View printer-friendly version
« Back
May 23, 2002 4:15 p.m.
Teva Announces Federal Judge Invalidates Remaining Augmentin Patents

Jerusalem, Israel, May 23, 2002 - Teva Pharmaceutical Industries, Ltd. (Nasdaq: TEVA) announced that a federal judge has ruled today in its favor, invalidating the three remaining GlaxoSmithKline patents that were being challenged by generic manufacturers, otherwise due to expire by December 24, 2002, covering the antibiotic Augmentin®. The ruling follows two earlier decisions by the same court on March 13, 2002 and December 14, 2001 that invalidated four GlaxoSmithKline patents otherwise scheduled to expire in 2017 and 2018. The most recent ruling was issued by the federal judge from the bench immediately following the conclusion of the trial.

Teva currently has ANDAs pending before the FDA for amoxicillin and clavulanic acid (the generic equivalent of Augmentin®) and anticipates receiving FDA clearance in the near future. This product is an antibiotic and, accordingly, is not a product for which any generic manufacturer is entitled to any 180-day period of exclusivity.

Bill Fletcher, President and CEO of Teva North America commented, "We are very pleased with the court's decision, which we once again believe validates our decision to challenge the patents. Favorable rulings such as the one today only enhance our Company's ability to offer consumers cost-effective medication. While awaiting our ANDA approval, we will be taking the necessary steps to prepare ourselves for the launch of this very important product."

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 35 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80% of Teva's sales are in North America and Europe. The company develops, manufactures and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell their own generic products or successfully extend the exclusivity period of their branded products, Teva's ability to rapidly integrate the operations of acquired businesses, the availability of product liability coverage in the current insurance market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration ("FDA") and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.