Viewpoint: Patent Disclosure Policy and Willful Infringement Doctrine
September 01, 2003
It seems fair to say that a major goal of the patent system ' to be a channel of technological disclosure ' remains largely unfulfilled. Scientists and engineers seldom, if ever, consult patents in the course of their work. It is the technical and scientific journals that are consulted by practitioners of a particular field, and such journal articles ' while almost always containing numerous references to other such journal articles ' seldom make reference to a patent. This article considers whether the willful infringement doctrine (<i>ie,</i> the punitive enhancement of damages for willful infringement) is a significant cause of the relative unimportance of patent disclosures to the process of technological innovation. This article also asks whether two fundamental objectives of the patent system, disclosure of patents and protection of the patent holder, might not be better served by elimination of the doctrine. While it would seem quite reasonable to question the further perpetuation of the willful infringement doctrine, given its potential chilling effect on those seeking to consult patent disclosures, this question is rarely asked, if at all, presumably due to the doctrine's antiquity.
Move Over Letterman: Top 10 Most Common IP Management Mistakes for New Companies
September 01, 2003
<b>1. TOO LATE TO FILE U.S. AND INTERNATIONAL PATENT APPLICATIONS.</b>Unfortunately for many good technology companies, it may be too late to file for patent protection. The current U.S. rule generally provides applicants with a one-year grace period during which a patent application must be filed after certain public or private disclosures of the invention. Such disclosures may arise, for example, from a mere 'offer for sale' of the technology, even if the product has not yet been built or prototyped. In comparison, the foreign rule, which applies to many industrialized jurisdictions, such as Japan and various European countries, does not give applicants the benefit of any grace period after a public disclosure has occurred. Thus, it is legally compelling for applicants to consider filing for patent protection as soon as possible after invention. Although in some situations there may be some special exception that allows for a late filing, it is not advisable for applicants to count on those exceptions.
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.
