COURT RULES FOR MERCK & CO., INC. IN PATENT LAWSUIT.WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--October 19, 1995--A federal district court in Alexandria, Virginia ruled in favor of Merck & Co., Inc. and several other research-based pharmaceutical companies in their lawsuits brought against the Patent and Trademark Office (PTO PTO abbr. 1. Parent Teacher Organization 2. or p.t.o. please turn over 3. power takeoff PTO or pto please turn over Noun 1. ) and Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). This ruling was the outcome of litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. filed on July 27 by Merck to overturn a U.S. Patent Office decision that would deny the Company the benefit of patent period restorations granted under the 1984 Drug Price Competition and Patent Term Restoration Act The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act" [Public Law 98-417], is a 1984 United States federal law which established the modern system of generic drugs. . Under the 1984 act, drug manufacturers are entitled to a limited restoration of patent time that is lost while their products undergo regulatory review by the FDA. The district court found that the PTO and FDA acted unlawfully and ordered that patent term restoration be added to the new GATT See General Agreement on Tariffs and Trade. GATT See General Agreement on Tariffs and Trade (GATT). patent of 20 years from date of filing. As a result of the district court's decision, the U.S. patent expiration date for Mevacor(R) is extended to June 15, 2001 (as opposed to the November 4, 1999 expiration date espoused by the PTO and FDA). The U.S. patent terms for Pepcid(R), Noroxin(R), and Chibroxin(R) have also been effectively extended as a result of the district court's decision. CONTACT: Gary Lachow Work: 908-423-6022 Home: 908-782-1232 |
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