held that “35 U.S.C. § 6(c) is unenforceable as applied to the Director insofar as it prevents the Director from reviewing the decisions of the [Patent Trial and Appeal Board] PTAB on his own.” United States v. Arthrex, Inc., No. 19-1434 slip op. at 22 (U.S. June…
The Patent Trial and Appeal Board (“the Board”) recently designated Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (March 20, 2020), as precedential. The decision provides practitioners a six-factor analysis that the Board will employ when assessing whether to apply its discretion to deny institution when there is co-pending district court litigation.
Continue Reading PTAB Precedential Decision Offers Guidance on Discretionary Denials of Institution in Light of Co-Pending Litigations
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
In Amerigen Pharmaceuticals v. UCB Pharmaceuticals, the Federal Circuit held that a generic Abbreviated New Drug Application (“ANDA”) filer with a Paragraph III certification to an Orange Book-listed patent has standing to appeal decisions from the Patent Trial and Appeal Board (“the Board”). Case No. 17-2529, Doc. 54, January 11, 2019 (the “Decision”). In this case, Amerigen was a Petitioner in inter partes review proceedings involving U.S. Patent No. 6,858,650 (“the ’650 patent”). The Board found the challenged claims not unpatentable, and Amerigen appealed. On appeal, UCB argued that Amerigen lacked standing to appeal because Amerigen had filed a Paragraph III certification with its ANDA. The Federal Circuit disagreed.
Continue Reading ANDA Filers with Paragraph III certifications = standing to appeal Inter Partes Review decisions according to Federal Circuit
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”
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
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
On April 13, 2018, the Federal Circuit issued a new decision in its recent line of cases analyzing whether generic drug labels may be evidence of induced infringement of method of treatment claims in Hatch-Waxman cases. In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., the Court, in upholding the District Court’s finding of induced infringement, held that proposed instructions to physicians can satisfy the specific-intent element of induced infringement. 887 F.3d 1117 (Fed. Cir. 2018) (Judges Lourie and Hughes, Chief Judge Prost dissenting on other issues). This decision follows and builds upon the Federal Circuit’s 2017 decisions in Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017) and Sanofi v. Watson Laboratories Inc., 875 F.3d 636 (Fed. Cir. 2017).
Continue Reading Generic Drug Labels May Establish Specific Intent to Induce Infringement of Method of Use Claims