Gilead contemplates lawsuit against Teva

Gilead is contemplating whether to file a lawsuit against Teva for possible patent infringements.

The former received a receipt of a paragraph IV certification notice letter declaring the latter had submitted an abbreviated new drug application (ANDA) to market a generic version of Atripla.

Gilead, which currently sells the drug through a joint venture with Bristol-Myers Squibb, was informed of the request by the Food and Drug Administration

Teva has alleged to the body that two patents associated with the drug ? numbers 6,642,245 and 6,703,396 ? are invalid and would not be breached by the use or sale of its own product as described in the ANDA.

Both exclusive rights under scrutiny are owned by Emory University and licensed exclusively to Gilead, which is currently reviewing the notification and has 45 days from the receipt date to file a lawsuit against Teva.

If the case is brought to court, the FDA is restricted from approving the application for up to 30 months or until a legal decision has been made ? whichever comes first.

Last week, Gilead announces its phase III study of Darusentan, a drug to treat resistant hypertension, had met primary endpoints.