Amgen announced the issuance of U.S. Patent No. 8,063,182 related to Enbrel (etanercept).
This news came from an Amgen press release which was issued on Tuesday. The patent was owned by Hoffman-La Roche Inc. (Roche) and is exclusively licensed to Amgen.
Immunex Corporation (acquired by Amgen in 2002) has 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 is issued 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 tumor necrosis factor (TNF) receptor with a clinical efficacy and safety profile established over 18 years of collective clinical experience. Enbrel is used for several different indications and biosimilar versions of etanercept was under development by many companies.
Hanwha, a South Korean chemicals company who is trying to develop the biosimilar version Enbrel, had also made deal with Merck Bioventures including the development and commercializing the product except South Korea and Turkey. Besides, other S.Korean companies like Dong-A and Celltrion were said to be developing their own versions.
This patent will protect the rights of Amgen till 2028 in the US but the protection in the EU for the licensing partner Pfizer (Wyeth) will not be that long.
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Source: Amgen press relase