Generic Drug Maker Pays Damages in Plavix Patent-Infringement Case

The makers of Plavix, Sanofi SA and Bristol-Myers Squibb Co., has settled a patent lawsuit with Apotex over a lower cost, generic version of the blood thinner. According to a report from the Associated Press, the generic drug maker has paid the companies $442.2 million in damages over Apotex’s ” at-risk launch” of a copycat version of Plavix in 2006.

The Plavix legal battle had lasted nearly a decade, with Apotex first challenging the patent on the drug in 2002. At the time of the at-risk launch, Apotex was in the midst of the court dispute with Sanofi and Aventis, and argued that key patents on Plavix were invalid. But last October, a federal appeals court upheld the intellectual property rights related to Plavix.

By early 2006, Bristol and Sanofi, then called Sanofi-Aventis, reached an out-of-court settlement to pay Apotex at least $40 million to delay selling generic Plavix until at least 2011, according to a report in The Wall Street Journal. But when the Justice Department learned of the deal, it launched an antitrust probe. The deal started to collapse, and Apotex went ahead with the at-risk launch of generic Plavix.

Plavix will officially lose its patent protection in May, and both Sanofi’s and Bristol’s bottom lines are expected to take a hit when that occurs.

Plavix (generic: clopidogrel bisulfate) was approved in 1997 for prevention of blood clots and to reduce the risk of heart attacks and strokes. Plavix is the second-best selling drug in the world, with $9.4 billion in global sales in 2010. It is often prescribed in conjunction with low dose aspirin therapy to prevent heart attacks in high-risk patients.

Recently, Plavix has been named in a number of lawsuits claiming the drug caused users to suffer serious side effects, including severe gastrointestinal bleeding, cerebral hemorrhaging, heart attacks, strokes and death. Other complications reported among people taking Plavix include Thrombotic Thrombocytopenic Purpura (TTP), a condition which is marked by small clots through the entire circulatory system.

Lawsuits filed against the makers of Plavix claim the companies marketed the drug as safe for use with aspirin without any evidence supporting that claim. The makers of Plavix also claimed the drug provided more cardiovascular benefits than taking regular aspirin, alone, the lawsuits allege.

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