Apotex filed an ANDA for a generic version of Plavix (clopidogrel bisulfate) with a paragraph IV certification in early 2001 and was subsequently sued by innovator Sanofi-Synthelabo and Bristol-Myers Squibb (BMS) for infringement of following product patent listed in Orange book, US4847265 (Expiring on Nov 17, 2011)-which covers Dextro-rotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-c)thieno pyridyl) (2-chlorophenyl)-acetate substantially separated from the levo-rotatory isomer and its pharmaceutically acceptable salts
The 30 month stay on Apotex ANDA approval expired in 2005 and its ANDA was subsequently approved in 2006. Apotex launched its product at risk with 180 days exclusivity but was enjoined after 23 days by preliminary injunction by District court on appeal from innovator. Apotex now wants that FDA should not allow Dr. Reddy to market its product before Apotex enjoy remaining exclusivity period of 157 days
It is pertinent to mention that Apotex failed to invalidate 265' patent in district court. The CAFC opinion is due in May 2008. (For complete review of this case link to orangebookblog )
