Tuesday, February 12, 2013

Bristol-Myers - Baraclude (entecavir) patent Invalidated by Teva

Teva had challenged patents on Bristol-Myers Hepatitis B drug Baraclude (entecavir) for invalidity and inequitable conduct through an ANDA containing Para-IV certification. Yesterday, judge Burke of the
District of Delaware has issued a judgement in favor of Teva, saying the US patent No  5,206,244, covering the entecavir molecule, is invalid as obvious.  The worldwide sales of Baraclude stands at $1.3b, while US sales are about $250million.

The thirty-month stay barring Teva from marketing its drug expires on or around February 12,2013. 
Though successful in the district court, it is unclear when Teva will begin marketing its generic entecavir tablets, as Teva's ANDA has apparently not yet received tentative approval.  Moreover, according to the Orange Book, BMS holds a three-year exclusivity on Baraclude that expires in October 2013 and another three-year exclusivity that expires in October 2015.  Meanwhile, BMS will very likely appeal today's decision to the Federal Circuit.Once the tentative approval is granted, Teva may opt to launch at risk.



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