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Editor's Corner: IP Management in New Companies
September 01, 2003
In the course of performing due diligence investigations on new technology companies (usually within the context of a potential venture capital investment), an attorney may uncover a number of common mistakes related to such companies' management of their intellectual property.
Make Global Filings Easier By Using Country Templates
September 01, 2003
It is important for a patent attorney to be able to quickly and effectively advise a client who is filing a large number of international patent applications as to where such patent applications should be filed. One tool that can be useful in such situations is a 'country template.'
Understanding the Potential Pitfalls Arising From Participation in Standards Bodies
September 01, 2003
Chances are that if your company is involved in research and development of new technology there is a standards setting organization exploring the potential standardization of such technology. While there are clear benefits to participation in standards organizations — keeping abreast of industry developments, targeting product development toward standard compliant products, steering research and intellectual property protection into potential areas of future standardization — such participation does not come without certain risks. Whether you are in-house counsel or outside counsel, you may be called upon to advise participants in standard-setting bodies about intellectual property issues or to participate yourself. You may also be asked to review patent policy of the standard-setting body that sets forth the disclosure and notification requirements with respect to patents for that organization. Here are some potential patent pitfalls that can catch the unwary off-guard.
Case Briefing
September 01, 2003
Recent cases of interest to your practice.
News from the FDA
September 01, 2003
The latest information for use in your practice, including rulings, draft guidances, seminars, and more.
We Need a No-Fault Compensation System for Drug Injuries
September 01, 2003
The FDA's approval of a prescription drug or biologic is the product of an often-delicate risk-benefit analysis of public benefit as opposed to individual safety. The therapeutic balance of these products must always be weighed against the risks inherent in their use. And there are always inherent risks associated with their use. Accordingly, while millions of Americans reap the benefits of prescription drugs every day, these same drugs may pose an unavoidable health hazard to a narrow, and often unidentifiable, subset of potential users. The American legal system currently regulates these risks by two means ' through the federal regulatory system as administered by the FDA, and through the common-law tort liability regime.
AstraZeneca Pleads Guilty in Zoladex Case
September 01, 2003
Major pharmaceutical manufacturer AstraZeneca Pharmaceuticals LP pleaded guilty to a large-scale health care crime and agreed to pay $355 million to resolve the associated criminal charges and civil liabilities, according to an announcement released by the FDA Office of Criminal Investigations (FDA OCI) on June 20.
When Is Compliance Necessary?
September 01, 2003
The pharmaceutical industry has been heavily regulated for many years, starting with the original enactment of the Food and Drug Act in 1906. Over the years, a bewildering array of regulations has been established that affect the sale and consumption of drugs at both the federal and state levels. While many of these past regulations have been subsumed into the FDA's rules and regulations, one of the most difficult and currently pressing questions a pharmaceutical manufacturer must ask itself is whether to comply with California's Proposition 65. The manufacturer's decision to comply may have significant adverse affects on marketing and use of the drug; or conversely, imposition of stiff, costly penalties. This article provides a basic roadmap of the current landscape for compliance with Proposition 65 in the pharmaceutical context.
ONLINE
September 01, 2003
As discussed in the article 'Statewide Coordination of Mass Tort Cases Becoming Increasingly Popular,' <i>infra,</i> page 3, three states now provide statewide coordination of mass tort cases similar to the Multidistrict Litigation System (MDL) in the federal courts.
CASE NOTES
September 01, 2003
Highlights of the latest product liability cases from around the country.

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