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Sen. Hatch on Amendment to Incentivize Generic Drug Development

Sen. Hatch on Amendment to Incentivize Generic Drug Development

by Matthew Johnson | Jul 30, 2018 | Pharmaceutical

As we reported in our July 2, 2018 article Hatch Bill: Restore Hatch-Waxman Balance; Limit Generics’ Access to PTAB, Senator Orrin Hatch (R-Utah), the namesake and coauthor of the Hatch-Waxman Act, proposed (but has not yet introduced) an amendment titled the...
PTAB Upholds GILENYA™ Method of Treatment Patent, Prompting New ANDA Litigation

PTAB Upholds GILENYA™ Method of Treatment Patent, Prompting New ANDA Litigation

by Cary Miller | Jul 30, 2018 | Pharmaceutical

By: J. Jason Williams and Cary Miller, Ph.D. In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not unpatentable on three separate grounds.  Shortly thereafter, Novartis filed suit...
Sen. Hatch on Amendment to Incentivize Generic Drug Development

Genentech to Defend 3 of 4 Herceptin® Patents Challenged by Hospira

by Cary Miller | Aug 9, 2017 | Pharmaceutical, Trial Institution

By Raffaella Faraoni, Ph.D. and Cary Miller, Ph.D. At least 19 IPRs have been filed against seven of Genentech’s patents covering its blockbuster antibody drug Herceptin® (trastuzumab). On July 27, 2017, the PTAB instituted IPRs filed by Hospira, Inc. (a subsidiary of...
PTAB Denies Joinder of IPR Petitioner That Won’t Take “Silent Understudy” Role

PTAB Denies Joinder of IPR Petitioner That Won’t Take “Silent Understudy” Role

by Cary Miller | Jul 20, 2017 | Pharmaceutical, Trial Institution

By Achim Brinker, Ph.D. and Cary Miller, Ph.D. In orders entered July 10 and 12, 2017, the PTAB instituted further inter partes review (IPR) of six Allergan Inc. (“Allergan”) patents relating to cyclosporine compositions.  Each of U.S. Patent Nos. 8,633,162,...
Known Solution to General Problem Provides Sufficient Motivation to Modify Prior Art

Known Solution to General Problem Provides Sufficient Motivation to Modify Prior Art

by Jones Day's PTAB Team | Jul 7, 2017 | Pharmaceutical

By Dominic J. Yee, Ph.D. and J. Patrick Elsevier, Ph.D. In a final written decision in Bass, et al., v. Fresenius Kabi USA, LLC (IPR2016-00254), the PTAB found that the challenged claims of Fresenius’s U.S. Patent No. 8,476,010, directed to a sterile pharmaceutical...
Federal Circuit Holds Objective Indicia Must Be Linked to Novel Features

Federal Circuit Holds Objective Indicia Must Be Linked to Novel Features

by Jones Day's PTAB Team | May 9, 2017 | Pharmaceutical

By J. Jason Williams and J. Patrick Elsevier, Ph.D. In Novartis AG v. Torrent Pharms. Ltd. (2016-1352), the Federal Circuit affirmed the PTAB’s decision in consolidated IPR proceedings (IPR2014-00784, IPR2015-00518) invalidating all claims of U.S. Patent 8,324,283. In...
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    The opinions expressed are those of the authors and do not necessarily reflect the views of Jones Day or its clients. The posts and information provided are for general information purposes and are not intended to be and should not be taken as legal advice.