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U.S. Court Grants Injunction
Against Generic Plavix

August 31, 2006 (updated September 5, 2006) -- U.S. District Court Judge Sidney H. Stein of the Southern District of New York today granted Sanofi/Bristol-Myers' request for a preliminary injunction against Apotex, prohibiting the Canadian-based firm from selling their generic clopidogrel product while the dispute over the validity of Sanofi's branded Plavix is decided.

The relationship between the three companies is complex -- a previous agreement had Apotex waiting to sell generic clopidogrel until 2011 and granted financial rewards to the company. However, that agreement was rejected on July 28 by the States' Attorneys General, setting the stage for Apotex to announce one week later that it was going to begin sales of its generic version of Plavix.

The immediate result was a steep drop in stock price for Bristol-Myers and Sanofi. Within days generic clopidogrel became available and the potential future sales lost to the pharmaceutical giants would be significant. So Sanofi (who makes Plavix) and Bristol-Myers (who markets it in the U.S.) requested the injunction that was granted today.

Clopidogrel is a major blood-thinning drug used in heart disease, one which is mandatory after stent implantation because its antiplatelet properties help keep the blood from forming clots around the stent structures. Most cardiologists prescribe Plavix for at least a year and many for life after drug-eluting stent implantation -- it is also used in a number of other clinical situations. It is the world's second largest-selling drug, worth $5.9 billion. It costs about $4.00/day. Consumers were told that with the introduction of a generic version they might see price reductions of up to 40%, but Angioplasty.Org has surveyed the online pharmacies and found the savings are closer to 11%.

The Court granted the injunction primarily because it found the Apotex case for invalidating the patent weak; that Sanofi would "suffer irreparable harm if the injunction is not granted" and interestingly that there were "substantial public interests on both sides" but that "the balance of those interests slightly favors Sanofi."

However, the Court did not grant Sanofi's request to recall the generic clopidogrel already distributed (Apotex had immediately flooded the market with several months supply). As is routine in these cases, the Court also required Sanofi to post a $400 million bond, in the event that Apotex eventually succeeds in proving its case and is found to have been unjustly restrained by the injunction from selling its product.

(Update) On September 5, Judge Stein rejected a request from Apotex to postpone the injunction, pending the outcome of its appeal to the U.S. Court of Appeals for the Federal Circuit in Washington. The company may now file with the same court for an emergency postponement of the injunction as well.

related stories:
Court Opinion of Sanofi/Bristol-Myers v. Apotex --U.S. District Court, Southern District of NY
Generic Version of Plavix® (Clopidogrel) is Launched by Apotex --August 8, 2006, Angioplasty.Org