Now, Whitehouse Station, N.J.-based Merck and Co. Inc. is suing PTO and the U.S. Food and Drug Administration (FDA) for denying the company the "benefit of patent period restorations granted under the 1984 Drug Price Competition and Patent Term Restoration Act."
The dispute centers on different interpretations of two statutes: the patent section of the Uruguay Round Agreement Act implementing the latest set of international trade rules (General Agreement on Tariffs and Trade, or GATT), and the 1984 Patent Term Restoration Act. The GATT legislation permitted any patent in force on June 8, 1995, to extend its term to 20 years from the original application date. The 1984 law extended the patent terms of drugs delayed from the market by regulatory requirements.
A number of drug companies, explains PTO senior counsel H. Dieter Hoinkes, argued that patents in force on June 8 that are eligible for regulatory delay extensions should ...
