News & Analysis as of

Noninfringement Hatch-Waxman

Axinn, Veltrop & Harkrider LLP

Bayer Covenants Not to Sue, Still Has Headache

Bayer's ‘053 patent on its drug Xarelto® expires in November 2024, and Bayer granted Mylan a covenant not to sue. Bayer has a second patent that is subject to a pediatric exclusivity that expires later - February 2025 - and...more

Venable LLP

[Ongoing Program] Life Sciences Series - Current Trends in ANDA Litigation - October 31st, 1:00 pm - 2:00 pm ET

Venable LLP on

We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more

McDermott Will & Emery

File Like an Eagle: ANDA pH Specification Rules Infringement Inquiry

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding of noninfringement in a Hatch-Waxman case under 35 U.S.C. § 271(e)(2) and § 271(a)-(b). The Court found that the alleged infringer’s...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

Morgan Lewis

Pharma Review - Issue 3

Morgan Lewis on

Welcome to the third issue of the Morgan Lewis Pharma Review, which summarizes key recent cases from the Federal Circuit and district courts that impact the pharma space, including Federal Circuit and district court decisions...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

McDermott Will & Emery

ANDA Update - July 2015

McDermott Will & Emery on

Supreme Court Holds Good Faith Belief of Patent Invalidity Is Not a Defense to Induced Infringement - Commil USA, LLC v. Cisco Systems, Inc. (Supr. Ct. May 26, 2015): Pharmaceutical patents commonly include...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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