[Ip-health] NYT: Patent for Amgen Drug May Undercut Health Care Plan

Krista Cox krista.cox at keionline.org
Wed Nov 23 08:09:25 PST 2011


Source:
http://www.nytimes.com/2011/11/23/business/amgens-new-enbrel-patent-may-undercut-health-care-plan.html?_r=1

(Full text of the article below bullet points)

*  The main patent on Enbrel was to expire in October of next year. But the
new patent could stave off such biosimilar competition until Nov. 22, 2028.
By that time, Enbrel will have been on the market 30 years, far longer than
the 20 years of protection expected in patent law.

Enbrel had sales of $3.5 billion in the United States and Canada in 2010,
accounting for nearly one-quarter of Amgen’s revenue. The drug costs more
than $20,000 a year. Pfizer sells Enbrel abroad.
*  The application for the new patent was filed in 1995. But it took until
Tuesday to get through the Patent Office because it was reworked and at one
point rejected, forcing Amgen to appeal.

* Amgen benefited from a similar situation with its anemia drug
Epogen<http://www.nytimes.com/2005/12/23/business/23epo.html>,
which is still protected by patents even though it has been on the market
since 1989.

Patent for Amgen Drug May Undercut Health Care Plan
By ANDREW POLLACK

Amgen said Tuesday that a new patent had been granted that could protect
its big-selling drug Enbrel from generic competition for 17 more years, a
development that could undermine some of the savings contemplated in the
federal health care legislation.

Enbrel, which is used to treat rheumatoid arthritis and psoriasis, was one
of several biotechnology drugs that were expected to face competition in
the next few years from copycat versions, eventually saving the health care
system billions of dollars a year.

The 2010 health care law established a way for such biologic drugs, which
can cost tens of thousands of dollars a year, to face competition from near
generic versions, which are often called biosimilars. A new law was needed
because biologic drugs, which are made in living cells, were not covered by
the 1984 law governing most pharmaceutical competition.

The main patent on Enbrel was to expire in October of next year. But the
new patent could stave off such biosimilar competition until Nov. 22, 2028.
By that time, Enbrel will have been on the market 30 years, far longer than
the 20 years of protection expected in patent law.

Enbrel had sales of $3.5 billion in the United States and Canada in 2010,
accounting for nearly one-quarter of Amgen’s revenue. The drug costs more
than $20,000 a year. Pfizer sells Enbrel abroad.

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

“Enbrel is widely considered to be one of the most important biosimilar
molecules,” a Merck executive said in a statement at that time. Merck had
no comment Tuesday on Amgen’s patent.

The application for the new patent was filed in 1995. But it took until
Tuesday to get through the Patent Office because it was reworked and at one
point rejected, forcing Amgen to appeal.

Patents now run 20 years from the date of application, to avoid situations
like this where an invention gets extended protection because of delays or
maneuvers at the patent office. But since this patent was filed before the
law changed, it is governed by the old rules and lasts for 17 years from
the date of issuance.

Amgen benefited from a similar situation with its anemia drug Epogen, which
is still protected by patents even though it has been on the market since
1989.

The new patent on Enbrel, No. 8,063,182, is owned by Roche but was licensed
to Amgen, which took it through the Patent Office.

Amgen executives said earlier this year that they did not anticipate
biosimilar competition to Enbrel in the next five years anyway, in part
because of other patents covering the use or formulations of Enbrel. But
such patents tend to be weaker than one that covers the basic composition
of the drug, as Amgen says the new patent does.

Still, it is possible that some biosimilar manufacturers will try to
challenge the patent or work around it. And Enbrel might face competition
from generic versions of other arthritis drugs, including Abbott
Laboratories’ Humira, and from new oral drugs that might reach the market
in the next few years.


-- 
Krista Cox
Staff Attorney
Knowledge Ecology International
www.keionline.org
(202) 332-2670



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