clinical trials, IP, data protection, patent law, innovation
Food and Drug Law | Intellectual Property | International Trade | Law | Pharmacy Administration, Policy and Regulation
This article is a later version of the author's presentation at the Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture March 26, 2008. Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a national and international public good instead of a private good and proposes that the government should oversee and fund the clinical trials to stimulate more innovative research and development with lower costs and better information.
Jerome H. Reichman, Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach, 13 Marquette Intellectual Property Law Review 1-68 (2009).