Tiazac antitrust claims tossed by US appeals court
This article was originally published in Scrip
Executive Summary
A US appeals court has ruled in favour of Biovailon wholesalers' claims that the company's patent defence of its antihypertensive Tiazac (diltiazem HCl extended-release) violated antitrust law. The plaintiffs claimed that Biovail unlawfully forestalled approval of Andrx's generic by initiating sham patent litigation. Andrx's ANDA received FDA tentative approval in September 2000 and May 2001, but the company encountered formulation difficulties and the generic did not get final clearance until April 2003. This was one year after Biovail withdrew its lawsuit asserting that a late-issued patent protected Tiazac. The US court of appeals for the District of Columbia said no reasonable juror could conclude that, but for Biovail's alleged misuse of the late-issued patent, the agency would have granted Andrx final approval in February 2001, when an appeals court ruled Andrx's product did not infringe an earlier Biovail patent.