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The Orphan Drug Act and the Myth of the Exclusivity Incentive

Rogyoski, Robert

For more than 20 years, the marketing exclusivity provision of the Orphan Drug Act has been hailed as a key component of the incentive for the United States’ pharmaceutical industry to develop drugs for rare disorders; this is the Official Story of the ODA. In this paper, I argue that the Official Story is a myth. Rather, the real engine for the development of drugs to treat rare disorders is the patent system.

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Published Here
May 23, 2025