News & Analysis as of

Pay-For-Delay Pharmaceutical Industry

FTC Competition Director Highlights Enforcement Priorities in the Pharmaceutical Industry

Last week Markus Meier, the Acting Director of the Bureau of Competition at the Federal Trade Commission, gave testimony to the House Judiciary Committee concerning “Antitrust Concerns and the FDA Approval Process.” ...more

Lidoderm Plaintiffs Survive Class Certification in Pay-for-Delay Suit

by McDermott Will & Emery on

The US District Court for the Northern District of California certified classes of direct purchasers and end-payers in a pay-for-delay multidistrict litigation involving Lidoderm. In re Lidoderm Antitrust Litigation, Case No....more

European Commission Sets its Sights on Allegedly Excessive Drug Prices

by Jones Day on

In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more

Third Circuit Declines to Send Pay-for-Delay Litigation to Federal Circuit

by McDermott Will & Emery on

Addressing questions of federal jurisdiction, the US Court of Appeals for the Third Circuit ruled that it, and not the US Court of Appeals for the Federal Circuit, had jurisdiction over two consolidated appeals arising from...more

ANDA Update - March 2017 Volume 3, Number 1

by McDermott Will & Emery on

Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more

Health Update - January 2017

Top Five Healthcare Antitrust Trends to Watch in 2017 - Antitrust enforcement and litigation had a big year in 2016. In this article, we look back at the most significant cases for the healthcare industry over the last...more

Nexium Case Extends Actavis Ruling

by McDermott Will & Emery on

Addressing a pay-for-delay and pharmaceutical-settlement antitrust jury trial for the first time since the 2012 Supreme Court of the United States decision in FTC v. Actavis (IP Update, Vol. 16, No. 7), the US Court of...more

Supreme Court Denies Cert in Lamictal Pay-For-Delay Litigation

by Latham & Watkins LLP on

Third Circuit has previously ruled that non-cash payments to settle patent litigation may violate antitrust laws. On November 7, 2016, the Supreme Court of the United States declined to hear the petition of...more

Competition law scrutiny of patent settlements - a new focus in Australia?

by DLA Piper on

Settlement agreements in patent disputes between pharmaceutical companies may soon face greater competition law scrutiny in Australia. The Productivity Commission has put ‘pay for delay’ patent settlements between originator...more

EU Court Confirms European Commission’s Decision on Pay-for-Delay Agreements

by McDermott Will & Emery on

On 8 September 2016, the General Court of the European Union upheld the European Commission’s decision in which the antitrust regulator imposed fines of approximately EUR 150 million on Lundbeck and a number of generic...more

Third Circuit Creates Framework for Analyzing Numerosity

by Carlton Fields on

The Third Circuit recently vacated class certification, granted by the Eastern District of Pennsylvania after nearly a decade of litigation, in an antitrust case alleging that a pharmaceutical company entered into agreements...more

General Court of the EU Confirms Fines Imposed on Lundbeck and Generic Drug Manufacturers for Entering into Patent Settlements

by McDermott Will & Emery on

On 8 September 2016, the General Court of the EU (GCEU) handed down five judgments upholding a decision by the Commission of 19 June 2013 imposing fines on Lundbeck, an originator company, and Merck (the parent company of...more

District Court Narrowly Defines the Relevant Market in Post-Actavis Pay-For-Delay Suit

On August 8, the District of Connecticut issued a noteworthy ruling on how to approach defining the relevant market definition in a pay-for-delay suit. In In re Aggrenox Antitrust Litigation, 3:14-md-02516 (D. Conn.), three...more

Recent Court Cases Interpreting “Reverse Payments” Post-Actavis

by Perkins Coie on

Patent settlement agreements were traditionally deemed outside the purview of antitrust scrutiny unless the patent holder’s conduct fell outside the legitimate scope of the patent’s exclusionary power. This all changed when...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

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

by FPA Patent Attorneys on

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

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

by Cooley LLP on

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

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

by BakerHostetler on

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

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

by Proskauer Rose LLP on

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

European Competition Law Newsletter – March 2016

by McGuireWoods LLP on

On 16 February 2016, the European Commission (EC) took the next step in its antitrust investigation into the use of price increase letters by 15 container liner shipping companies (carriers). The concern identified by the...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

1st Circuit Joins 3rd Circuit: Non-Cash Reverse Payments Subject to Antitrust Scrutiny

Courts continue to evaluate the degree to which “reverse payments” are permitted post-Actavis. In the latest of these decisions, issued on February 22, 2016, the First Circuit held that non-cash payments may run afoul of the...more

Large ‘pay for delay’ fine imposed by CMA

by Bryan Cave on

On the 12th of February 2016, the UK Competition and Markets Authority (CMA) fined GlaxoSmithKline (GSK) and the successor companies to Alpharma Limited around £45m in total for breaches of Chapter I of the Competition Act...more

Blog: Heath Provisions in President’s Budget Take Aim at Drug Prices and Opioid Abuse

by Cooley LLP on

Today, the President sent Congress the $4 trillion Fiscal Year 2017 Budget Proposal – his last while in office. While the Budget on the whole is dead on arrival in the Republican-controlled Congress, there are provisions...more

More on Patent Settlements Including Litigation at the European Courts

by McGuireWoods LLP on

Last week I posted on the European Commission’s (EC) latest report into patent settlement agreements between originator and generic companies in the European Union (EU). The EC says each time it produces these reports that...more

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