Volume 1
Advances in synthetic chemistry offer pharmaceutical manufacturers a novel means of extending their monopolies over proprietary drugs beyond the 20-year limit of the patent laws. Pharmaceutical companies now have the capability to produce superior drugs by purifying existing drugs into their isomer components. The Food and Drug Administration (FDA) is considering whether to grant new drug status to these purified compounds, and to afford them several years of market exclusivity. This Comment argues that the FDA should not extend such market exclusivity to purified isomers of existing drugs.
Data privacy law is ripe for review by federal courts. Recent case law, however, has withheld pronouncements on federal privacy rights in favor of resolving disputes according to more traditional doctrines of federalism. Three federal circuit courts of appeals have heard challenges to the Driver's Privacy Protection Act. The cases, bringing to the bench novel issues of privacy law, have been resolved largely under the Commerce Clause. The cases leave open the question of how broadly in scope federal constitutional protection applies to personal data.
Cynics might suggest that seeking privacy in a cyberspace world has all the promise of looking for a unicorn in a forest. I disagree. Unlike the situation with unicorns, privacy is not a "yes or no" proposition, but instead exists on a spectrum, and you can preserve it to a greater or lesser degree. In my view, the FTC's law enforcement, self-regulatory, and legislative activities have increased privacy protections for consumers, with great benefits for them and little cost to businesses.
A year ago, I was asked to give a briefing on what I envisioned the world patent system to be in the future. I have chosen to call that system the World Patent System Circa 20XX, A.D. I have broken down the World Patent System article into four major subjects: (1) patent treaties, (2) regional patent systems that exist today, (3) the essential characteristics of a world patent system, and (4) leadership toward that world patent system.
In 1994, Congress enacted the Uruguay Round Agreements Act (URAA) in an effort to bring the United States into conformance with international patent standards and "place domestic applicants on an equal footing with foreign applicants." The URAA introduced substantial changes in U.S. patent law. One of the most significant changes was the amendment of 35 U.S.C.A. § 111 (West 1994) to allow inventors (both domestic and foreign) to file a special application: the provisional patent application. In the years following ratification of the URAA, much has been written about the various nuances and intricacies of filing provisional patent applications in the United States. In the midst of this voluminous discourse, it has been difficult for the conscientious practitioner to determine exactly what to say to a client who asks, "Should I file a provisional application?" The purpose of this Note is to provide a quick and practical guide to the benefits and shortcomings of filing provisional patent applications, including the use of provisional applications as part of an overall patent filing strategy.
What I would like to do is to comment about some of the current trends in intellectual property law as seen from the U.S. Court of Appeals for the Federal Circuit and emphasize certain areas where I think there are a lot of misunderstandings. I also hope to stimulate some responses, ranging from agreement to disagreement to bewilderment, because what I look forward to most is the dialogue that will hopefully follow my remarks.