The Orphan Drug Act and the Myth of the Exclusivity Incentive

by Robert Rogoyski, J.D.

7 Colum. Sci. & Tech. L. Rev. 4 (2006) (Published April 15, 2006)


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.

About the Author

Robert Rogoyski: J.D. cum laude, Harvard Law School, 2005.

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