Amgen announces US patent issued for Enbrel

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Amgen announced that a US patent was issued for it and partner Pfizer's rheumatoid arthritis and psoriasis drug Enbrel (etanercept), a development that could protect the product from generic competition for another 17 years.

The patent, which is owned by Roche and is exclusively licensed to Amgen, describes and claims the fusion protein that is etanercept. The main patent on the drug was scheduled to expire in October 2012, but the new patent could prevent competition from biosimilars until November 2028.

Before the latest patent was approved, Amgen executives had stated that they did not anticipate competition for Enbrel in the next five years because of other patents covering the use or formulations of the therapy. However, the drugmaker conceded that these patents tend to be weaker than the patent that covers the basic composition of the agent, as is the case with the newest patent.

Still, it is possible that some companies will try to challenge the patent or work around it. Merck & Co. in June announced an exclusive deal with Hanwha Chemical to develop and commercialise a biosimilar version of Enbrel based on the South Korean company’s HD203 compound. Moreover, Enbrel may face competition from generic versions of other arthritis drugs, such as Abbott’s Humira (adalimumab), as well as from new oral therapies that may reach the market in the next few years.

Enbrel generated sales of $3.5 billion in the US and Canada in 2010.