News & Analysis as of

Declaratory Judgments Generic Drugs Pharmaceutical Industry

Venable LLP

Spotlight On: Biosimilar Litigations - March 2025

Venable LLP on

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Axinn, Veltrop & Harkrider LLP

CREATing Controversy: Can a Brand Manufacturer Deny Sample Requests?

Can a drug manufacturer refuse to provide samples of its innovator product under the CREATES Act if it thinks that the requester will not actually use them to develop a biosimilar or generic drug? A recently filed suit in the...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Getting Lost in the Thicket: AbbVie Wields Its Expansive Humira® Patent Portfolio Against Alvotech’s Adalimumab Biosimilar

In the most recent of a series of litigations by AbbVie against manufacturers seeking to market biosimilar versions of Humira®, the world’s most profitable drug, AbbVie initiated an action against Alvotech in the district...more

Fenwick & West LLP

Valeant v. Mylan: Restrictions on Venue in Hatch-Waxman Litigation

Fenwick & West LLP on

For the first time since the U.S. Supreme Court’s TC Heartland decision, the U.S. Court of Appeals for the Federal Circuit addressed the issue of venue specific to Hatch-Waxman litigation, pursuant to which branded...more

Robins Kaplan LLP

Valeant Pharms. N. Am. LLC v. Zydus Pharms. (USA) Inc.

Robins Kaplan LLP on

BECAUSE PLAINTIFFS FAILED TO SHOW SPECIFICALLY HOW DEFENDANTS COMMITTED ANY ACT OF INFRINGEMENT IN NEW JERSEY—PARTICULARLY BY FILING AN ANDA IN WEST VIRGINIA WITH THE FDA IN MARYLAND—OR THAT ANY FUTURE, INTENDED ACTS WERE A...more

Womble Bond Dickinson

Basics of the BPCIA

Womble Bond Dickinson on

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - May 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Endo Pharmaceuticals Inc. v. Impax Laboratories, Inc. 2:16-cv-02526; filed May 6, 2016 in the District Court of New Jersey...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

Troutman Pepper

Post-Grant Challenges in Life Sciences: A Midyear Assessment

Troutman Pepper on

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - July 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Hetero Labs Ltd, Unit V et al. v. Pharmacia & Upjohn Co. LLC 1:15-cv-05396; filed June 18, 2015 in the Northern District...more

Polsinelli

Federal Circuit Delays Sandoz Biosimilar Launch

Polsinelli on

In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's...more

McDermott Will & Emery

Declaratory Judgment of Non-Infringement of a Disclaimed Patent Warranted in Hatch-Waxman - Apotex Inc. v. Daiichi Sankyo, Inc.

Addressing the issue of subject matter jurisdiction in Hatch-Waxman litigation, the U.S. Court of Appeals for the Federal Circuit reversed a district court’s dismissal for lack of case or controversy of an action seeking...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

13 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide