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Law Commons

Open Access. Powered by Scholars. Published by Universities.®

2009

Series

Faculty Scholarship

Health Law and Policy

Abbreviated New Drug Application (ANDA) Process

Articles 1 - 1 of 1

Full-Text Articles in Law

Death From The Public Domain?, Kevin Outterson Jan 2009

Death From The Public Domain?, Kevin Outterson

Faculty Scholarship

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 …