ANDRX Files Suit to Require Patent Delisting.Business Editors FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Feb. 12, 2001 ANDRX CORPORATION -- Andrx Group (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) today announced that it has filed a lawsuit in the Southern District of Florida to require Biovail Corporation (NYSE NYSE See: New York Stock Exchange :BVF BVF Biovail Corporation (stock symbol) BVF Berufsverband der Frauenärzte eV (Muenchen, Germany) BVF Bearing Versus Frequency ) to delist from the Orange Book the recently issued patent (No. 6,162,463) that Biovail claims "covers" Tiazac(R). Andrx contends that Biovail's listing of that patent is an improper manipulation of the Hatch-Waxman statutory scheme, intended to deny patient access to a lower cost generic version of Tiazac(R). Andrx' complaint describes Biovail's prior efforts to delay Andrx from making its generic product available to consumers, which have included delaying 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 for an initial 30-month period while the parties litigated an earlier patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. action brought by Biovail, which Biovail lost at trial (the parties are awaiting the decision on appeal); requiring Andrx to prove that its product remains bioequivalent bi·o·e·quiv·a·lent n. A value indicating the rate at which a substance enters the bloodstream and becomes available to the body. to Tiazac(R) when "sprinkled" over applesauce; filing a Citizen Petition to delay FDA approval of Andrx' product; seeking additional testing of the Andrx product that is neither required by law nor justified by science; and filing a lawsuit challenging FDA's handling of the Andrx ANDA ANDA abbr. abbreviated new drug application for Tiazac(R). In addition to filing its Complaint, Andrx has contacted representatives of both the Federal Trade Commission and the Food and Drug Administration to investigate Andrx' complaints of Biovail's most recent statutory abuse. Andrx also announced that Biovail now contends that Andrx' sale of Cartia XT(R), Andrx' generic version of Cardizem CD(R), breaches an agreement made between Andrx and Aventis to settle patent infringement 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. over Cartia XT(R). Biovail claims a right to enforce that agreement because of its acquisition of the Cardizem(R) line from Aventis and alleges that product manufactured by Andrx is not in conformity with the agreement and should be withdrawn from the market. Having investigated the matter, Andrx believes that Biovail's contention is wholly without merit. "It is unfortunate that, instead of competing in the marketplace, Biovail prefers to continually engage us in litigation," said Elliot F. Hahn, Ph.D., President of Andrx. "We have been successful against all of Biovail's tactics to date, and Andrx will continue to do what is necessary to make cost effective products available to consumers as soon as lawful and practicable." Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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 or other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties. Andrx Group is a class of common stock of Andrx Corporation, therefore Andrx Corporation shareholders are subject to the risks and uncertainties described in Andrx Corporation's filings with the Securities and Exchange Commission, including Andrx Corporation's Annual Report on Form 10-K for the year ended December 31, 1999. |
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