News & Analysis as of

Personal Jurisdiction Generic Drugs

Mintz - Intellectual Property Viewpoints

In Hatch-Waxman litigation, Federal Circuit restricts venue under the TC Heartland to districts relating to ANDA filings

On November 5, 2020, the United States Court of Appeals for the Federal Circuit, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 19-2402, resolved a split among district courts over what constitutes...more

Morrison & Foerster LLP - Federal Circuitry

Last Week in the Federal Circuit (November 2-6): Limits on Venue in Hatch-Waxman Cases

Last week was argument week at the Federal Circuit, which as usual meant the Court issued several Rule 36 affirmances and short non-precedential decisions. But tucked in between those was at least one case—a Hatch-Waxman...more

McDonnell Boehnen Hulbert & Berghoff LLP

Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

Somewhat remarkably, there is no settled Federal Circuit precedent regarding where a patentee can bring suit against a generic competitor in Hatch-Waxman litigation under 35 U.S.C. § 271(e)(2).  While recognizing that this...more

Goodwin

Federal Circuit Narrows Venue for Patent Infringement Suits Under the Hatch-Waxman Act

Goodwin on

The Federal Circuit Thursday issued a decision that narrows the venue options available to patent owners bringing suit against generic drug manufacturers under the Hatch-Waxman Act. In a unanimous decision, the court held...more

Fish & Richardson

EDTX & NDTX Monthly Wrap-Up – April 2019

Fish & Richardson on

A Tale of Two ANDAs: Jurisdiction and Venue in a Non-Traditional Sense - Judge Gilstrap’s recent opinion in Apicore US LLC v. Beloteca, Inc., No. 2:19-CV-00077-JRG, 2019 WL 1746079 (E.D. Tex. Apr. 18, 2019), highlights...more

Robins Kaplan LLP

Hatch-Waxman Venue Update: Will SCOTUS Limit Where Brands Can Sue Generics?

Robins Kaplan LLP on

Generic and branded pharma companies alike are waiting with baited breath to see if the U.S. Supreme Court will take up the issue of personal jurisdiction in Hatch-Waxman patent cases this term. After a broad ruling from the...more

Foley Hoag LLP

Product Liability Update: April 2016

Foley Hoag LLP on

Massachusetts Superior Court Rejects “Innovator Liability” Failureto-Warn Claim, Holds Branded Pharmaceutical Manufacturer Owed No Duty to Plaintiff Alleging Injury From Equivalent Generic Drug That Copied Defendant’s...more

Robins Kaplan LLP

Helsinn Healthcare S.A. v. Hospira, Inc.

Robins Kaplan LLP on

Case Name: Helsinn Healthcare S.A. v. Hospira, Inc., Civil No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. Apr. 5, 2016) (Cooper, J.) - Drug Product and Patents-in-Suit: Aloxi® (palonosetron); U.S. Patents Nos....more

Patterson Belknap Webb & Tyler LLP

Full Federal Circuit Denies En Banc Review of Jurisdictional Decision with Important Implications for BPCIA Litigation

On June 20, 2016, the full Federal Circuit denied Mylan’s petitions for rehearing en banc in Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016), leaving intact the panel’s decision affirming two...more

Morris James LLP

ANDA Filing Alone Suffices For Specific Personal Jurisdiction Over ANDA Filer; Related Canadian Entity With No Contacts To...

Morris James LLP on

Sleet, J. Defendant PSI’s motion to dismiss the complaint for lack of personal jurisdiction is denied. Defendant PSL’s motion to dismiss the complaint for lack of personal jurisdiction and for failure to state a claim is...more

K&L Gates LLP

ANDA Filing May Subject a Pharmaceutical Company to Personal Jurisdiction in Patent Infringement Suits Anywhere in the U.S.

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On March 18, 2016, the Federal Circuit held that filing an abbreviated new drug application (“ANDA”) with the FDA for a generic drug product, and thus indicating an intention to sell that product in every state (including...more

BakerHostetler

Filing an ANDA May Expose Generic Manufacturers to Nationwide Personal Jurisdiction in Patent Infringement Suits

BakerHostetler on

On March 18, 2016, the Federal Circuit affirmed the District of Delaware’s ruling in two companion cases that West Virginia-based defendant Mylan Pharmaceuticals is subject to specific personal jurisdiction in Delaware....more

Foley & Lardner LLP

Federal Circuit Finds Personal Jurisdiction Based On Plans To Market ANDA Product

Foley & Lardner LLP on

In Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit held that the filing of an Abbreviated New Drug Application (ANDA) and intentions to market the product across the United States–including in the...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

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

Morris James LLP

ANDA Case Is Dismissed For Lack Of Personal Jurisdiction

Morris James LLP on

The disputed technology is a generic rivastigmine patch. Defendant is a New Jersey corporation with a principal place of business in Vermont. Only specific jurisdiction is at issue since it is not “at home” in Delaware. ...more

Saul Ewing LLP

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

Saul Ewing LLP on

Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

Mintz - Intellectual Property Viewpoints

Court Denies Generic Drug Manufacturer’s Motion to Dismiss Hatch-Waxman Patent Infringement Action on Jurisdiction Grounds

On March 12, the United States District Court for the Southern District of Indiana joined the District of Delaware and Eastern District of Texas as the first courts to consider a generic drug manufacturer’s motion to dismiss...more

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