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 generic pharmaceutical company will be subject to personal jurisdiction if they file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). In Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals, Inc., 817 F.3d 755 (Fed. Cir. 2016), the Federal Circuit held that an ANDA filer opens themselves up to nationwide personal jurisdiction merely by virtue of filing an ANDA application. This is a broad holding that, in effect, subjects a generic company to personal jurisdiction in any forum that has a district court.

Jennifer Mauri

September 2, 2016

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 for a generic version of Pennsaid, a topical nonsteroidal anti-inflammatory drug (NSAID) marketed in the U.S. by Horizon. Both cases were filed in the U.S. District Court for the District of New Jersey.

Steve Brachmann

August 28, 2016

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 of equivalents to apply. It looked to what the claim element’s function in the claimed composition is to one of skill in the art, which it held may be determined by looking at extrinsic evidence. The Court found no error in the district court’s finding of infringement under the doctrine of equivalents. In applying the two part test (constructing a hypothetical claim that covers the accused device and comparing that claim to the prior art), the district court correctly determined that the hypothetical claim properly included the disputed excipients, i.e. Glenmark’s excipient.

Robert Schaffer & Joseph Robinson

May 20, 2016

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 new drug application (“ANDA”) and “contemplate[d] plans to engage in marketing of the proposed generic drugs” in the state.[1] The ruling affirmed two different decisions by judges in the United States District Court for the District of Delaware that Mylan was subject to specific jurisdiction in Delaware.[2] However, as noted below, it looks like Mylan intends to seek panel or en banc rehearing and possibly pursue a petition for certiorari if the Federal Circuit does not grant the rehearing or re-hears the case and continues to find personal jurisdiction.

Paul Dietze Ph.D. & Mini Kapoor

May 2, 2016

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). Not only is the United States government a patent troll, but the government is also trying to deprive patients who need live saving HIV drugs an affordable generic version. Egad!

Gene Quinn

April 17, 2015

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 reacts to a particular motion in ANDA litigation is not necessarily how he or she might deal with the same motion in an electrical, mechanical or software case. Because of this substantial difference, Lex Machina decided to separately tag over 2,500 ANDA cases filed since January 1, 2000. Thus, for the first time, litigators can make decisions based solely on reviewing the ANDA cases that a specific judge has handled.

Steve Moore

September 24, 2014

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 Actavis’ generic version of Acanya®… Actavis believes it was the first applicant to file an ANDA for the generic version of Acanya® Gel and, should its ANDA be approved, should be entitled to 180 days of generic market exclusivity.

Gene Quinn

May 13, 2014

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 for an Injunction Relating to Generic Copaxone® — Actavis Announces Celebrex® Patent Challenge Settlement — Actavis Net Revenue Increases 40% to $2.66 Billion in First Quarter 2014.

Gene Quinn

May 2, 2014

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 — AzaSite® Patents Upheld in Patent Infringement Lawsuit Against Sandoz — Surgeons Successfully Remove “Inoperable” Metastatic Breast Cancer — Actavis Files ANDA on Acanya® Gel, Gets Sued by Dow, Valeant — NYSE Inquires About Unusual Market Activity for Ampio Pharmaceuticals — Cannabis Biotech Hires Patent Attorney to Protect Medical Marijuana Innovation — Merck’s Hepatitis C Drug Gets Breakthrough Therapy Designation — Therapeutic Vaccine for Hepatitis C Enters Phase I — Urine Test for Cancer Monitoring — Popular Prenatal Vitamin Patent Upheld in District Court — Clinical Trials on Brain Technology to Assist ALS Patients — Teva Gets Favorable Ruling on COPAXONE in the Netherlands — BVGH Recruits Dr. Linda Venczel as New Program Director — Actavis’s settles with FTC over $8.5 Billion acquisition of Warner Chilcott

Gene Quinn

October 28, 2013

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 Term Restoration Act, commonly referred to as Hatch-Waxman. I don’t know if you would call me an expert, but I’ve studied many, many cases involving Paragraph IV Certifications under Hatch-Waxman. The courts have found Hatch-Waxman to be a hydra-like monster with a labyrinth of sections that are frequently confusing (or worse yet, conflicting). Paragraph IV Certifications are a particular trouble spot in Hatch-Waxman. So if you’re up to diving into the “belly of this beast,” let’s examine the characteristics of this most infamous of the Hatch-Waxman monsters. To understand Paragraph IV Certifications, you must first address what an Abbreviated New Drug Application (ANDA) is. ANDAs are how generic drug manufactures expedite the approval of their generic drugs.

Eric Guttag

April 3, 2013