Features
The Changing Face of FDA Consent Decrees
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
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
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.
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
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
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
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.
'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
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
Highlights of the latest franchising news from around the country.
Need Help?
- Prefer an IP authenticated environment? Request a transition or call 800-756-8993.
- Need other assistance? email Customer Service or call 1-877-256-2472.
MOST POPULAR STORIES
- 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 ›
- 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 FTC Gets Into the College Athlete NIL GameAs national champions are crowned in men's and women's basketball, hundreds of thousands of college athletes are entering the influencer marketplace for the first time and now find themselves attractive candidates in the fast growing influencer marketing arena. With influencer marketing potentially providing a 5x return on investment, many brands are eager to get into the industry, but it doesn't come without risks as the FTC Commissioner is taking a closer look at the use of influencers for marketing.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 ›
- The Roadmap of Litigation AnalyticsLitigation analytics can be considered a roadmap of sorts — an important guide to ensure the legal professional arrives at the correct litigation strategy or business plan. However, like roadmaps, litigation analytics will only be useful if it's based on data that is complete and accurate.Read More ›
