News & Analysis as of

Noninfringement Abbreviated New Drug Application (ANDA)

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

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

Knobbe Martens

Patent Claim Reciting a List “Consisting Essentially of” Is Indefinite Where the Basic and Novel Property of the Invention Is...

Knobbe Martens on

HZNP Medicines LLC, Horizon Pharma USA, Inc. v. Actavis Laboratories UT, Inc. Before Prost, Newman, and Reyna.  Appeal from the District Court for the District of New Jersey. Summary: Claims using “consisting...more

Foley & Lardner LLP

CAFC Finds ANDA Infringement Despite Differences Between FDA Labeling And Claim Language

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In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and...more

Foley & Lardner LLP

Angiomax Patents Limited To Example

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In The Medicines Co. v. Mylan, Inc., the Federal Circuit construed composition claims of two Angiomax patents as requiring the recited “batches” to be made by a specific “efficient mixing” process illustrated in one of the...more

WilmerHale

Federal Circuit Patent Updates - May 2016

WilmerHale on

Ruckus Wireless, Inc. v. Innovative Wireless Solutions (No. 2015-1425, 1438, 5/31/16) (Prost, Reyna, Stark) - May 31, 2016 3:11 PM - Reyna, J. Affirming summary judgment of non-infringement of patents based on...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - May 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Ventana Medical Systems, Inc. v. Hologic, Inc. 3:16-cv-02703; filed May 18, 2016 in the Northern District of California. ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - January 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme B.V. v. Teva Pharmaceuticals USA Inc. 1:15-cv-00806; filed September 11, 2015 in the District Court...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - January 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Sage Labs Inc. v. Transposagen Biopharmaceuticals Inc. 1:15-cv-00791; filed September 9, 2015 in the District Court of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - December 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme Corp. et al. v. Med-Pharmex, Inc. 3:15-cv-01905; filed August 28, 2015 in the Southern District of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - November 2015 #5

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme Corp. v. Savior Lifetec Corp. 5:15-cv-00415; filed August 21, 2015 in the Eastern District of North...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - November 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Biotech Inc. et al. v. Par Pharmaceutical Inc. et al. 1:15-cv-00679; filed August 3, 2015 in the District Court of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - October 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Mylan Pharma Acquisition Ltd. et al. v Fresenius Kabi USA, LLC 1:15-cv-06700; filed July 30, 2015 in the Northern District...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - August 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Bristol-Myers Squibb Co. et al. v. Merck & Co., Inc. et al. 1:15-cv-00572; filed July 7, 2015 in the District Court of...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

Foley & Lardner LLP

Federal Circuit Upholds Fentora Patents, But Affirms Non-Infringement

Foley & Lardner LLP on

In Cephalon, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court’s finding that two Orange Book-listed patents for Cephalon’s FENTORA® product were invalid, but affirmed the district court’s...more

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