News & Analysis as of

Hatch-Waxman Noninfringement Patent Litigation

McDermott Will & Emery

The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

McDermott Will & Emery on

Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a...more

Robins Kaplan LLP

Astellas US LLC v. Hospira, Inc.

Robins Kaplan LLP on

Case Name: Astellas US LLC v. Hospira, Inc., No. 18-cv-1675-CFC, 2022 WL 1591277 (D. Del. May 19, 2022) (Connolly, J.)   Drug Product and Patent(s)-in-Suit: Lexiscan® (regadenoson); U.S. Patents Nos. 106,183 (“the ’183...more

Robins Kaplan LLP

Horizon Medicines LLC v. Alkem Labs. Ltd. (UPDATED)

Robins Kaplan LLP on

Case Name: Horizon Medicines LLC v. Alkem Labs. Ltd., No. 2021-1480, 2021 WL 5315424 (Fed. Cir. Nov. 16, 2021) (Circuit Judges Dyk, O’Malley, and Hughes presiding; Opinion by Dyk, J.) (Appeal from D. Del., Andrews, J.)...more

Robins Kaplan LLP

Almirall, LLC v. Torrent Pharms., Ltd.

Robins Kaplan LLP on

Case Name: Almirall, LLC v. Torrent Pharms., Ltd., Civ. No. 20-1373-LPS (D. Del. July 13, 2021) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Aczone® Gel, 7.5% (Dapsone); U.S. Patent No. 9,517,219 (“the ’219 patent”)...more

WilmerHale

Federal Circuit Patent Updates - February 2017

WilmerHale on

MPHJ Technology Investments v. Ricoh Americas Corporation (No. 2016-1243, 2/13/17) (Newman, Lourie, O'Malley) - Newman, J. Affirming PTAB decision in IPR that claims directed to document managing system and process were...more

McDonnell Boehnen Hulbert & Berghoff LLP

Apotex Inc. v. Daiichi Sankyo, Inc. (Fed. Cir. 2015)

Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more

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