FDAnews Drug Daily Bulletin

Biovail Granted Summary Judgment in Tiazac Cases

April 12, 2005
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In a major win for Toronto-based biotechnology company Biovail, a U.S. district court has granted the company's request for summary judgment in two related class-action lawsuits involving the company's hypertension and angina medication, Tiazac.

The U.S. District Court for the District of Columbia granted Biovail's motion for summary judgment. The lawsuits were launched against Biovail in 2001 and 2003 by two groups of health plans. The plaintiffs claimed that Biovail prevented Andrx from marketing "Taztia," its generic version of Tiazac (diltiazem HCl), by listing a patent for the drug with the FDA.

"In granting Biovail's motions for summary judgment, the court agreed with Biovail's position that, in light of the evidence and facts pleaded, the plaintiffs had been unable to prove that they had suffered any damages for which Biovail could be responsible," Biovail said in a statement.

In the company's motion for summary judgment, Biovail claimed that Andrx had not launched its generic product as early as Andrx would have liked because it could not receive final FDA approval for the product, not because of any action by Biovail. "[The] fundamental factual premise underlying all of plaintiffs' claims -- that plaintiffs were unable to purchase Andrx's generic product as a result of alleged unlawful conduct by Biovail -- is indisputably false," Biovail told the court.