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Plavix Makers Prevail in Patent Battle

Filed February 14th, 2012 Julie

Sanofi SA and Bristol-Myers Squibb Co. have reached a settlement with Apotex over a cheaper, generic version of the blood-thinning drug Plavix. Sanofi and Bristol-Myers, the manufacturers of Plavix, will reportedly collect $442.2 million in damages from Apotex.

Apotex first challenged Plavix’s patent in 2002. Apotex’s generic copy first underwent an “at-risk” launch in 2006 while the company was going through court proceedings with Sanofi and Bristol-Myers. They argued against the validity of patents on Plavix, but a federal appeals court chose to uphold the intellectual property rights related to Plavix.

In 2006, Sanofi and Bristol agreed to pay Apotex upwards of $40 in an out-of-court settlement in order to delay selling the generic drug until 2011. However, the Justice Department reportedly launched an antitrust probe when it learned of the agreement, and Apotex began moving forward with the at-risk launch.

Plavix will officially lose its patents in May.

Plavix is facing a number of lawsuits filed by plaintiffs that allege the drug caused serious side effects, including severe stomach bleeding, brain hemorrhaging, as well as stroke and cardiac events. The medication can also cause blood clots. Plaintiffs accuse the drug makers of marketing Plavix as a drug that is safe to use with aspirin therapy, but have no scientific information to support their claims.

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