Analyzing Manufacturers' Duties with Respect to Post-Sale Safety Improvements
December 01, 2003
According to Professors Henderson and Twerksi, the Reporters for the Restatement (Third) of Torts: Products Liability, "... post-sale warnings are probably the most expansive area in the law of products liability." The authors go on to say that "[I]f you want to see people turn ashen white quickly, we recommend that you gather representatives from industry in a room and then flash the words 'post-sale warnings' on a screen." They further describe post-sale warnings as "timeless" and a "monster duty."
Compliance Risk Assessment
December 01, 2003
The Report of the Ad Hoc Advisory Group on the Organizational Sentencing Guidelines asks the Sentencing Commission to adopt a new guideline defining "effective program to prevent and detect violations of law" as used in USSG ' 82C.5(f). The Report recommends that the definition include conducting ongoing risk assessments as one of its elements. The assessments would have two aspects: 1) a determination of "the scope and nature of the risks of violations of law associated with an organization's activities," and 2) use of the results of the assessments to "influence the design and implementation of a broad range of features of an effective [compliance] program."
MLATs and the Foreign Discoverability Requirement
December 01, 2003
Anyone who has gone through the cumbersome and laborious process of trying to obtain discovery from abroad through letters rogatory will appreciate the frustration that gave rise to Mutual Legal Assistance Treaties in Criminal Matters (MLATs). Generally, these treaties, which the United States has negotiated with dozens of countries, provide procedures by which prosecutors in one signatory country can obtain evidence located within the territory of the other.
In The Courts
December 01, 2003
Analysis of recent rulings that affect your practice.
Sentencing Convicted Corporations
December 01, 2003
The Ad Hoc Advisory Group to the United States Sentencing Commission on the Organizational Sentencing Guidelines (OSG) has recommended significant changes, particularly in the seven criteria for an effective compliance program to prevent and detect violations of law that, if implemented by an organization, may qualify it for a reduced fine in the event of a conviction.
Federal Circuit Holds that Importing Data is Not Patent Infringement
December 01, 2003
It is no secret that more than a few biotech and pharmaceutical companies perform drug discovery offshore and then import the results. Holders of U.S. patents on drug discovery tools (such as molecular screening methods) have wondered for years whether data or drugs resulting from such activities constitute a "product made" under The Process Patent Amendments Act of 1988 (the "Act"). The Court of Appeals for the Federal Circuit ("Federal Circuit") — in a setback to the U.S. drug discovery industry — has now held that they do not. <i>See Bayer AG v. Housey Pharm., Inc.,</i> 340 F.3d 1367 (Fed. Cir. 2003).
Avoiding Common Misperceptions and Mistakes in Patent License Agreements
December 01, 2003
Negotiating and drafting the terms of a patent license can be difficult, contentious, and time consuming, especially when the parties are in a hurry to proceed with the broader business venture of which the license is but one part. However, those who decide to skip or skimp on the troublesome details of license drafting will often later face the consequences of a poorly thought-out license relationship — consequences that are significantly more troublesome and costlier than the burden of thoroughly and accurately documenting the intended terms of the relationship at the outset. Even more frustrating is the experience of drafting a license that diligently attempts to address the business or legal issues thought to be important at the outset of the license relationship, only to discover later that a crucial (but possibly latent) problem was overlooked or inadequately addressed.
Add Inter Partes Re-Examination to Your Patent Infringement Defense
December 01, 2003
Inter partes re-examination can stop patent litigations dead in their tracks. The procedure often leads to narrowing or even cancellation of the patent claims. Practitioners may shy away from inter partes re-examination because it is considered an unsatisfactory substitute for the courtroom when seeking to prove invalidity. However, many may be overlooking that when it comes to proving noninfringement, inter partes re-examination has tremendous value.
