Tamiflu was invented by Gilead Sciences and licensed to F Hoffmann-La Roche in 1996.
In the notice letter, Natco requested permission to manufacture and market a generic version of Tamiflu (oseltamivir phosphate) 75 mg capsules.
Natco alleges that a patent associated with Tamiflu – US Patent Number 5,763,483 – owned by Gilead Sciences is invalid, unenforceable and/or will not be infringed by Natco’s manufacture, use or sale of the product described in its ANDA submission.
Gilead has 45 days from the date of receipt to commence a patent infringement lawsuit against Natco.