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news.A US court has ruled that Baxter's generic version of Abbott Laboratories' sevoflurane, the world's most widely used anesthetic agent, does not infringe Abbott's patent on the drug.
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Sevoflurane 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, which subsequently sublicensed the patents to Abbott.
In June 2000, Baxter submitted to the FDA an abbreviated new drug application for the product, which the FDA approved in 2002. Abbott filed a lawsuit alleging patent infringement. In March 2002 the federal district court granted summary judgment to Baxter. Abbott filed an appeal, and in July 2003 the US 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 US until after December 10, 2005. With the court’s decision, Baxter will be free to sell its generic sevoflurane product in the US after that date. The company is also seeking regulatory approval for the product in other parts of the world.