BIOVAIL HURT BY COURT DECISSION ON DRUG APPROVAL, LAWYERS SAY
4/16/98
A new court ruling will give Andrx Corp. the upper hand over Biovail Corp. in their competition to market the first generic version of a successful Hoechst AG heart drug, lawyers said.
The federal appeals court decision, handed down Tuesday, involved bids by Mova Pharmaceutical Corp. and Mylan Laboratories Inc. to market generic versions of a Pharmacia & Upjohn diabetes drug.
The appeals court held that Mova, the first company to apply for approval of its generic drug, should win federal clearnace first for its version--even though there is still an unresolved patent dispute with Pharmacia & Upjohn.
That meant Mylan had to wait to market its drug.
In Biovail's case, Andrx filed the first application to market a generic version of Hoechst's Cardizem CD. So even though Andrx and Hoechst are in litigation, Biovail can't get clearance to market the drug from the FDA until after Andrx does, said Ronald Grudziecki, an attorney for Mova.
"I don't see where Biovail is in any different position than Mylan," Grudziecki said.
Grudziecki and others familiar with the ruling disagreed with a Biovail statement that suggested the ruling was good for the company. In a statement headlined "Biovail Applauds Court Ruling" the company suggested the company could actually benefit from the ruling if it prompted the FDA to rewrite the rules governing competing generic drug applications.
Trading in Biovail shares was halted much of the day before the company released its statement.
Afterward, U.S. shares of the Canadian rose 2 3/4 to 42 7/16 in trading of nearly 1.1 million shares, about four times its previous three-month daily average. Andrx shares rose 1 3/8 to 39.
Getting its product to drug store shelves first is critical for generic drug makers because in many cases FDA approval allows them a 180-day period of exclusive marketing rights. That period allows drugmakers to gain a foothold that gives them a leg up after the period of exclusivity ends.
In Tuesday's opinion, the Washington-based federal appeals court struck down an FDA rule, known as the successful-defense requirement, that denied exclusivity to first applicants facing patent suits until after they won their cases.
The FDA rule allowed companies embroiled in patent litigation to be leapfrogged by later applicants that didn't face patent-infringement charges.
Source: Bloomberg News |
