Biovail celebrating Florida decision in Tiazac court case

Biovail Corp of Canada is claiming victory in a court case concerningits antihypertensive Tiazac (diltiazem), after a Florida, USA, court rejected an application from Andrx to compel the US Food and Drug Administration to delist the Toronto-based firm's patent number '463 from the agency's Orange Book. Andrx is looking to launch a generic version of Tiazac, which is marketed in the USA by Forest Laboratories.

Biovail said that the South District of Florida court decision upholds the company's position that "the listing of the '463 patent is an issue exclusively for the FDA to administer." Eugene Melnyk, Biovail's chairman, added that the firm's New Drug Application for Tiazac was properly listed in the Orange Book and that "Biovail is confident that it will demonstrate this in an appropriate forum."

Biovail said it will examine a notice of certification from Andrx dated February 21 to determine whether the Andrx product infringes upon its patent. The former has 45 days to file a patent infringement suit from receipt of the letter, and if this measure is carried out, approval of Andrx' generic diltiazem could be delayed for up to 30 months thereafter.