Cubist told of Teva ANDA submission for Cubicin

Massachusetts, USA-based Cubist Pharmaceuticals says that it has received a Paragraph IV Certification Notice Letter from Teva Parenteral  Medicines, a part of Israel Teva group, notifying it that TPM had  submitted an Abbreviated New Drug Application to the US Food and Drug  Administration for approval to market a generic version of Cubicin  (daptomycin for injection). TPM's notice letter advised that it is  seeking FDA approval to market daptomycin for injection prior to the  expiration of US patent nos 6,468,967 and 6,852,689, which lapse on  September 24, 2019, and US patent  RE39,071, which expires on June 15,  2016. The notice letter further stated that TPM is asserting that claims  in the referenced patents are not infringed and/or invalid.

By statute, if Cubist initiates a patent infringement law suit against  TPM within 45 days of receiving the notice letter, then the FDA would be  automatically precluded from approving TPM's ANDA for 30 months, or  until a district court decision finding the patents invalid or not  infringed, whichever occurs earlier. Once the law suit is filed, the  30-month stay period will begin as of the date Cubist was notified of  the filing.

"We have confidence in our patents and intend to assert our rights  vigorously," said Michael Bonney, Cubist's chief executive. "TPM's  filing in no way affects the priorities we have as a business. Our  business goals and guidance for 2009 remain unchanged," he added.  Cubist also announced that it plans to file a patent infringement suit  against TPM in response to the ANDA filing.