Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information Act Should Be Restored

By: Janene Boyce Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors strive to keep this resource secret to ensure their ability to profit from their own research. In the wake of the controversy over antidepressant use in children, both the public and Congress have called for the disclosure of all clinical trial data. However, rather than taking an all-or-nothing approach that could harm the development of new drugs, this iBrief argues that Congress should address the issue of trial data disclosure by restoring the proper balance to Exemption 4 of the Freedom of Information Act. Download Full Article (PDF) Cite: 2005 Duke L. & Tech. Rev. 0003

Patent Damage Strategies and the Enterprise License: Constructive Notice, Actual Notice, No Notice

By: James W. Soong For the patent owner, early provision of patent notice can help maximize recoverable infringement damages during subsequent litigation. This iBrief recognizes a growing trend of infringement suits predicated on patented enterprise software technology, and analyzes application of patent notice principles against industry convention. This iBrief examines the licensing paradigm of enterprise software and questions whether mechanical compliance with the marking statute should qualify as constructive notice. Borrowing from analogous Federal Circuit principles, this iBrief concludes by proposing alternate notice theories that would empower patentees to seek increased remedies consistent with industry reality, case law, and fundamental statutory purpose. Download Full Article (PDF) Cite: 2005 Duke L. & Tech. Rev. 0002