Under interim rules included in the Uruguay Round Agreements Act (P.L. 103-465), a number of pharmaceutical companies believed they stood to gain an extended patent term for some very profitable drugs. Initially, the United States Patent and Trademark Office (PTO) agreed with the drug-makers, then reversed its position and turned down about 80 of the hoped-for patent-term extensions.

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...

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