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...