Hatch-Waxman AstraZeneca

News & Analysis as of

Two reverse-payment appeals to watch

It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The...more

Subject Matter Jurisdiction Remains in Hatch-Waxman Patent Infringement Action after ANDA Filer Changes from Paragraph IV to...

The District Court of Delaware denied defendant Wockhardt’s motion to dismiss a patent infringement action based on the reasonable inference that plaintiff AstraZeneca may need to assert its patent rights in the future. On...more

Federal Circuit Clarifies Scope of Personal Jurisdiction in Hatch-Waxman Cases

On March 18, 2016, a panel of the Federal Circuit issued its decision in Acorda Therapeutics Inc. v. Mylan Pharms. Inc. and AstraZeneca AB v. Mylan Pharms. Inc., holding that Mylan is subject to specific personal jurisdiction...more

Federal Circuit Hears Argument on Personal Jurisdiction in Two Hatch-Waxman Appeals

On Monday, January 4, the Court of Appeals for the Federal Circuit heard oral argument in two appeals that may determine what effect the Supreme Court’s Daimler AG v. Bauman decision will have on the exercise of personal...more

ANDA Update - October 2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

AstraZeneca AB v. Apotex Corp.

Case Name: AstraZeneca AB v. Apotex Corp., 2014-1221, 2015 U.S. App. LEXIS 5543 (Fed. Cir. Apr. 7, 2015) (Circuit Judges O’Malley, Clevenger, and Bryson presiding; Opinion by Bryson, J.) (Appeal from S.D.N.Y., Cote, J.)...more

AstraZeneca LP v. Breath Ltd.

Case Name: AstraZeneca LP v. Breath Ltd., 2015-1335, 2015 U.S. App. LEXIS 7525 (Fed. Cir. May 7, 2015) - Drug Product and Patent(s)-in-Suit: Pulmicort Respules® (budesonide inhalation suspension); U.S. Patent No....more

AstraZeneca LP v. Breath Ltd.

Case Name: AstraZeneca LP v. Breath Ltd., Civ. No. 08-1512 (RMB/AMD), 2015 U.S. Dist. LEXIS 17687 (D.N.J. Feb. 13, 2015) (Bumb, J.). Drug Product and Patent(s)-in-Suit: Pulmicort Respules® (budesonide inhalation...more

Federal Circuit Addresses Damages in the Hatch-Waxman Context

On April 7, 2015, the United States Court of Appeals for the Federal Circuit issued its decision in Astrazeneca AB v. Apotex Corp., No. 2014-1221, affirming an award of a reasonable royalty of 50% in a case arising from the...more

Hatch-Waxman Watch: Personal Jurisdiction Edition

Is the ability to obtain personal jurisdiction against an ANDA filer for a Hatch-Waxman-type litigation going to become exceedingly more difficult? In the past, jurisdiction against such a defendant was often predicated on...more

In re Rosuvastatin Calcium Patent Litigation (Fed. Cir. 2012)

Late last year, in AstraZeneca v. Aurobindo (In re Rosuvastatin Calcium Patent Litigation), the Federal Circuit affirmed that a reissue patent covering the active ingredient of Crestor® was valid, enforceable, and infringed...more

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