Baxter Prevails in Sevoflurane Patent Dispute

CHICAGO, Sept. 23 /PRNewswire-FirstCall/ -- A ruling by Judge Ronald Guzman of the U.S. District Court for the Northern District of Illinois concluded an Abbott Laboratories patent related to sevoflurane combined with water was not infringed by Baxter's generic version of sevoflurane.

Sevoflurane, the world's most widely used anesthetic agent, is an inhaled anesthetic originally developed by Baxter in the 1970s. The company licensed the patents for making the product in the 1980s to Maruishi Pharmaceutical Company, which subsequently sublicensed the patents to Abbott.

Through its acquisition of Ohmeda Pharmaceutical Products that occurred in the late 1990s, Baxter expanded its presence in the anesthesia market to include pharmaceuticals and anesthesia agents, including SUPRANE(R), propofol and a generic sevoflurane product, which Ohmeda had developed using a different, unique production process. In June 2000, Baxter submitted to the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application for the product, which the FDA approved in 2002. Abbott filed a lawsuit alleging patent infringement, and on March 22, 2002 the federal district court granted summary judgment to Baxter. Abbott filed an appeal, and in July 2003 the U.S. Appeals Court vacated the decision and remanded the case back to the district court for a full trial.

In parallel to the patent litigation, Abbott also sought arbitration under the licensing agreements to prevent Baxter from selling sevoflurane before the licenses expired. Under the ruling by the arbitration panel, Baxter cannot market sevoflurane in the United States until after December 10, 2005. With the court's decision, Baxter will be free to sell its generic sevoflurane product in the United States after that date. The company also is seeking regulatory approval for the product in other parts of the world.

Baxter's Medication Delivery business is a leading manufacturer of specialty pharmaceuticals and devices that help physicians, pharmacists and nurses effectively deliver critical fluids and drugs to patients. Baxter's products help clinicians provide fluid replenishment, general anesthesia, parenteral nutrition, pain management, antibiotic therapy, chemotherapy and other therapies to patients in acute care settings.

Baxter International Inc. , through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

This release includes forward-looking statements concerning the anticipated launch of a generic sevoflurane product. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward- looking statements: any further litigation with respect to sevoflurane, including appeals relating to the decision described in this release; further steps in product development, including scaling up production and completion of quality and regulatory work; and other risks identified in the company's most recent filing on Form 10-Q and other SEC filings, all of which are available on the company's web site. The company does not undertake to update its forward-looking statements.