Appellate Court Confirms That Andrx ANDA For Tiazac Does Not Infringe Patent; Timing of Generic Availability Depends on Review of Recent Biovail's Actions.Business Editors/Health & Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Feb. 14, 2001 Andrx Corporation (Nasdaq:ADRX) today announced that the United States Court of Appeals for the Federal Circuit The United States Court of Appeals for the Federal Circuit is a United States court of appeals. The Federal Circuit was created by Congress with passage of the Federal Courts Improvement Act of 1982. The court is headquartered in Washington, D.C., and occupies the Howard T. affirmed the district court's earlier determination that the product described in Andrx's abbreviated new drug application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA) for Tiazac(R) does not infringe the patent claims of Biovail Corporation (NYSE NYSE See: New York Stock Exchange :BVF) and its affiliates. However, and unfortunately for consumers, as a result of Biovail's delay tactics, 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. ) approval of the marketing of this product has now been delayed by Biovail's listing of a recently issued patent that it contends "covers" Tiazac(R). Andrx believes that this listing is blatantly improper and is a clear abuse of the law intended to unlawfully extend patent protection over this product. Andrx has alerted both FDA and FTC FTC See Federal Trade Commission (FTC). authorities of this abuse and has commenced legal action to remedy the situation. Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. For this purpose, any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, including those risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com |
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