Judge Permanently Blocks Sale Of Generic Version Of Plavix

Tuesday, June 19th 2007, 9:48 am

By: News On 6

NEW YORK (AP) _ A federal judge Tuesday permanently blocked a Canadian maker of a cheap generic version of blood thinner Plavix from marketing the drug, saying its version infringed on a valid patent for Plavix.

U.S. District Judge Sidney H. Stein said Apotex Inc. had failed to prove during a trial in Manhattan that lasted from Jan. 22 through Feb. 15 that the patent was invalid. He said damages will be set in an amount to be determined at future proceedings.

Last year, Stein had granted a request by Sanofi-Aventis, the holder of a patent on Plavix, to stop Apotex from producing the generic drug, which had gained a majority of market share after its launch last summer.

But Stein allowed Plavix to continue selling a six-month supply of product that Apotex had already shipped to distributors in the United States.

In Tuesday's opinion, Stein said Sanofi had shown it was likely to suffer irreparable price erosion, loss of goodwill and a negative impact on the amount of research devoted to developing other medical uses for Plavix if sales of the generic version are allowed.

Sanofi-Aventis, which is based in France, sells Plavix in the United States through its U.S. partner, Bristol-Myers Squibb Co.

The companies had no immediate comment on the ruling.

But shares of Bristol-Myers surged $1.33, or 4.4 percent, to $31.64 in morning trading, while Sanofi-Aventis' U.S. shares rose 60 cents to $41.95.

Plavix is the world's second best selling drug after Pfizer Inc.'s cholesterol-lowering agent Lipitor. Plavix, used by 48 million Americans, is Bristol-Myers' best selling product.

Ontario-based Apotex began selling its product Aug. 8 after negotiations among the three companies failed to settle the dispute.

When he ruled last year, Stein had required Sanofi to post bond of $400 million, an amount meant to cover losses Apotex will have suffered if it eventually won.