In Reply Dr Karas makes some important points that we believe are consistent with our argument regarding the ODA.1 While we did not wish to dive into the nuances of intellectual property law, she helpfully points out that the ODA does not extend patent protection. The origin of the extended rights provided by the ODA are not the same as those provided by patent protection. However, the act provides extended market exclusivity, which effectively extends the economic advantage of patent protection. Thus, while the legal basis for the extended exclusivity is not the same, thinking of it as extended patent protection is an easy way of conceptualizing it because it has a similar effect on the market. The terminology in the Viewpoint has been corrected.2
Thomas S, Caplan A. Incentivizing Therapies for Rare Diseases—Reply. JAMA. 2019;322(5):465. doi:10.1001/jama.2019.6958
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