ANDA

News & Analysis as of

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 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

ANDA Filings Create Personal Jurisdiction Everywhere

In Acorda Therapeutics, Inc. v, Mylan Pharmaceutical Inc., [2015-1460) (March 18, 2016), the Federal Circuit affirmed that Mylan was subject to specific personal jurisdiction in the District of Delaware, The Federal Circuit...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

Claims Are Construed In ANDA Case

Sleet, J. Claim construction opinion issues regarding three terms from four patents. A Markman hearing took place on February 5, 2016 The disputed technology relates to the drug Copaxone. Thirty-one terms were found...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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