ANDA

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

CAFC Affirms Finacea Gel Infringement Under Doctrine of Equivalents

In Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, the Federal Circuit affirmed the district court decision that found infringement under the doctrine of equivalents. This case shows that the doctrine of equivalents...more

AGG Food and Drug Newsletter - May 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA (Fed. Cir. 2016)

The Federal Circuit and the Supreme Court spent an inordinate amount of time wrestling with each of their conceptions of the scope and application of the doctrine of equivalents a dozen years ago, coming to an accommodation...more

Merck & Cie v. Watson Laboratories, Inc. (Fed. Cir. 2016)

The Federal Circuit had the occasion to revisit the proper application of the on-sale bar under 35 U.S.C. § 102(b) in ANDA litigation over claim 4 of U.S. Patent No. 6,441,168, which reads...more

Judgment Issues For Plaintiffs In ANDA Case

Sleet, J. The court issues findings of fact and conclusions of law and rules on post-trial motions. A 4-day trial took place between November 9-13, 2015. The disputed product is generic forms of plerixafor, which is...more

Patents-In Suit In ANDA Trial Are Non-Obvious

A 6-day bench trial was held from April 6-14, 2015. After trial, the court entered stipulations and orders regarding infringement of certain claims of the ‘178 and ‘206 patents. The court rejected defendant’s claim that the...more

Judge Griesa Grants Endo an Injunction Against Generic Manufacturers of Opioid Opana ER

On April 29, 2016, S.D.N.Y. District Judge Thomas P. Griesa granted Defendants Actavis, Inc., Actavis South Atlantic LLC (together “Actavis”) and Roxane Laboratories, Inc.’s motion to correct the court’s August 14, 2015...more

Apotex, Inc. v. Daiichi Sankyo, Inc.

Case Name: Apotex, Inc. v. Daiichi Sankyo, Inc., C.A. Nos. 12-cv-9295, 15-cv-3695, 2016 U.S. Dist. LEXIS 2126 (N.D. Ill. Jan. 8, 2016) (Coleman, J.)... Drug Product and Patent(s)-in-Suit: Benicar® and Benicar® HCT...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

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...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

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

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

Report And Recommendation Regarding Motion To Dismiss Is Denied In Part And Granted In Part

Fallon, M. J. Report and recommendation recommending that defendants’ motion to dismiss for lack of personal jurisdiction and failure to state a claim be denied in part and granted in part. The disputed technology in...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 Upholds Home Field Advantage in Generic Drug Cases

Under United States law, the holder of a patent on a brand-name, FDA-approved drug can bring suit for patent infringement against a generic drug manufacturer even before the generic manufacturer brings the drug to market....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 Finds Personal Jurisdiction Based On Plans To Market ANDA Product

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

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