Posts Tagged: Abbreviated New Drug Application


Is Nome, Alaska ready for Paragraph 4 ANDA litigation? How about San Juan, Puerto Rico?

Nome, Alaska and San Juan, Puerto Rico are both home to a federal courthouse where, ostensibly, under the recent Acorda Therapeutics holding and subsequent court decisions, a …
By Jennifer Mauri
5 years ago 2

Horizon Pharma sues Actavis, Lupin for Paragraph IV certifications on generic Pennsaid

Horizon Pharma filed an action for patent infringement against Actavis and Lupin Pharmaceuticals in response to the filing of Abbreviated New Drug Applications (ANDAs) by both defendants …
By Steve Brachmann
5 years ago 0

Federal Circuit Affirms Doctrine of Equivalents Analysis Using Appropriate Hypothetical Claim

The Federal Circuit held that it is not the case that a patent must spell out a claim element’s function, way, and result, for the doctrine …

Acorda Therapeutics v. Mylan Pharmaceuticals May Not be the Last Word on Personal Jurisdiction in ANDA Cases

The Federal Circuit held that Mylan Pharmaceuticals, Inc. (“Mylan”), a generic drug manufacturer, was subject to specific personal jurisdiction in Delaware because Mylan had filed an abbreviated …

Uncle Sam the Patent Troll Sues to Stop Generic HIV Drug

HHS is suing a defendant that merely wants to market a generic version of a drug that is used to treat patients with human immunodeficiency virus (HIV). …
By Gene Quinn
7 years ago 12

A Big Change in the ANDA Litigation Paradigm: Lex Machina’s Legal Analytics

For those of you that do ANDA litigation, as well as other types of patent litigation, you know that ANDA litigation is very different. How a judge …
By Steve Moore
7 years ago 1

Acanya® Patent Litigation Settled, ANDA Approval Awaited

Actavis plc (NYSE: ACT) announced yesterday that it has entered into an agreement with Valeant Pharmaceuticals International (NYSE: VRX) to settle all outstanding patent litigation related to …
By Gene Quinn
8 years ago 0

Pharma Update: News for April 2014

What follows below is a review of some of the pharma news stories that caught my attention during the month of April 2014. Supreme Court Denies Teva's Request …
By Gene Quinn
8 years ago 0

Pharma & Biotech Update: News for October 2013

Mouse Model of Parkinson's Disease Shows Improved Brain Function --- DARPA Awards $25 Million To Develop Messenger RNA Therapeutics™ --- Actavis Files ANDA for Generic Suboxone® Sublingual Film …
By Gene Quinn
8 years ago 2

A Primer on Paragraph IV Certifications: Into the Belly of the Hatch-Waxman Beast Part 1

In a moment of extreme weakness, I agreed to Gene’s request to doing a primer on Paragraph IV Certifications under the Drug Price Competition and Patent …
By Eric Guttag
9 years ago 1