Amgen, a biotechnology pioneer that discovers, develops, manufactures and delivers innovative human therapeutics, has announced that the US FDA issued US Patent No. 8,063,182 related to Enbrel (etanercept).
According to a Amgen press release, this patent is owned by Hoffman-La Roche Inc. (Roche) and exclusively licensed to Amgen. Immunex Corporation (acquired by Amgen in 2002) originally licensed this patent application from Roche in 1999, and in 2004, Amgen paid Roche a one-time payment and obtained an exclusive, fully paid-up license to the application which issued today as the '182 patent. The patent describes and claims the fusion protein that is etanercept, and by statute, the '182 patent has a term of 17 years from today.
Enbrel is a soluble form of a fully human tumour necrosis factor (TNF) receptor with a clinical efficacy and safety profile established over 18 years of collective clinical experience. Enbrel was first approved in the US in 1998 for moderate to severe rheumatoid arthritis and was later approved to treat children and adolescents with moderate to severe juvenile rheumatoid arthritis (now called juvenile idiopathic arthritis) in 1999. In 2004, Enbrel was approved in the US to treat adult chronic moderate to severe plaque psoriasis. Prescription Enbrel is given by injection.