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The Changing Face of FDA Consent Decrees Image

The Changing Face of FDA Consent Decrees

Joseph Savage & Adam Ziegler

Historically, when a health care company had a compliance failure, counsel could help it remain in business by negotiating with the relevant agency. If the problem involved sales, marketing or pricing, the company could seek a Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) at Health and Human Services (HHS). If the problems related to manufacturing, counsel could obtain a consent decree of permanent injunction ('consent decree') with the Food and Drug Administration (FDA) under the Food Drug and Cosmetic Act (FDCA). Consent decrees and CIAs each had their particular burdens and benefits, which health care practitioners had learned to navigate. Now this tidy distinction has become blurred as the FDA has borrowed features from HHS's CIAs.

Features

Paddling Down Esopus Creek Image

Paddling Down Esopus Creek

Jonathan Friedland & Mazen Asbahi

An end-of-year (Nov. 29) Delaware Chancery Court decision, <i>Esopus Creek Value LP v. Hauf</i>, is receiving a great deal of attention from corporate transactional and corporate restructuring attorneys alike. In Esopus, the Delaware Chancery Court prevented a financially sound company that was prohibited by federal securities law from holding a shareholder vote, because it failed to meet its reporting requirements, from executing an agreement outside of bankruptcy to sell substantially all of its assets under Section 363 of the Bankruptcy Code without first obtaining common stockholder approval as required under Section 271(a) of the Delaware General Company Law ('DGCL').

Features

Predicting Bondholder Activism Image

Predicting Bondholder Activism

J. Andrew Rahl, Jr.

The image of bondholder activism in many quarters is one of rapacious bondholders aggressively pursuing a ruthless quest for returns. The reality is far more complex, but the outcome of particular cases may be surprisingly predictable for the astute analyst.

Features

Foreign Use of a Mark May Establish Trademark Priority in the U.S. Image

Foreign Use of a Mark May Establish Trademark Priority in the U.S.

Deena R. Sturm

In the recent decision of <i>First Niagara Ins. Brokers, Inc. v. First Niagara Fin. Group, Inc.</i> (Fed. Cir. 2007) (the 'Federal Circuit's decision'), the Federal Circuit overturned a ruling by the Trademark Trial and Appeal Board (the 'Board') dismissing an opposition by First Niagara Insurance Brokers ('FN-Canada'), a Canadian company, to registration of 'First Niagara' and related marks by First Niagara Financial Group ('FN-US'), a U.S. company. In rendering its holding, the Federal Circuit declared that, in some cases, what would seem to be purely foreign trademark activity may establish superior trademark rights in the United States.

Features

Adjacent Landowners Entitled to Hearing Image

Adjacent Landowners Entitled to Hearing

ALM Staff & Law Journal Newsletters

If an entity claims a vested right pursuant to the Surface Mining and Reclamation Act ((SMARA) Pub. Resources Code, ' 2710 et seq.) to conduct a surface mining operation that is subject to the 'diminishing asset' doctrine, that claim must be determined in a public adjudicatory hearing that meets procedural due process requirements of reasonable notice and an opportunity to be heard. <i>Calvert v. County of Yuba'- County of Yuba.</i>

Features

Predispute Contractual Waivers of Jury Trial Image

Predispute Contractual Waivers of Jury Trial

Mark Mengelberg

Predispute waivers of jury trials are unenforceable under California law, subject to certain limited exceptions. While the recent California Supreme Court case of <i>Grafton Partners v. Supreme Court</i>, invalidated such waivers, there remain two ways that parties can agree, predispute, to avoid a jury trial in commercial real property related transactions.

Features

Trends in Financial Services Patents Image

Trends in Financial Services Patents

Joel Lehrer

Armed with a well-stocked patent portfolio, a company can effectively corner valuable markets for a limited amount of time. While this concept is second nature for most makers of tangible products, pharmaceuticals, or even software, it is only now becoming widely accepted in the financial services sector. As a result, another battlefield is emerging in which patents are becoming the weapon of choice, and trading floors and back-office processing centers have become the new settings for patent disputes.

Features

Licensees May Challenge a Patent Without Breaching License: The Supreme Court's Decision in MedImmune, Inc. v. Genentech, Inc. Image

Licensees May Challenge a Patent Without Breaching License: The Supreme Court's Decision in MedImmune, Inc. v. Genentech, Inc.

Benjamin Hershkowitz & Scott Kolassa

'We hold that petitioner was not required, insofar as Article III is concerned, to break or terminate its 1997 license agreement before seeking a declaratory judgment in federal court that the underlying patent is invalid, unenforceable, or not infringed.'With this language, the U.S. Supreme Court concluded its 8-1 landmark decision in <i>MedImmune, Inc. v. Genentech, Inc.</i>, reversing the holding of the U.S. Court of Appeals for the Federal Circuit ('Federal Circuit'). This decision has potentially wide-ranging ramifications for patent licensing.

Features

Supreme Court Revisits Test for Deciding Obviousness Image

Supreme Court Revisits Test for Deciding Obviousness

Elizabeth Rader & Thomas Goldstein

The U.S. Supreme Court has recently shown an interest in intellectual property in general and patents in particular. Most prominent among the recent cases is <i>KSR International Co. v. Teleflex Inc.</i>, which presents perhaps the most difficult question in substantive patent law: When is the subject of a patent application a true 'invention' ' that is, something that promotes the progress of a useful art sufficient to warrant giving the applicant exclusive rights to the technology claimed for the next 20 years. Conversely, when is the invention 'obvious' ' merely taking a step that anyone of ordinary skill would take, confronted with the same problem and possessing all the knowledge already known to the field?

Features

News Briefs Image

News Briefs

ALM Staff & Law Journal Newsletters

Highlights of the latest franchising news from around the country.

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