ANDA Hatch-Waxman

News & Analysis as of

FTC Maintains Aggressive Stance Against Pay-for-Delay Deals

A recent complaint filed by the Federal Trade Commission (FTC) indicates that the agency is continuing its aggressive pursuit of agreements between drug manufacturers that delay the entry of generic pharmaceuticals into the...more

Amarin Pharma, Inc. v. Apotex, Inc.

Case Name: Amarin Pharma, Inc. v. Apotex, Inc., Civil Action No. 14-2250 (MLC), 2016 U.S. Dist. LEXIS 7555 (D.N.J. Jan 22, 2016) (Cooper, J.)... Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S....more

Supernus Pharms., Inc. v. Actavis Inc.

Case Name: Supernus Pharms., Inc. v. Actavis Inc., Civil Nos. 13-4740 (RMB/JS), 14-1981 (RMB/JS), 2016 U.S. Dist. LEXIS 14111 (D.N.J. Feb 5, 2016) (Bumb, J.)... Drug Product and Patent(s)-in-Suit: Oxtellar XR®...more

Helsinn Healthcare, S.A. v. Dr. Reddy’s Labs. Ltd.

Case Name: Helsinn Healthcare, S.A. v. Dr. Reddy’s Labs. Ltd., Civ. No. 11-3962 (MLC), 2016 U.S. Dist. LEXIS 27477 (D.N.J. Mar. 3, 2016) (Cooper, J.)... Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron); U.S....more

Braintree Labs. Inc. v. Breckenridge Pharm., Inc.

Case Name: Braintree Labs. Inc. v. Breckenridge Pharm., Inc., C.A. No 12-cv-6851 (AJN), 2016 U.S. Dist. LEXIS 33336 (S.D.N.Y. Mar. 15, 2016) (Nathan, J.)... Drug Product and Patent(s)-in-Suit: Suprep® (sodium sulfate /...more

Shire Development, LLC v. Watson Pharms., Inc.

Case Name: Shire Development, LLC v. Watson Pharms., Inc., Civ. No. 12-60862-CIV-MIDDLEBROOKS/BRANNON, 2016 U.S. Dist. LEXIS 40360 (S.D. Fla. Mar. 25, 2016) (Middlebrooks, J.)... Drug Product and Patent(s)-in-Suit:...more

Acorda Therapeutics Inc. v. Mylan Pharms. Inc.

Case Name: Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 2015-1456, 2015-1460, 2016 U.S. App. LEXIS 4942 (Fed. Cir. Mar. 18, 2016) (Circuit Judges Newman, O’Malley, and Taranto presiding; Opinion by Taranto, J.; Concurring...more

Quo Vadis FTC: What Does the Commission's Complaint Against Endo Pharmaceuticals and Others Say About the Future of Post-Actavis...

This alert, the title of which is adapted from a March 30, 2016 FTC Staff Attorney blog post, considers the FTC's first lawsuit challenging a so-called "no-AG" agreement. No-AG agreements are components of Hatch-Waxman...more

March 2016 Life Sciences Litigation Update

Federal Circuit Affirms Broad Personal Jurisdiction Over ANDA Filers. On March 18, 2016, in the first decision of its kind since the U.S. Supreme Court decided Daimler AG v. Bauman, 134 S. Ct. 746 (2014), the Federal...more

Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month Regulatory Stay in Hatch-Waxman Litigation

Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval...more

Federal Circuit Patent Updates - March 2016

Clare v. Chrysler Group LLC (No. 2015-1999, 3/31/16) (Prost, Moore, Wallach) - Moore, J. Affirming summary judgment of non-infringement of patents related to storage compartment for pickup trucks. The Court rejected...more

Federal Circuit Finds Personal Jurisdiction over Mylan in Two Hatch-Waxman Appeals

On Friday, March 18, the Court of Appeals for the Federal Circuit affirmed two District of Delaware rulings that non-resident defendant generic ANDA filer, Mylan, is subject to personal jurisdiction in two Hatch-Waxman suits...more

Federal Circuit Issues Sprawling Opinion Certain to Continue Big Pharma Forum Shopping in ANDA Litigation

In an opinion handed down Friday that will continue the trend of forum shopping, the Federal Circuit in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals, Inc., 2015-1456, (Fed. Cir. 2016) held that the filing of an...more

The First Circuit Agrees that Non-Cash Reverse Payments Are Subject to Antitrust Scrutiny. Does the Loestrin Decision Point to...

Recently, the First Circuit became the second federal appellate court interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc. to hold that non-cash "reverse payments" between pioneer and generic...more

FTC Issues Report on ANDA Settlement Agreements

In January, the Federal Trade Commission issued a report on the terms of settlement agreements between branded and generic drug companies in ANDA litigation under the Hatch-Waxman Act, according to the provisions of the...more

Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA,

Case Name: Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA, C.A. Nos. 14-3168 (JBS/KMW),14-4671 (JBS/KMW),14-5878 (JBS/KMW),14-6398 (JBS/KMW),14-7252 (JBS/KMW), 2015 U.S. Dist. LEXIS 138853 (D.N.J. Oct. 13, 2015) (Simandle,...more

Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd.

Case Name: Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd., Civ. No. 11-3962, 2015 U.S. Dist. LEXIS 167048 (D.N.J. Nov. 13, 2015) (Cooper, J.)... Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron); U.S. Patents...more

Spectrum Pharms., Inc. v. Sandoz, Inc.

Case Name: Spectrum Pharms., Inc. v. Sandoz, Inc., 2015-1407, 2015 U.S. App. LEXIS 17313 (Fed. Cir. Oct. 2, 2015) (Circuit Judges Lourie, Wallach, and Hughes presiding; Opinion by Lourie, J.) (Appeal from D. Nev., Navarro,...more

Prometheus Labs., Inc. v. Roxane Labs., Inc.

Case Name: Prometheus Labs., Inc. v. Roxane Labs., Inc., 2014-1634, -1635, 2015 U.S. App. LEXIS 19556 (Fed. Cir. Nov. 10, 2015) (Circuit Judges Dyk, Taranto, and Hughes presiding; Opinion by Dyk, J.) (Appeal from D.N.J.,...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

A Stay of Litigation Pending IPR Does Not Provide a Basis For Extending 30-Stay of FDA ANDA Approval

On December 11, 2015, the United States District Court for the Southern District of Indiana granted a motion to stay a Hatch-Waxman litigation pending the outcome of inter partes reviews (IPRs) on two of the patents-in-suit...more

Novartis Pharm. Corp. v. Zydus Noveltech Inc.

Case Name: Novartis Pharm. Corp. v. Zydus Noveltech Inc., Civ. No. 14-cv-1104-RGA, 2015 U.S. Dist. LEXIS 103708 (D. Del. Aug. 7, 2015) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Exelon® (rivastigmine); U.S....more

Endo Pharms. Inc. v. Amneal Pharms. LLC

Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ. Nos. 12 Civ. 8115 (TPG), 12 Civ. 8060 (TPG), 12 Civ. 8317 (TPG), 12 Civ. 8985 (TPG), 13 Civ. 435 (TPG), 13 Civ. 436 (TPG), 13 Civ. 3288 (TPG), 13 Civ. 4343 (TPG), 13...more

Eli Lilly & Co. v. Nang Kuang Pharm.Co., Ltd.

Case Name: Eli Lilly & Co. v. Nang Kuang Pharm.Co., Ltd., 1:14-cv-1647-TWP-DKL, 2015 U.S. Dist. LEXIS 11510 (S.D. Ind. Aug. 24, 2015) - Drug Product and Patent-in-Suit: Alimta® (pemetrexed disodium); U.S. Patents Nos....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

77 Results
|
View per page
Page: of 4
JD Supra Readers' Choice 2016 Awards

"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:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×