Never mind Sicko. Everyday expressions of outrage over the soaring healthcare costs don't seem to matter either for US judges. A Canadian company's cheap generic version of the blood thinner Plavix has been blocked from the U.S. market until at least 2011. U.S. District Judge Sidney H. Stein said Tuesday that Apotex Inc. had failed to prove during a three-week trial in New York City earlier this year that the patent protecting Plavix from competitors was invalid.
· Plavix (generic name clopidogrel) prevents platelets (substances in the blood) from clustering. This helps to prevent blood from forming blood clots.
· Clopidogrel is used in the prevention and treatment of heart attack, stroke, blood clots, and acute coronary syndrome.
Plavix used by 48 million Americans, is Bristol-Myers Squibb Co.'s best selling product. It is the world's second best selling drug after Pfizer Inc.'s cholesterol-lowering agent Lipitor. The ruling also was a victory for the French patent-holder, Sanofi-Aventis, which sells Plavix in the United States through Bristol-Myers.
"We're pleased that our intellectual property rights have been maintained," said Bristol-Myers spokesman Tony Plohoros.
Robert L. Baechtold, a lawyer for Bristol-Myers and Sanofi, said Stein delivered a "carefully thought out and well reasoned decision."
Apotex said it would file an immediate appeal with the Federal Circuit in Washington. A win would allow the company to "once again make possible billions of dollars in savings for the public," said Chief Executive Barry Sherman.
Apotex's drug sells for about $124 for 30 pills, compared with $148 for a month's supply for the branded version. Shares of Bristol-Myers surged $1.27, or 4.2 percent, to $31.58 Tuesday, while Sanofi-Aventis' U.S. shares rose 24 cents to $41.59. Last year, Stein had granted a request by Sanofi-Aventis to stop Apotex from producing the generic drug, which had gained a majority of market share after its launch last summer. The judge had allowed Apotex to continue selling a six-month supply of product that it already had shipped to U.S. distributors.
Sherman said the issues in the case were "extremely similar" to those in a dispute over a patent for a blood pressure medication, Norvasc. Earlier this year, a federal appeals court cleared the way for Apotex to sell a cheaper generic version of the blood pressure drug.
The judge, however, rejected Apotex's claims that his findings in the Plavix case were similar to the overturned Norvasc ruling. Sherman said Apotex will pursue the Plavix case "full bore and work relentlessly" to invalidate the patent covering clopidogrel bisulfate, the active ingredient in Plavix. Sanofi obtained the patent in July 1989, naming two employees as inventors.
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 were allowed. The judge said damages will be set in an amount to be determined at future proceedings.