The Plavix case stops here. That's what the U.S. Supreme Court has decided, refusing to consider a last-ditch patent challenge from Canadian generics maker Apotex. Now, Bristol-Myers Squibb and Sanofi-Aventis only have to worry about the U.S. Patent Office interfering with their multibillion-dollar drug's market exclusivity.
Apotex has been trying for years to grab a share of the Plavix market. The company even dared an at-risk launch of its version of the drug back in 2006, in a move that cut deeply into Bristol-Myers' sales for months to come. The company lost as much as $1.75 billion in Plavix revenues as Apotex stuffed U.S. pharmacies with cheap copies. And as Bloomberg points out, the Supreme Court's decision to turn away Apotex's appeal lends strength to Bristol and Sanofi as they seek reimbursement from Apotex for those lost sales.
Apotex had argued that Plavix was fair game after one Sanofi patent on the drug expired in 2003. The Canadian company contended that the second Plavix patent was invalid, serving only to "prolong Sanofi's monopoly by eight years" (as quoted by Bloomberg). U.S. courts sided with Sanofi, and obviously, the Supreme Court declined to second-guess those decisions.
But Apotex has also requested that the U.S. Patent and Trademark Office reconsider that second patent. If the PTO sides with the branded drugmakers, they'll be able to breathe easy at least until November 2011, when the multibillion-dollar drug may finally face copycat competition. Plavix may get another six months' protection from FDA, in return for pediatric studies. So stay tuned.