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Andrx Corp. Announces Biovail Abuses System; Knowingly Lists Patent That Can Not Cover Tiazac.


Business Editors/Health & Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Jan. 30, 2001

ANDRX CORPORATION (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) today announced that Biovail Corporation's (NYSE NYSE

See: New York Stock Exchange
:BVF BVF Biovail Corporation (stock symbol)
BVF Berufsverband der Frauenärzte eV (Muenchen, Germany)
BVF Bearing Versus Frequency
) claim, that a recently issued Patent "covers" its Tiazac(R) product, appears to constitute a clear abuse of the Hatch-Waxman Act and is a transparent ploy unlawfully to attempt to extend patent protection over its Tiazac(R) product. Biovail's Tiazac(R) product was approved in September 1995 by the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 (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.
), and has been sold commercially since late 1995. Tiazac(R) therefore can not be "covered" by Patent No. 6,162,463, whose earliest application date is May 1, 1997. In addition, the Patent specifically refers to Tiazac(R), and indicates that it provides a therapeutic improvement over Tiazac(R) and other extended release diltiazem products. The Patent therefore can not "cover" the Tiazac(R) product for that reason as well.

As admitted in its press release, Biovail's purpose in listing this Patent is to try to require generic ANDA ANDA
abbr.
abbreviated new drug application
 filers such as Andrx to submit a "Notice of Certification" under Hatch-Waxman and thereby give Biovail the ability to delay final FDA approval of such ANDA for up to 30 months. Andrx has anticipated receiving final approval of its ANDA shortly, following either a Court of Appeals decision upholding the lower court's decision that the Andrx product does not infringe other meritless patent claims made by Biovail or upon the expiration of the original 30 month statutory period in the coming weeks.

"This is just the latest in a series of legalistic le·gal·ism  
n.
1. Strict, literal adherence to the law or to a particular code, as of religion or morality.

2. A legal word, expression, or rule.
 and public relations ploys engineered by Biovail to delay consumer access to a generic version of Tiazac(R), and to obfuscate To make unclear or confuse. See obfuscator and e-mail obfuscator.  the true facts," said Andrx President, Elliot F. Hahn, Ph.D. "We are confident that we can overcome this blatant abuse."

Andrx has notified federal regulators of Biovail's most recent listing abuse and intends vigorously to pursue its rights to enable FDA to approve its generic version of Tiazac(R) as originally projected. Andrx believes that its ANDA product does not infringe this new Patent.

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
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jan 30, 2001
Words:481
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