Hatch-Waxman Pharmaceutical Industry

News & Analysis as of

Amgen v. Hospira: Court Considers Issues Regarding the Scope of Discovery and the RPS’s Ability to Assert Additional Patents in...

In a recent hearing held in Amgen v. Hospira, the parties offered arguments on some novel issues relating to litigation under the BPCIA, particularly: - ..Whether a reference product sponsor (“RPS”) can compel a...more

The right policy prescription for pharmaceutical patents? The Australian Productivity Commission proposes a new formula

As mentioned in our earlier article Australia’s Productivity Commission has released a draft report (Report) regarding intellectual property (IP) in Australia. The Report covers various IP rights and provides the Commission’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

Purdue Pharma L.P. v. Epic Pharma, LLC

Case Name: Purdue Pharma L.P. v. Epic Pharma, LLC, 811 F.3d 1345 (Fed. Cir. Feb. 1, 2016) (Circuit Judges Prost, Reyna, and Stark [sitting by designation] presiding; Opinion by Prost, C.J.) (Appeal from S.D.N.Y., Stein,...more

Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc.

Case Name: Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc., 2015-1588, 2016 U.S. App. LEXIS 4945 (Fed. Cir. March 18, 2016) (Circuit Judges Lourie, Dyk, and Hughes presiding; Opinion by Lourie, J.) (Appeal from D.N.J.,...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

Alert: FTC Challenges "No-AG" Agreement as Illegal Reverse Payment

On March 30 the US Federal Trade Commission filed suit in federal court alleging that settlements of patent litigation in the pharmaceutical industry in which a pioneer firm agrees not to market an "authorized generic"...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

FTC’s Latest “Pay for Delay” Action Focuses on Noncash “Payments” and New “Product Hopping” Theory of Harm

The Federal Trade Commission (FTC) filed an antitrust complaint this week against Endo Pharmaceuticals and several generic companies, alleging that these companies entered into anticompetitive “reverse payment” settlements of...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 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

FTC’s Amicus Brief in Wellbutrin XL Appeal Highlights Significance for Interpretation of Actavis

The FTC has recently weighed in again on the evolving interpretation of the Supreme Court’s 2013 opinion in FTC v. Actavis, 133 S. Ct. 2223 (2013). The agency submitted an amicus brief to the Third Circuit in the appeal of...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

A Brand Must Allege Facts to Survive a Motion to Dismiss Induced Infringement Claims - Otsuka Pharmaceutical Co., Ltd. v. Zydus...

Addressing the pleading standard for induced infringement, the U.S. District Court for the District of New Jersey dismissed Otsuka Pharmaceutical’s claims finding that a formulaic recitation of the legal standard without...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

Cumberland Pharms., Inc., v. Mylan Institutional LLC

Case Name: Cumberland Pharms., Inc., v. Mylan Institutional LLC, Civ. No. 12-C-3846, 2015 U.S. Dist. LEXIS 134495 (N.D. Ill. Oct. 2, 2015) (Pallmeyer, J.)... Drug Product and Patent(s)-in-Suit: Acetadote®...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

Cubist Pharms., Inc. v. Hospira, Inc.

Case Name: Cubist Pharms., Inc. v. Hospira, Inc., 2015-1197, 2015-1204, 2015-1259, 2015 U.S. App. LEXIS 19662 (Fed. Cir. Nov. 12, 2015) (Circuit Judges Wallach, Bryson, and Hughes presiding; Opinion by Bryson, J.) (Appeal...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

Patent Infringement Safe Harbor and Importation Redefined: Ruling Incentivizes Generic Pharmaceutical Offshore Product Testing

A recent ruling by the U.S. Court of Appeals for the Federal Circuit has provided an apparent loophole for manufacturers to avoid infringement liability for conducting patented manufacturing quality control steps offshore. On...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

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