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The Texas Law Review Association




In his recent article in the Texas Law Review, Ben Roin advances the claim that pharmaceutical innovation and the public’s health are harmed by the doctrines of non-obviousness and novelty. He does not mince words, labeling the nonobvious requirement as “perversity” with a “pernicious” effect on drug development. In his view, these standards pose an insurmountable barrier for drug companies seeking to commercialize inventions already in the public domain. He claims that valuable, life-saving drug ideas languish in the public domain because the companies face high barriers to entry from the FDA, but potential free riders are encouraged through the generic Abbreviated New Drug Application (ANDA) process. A major example given in the article is Ultracet, but in that case the public domain did not hinder commercialization of the drug. His second major argument suggests that FDA-administered data exclusivity periods are the best response to this problem. This brief Comment will challenge both aspects of Roin’s argument and then briefly propose alternatives for addressing the free rider problem.

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