New Regs for Reprocessed Single-Use Devices
Single-use medical devices (SUDs) are designed and approved by the FDA to be used once and thrown away. The practice of cleaning and reusing disposable medical devices has resulted from hospitals' continuing search for cost-cutting alternatives. The safety and efficacy of reprocessing SUDs has been the subject of significant - and heated - debate.
Flight to Quality: Why Business Plans Don't Get Funded
Your business plan is very often the first impression potential investors get about your venture. But even if you have a great product, team, and customers, it could also be the last impression the investor gets if you make any of these avoidable mistakes.
Patent Infringement Damages: Riding The Wine Railway Can Be Expensive
When the plaintiff in a patent litigation contends that it has never made or sold the product protected by its patent, alarm bells should start clanging in the ears of defense counsel. For the odds are that the plaintiff is angling to take advantage of a little-used aspect of the law of patent damages that can lead to a windfall recovery for patent infringement. It is the <i>Wine Railway</i> exception to the well-known "notice" provision of the patent statute. Created by the Supreme Court in <i>Wine Railway Appliance Co. v. Enterprise Railway Equipment Co.</i>, 297 U.S. 387 (1936), the exception can lead to catastrophic and unforeseen patent damage awards. Such damages are unforeseen (and, some would argue, unfair and undeserved) because they arise without any notice of infringement, actual or constructive.
The Reverse Doctrine of Equivalents Part 1 of 2
The ability of patents to encourage innovation by granting exclusive rights is well-recognized. However, patents can serve an antithetical role as well by, in certain circumstances, deterring, rather than encouraging, innovation.
Standing to Assert a U.S. Patent: Do Infringement Actions Belong Solely to the 'Patentee'?
Who can sue on a U.S. patent? The answer is not always as clear-cut as one may think. A patent plaintiff or other party seeking to enforce rights in a U.S. patent portfolio will thus wish to ensure before commencing any such action that he enjoys sufficient legal standing with respect to the patents in his portfolio. Otherwise, a challenge to the plaintiff's legal standing may lead to unexpected chagrin for the would-be asserter of the patent and unlooked-for advantage on the part of the alleged infringer against whom the patent was to be asserted.
In the Spotlight
On 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.
Why Grokster Stands Where Napster Fell
In a landmark decision issued on April 25, 2003, a federal district judge in Los Angeles rejected claims that two leading decentralized, peer-to-peer (P2P) networks were liable for copyright infringement. The court quashed the request of motion picture and recording industry associations, professional songwriters and music publishers to shut down the Grokster and StreamCast Networks, two companies that distribute free, P2P software allegedly used for the exchange of copyrighted music, movies and other digital media over the Internet.
Do the SEC's Proposed Standards of Professional Conduct Apply to You?
When The Security and Exchange Commission (SEC) or Department of Labor (DOL) or FBI Special Agent investigator knocks on a defense counsel's office door to conduct an interview relating to her client's alleged violation of the Sarbanes-Oxley Act (the Act), she might recall skimming an article and concluding that it did not apply to her role as defense counsel in product liability cases. She should think again. In light of the recent financial debacles, including Enron and World Com, the SEC is fulfilling the Congressional mandate to require public companies to disclose and remediate material violations, breaches of fiduciary duties, and similar violations of the SEC regulations. This article discusses the SEC's definition of an "attorney" under 17 CFR Part 205 and its newly proposed alternative to an earlier draft "noisy withdrawal" ethics rule, attorney withdrawal and disaffirmance with client notification to the SEC of withdrawal. The following scenarios demonstrate when and how an attorney may have to respond under the Act.
