---------- Forwarded message ---------- Date: Tue, 7 Apr 1998 19:33:21 -0400 (EDT) From: James Love <[EMAIL PROTECTED]> To: Multiple recipients of list INFO-POLICY-NOTES <[EMAIL PROTECTED]> Subject: Amgen, EPO and US Pat. 5,625,035 Amgen, EPO and US Pat. 5,625,035 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 may dramatically economize on the use of EPO, an important but costly drug used to treat anemia (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, which hurt rather than helped Amgen profits, was rejected by Amgen. If the claims by the inventor are true, it presents an important dilemma for policy makers. Not only does it highlight the problem of funding health care research which lowers company profits (such as adverse effects research), but it raises issues relating the right of a company with a legal monopoly to refuse to use a technology which greatly reduces the amount of the product a consumer needs -- in this case an essential one that can mean life or death. CPT intends to ask public health authorities to investigate policy responses, under laws concerning public health, patents and antitrust remedies. On a related topic, CPT is among several consumer and public health groups who are organizing a May 7-8, 1998 Washington, DC meeting on intellectual property and health care. Information about this meeting will be posted to [EMAIL PROTECTED] Jamie Love [EMAIL PROTECTED] http://www.cptech.org 202.387.8030 ------------------------------- Subject: Re: WHA- EBl0l.R24, Revised Date: 7 Apr 1998 13:18:23 -0700 From: "Martha Luehrmann" <[EMAIL PROTECTED]> To: "Jamie Love" <[EMAIL PROTECTED]> 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 () 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 --