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Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman
Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman
Faculty Scholarship
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 …
Compulsory Licensing Of Patented Pharmaceutical Inventions: Evaluating The Options, Jerome H. Reichman
Compulsory Licensing Of Patented Pharmaceutical Inventions: Evaluating The Options, Jerome H. Reichman
Faculty Scholarship
In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to esential medicines can collaborate in ways that would avoid undermining incentives to innovation and other social costs attributed to compulsory licensing. It ends …