Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Cubist Pharmaceuticals, a biopharmaceutical company, has said that it intends to file a patent infringement lawsuit against Teva Parenteral Medicines in response to the abbreviated new drug application filing that TPM had submitted to the FDA for approval to market a generic version of Cubicin.
Subscribe to our email newsletter
Teva Parenteral Medicines’s (TPM) notice letter advised that it is seeking FDA approval to market daptomycin for injection prior to the expiration of two US patents, which expire on September 24, 2019 and June 15, 2016. The notice letter further said that TPM is asserting that claims in the referenced patents are not infringed or invalid.
By statute, if Cubist initiates a patent infringement lawsuit against TPM within 45 days of receiving the notice letter, then the FDA would be automatically precluded from approving TPM’s abbreviated new drug application for 30 months, or until a district court decision finding the patents invalid or not infringed, whichever occurs earlier. Once the lawsuit is filed, the 30 month stay period will begin as of the date Cubist was notified of the filing.
Michael Bonney, Cubist’s president and CEO, said: We have confidence in our patents and intend to assert our rights vigorously. TPM’s filing in no way affects the priorities we have as a business. Our business goals and guidance for 2009 remain unchanged.