Antitrust & Trade Regulation Science, Computers & Technology Health

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Federal court blocks rule restricting telemedicine practice in Texas

A federal court has temporarily enjoined the Texas Medical Board (TMB) from implementing and enforcing a rule restricting the practice of telemedicine pending resolution of an antitrust lawsuit filed by Teladoc, Inc. The...more

TelaDoc Wins Injunction Against Texas Medical Board re: Telehealth Restrictions

The Federal District Court of the Western District of Texas has ruled against the Texas Medical Board and granted TelaDoc’s Motion for a Preliminary Injunction prohibiting the Texas Medical Board from enforcing new rules...more

Alert: Second Circuit Rules that "Product Hopping" May Constitute Unlawful Monopolization; Pharmaceutical Companies are Likely...

Recent antitrust challenges to pharmaceutical companies' efforts to transition patients from drugs nearing the end of their patent life to next-generation drugs have increased the risk of pursuing such "product hopping"...more

Federal Appeals Court Upholds FTC HSR Rule on Pharma Patent Licenses

Background – the HSR Act: Under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the HSR Act), acquisitions of voting securities, assets and other commercial interests which exceed certain monetary thresholds...more

Is the Competition Bureau Targeting You? New IP Enforcement Guidelines

On June 9, 2015, the Canadian Competition Bureau released updated draft Intellectual Property Enforcement Guidelines (IPEGs) for public comment. The comment period is open until August 10, 2015. It is the third publication of...more

NDRC Issued Opinions and Notice on Drug Price Reform

On May 4, 2015, the National Development and Reform Commission (“NDRC”) and seven agencies including the National Health and Family Planning Commission and the Ministry of Human Resources and Social Security jointly published...more

All Eyes on Homeopathics: FTC Workshop Signals Targeted Regulatory Scrutiny of Homeopathic Products

On Tuesday, the Federal Trade Commission “FTC” announced it will be hosting a workshop in September to evaluate advertising for over-the-counter homeopathic products. Homeopathy is an alternative medicine practice dating back...more

Product Liability Hopping & the FDA’s Generic Drug Proposal – Awful Together

A major basis for our criticism of the FDA’s still pending generic drug labeling proposal, and why we prefer industry’s EAR (“Expedited Agency Review”) system better, is that the FDA’s proposal would create festival-seating...more

REMS and Antitrust: Latest Litigation Lessons

Brand name pharmaceutical companies have long stood in the way of generic pharmaceuticals entering the market. To keep generics at bay, brands have used a variety tactics, including ultimately unlawful ones like fraudulently...more

Second Circuit Holds a Hard Switch Between Drugs Is an Unlawful Product Hop Under Section 2

On May 22, 2015, in a much-watched case, the Second Circuit upheld a preliminary injunction against Actavis PLC and its wholly owned subsidiary, Forest Laboratories, LLC (collectively “Actavis” or “Forest”), finding that...more

Injunction Blocks Implementation of Texas Telemedicine Regulations

Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that...more

Second Circuit Becomes First Court of Appeals to Address Pharmaceutical “Product Hopping” Under Antitrust Laws in Decision Barring...

Few courts have addressed antitrust challenges to pharmaceutical “product hopping,” i.e., the practice of shifting customers from a drug nearing the end of its patent protection to a modified version that is covered by newer...more

Texas Telemedicine Rule Delayed by Antitrust Suit

A Texas Medical Board rule requiring a physician to conduct an in-person evaluation before prescribing certain drugs will not go into effect today, June 3, as originally planned. A federal court granted a preliminary...more

Actavis Loses Nameda® Appeal Over “Hot Documents”

The U.S. Court of Appeals for the Second Circuit’s opinion (issued May 22, 2015 with a public, redacted version available May 28, 2015), affirming the district court’s grant of a preliminary injunction in State of New York v....more

Product Hopping and Antitrust: Mylan Court Dismisses Claims on Summary Judgment, Citing Need to Avoid Chilling Pharmaceutical...

A recent summary judgment opinion from the Eastern District of Pennsylvania breaks new ground in the developing antitrust law on “product hopping” claims. “Product hopping” refers to the practice of changing the form or...more

Health Update - May 2015

Building a Culture of Health: The Value Proposition of Retail Clinics - Editor’s Note: Since first emerging on the healthcare landscape more than 15 years ago, retail clinics have seen significant growth. There are now...more

Generic Pricing Investigations Expand: Par Is Subpoenaed and the OIG Launches Its Own Investigation

Since we last reported on the generic pricing investigations the investigations have expanded. Par Pharmaceutical Companies, Inc. disclosed in its March 13, 2015 Annual Report that it had received a December 5, 2014...more

Federal Trade Commission Obtains a Near Record-Breaking Disgorgement in a Monopolization Case

On April 20, 2015, the Federal Trade Commission (“FTC”) announced that Cardinal Health, Inc. (“Cardinal”), agreed to pay $26.8 million to resolve allegations that it violated Section 2 of the Sherman Act by monopolizing the...more

Recent Court and Agency Actions Suggest Increased Antitrust Risk Over Disgorgement, Particularly in the Pharmaceutical Industry

Recent court and agency rulings highlight important takeaways involving disgorgement in antitrust proceedings. Companies, especially those in the pharmaceutical industry, increasingly should ensure they properly calibrate...more

Sorin-Cyberonics Deal Gets US Antitrust Clearance

Sorin S.p.A. and Cyberonics, Inc. recently announced that the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for their pending merger has ended. In February, the two companies...more

Pfizer’s strategic response to the threat of generic competition upheld by the Federal Court

On 25 February 2015, the Federal Court handed down its much-anticipated judgment in the matter of ACCC v Pfizer Australia Pty Ltd. In dismissing the Australian Competition and Consumer Commission’s (ACCC) allegations, Justice...more

FTC Obtains $26.8 Million in Disgorgement to Settle Monopolization Claims

On April 17, 2015, the Federal Trade Commission (FTC) entered into a settlement with Cardinal Health, Inc. (Cardinal) to resolve allegations that Cardinal, the largest and in certain areas the sole operator of...more

Cardinal Health Agrees to Settle Monopolization Claims

The Federal Trade Commission ("FTC") announced on April 20, 2015 that it had entered into a stipulated consent order ("Order") with Cardinal Health, Inc. ("Cardinal"). The Order, which is pending court approval, requires...more

FTC Settles Radioactive Allegations Against Cardinal Health with a Near Record-Breaking Disgorgement Agreement

In a 3-2 decision, as part of its aggressive antitrust enforcement in health care industries, the Federal Trade Commission (FTC or the Commission) announced that Cardinal Health, Inc. (Cardinal) agreed to pay $26.8 million to...more

FTC Seeks to Secure First Disgorgement in Nearly a Decade

The FTC announced yesterday that Cardinal Health, Inc. (“Cardinal”) has agreed to pay $26.8 million to resolve its investigation into the company’s alleged anticompetitive behavior. If approved by a federal court, the...more

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