FDAnews Drug Daily Bulletin

Roche Sues Teva Over Generic Boniva Application

Sept. 19, 2007

Roche filed a lawsuit last week after receiving notice from Teva Pharmaceuticals that the generic drugmaker has submitted an abbreviated new drug application (ANDA) for Boniva containing a Paragraph IV certification challenging two Roche patents, according to court documents.

The suit, filed Sept. 7 in the U.S. District Court for the District of New Jersey, alleges Teva’s 150-mg generic Boniva (ibandronate sodium) tablets would infringe on Roche’s ‘196 and ‘938 patents, according to the complaint. The patents expire in 2019 and 2023, respectively.

The ‘938 patent covers the method of use of Boniva — a once-monthly osteoporosis treatment — and the ‘196 patent covers the drug’s composition, Roche said in the complaint.

In the case of the ‘196 patent, Teva’s ANDA notice claims the patent is invalid and unenforceable. However, Roche has not been able to fully analyze this assertion because Teva’s offer of confidential access restricted disclosure to Roche’s outside counsel and certain of its staff, according to the complaint.

Roche has asked the court to rule that the patents are valid and enforceable, that Teva infringed on the patents by submitting its ANDA and that Teva may not market its product until after the expiration of the patents.