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Finally Certainty About Licensing SPVs Under the FCA Consumer Credit Regime

From 1 April 2014, responsibility for the regulation of consumer credit in the UK was transferred from the Office of Fair Trading (“OFT”) to the Financial Conduct Authority (“FCA”), drawing certain activities relating to...more

The SEC Tackles Technicality

Within several months of Securities and Exchange Commission Chair Mary Jo White’s announcement in late 2013 of a commitment to improving the SEC’s trial readiness, the Commission suffered a number of losses in federal...more

Revenue-Driven Licensing Activities Fail to Satisfy Domestic Industry Requirement for ITC Action

The ALJ terminated the ITC investigation upon granting respondent's motion for summary judgment for lack of domestic industry, finding that the complainant's (a licensing entity) patent-related activities were solely...more

ITC ALJ Breaks New Ground, Further Heightening the DI Requirement for NPEs in § 337 Cases

According to a recent initial determination by an Administrative Law Judge of the International Trade Commission, a purely revenue-driven NPE cannot prove the existence of a domestic industry by relying solely on the...more

Judge Rakoff’s “Sour Grapes”: SEC v. Citigroup Settlement Approved

On August 5, 2014, U.S. District Judge Jed Rakoff reluctantly approved a$285 million settlement in the SEC’s enforcement action against Citigroup. In SEC v. Citigroup, the SEC alleged that after Citigroup realized in early...more

Landry's Inc. v. Flores: NLRB Ruling Bucks Trend, Hints that Non-Infringement Provisions in Employee Handbooks may be Lawful

On June 26, a National Labor Relations Board (NLRB) judge ruled that Landry’s Inc., parent of Bubba Gump Shrimp Co., did not violate federal labor laws with its policy governing employees’ use of social media. Administrative...more

ANDA Preparation (with an Eye toward Approval and Litigation) and the FDA Review

As a manufacturer of generic drug products, undoubtedly one of your goals is to prepare an Abbreviated New Drug Application (ANDA) that will pass regulatory scrutiny efficiently. Your ANDA submission is a culmination of time,...more

Supreme Court Nets Sarbanes-Oxley Case Involving Fisherman

The U.S. Supreme Court recently agreed to hear a case that will determine the fate of a fisherman whose attempt to avoid penalties for catching undersized fish netted him a conviction for violating a law designed to prevent...more

When Goods Are Shipped from Overseas, When Are They Considered “Received by the Debtor” for Purposes of Asserting a Section...

A bankruptcy court in Pennsylvania recently held that trade creditors who supplied goods to a debtor prior to its bankruptcy filing were not entitled to administrative priority status under Bankruptcy Code section 503(b)(9)...more

SEC Gives Itself the Home Court Advantage in an Accounting Fraud / Internal Controls Action Against a Corporate CEO

An otherwise mundane SEC announcement on July 30, 2014 of an enforcement action charging a public company CEO and CFO with accounting fraud and internal controls violations is significant because the SEC is proceeding against...more

The 10 Most (and Least) Corrupt States in America

Corruption of state governments costs American taxpayers billions of dollars each year, according to a new study by researchers at Indiana University and City University of Hong Kong that reports on the risk of corruption and...more

Drones: When, Why, and How Will the FAA Investigate Unauthorized UAS Use?

On July 15, 2014, the Federal Aviation Administration (FAA) published its latest National Policy Notice concerning drones, titled “Education, Compliance, and Enforcement of Unauthorized Unmanned Aircraft Systems Operators.”...more

Stacking the Deck: SEC’s Use of Administrative Proceedings

The SEC has a real perception problem. They cannot win in court. Whether this is fair or not, the SEC needs to move beyond this fear of losing since it only undermines the integrity of its enforcement program....more

Guns and More Guns: SEC Hits Smith & Wesson for FCPA Violations

One thing the SEC likes to do is bring cases with a lot of deterrent value. That is, cases that it hopes will scare other people and companies into complying with the law. Often that means cases with large price tags...more

Favorable Ruling: Taxability of HMOs Under New York City General Corporation Tax

A New York City Tax Appeals Tribunal Administrative Law Judge (ALJ) recently ruled in favor of Aetna, Inc. (Aetna) on whether a health maintenance organization (HMO) was “doing an insurance business” in New York State,...more

The FDA’s Informed Consent Draft Guidance: Insights and Challenges for IRBs, Clinical Investigators and Sponsors

On July 15, 2014, the FDA released a draft guidance document (“Guidance”), proposing recommendations to Institutional Review Boards (IRBs), clinical investigators and research sponsors relating to the informed consent process...more

Unmanned Aircraft Systems and Oil and Gas Operations—Q and A

The desire to use unmanned aircraft systems (UAS) in commercial operations is steadily building. A wide variety of businesses would like to use these devices to improve efficiency and safety, and reduce costs. One field that...more

"FDA Guidance Limits Flexibility in Social Media Promotional Communications"

Three recently issued draft guidance documents (Draft Guidances) from the U.S. Food and Drug Administration (FDA or Agency) are designed to assist manufacturers in product communications via social media and other interactive...more

Health Care Reform Implementation Update - July 2014

Last week the Senate debated a bill to reverse the Supreme Court’s contraception mandate decision, a group of House Republicans introduced a bill to replace Affordable Care Act (ACA) cuts to the Medicare home health benefit...more

U.S. Brokers Doing Business Overseas

Recently, regulators have made inquiries about the lawfulness of U.S. brokerage firms soliciting foreign clients. The regulators want to know under what exemptions or rules U.S. firms can do business overseas. This is a new...more

FSIS Proposes New Recordkeeping Requirements for Ground Beef Processors/Retailers

The proposal, if adopted, will require new recordkeeping by both processing establishments and retail facilities that grind raw beef products....more

When is a Consultant an Executive Officer? – SEC Brings Another Case

The SEC has instituted administrative proceedings against a registrant and others alleging that two individuals with prior law violations secretly controlled the operational and management decisions of the registrant while...more

Supreme Court: FDCA Compliance Does Not Bar Lanham Act Claims

POM Wonderful LLC v. Coca-Cola Co. - In a unanimous decision, the Supreme Court of the United States reversed the U.S. Court of Appeals for the Ninth Circuit ruling that the Food, Drug, and Cosmetic Act (FDCA) and its...more

Harsh Justice

Concerned that its own decision might have "the potential to conflict" with that of the Pennsylvania Insurance Department, a Pennsylvania federal court relied on the primary jurisdiction doctrine to dismiss a putative class...more

PCAOB Standard-Setting Agenda Offers Insight into Rulemaking Activities

The Office of the Chief Auditor of the PCAOB issued an updated standard-setting agenda, providing the expected timing and key milestones for various PCAOB rulemaking projects. Some of the highlights from the agenda, which was...more

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