Biovail Announces Its Appeal to District Court Decisions.Business Editors, Health & Medical Writers TORONTO--(BW HealthWire)--March 8, 2000 Biovail Corporation ("Biovail") (NYSE NYSE See: New York Stock Exchange :BVF)(TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :BVF) announced today that it has launched an appeal to the decision released earlier today by the United States District Court United States District Court In the U.S., any of the 94 trial courts of general jurisdiction in the federal judicial system. Each state, as well as the District of Columbia and the Commonwealth of Puerto Rico, has at least one federal district court. of the Southern District of Florida which found that Andrx Pharmaceutical's formulation of a generic version of Tiazac(R) does not infringe Tiazac(R)'s patent. Biovail's position is that Andrx' formulation clearly infringes Biovail's patent. Biovail has launched an appeal of that decision. Biovail is confident of its legal position and expects the Court of Appeals to overturn the District Court's finding(s). The court also found, however, that Biovail's Tiazac(R) patent is valid and therefore rejected Andrx' claim of invalidity. Biovail expects that if and when Andrx receives tentative 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, the FDA will not grant final approval to Andrx, thus precluding Andrx from marketing its product, until the Waxman Hatch thirty-month stay has elapsed (February 2001) or a final decision of the Court of Appeals is released, whichever occurs earlier. "Safe Harbor" statement under 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. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of producing FDA and TPP TPP thiamine pyrophosphate. Thiamine pyrophosphate (TPP) The coenzyme containing thiamine that is essential in converting glucose to energy. Mentioned in: Beriberi TPP 1. total plasma protein. 2. approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the U.S. Securities and Exchange Commission. |
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