SAN FRANCISCO (Thomson Financial) - Salix Pharmaceuticals Ltd. said
Wednesday that Novel Laboratories Inc. has filed an abbreviated new drug
application to market a generic version of Moviprep, a product indicated for
cleansing of the colon as a preparation for colonoscopy.
In a letter, Novel said the patent for Moviprep, which is owned by Norgine
Europe B.V. and licensed by Salix, is invalid and unenforceable. The U.S. patent
expires on Sept. 1, 2024.
Raleigh, N.C.-based Salix said it has 45 days to begin a patent infringement
lawsuit against Novel that would automatically stay, or bar, the Food and Drug
Administration from approving Novel's application for up to 30 months or until a
district court decision that is adverse to Salix.
Salix said both it and Norgine have full confidence in the intellectual
property rights that protect Moviprep. The companies also said they plan to use
all reasonable means to defend Moviprep "from any and all generic intrusion."
Novel is a privately held company that has been affiliated with Elite
Pharmaceuticals Inc.
Salix shares were down 23 cents, or about 3.2%, at $7.01.
Katherine Hunt
kh/vj
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