Generic Drugs, FDA, and IP Law
This course examines, in depth, the unique interface of intellectual property law and regulatory law in the FDA-regulated industries, principally the pharmaceutical industry but also medical devices and food additives. Primary attention is given to the 1984 Hatch-Waxman Amendments to the Patent Code and the Federal Food, Drug, and Cosmetic Act, which for the first time injected patent-law considerations into the FDA regulatory process and simultaneously created special patent rules for products subject to an FDA pre-market approval requirement. The impact of FDA regulation on copyright and trademark rights in the FDA-regulated industries also will be considered. Although the course should be of interest both to students planning careers in patent law and to those whose primary interest is in FDA regulatory law, neither the Regulation of Food and Drugs course nor previous exposure to patent law is a prerequisite to registration.