ANDA Pharmaceutical Industry

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Post-Grant Review Roils Patent Litigation Waters

The America Invents Act (AIA) has had a profound impact on patent litigation, particularly surrounding inter partes and other post-grant proceedings. Below, Manish K. Mehta, who handles patent litigation across an array of...more

Court Report - May 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Ventana Medical Systems, Inc. v. Hologic, Inc. 3:16-cv-02703; filed May 18, 2016 in the Northern District of...more

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

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

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

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 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 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

Federal Circuit’s Jurisdictional Decision for ANDA Cases Has Important Implications for BPCIA Litigation

Since the Supreme Court’s decision in Daimler AG v. Bauman, 134 S.Ct. 746 (2014)—effectively limiting the reach of general jurisdiction to defendant’s “home” states of incorporation or principal place of business—generic drug...more

Breaking News – No Circuit Split (Yet) Over Post-Bauman General Jurisdiction by Consent

We’ve been watching competing interlocutory appeals in a couple of post-Bauman personal jurisdiction cases out of Delaware: Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals, Inc., 78 F. Supp.3d 572 (D. Del. 2015), and...more

Court Report - March 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Vanda Pharmaceuticals Inc. v. Roxane Laboratories Inc. 1:15-cv-00919; filed October 13, 2015 in the District Court of...more

Court Report - March 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals LLC et al. v. Lupin Atlantis Holdings SA et al. 1:15-cv-00904; filed October 9, 2015 in the...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

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