Vioxx and the FDA Advisory Committees: Yesterday, Today, and the Search for Tomorrow
June 14, 2005
Amid a cacophony of wailing and gnashing of teeth decrying the Food and Drug Administration's ("FDA's") failure to protect the public from unsafe drugs, the FDA held an emergency advisory committee meeting, which included consultants, to address the safety issues associated with the use of COX-2 selective and non-selective non-steroidal anti-inflammatory drugs ("NAIDs"). The meeting was scheduled and held at warp speed. It provided a transparent dispassionate opportunity to address the safety issues for scientists, affected parties and the public. The decisions of the advisory committee were to some extent, unexpected. This accelerated review process differs from the current advisory committee process of reviewing limited data in a product pre-approval setting. However, this use is a natural extension of the FDA's historic use of advisory committees, <i>ie</i>, analysis of voluminous data on any active ingredient over a period of years and application of the analysis to specific drug products containing the active ingredient.
The Challenge of Electronic Records Corporate Compliance
June 01, 2005
Legal standards regarding electronic discovery and document retention have recently undergone a rapid transformation. Increased regulatory oversight of corporations ' and resulting recordkeeping obligations ' coupled with the increasing volume of electronic communication have created new challenges with regard to document retention and production. More than 99% of information is now being created and stored electronically. Anything that can store, transmit, replay or access electronic data may potentially hold useful corporate records and electronic evidence. Recently, courts and regulators have issued a multitude of new obligations requiring document retention that attempt to define and reconcile the duties of parties and counsel with regard to electronic documents as the judiciary struggles to keep pace with technology. In determining whether a document should, or is required to, be kept, the focus should not and cannot be on the media ' <i>ie</i>, whether it is an e-mail, paper copy, facsimile, instant message, text file, or a Web site. Rather, the relevant question is what information is contained in that document.
Practice Tip: What You Need to Know About Fighting Spyware and Adware
May 31, 2005
While obvious security threats like fast-spreading worms have a tendency to garner news headlines, other stealthy security risks threaten law firms and other businesses every day. An increasing amount of spyware and adware programs have the ability to facilitate the disclosure of business information and risk privacy, confidentiality, integrity, and system availability. Law firms ' like other corporations ' usually accumulate a vault of information that could cause serious problems if it were shared with the wrong contacts or, even worse, stolen. Spyware's evolution from simple cookies to a range of sophisticated user-tracking systems has left many businesses without the control over their proprietary data and <br>A recent survey by IT industry analysts IDC identified spyware as the fourth greatest threat to enterprise security.
Legal Acrobatics A Review of Adobe Acrobat Professional 7.0
May 31, 2005
If you haven't already seen a couple reviews of Acrobat 7.0, you must not be reading much legal tech trade literature! I've caught at least half a dozen already. Adobe Systems has accompanied the release of their latest version with quite a media blitz, at least in the legal sector. And for good reason. The Acrobat product family encompasses a host of features highly useful for legal professionals.
Bit Parts
May 27, 2005
Recent developments in entertainment law.
We Should Get Together More
May 27, 2005
There's a marketing concept out there that many law firms have just recently stumbled upon, one that most other types of industries have known well for decades ' return on investment, or ROI. As firms become more sophisticated in marketing, as budgets for marketing increase, and as competition becomes more fierce, firms are beginning to demand that their marketing dollars they spend produce results. <br>Nowhere is the concept of ROI more easily implemented, tracked, and realized than in the area of Internet marketing, through the use of Web sites and the search engines that locate them.
Pros and Cons of Drafting Patent Applications in India
May 26, 2005
A call center in New Delhi, India, fields questions from a utility customer in a small town in Pennsylvania. An accounting firm in Mumbai, India, provides back-office services for a growing Texas company. An IT company in Perumbavoor, India, provides Internet support to a manufacturer of amplifiers in Washington state.
Eureka v. Wentworth: Further Erosion of the 'Hell or High Water' Principle
May 26, 2005
A fundamental tenet of equipment leasing has been the concept of "hell or high water" rental payments. Once the lease is signed and the lessee accepts the goods, then the lessee's promises under the lease become irrevocable, especially the promise to pay rent. The draftsmen of UCC Article 2A recognized this critical element and codified it with respect to a finance lease in UCC §2A-407(1)-(2) (all citations herein refer to Uniform Commercial Code Article 2A pre-2003 revisions). A finance lease is a particular type of "true" equipment lease in which the lessee itself selects the item of equipment it wants and instructs the lessor to acquire it for lease to the lessee. UCC §2A-103(g). A finance lessor is neither the manufacturer nor supplier of the item of equipment; it is merely providing the money. Article 2A of the Uniform Commercial Code (the "Code" or the "UCC") extends certain benefits to finance lessors, one of the most important of which is that the lessee's promises are not subject to termination, modification or repudiation; in other words, the lessee must comply with them come "hell or high water." UCC §2A-407(2)(b).
Google v. American Blind: Staying in Line with Online Advertising?
May 26, 2005
One of the hot intellectual property topics for 2005 — and perhaps beyond — is whether the sale and use of trademarks as keywords constitutes trademark infringement, and, if so, who is liable for that infringement. How the courts ultimately resolve this issue will affect the billion-dollar Internet advertising industry, those who participate in online advertising and those seeking to prevent the unauthorized use of their trademarks on the Internet. This article discusses <i>Google v. American Blind & Wallpaper Factory, Inc.</i>, 2005 U.S. Dist. LEXIS 6228 (N.D. Cal. Mar. 30, 2005), the most recent case to address the emerging issue of "markmatching" in Internet contextual advertising, and its relationship to trademark infringement.
