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Drug Makers Reach Accord in Patent Case Over

Submitted by STEPHANIE SAUL  l  March 24 2006  l  Viewings: 5347

Drug Makers Reach Accord in Patent Case Over Plavix

Published: March 22, 2006
Sanofi-Aventis and its partner Bristol-Myers Squibb said late yesterday that they had tentatively settled a patent dispute involving Plavix, the anticlotting agent that is the world's second-best-selling drug.

The agreement, with a Canadian maker of generic drugs, would protect the companies' exclusive right to market the drug until 2011, eliminating a major uncertainty for investors.

The settlement, with Apotex, of Canada, calls for the companies to pay an undisclosed amount to Apotex and also allows the generic company to sell its version of Plavix beginning in September 2011, eight months before the United States patent is expected to expire.

The companies said they would split the payments to Apotex 50-50, adding that they expected to establish reserves this quarter for the minimum estimated amount of the payment.

Under the agreement, Apotex will make undisclosed royalty payments to the companies beginning in 2011.

The settlement, which needs approval by the Federal Trade Commission, was considered a positive development for both Sanofi-Aventis, a French company, and Bristol-Myers Squibb, which is based in New York.

In after-hours trading, shares of Bristol-Myers climbed $1.92, to $24.75. American depository receipts of Sanofi-Aventis were up $2.92, to $46.60 in after-hours trades.

Sanofi-Aventis makes Plavix, but under its co-marketing agreement Bristol-Myers's share of Plavix sales were $3.8 billion in 2005, making it the American company's largest product by far.

A Canadian court last year ruled against Apotex's claim that the fundamental patent on Plavix had expired in 2003. But because of differences in American patent law, that case was not seen as predictive of how the dispute might be resolved in this country.

The United States patent lawsuit had been set to go to trial in June in federal court in Manhattan, and some analysts had estimated the chances as high as 40 percent that Sanofi-Aventis and Bristol-Myers could lose their exclusive right to market the drug, which had global sales last year of $6.2 billion, second only to the cholesterol treatment Lipitor, which is made by Pfizer.

Both Sanofi-Aventis and Bristol-Myers had said that losing the patent could have materially affected their financial strength and liquidity.

Although Apotex was considered the major litigant opposing the two companies, they said in a joint statement that they had also approached another company involved in the patent litigation, Dr. Reddy's Laboratories of Hyderabad, India, to discuss a settlement.

Sanofi-Aventis and Bristol-Myers sued Apotex and Dr. Reddy's in 2002 after they each filed an application with the Food and Drug Administration to market generic Plavix, known as clopidogrel bisulfate, in the United States. After the suit was filed, the F.D.A stayed action on the generic application for 30 months.

The stay expired last May, and the F.D.A. approved Apotex's application in January. If the company had marketed the product before the lawsuit's end, however, it would have been subject to treble damages if it later lost the patent case.

The companies said yesterday that they would also approach two other generic companies, Teva Pharmaceuticals of Israel and Cobalt Pharmaceuticals of Canada, which had sought to market generic Plavix in this country as well.

If approved, the settlement would remove the last major impediment that has hindered Bristol-Myers Squibb during the last five years. During that period the company had also been the target of investor lawsuits and a criminal investigation involving its inventory practices Ч cases that have since been settled.

Peter R. Dolan, chief executive of Bristol-Myers, has said he will return the company to sales and earnings growth in 2007 with a positive Plavix outcome. Mr. Dolan was not available for comment yesterday.

Article source: http://library.rusbiz.com

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