Amgen, EPO and US Pat. 5,625,035

[James Love <love@cptech.org>]

The following is an interesting note from Martha Luehrmann, who works on
technology licensing for the 
Lawrence Berkeley Laboratory.  This is a national lab, run by the
University of California, funded by the US Department of Energy.  It
concerns an invention which dramatically economizes on the use of EPO
(i.e. usage would drop to 2 to 10 percent of current doses).  Martha is
involved in efforts to commercialize this invention, but the incentives
to the drug companies are perverse -- it reduces the needed doses, and
mostly benefits consumers.  This is particularly important for consumers
in less developed countries who cannot afford the drug.  The invention
was rejected by Amgen, because it hurt rather than helped Amgen
profits.   
 
  Jamie Love
  love@cptech.org
  http://www.cptech.org
  202.387.8030

-------------------------------
Subject: Re: WHA- EBl0l.R24, Revised
   Date: 7 Apr 1998 13:18:23 -0700
   From: "Martha Luehrmann" <Martha_Luehrmann@macmail.lbl.gov>
     To: "Jamie Love" <love@cptech.org>

        Reply to:   RE>WHA: EBl0l.R24, Revised drug strategy

Dear Jamie

I have a good story with regards to intellectual property rights and
drug companies.  EPO (erythropoetin) has proven to be extremely
effective in encouraging the development of oxygen-carrying red blood
cells and has meant life for many anemic people, including premature
infants and those with anemia due to kidney failure, other disease, or
surgery needs.  

But recombinant bio-engineered EPO, which is made by Amgen, who holds
the major patents to EPO, is very costly.  Just for temporary blood-loss
due to surgery, _ estimated the costs to be between $1,000 and $3,000
per 70kg patient undergoing surgery.  One of the reasons for the high
costs is that each patient needs very high levels of EPO, which, unless
you have a natuarally occuring binding factor, immediately excrete into
the urine.  At those rates it is surely outside the reach of third world
children with chronic anemia.

Some adults have the binding factor that keeps the EPO from being
excreted out in the urine, but many do not, especially including those
with immature renal systems such as infants and children.  Gisella
Clemons, a scientist at the Lawrence Berkeley National Lab, came up with
a protein binding factor that allowed EPO to bind in the body instead of
being excreted immediately into the urine, increasing the uptake of EPO
by a factor of 10-50.  On April 29, 1997 we were issued US Pat.
5,625,035.

Well before the patent issued we offered it to drug companies, including
Amgen.  Amgen wasn't interested BECAUSE IT WOULD DECREASE THEIR
LUCRATIVE MARKET FOR EPO.  People would need much less EPO per dose, and
Amgen didn't trust that they could make up the shortfall in selling more
widely to people who at the present time can't afford the drug.  Other
drug companies weren't interested because they would have to combine the
binding protein with EPO, and all the rights to EPO were in the hands of
Amgen.

So, a wonderful advance that could save hundreds of thousands of
children from anemia and death stays on the shelf because the patent
system protects a company that doesn't want to see any risk to its
bottom line.

I really think the patent system is generally great for encouraging new
efforts, but this case sure got to me.

Love,
Martha

-- 
James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
love@cptech.org | http://www.cptech.org
202.387.8030, fax 202.234.5176