CHAL 6 |
| Enacted in 1984, the Hatch-Waxman Act extended the term of patent protection for pioneer drug manufacturers, and at the same time simplified the FDA approval mechanism for generic versions of pharmaceuticals in the United States. Under the Hatch-Waxman Act, generic manufacturers may conduct experiments on patented drug products, "solely for uses reasonably related to" FDA approval, without liability for patent infringement. Upon filing an Abbreviated New Drug Application for FDA approval to market a generic drug, the generic manufacturer typically certifies that for each patent covering the pioneer drug, the patent is invalid or will not be infringed by the manufacture, use, or sale of the generic product. This paper will explore the complexities of pharmaceutical patent litigation under the Hatch-Waxman Act, examining both the substance and procedure of such litigation, as well as recent developments. |
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Intellectual Property Value Creation for Pharmaceutical Companies
9:00 AM-11:00 AM, Monday, 27 March 2006 Georgia World Congress Center -- C210, Oral
Division of Chemistry and the Law |