Off-Label Promotion of Drugs and Medical Devices
A spate of billion- and hundred-million-dollar settlements with the Department of Justice (DOJ) illustrates how the investigation of off-label promotions of drugs and devices has emerged as a predominant theory in pharmaceutical and medical-device prosecutions.
Features
From Booker to Spears
Chief Justice Roberts commented in a recent dissent that the Supreme Court's sentencing rulings "have given the lower courts a good deal to digest over a relatively short period." Indeed. Since its landmark holding in United States v. Booker, 543 U.S. 220 (2005), that the Sentencing Guidelines were simply advisory, the Court has swiftly and significantly diminished the relevance of the Guidelines and increased the discretion of district court judges in sentencing defendants. As a…
Pre-Trial Detention and White-Collar Defendants
This article reviews how courts assess the right to bail in cases where the defendant allegedly has inflicted massive economic harm on the public.
Features
Developments, Risks and Advanced Structures in the Lease Syndication Market
Lease syndications have enjoyed a significant rise in popularity in recent years. This rise in popularity has brought about an evolution in the commonly used structures, leading to additional complexity and confusion in practice. In this article, we provide a framework for analyzing syndications and addressing the practical needs of originators and funders.
<B>BREAKING NEWS:</b> Second Circuit: Google Must Face Trademark Suit Involving Keyword Ads
In a long-awaited opinion, the Second U.S. Circuit Court of Appeals ruled that Google must face a trademark infringement lawsuit for selling keywords that trigger ads.
Features
<B>BREAKING NEWS:</b> Supreme Court Strengthens Arbitration in Labor Case Ruling
The Supreme Court's growing embrace of the virtues of arbitration continued on April 1 with a 5-4 ruling endorsing labor contracts that send age discrimination claims to arbitration rather than to federal courts.
Features
Warn Potential Patent Infringers: But Do Your Homework First
In order to better understand the required level of care that must be taken before issuing notice letters to potential patent infringers, and the legal standard under which that care may be later judged in court, we address two recent Federal Circuit cases on this topic.
Features
The Little License That Could: Dangers of Using Open-Source Code After Jacobsen v. Katzer
Although the open-source movement has been active for more than a decade, it is only in recent months that such a copyright license actually has received the imprimatur of enforceability ' from an unlikely court (the Federal Circuit) construing a perhaps unlikely license (the Java Model Railroad Interface for model train software).
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MOST POPULAR STORIES
- Use of Deferred Prosecution Agreements In White Collar InvestigationsThis article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.Read More ›
- The DOJ's Corporate Enforcement Policy: One Year LaterThe DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.Read More ›
- Surveys in Patent Infringement Litigation: The Next FrontierMost experienced intellectual property attorneys understand the significant role surveys play in trademark infringement and other Lanham Act cases, but relatively few are likely to have considered the use of such research in patent infringement matters. That could soon change in light of the recent admission of a survey into evidence in <i>Applera Corporation, et al. v. MJ Research, Inc., et al.</i>, No. 3:98cv1201 (D. Conn. Aug. 26, 2005). The survey evidence, which showed that 96% of the defendant's customers used its products to perform a patented process, was admitted as evidence in support of a claim of inducement to infringe. The court admitted the survey into evidence over various objections by the defendant, who had argued that the inducement claim could not be proven without the survey.Read More ›
- The DOJ's New Parameters for Evaluating Corporate Compliance ProgramsThe parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.Read More ›
- In the SpotlightOn May 9, 2003, the U.S. Attorney's Office for the District of Massachusetts announced that Bayer Corporation, the pharmaceutical manufacturer, had been sentenced and ordered to pay a criminal fine of $5,590,800 stemming from its earlier plea of guilty to violating the Federal Prescription Drug Marketing Act by failing to list with the FDA its drug product, Cipro, that was privately labeled for an HMO. Such listing is required under the federal Food, Drug & Cosmetic Act. The Federal Prescription Drug Marketing Act, Pub. L. 100-293, enacted on April 22, 1988, as modified on August 26, 1992 by the Prescription Drug Amendments (PDA) Pub. L. 102-353, 106 Stat. 941, amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. '' 331, 333, 353, 381, to establish requirements for distributing prescription drug samples.Read More ›
