Was the FDA Exemption to Patent Infringement, 35 U.S.C. § 271(e)(1), Intended to Exempt a Pharmaceutical Manufacturer’s Activities in the Development of New Drugs?
Paul Wiegel Esq. The FDA exemption was not created to assist in the generation of new drug candidates, which are included in the broad interpretation of the “reasonably related” language by the Supreme Court in Merck. Applying the Supreme Court’s interpretation to the facts of Merck means that a pharmaceutical manufacturer may use the patented products and methods of another manufacturer to identify new drug candidates and not infringe. In fact there is almost no limit to what can be considered “reasonably related” to the development of information for submission to the FDA since a great deal of the research...
Saving Trade Secret Disclosures on the Internet Through Sequential Preservation
Elizabeth A. Rowe When, for instance, an employee discloses an employer’s trade secrets to the public over the Internet, does our current trade secret framework appropriately address the consequences of that disclosure? What ought to be the rule which governs whether the trade secret owner has lost not only the protection status for the secret, but any remedies against use by third parties? Should the ease with which the Internet permits instant and mass disclosure of secrets be taken into consideration in assessing the fairness of a rule which calls for immediate loss of the trade secret upon disclosure? The...
An Exploration of Rights Management Technologies Used in the Music Industry
Nika Aldrich On November 19, 2005, the Attorney General of the State of Texas filed a lawsuit against Sony BMG. This action was followed promptly by class action lawsuits in California and New York. Nine actions from New York, one from California, and one from New Mexico were involved in the consolidation action of April 2006. Elsewhere, a complaint to the Federal Government was filed in Italy against Sony BMG. With this flurry of lawsuits, the term, “Digital Rights Management” was thrust into the court system. As the consolidated action settles and the term “Digital Rights Management” makes its way...
Are Auteurs Really All That Special?
Jordan S. Hatcher Ever since 1954, when film critic Francois Truffaut “asserted that the worst of Jean Renoir’s movies would always be more interesting than the best of Jean Delannoy’s,” the director has come to be seen as the auteur of the films she directs. This idea, while fine for film critics, has unnecessarily crept into the law. Directors currently enjoy a unique status under UK law due in part to the idea that they are the sole creative auteur of a film. This article questions this special status and suggests some changes within the framework of existing EU directives...
“Fair Use” Trumps Likelihood of Confusion in Trademark Law the Supreme Court Rules in KP Permanent v. Lasting Impression
Michael Fuller In KP Permanent Make-Up, Inc., v. Lasting Impression I, Inc., the U.S. Supreme Court held that a defendant asserting the affirmative defense of fair use in response to a claim of trademark infringement does not have to shoulder the burden of proving there was no likelihood of confusion as a result of their fair use. The Supreme Court granted KP Permanent’s petition for certiorari in this matter to resolve a split among six of the federal courts of appeal. This article will first consider both the common law and statutory history underlying the fair use doctrine of trademark law....
Shooting the Messenger: ISP Liability for Contributory Copyright Infringement
David Ludwig Recent trends in judicial enforcement of contributory copyright infringement claims against ISPs and judicial interpretation of the DMCA safe harbor provisions undermine the balance sought by Congress in the DMCA by imposing excessive liability upon ISPs. The danger of this trend is that such enforcement will have a significant chilling effect on ISP investment in the internet, which fosters both the growth of e-commerce and the ability of a larger segment of the population to participate in the internet community– both of which ultimately benefit the holders of intellectual property rights. Shielding ISPs from liability for contributory copyright...
Remembering the Public’s Interest in the Patent System – A Post-Grant Opposition Designed to Benefit the Public
Eric Williams The problems associated with the existence of bad patents and the need for an effective, inexpensive vehicle for challenging them are nothing new. Over the past twenty-five years, several laws were proposed and passed intending to remedy these ills. Most recently, Congress introduced a bill aimed at curbing the adverse effects of bad patents, and prominent policy organizations and commentators advocated for, inter alia, the adoption of a new post-grant opposition as an antidote to the poison of bad patents. While these recent developments are certainly promising, without due attention given to the “advancement or social benefit gained...
“For Limited Times”: The Supreme Court Finds the Copyright Term Extension Act Constitutional in Eldred v. Ashcroft, but When Does It End?
Sue Ann Mota In 1993 a European Union directive extended the copyright term to the author’s life plus seventy years. The United States followed suit in 1998 with the Sonny Bono Copyright Term Extension Act, which, like the E.U. directive, extended the copyright term for an individual’s works by twenty years, resulting in a term of the author’s life plus seventy years. It also extended the term for anonymous, pseudonymous, or works made for hire by twenty years, resulting in a term of ninety-five years from publication or 120 years from creation, whichever comes first. The CTEA also applied retroactively,...
Google’s Literary Quest in Peril
Michael Goldstein Recently, Google, Inc. (hereinafter “Google”), owner of the eponymous search engine, partnered with several libraries, in an effort to make their collections available for search on the Internet. This project has come under attack by The Author’s Guild (hereinafter “The Guild”). The Guild complains that scanning and uploading copyrighted works without the authors’ consent violates their rights under the Copyright Act. Google counters that its use of sections from the copyrighted works falls under the “fair use” doctrine described in the Copyright Act. However, the Guild notes that in order to use these sections, Google first reproduced the...
Repairing the Bayh-Dole Act: A Proposal for Restoring Non-Profit Access to University Science
Aaron Miller The United States government invests billions of dollars every year in scientific research. Government agencies such as the Department of Energy, NASA and the Pentagon directly employ legions of scientists and engineers. The National Institutes of Health (NIH) funds a tremendous amount of biomedical research. Besides running its own labs, the NIH gives generous grants to hundreds of universities and medical schools, and to the thousands of research professors who fill them. The federal government today provides about 60% of the total research funding for America’s many prestigious research universities. In addition, the government pays private, for-profit contractors...