Enbrel's patent extended; healthcare savings impacted

Thousand Oaks, Calif. - Amgen has announced that a new patent has been granted that could protect its blockbuster drug Enbrel (etanercept) from generic competition for another 17 years - a move that could undermine some of the savings expected under federal healthcare reform, the New York Times reports.

Enbrel, used to treat psoriasis and rheumatoid arthritis, had been due to come off patent in October 2012. Near-generic versions of the medication and several other biotechnology drugs - often called biosimilars - had been expected to eventually save the healthcare system billions of dollars a year.

The 2010 healthcare reform law established a pathway for such follow-on drugs. A new law was needed because biologics were not covered by the 1984 law governing most pharmaceutical competition.

Enbrel’s new patent will expire Nov. 22, 2028, by which time the drug will have been on the market for 30 years. The drug had sales of $3.5 billion in the United States and Canada in 2010, accounting for nearly one-quarter of Amgen’s revenue. Enbrel costs more than $20,000 a year, according to the Times. Pfizer sells Enbrel abroad.

Competitor Merck announced in June that it planned to develop a biosimilar version of Enbrel, in partnership with Hanwha Chemical of South Korea.

The application for the new patent was filed in 1995, but took until Nov. 22 to get through the Patent Office because the application was reworked and at one point rejected, forcing Amgen to appeal, the Times reports.

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