Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach

68 Pages Posted: 14 Apr 2010

Multiple version iconThere are 2 versions of this paper

Date Written: March 14, 2009

Abstract

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.

Keywords: Clinical Trials, IP, Data Protection, Patent Law, Innovation

Suggested Citation

Reichman, Jerome H., Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach (March 14, 2009). Marquette Intellectual Property Law Review, Vol. 13, pp. 1-68, 2009, Available at SSRN: https://ssrn.com/abstract=1589585

Jerome H. Reichman (Contact Author)

Duke University School of Law ( email )

210 Science Drive
Box 90362
Durham, NC 27708
United States

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