Mylan Files Suits on Buspirone.Business Editors PITTSBURGH--(BUSINESS WIRE)--Nov. 30, 2000 Mylan Laboratories Inc. announced today that its wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , Mylan Pharmaceuticals Inc. filed a Complaint in the Federal District Court for the District of Columbia District of Columbia, federal district (2000 pop. 572,059, a 5.7% decrease in population since the 1990 census), 69 sq mi (179 sq km), on the east bank of the Potomac River, coextensive with the city of Washington, D.C. (the capital of the United States). against the Food and 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. "), Donna Shalala, Secretary of the U.S. Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Health and Human Services, HHS , Jane E. Henney Jane E. Henney is an American physician who was the first woman to serve as commissioner of the U.S. Food and Drug Administration. Appointed by President Bill Clinton, she served at the FDA between 1998 and 2001. , Commissioner of the FDA, and Bristol-Myers Squibb Co. In its Complaint, Mylan alleges that the FDA should have granted Mylan final approval of its tentatively-approved generic buspirone hydrochloride product notwithstanding the listing of U.S. Patent No. 6,150,365 in the FDA's publication Approved Drug Products with Therapeutic Equivalence Evaluation (the "Orange Book"). Mylan contends approval should be granted because it filed the statutorily-required statement that the listed U.S. Patent No. 6,150,365 does not claim a use for which Mylan was seeking approval of its ANDA ANDA abbr. abbreviated new drug application product. Mylan further alleges that Bristol-Myers Squibb improperly filed the patent with the FDA for listing in the Orange Book. Specifically, Mylan contends that in filing U.S. Patent No. 6,150,365 with the FDA, Bristol-Myers Squibb incorrectly stated that the patent covered the current approved uses of its BuSpar(R) product. Mylan requests that the court order the FDA to approve Mylan's generic buspirone hydrochloride product, which the FDA has already determined is safe and effective. Mylan also requests the court to order Bristol-Myers Squibb to delist the patent from the Orange Book. In addition to its suit against the FDA, Mylan filed a Complaint for Declaratory DECLARATORY. Something which explains, or ascertains what before was uncertain or doubtful; as a declaratory statute, which is one passed to put an end to a doubt as to what the law is, and which declares what it is, and what it has been. 1 Bl. Com. 86. Judgement against Bristol-Myers Squibb Co. in the Federal District Court for the Northern District of West Virginia. In its Complaint Mylan alleges that U.S. Patent No. 6,150,365 entitled Anxiety Method, will not be infringed by the manufacture, use or sale of Mylan's tentatively-approved generic buspirone hydrochloride product. Mylan further alleges that this patent is invalid as anticipated by the long-standing prior use and sale of Bristol-Myers Squibb's BuSpar(R) brand buspirone hydrochloride product for the treatment of anxiety. Mylan has requested the District Court to declare that U.S. Patent No. 6,150,365 will not be infringed by Mylan's tentatively approved product, and that the patent is invalid. |
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