Antitrust & Trade Regulation Science, Computers & Technology Administrative Agency

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Alert: Federal Policy Developments Impacting Medical Technology Companies

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. Thus far, 2015 has produced a major legislative initiative in the form of...more

Wyndham Challenges Authority Of FTC To Regulate Cybersecurity

On March 3, 2015, a judicial panel from the U.S. Court of Appeals for the Third Circuit heard oral arguments in a challenge brought by Wyndham Worldwide Corp. (“Wyndham”) against the Federal Trade Commission’s (“FTC”)...more

Why the FTC Can Go After Companies For Insufficient Data Security Allegations

The FTC seems more confident than ever in its authority to go after companies with insufficient data security measures. As of January 2015, it had settled 53 data-security enforcement actions, and FTC Senior Attorney Lesley...more

Third Circuit Hears Oral Argument Over Whether FTC Has Authority To Regulate Data Security

After much anticipation, the Third Circuit heard oral arguments (audio) last Tuesday in the interlocutory appeal in FTC v. Wyndham Worldwide Corp. We have written previously about this case, which likely will be a significant...more

DOJ Releases Electrifying New Guidance on Standard-Essential Patent Policy

The Department of Justice (the “Department” or “DOJ”) continued its multi-pronged defense of standards-setting organizations (SSOs) who adopt patent policies to prevent hold-up during licensing negotiations. Last week’s...more

Citizen Petitions Aimed at Delaying Generic Competition Remain a Concern

Despite Congress enacting legislation in 2007 to curb misuse, citizen petitions submitted by pharmaceutical companies to the Food and Drug Administration (FDA) may still provide a mechanism for competitors to delay the...more

DOJ Provides New Guidance on Required Licensing of Essential Patents in Standard-Setting

DOJ recently concluded that a standard-setting organization's proposal to update its policy regarding patents underlying its standards was pro-competitive. DOJ's analysis of the association's process and legal structure...more

ALJ Denies LabMD’s Motion for Sanctions Against the FTC

Although the litigation between LabMD and the Federal Trade Commission (FTC) continues in the Eleventh Circuit, an administrative law judge has resolved one battle between the two entities. Chief Administrative Law Judge D....more

Sham-Wow! Antitrust Liability May Attach to Sham Administrative Petitions

Addressing whether the “sham” exception to Noerr-Pennington immunity is limited to sham litigation in courts, the U.S. Court of Appeals for the Federal Circuit vacated a lower court’s summary judgment of no antitrust...more

Federal Circuit Finds That FDA Citizen Petition Could Give Rise to Antitrust Liability

In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge...more

Enforcement Action – FTC Is Not Backing Down and Laboratory Company Goes After a Cyber-Intelligence Company

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is not the only government arm that enforces data breaches. The Federal Trade Commission (FTC) has broad authority to regulate the security of...more

Court Endorses FTC Authority To Require Special Reporting for Pharmaceutical Licenses

A federal court has endorsed the Federal Trade Commission’s authority to adopt regulations under the Hart-Scott-Rodino (HSR) Act that target specific industries. In Pharmaceutical Research and Manufacturers of America v....more

No Judicial Review of FTC Jurisdiction until the Agency Takes a Final Action

Companies that handle personal data may need to litigate an FTC enforcement action to its conclusion before a court will review the Commission's jurisdiction to commence the enforcement action in the first place....more

FTC Data Security Authority Confirmed, For Now: Wyndham’s Motion to Dismiss Denied

The FTC’s Claim - A New Jersey federal judge has confirmed the Federal Trade Commission’s (“FTC”) authority to regulate data security and bring claims against companies suffering data breaches due to inadequate...more

Part II: Fair Notice or No Notice? The Wyndham Worldwide Case and the Expanding Power of the FTC to Police Data Security

In our first blog in this series, we provided a summary of the District Court of New Jersey’s recent decision in FTC v. Wyndham Worldwide Corp., in which Judge Salas confirmed the FTC’s authority to bring enforcement actions...more

Has the FTC Met Its Match?

Companies across the Country should be following the Federal Trade Commission’s (“FTC”) civil suit brought against Wyndham Worldwide Corporation and Wyndham Hotels and Resorts, LLC (“Wyndham”) entitled Federal Trade...more

The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin [Video]

Attorney Karen Lovitch, Practice Leader of Mintz Levin's Health Law Practice, discusses the challenges facing pharmaceutical and medical device manufacturers in complying with the Sunshine Act....more

With Complaint Against LabMD, FTC Continues to Flex Enforcement Muscle on Data Security

The Federal Trade Commission recently filed another complaint against a company for alleged data security lapses. As readers of this blog know, the FTC has initiated numerous lawsuits against companies in various industries...more

Wyndham Case Challenges FTC’s Authority Over Cybersecurity

Over the past decade the Federal Trade Commission has brought cybersecurity enforcement actions against various private companies, imposing tens of millions of dollars in monetary penalties and requiring companies to maintain...more

FTC’s Authority to Police Data Security Practices Challenged

Hotelier Wyndham Worldwide Corp’s motion to dismiss an FTC lawsuit alleging lax data security practices is likely to have significant implications for the agency’s ability to police cybersecurity practices at American...more

FTC and DOJ Explore Role of Patent Assertion Entities in the Patent Innovation Market

On December 10, 2012, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) jointly presented the “Patent Assertion Entities (PAEs) Activities Workshop.” This publicly-held workshop signaled a recognition by...more

Antitrust Monopolization Considerations in Licensing Cutting-Edge Food Technology Patents

The term pioneer patent is often misapplied with hyperbole and exaggeration. When it comes to the shrimp peeling machine invented by Fernand and James Lapeyre, however, that blockbuster label is spot-on. Their automated...more

Health Care Legal News - November 28, 2012 • Volume 2, Number 10

In This Issue: - Medicare Finalizes 2013 Physician Payment Schedule - Ohio Court Rules That A Court CAnnot Compel A Terminated Employee To Return PHI To The Former Employer - Insurer’s Antitrust Action AGainst...more

Patent Wars: EU’s Top Regulator Takes Front Line Position

Essential Patents, FRAND Licensing and Abuse of Market Power There has been a spate of antitrust complaints to the European Commission and other antitrust authorities of late, regarding the licensing of "essential...more

Healthcare Legal News - August 15, 2012 • Volume 2, Number 7

In This Issue: - Recent Cases Deal With Impact Of Termination Of Employed Physicians - Reimbursement News: Happy New Year!: Increase In Payments To Hospital Outpatient Departments and Ambulatory Surgical Centers -...more

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