Features

It is well known that the doctrine of strict liability imposes responsibility upon manufacturers without regard to their fault or the degree of care they may have exercised in designing their products. Yet, in some jurisdictions the law of strict liability is stricter than in others, and courts in these "strict-strict liability" jurisdictions may prohibit the employment of certain common defenses to product liability claims. Manufacturers that find themselves on the defense in such jurisdictions may face the unexpected and initially unpleasant news that the trial on the horizon really will be about the product, the whole product and nothing but the product, and that the sole question for the jury may be "can someone given 20/20 hindsight fathom a plausible way to make this product safer?" Such manufacturers will often find that what they were hoping to rely upon for the cornerstone of their defense — explaining who, what, where, when, why and how from the company's perspective — is not only irrelevant but also inadmissible at trial.

Features

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."

Features

Recent rulings of interest to you and your practice.

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.

Analysis of recent rulings that affect your practice.

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.

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") &mdash; in a setback to the U.S. drug discovery industry &mdash; has now held that they do not. <i>See Bayer AG v. Housey Pharm., Inc.,</i> 340 F.3d 1367 (Fed. Cir. 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 &mdash; 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.