OSI to defend Teva challenge to Tarceva patents
This article was originally published in Scrip
Teva Pharmaceutical Industries has challenged key US patents claiming OSI Pharmaceuticals' cancer drug Tarceva (erlotinib) as it seeks to market a generic version. Its ANDA contains a paragraph IV certification stating that certain Orange Book-listed patents are invalid and/or unenforceable or will not be infringed. OSI says that it plans to file a patent infringement suit.
Tarceva is currently protected by three Orange Book-listed patents, some of which are not set to expire until 2020; all of the patents listed are use patents. If OSI chooses to sue Teva, the lawsuit will trigger the automatic 30-month stay on approval while the legal challenge is fought.
A lawsuit brought with respect to one or more of those patents would restrict the FDA from approving Teva's ANDA until May 18th, 2012 (the statutory stay period), "unless an adverse court ruling occurs prior to such time", OSI said.
Erlotinib is licensed to Genentech for US commercialisation and Roche elsewhere, and is approved for use in locally advanced or metastatic non-small cell lung cancer and advanced pancreatic cancer.