Orange County – Apotex Corp., Canada’s largest pharmaceutical manufacturer, has paid Bristol-Myers Squibb Co. and Sanofi SA nearly $445 million in damages to end a decade-long patent infringement lawsuit over Apotex’ improper sales of its generic version of Plavix.
The Plavix patent battle began in 2002 with litigation over an illegal deal to delay the sales of generic Plavix, a criminal antitrust investigation by the United States Justice Department, the firing of a former Bristol-Myers CEO, and an investigation over alleged inflated sales numbers by the company.
In early 2006, Bristol-Myers and France’s Sanofi, which at the time was Sanofi-Aventis, reached a confidential settlement with Apotex to pay the Canadian company at least $40 million to delay selling generic Plavix until at least 2011, when the drug’s primary patent was to expire.
Eventually, federal authorities gained knowledge of the illegal agreement and launched a criminal antitrust probe in August 2006. As a result of the investigation, FBI agents raided the headquarters for Bristol-Myers and confiscated incriminating documents and some senior executives at Sanofi-Aventis were served grand jury subpoenas to produce additional documents.
As the investigation ensued and the deal among the companies fell apart, Apotex took the opportunity to do an “at-risk launch” of clopidogrel, a copycat version of Plavix. Drug distributors quickly began stocking large quantities of the pills, which were at a cost of 20 percent less than the patented Plavix.
Shortly after, Bristol-Myers and Sanofi-Aventis won their motion for an injunction to block any further sales of the generic version, however the federal judge granting the injunction refused to require that Apotex take back the existing pills in its distributors’ inventory, which cost Bristol and Sanofi significant revenue.
The Plavix patent battle continued, with a federal judge blocking Apotex’ claim that the Plavix patent was invalid. Apotex challenged the validity, but it was upheld by the U.S. Court of Appeals for the Federal Circuit in December 2008. Eventually, Bristol-Myers won a six-month extension on the patent’s U.S. term by performing tests of Plavix in children. The case dragged on until October 2011, when Apotex was ordered to pay both companies for lost revenue and other damages.
Bristol and Sanofi are not the only companies to face the threat of generic substitutes competing for valuable market share. The patent for Lipitor, Pfizer’s flagship cash cow drug, expired in November 2011, leaving the market wide open for generics that will come in a half the cost.