The letter to President Clinton asks that:
The letters are on the Internet at http://www.cptech.org/pharm/amgen.html
April 16, 1998
President Bill Clinton
The White House
Dear President Clinton:
We are writing to ask for an investigation concerning the possible suppression of an important public health invention. In this respect we are attaching copies of our April 16, 1998 letter to Gordon Binder, Chairman of the Board and Chief Executive Officer of Amgen Inc., the company which currently markets EPOGEN® which is Amgen's trademark for its recombinant human erythropoietin, or EPO.
Our concern is the following. Public health researchers, supported by public funds, have identified a mechanism to reduce a patient’s loss of EPO during treatment, significantly reducing the amount of EPO a patient needs to take. This invention has the potential to save consumers hundreds of millions of dollars per year, and to make EPO more broadly available to patients who cannot currently afford the drug.
The invention was developed at Lawrence Berkeley Laboratory (LBL), a national laboratory, and was supported by grants from the National Institutes of Health (NIH). According to the inventor and LBL officials involved in attempts to commercialize the invention, Amgen was approached several years ago about research which would solve an important problem in treating patents for anemia – the natural discharge of EPO into the urine which requires patients to take large doses of EPO. This problem is particularly important for patients with immature renal systems such as infants and children. The LBL invention involves a protein binding factor which may eliminate entirely the need for the purchase of EPO for some patients, and for other patents the invention would reduce the needed doses of EPO. The inventor believes this may reduce by half the average doses needed for EPO – a very expensive drug which can cost several thousand dollars.
LBL staff believe Amgen is hostile to the commercialization of this invention simply because it would significantly reduce demand for EPO -- a product which generated $1.16 billion for Amgen in 1997. Other U.S. and European biotechnology companies have reportedly expressed concerns that Amgen would oppose the development of the invention through costly and time-consuming litigation, and would withhold important intellectual property licenses from firms which made efforts to commercialize this invention.
Public health concerns should be paramount in determining which therapies are available to consumers. Amgen’s EPO product was made possible by decades of public funded research on EPO, and Amgen has benefited also from subsidies from EPO’s designation as an Orphan Drug and other public programs to support the biotechnology industry. Amgen is currently seeking support from public institutions to obtain additional intellectual property rights on gene research and EPO.
We are appalled at the reports that Amgen, a company which has so richly benefited from public research, would not respond responsibly to public health research that would benefit patients. The fact that the client population most affected are children underscores the ethical issues that you must address.
We ask that you investigate every aspect of this matter, to determine if there are indeed barriers to the development of the LBL invention, and if so, whether Amgen’s actions run counter to antitrust laws, and also whether are there are other remedies available to address this issue.
As part of this investigation, we specifically ask that you determine how Amgen currently benefits from government subsidies to the biotechnology sector, and if it would be appropriate to withhold publicly supported intellectual property rights or research support for a company, if that company refuses to address legitimate and important public health concerns.
Finally, we ask that the U.S. Patent and Trademark Office, the U.S. Trade Representative, the Department of Health and Human Services and the Federal Trade Commission evaluate U.S. positions in trade negotiations on intellectual property rights, and determine if provisions on compulsory licensing that exist in the WTO, NAFTA or the proposed Multinational Agreement on Investments permit governments to adequately address public health concerns.
We also ask you to consult the World Health Organization (WHO) to determine
what steps if any WHO recommends to address this or similar public health
problems, and we urge the United States to support the World Health Assembly
Executive Board Resolution EBl0l.R24, on the WHO Revised Drug strategy,
that urges member states:
(2) to ensure that public health rather than commercial interests have primacy in pharmaceutical and health policies and to review their options under the Agreement on Trade Related Aspects of Intellectual Property Rights to safeguard access to essential drugs;
We look forward to receiving a response from your office on this matter. We also invite your staff to attend a meeting on intellectual property rights and health care that will be held on May 7 and 8, 1998, in Washington, DC. Information about this event is available on the Internet at http://www.cptech.org/may7-8.
April 16, 1998
Chairman of the Board
and Chief Executive Officer
Thousand Oaks, CA 91320-1789
Via fax: 805/447-1010
We are writing to express our concern over reports that Amgen is opposed to the development of an invention that significantly reduces the amount of Erythropoietin (EPO) needed to treat anemia. The invention was developed at Lawrence Berkeley Laboratory (LBL), which was supported by the National Institutes of Health (NIH), Lung, and Blood Institute grant HL 22469, and received U.S. Patent 5625035. According to the inventor, Gisela K. Clemons, of Berkeley, CA, this dates back to research done in 1991, and the inventor and the LBL have engaged in extensive discussions with Amgen regarding the significance of the invention, and the benefits to EPO patients. According to the inventor and LBL officials involved in attempts to commercialize the invention, Amgen has declined to further test the invention, and other U.S. and European biotechnology companies have expressed concerns that Amgen would oppose the development of the invention through costly and time consuming litigation, and would withhold important intellectual property licenses from firms which made efforts to commercialize this invention.
The invention would reduce the amount of EPO needed by patients suffering from anemia, including premature infants and those with anemia due to kidney failure, AIDS related illnesses or other diseases, or surgery needs. According to the inventor, this invention may eliminate entirely the need for the purchase of EPO for some patients, and for other patients the invention would significantly reduce the needed doses of EPO. It is possible that the invention would reduce by half, on average, the amount of EPO needed by those suffering from anemia.
As you know, the commercial development of EPO benefited from decades of government funded research on Erythropoietin. Amgen is also expecting to benefit from government funded research in other areas, and has recently approached government funded research laboratories for assistance in further research relating to the use of EPO. Amgen has benefited due to generous tax credits from manufacturing goods in Puerto Rico, the Orphan Drug Tax Credit, and the Research and Development Tax credit and from other government subsidies.
As a result of all these subsidies by taxpayers, Amgen has benefited richly from the commercial development of EPO, which produced 1997 sales of $1.16 billion. According to the Amgen 10K report, gross margins on EPO and Amgen’s other products are greater than 86 percent.
Researchers and licensing officials at LBL believe Amgen is opposed to the development of the new binding protean technology because such an invention might reduce by half the average doses of EPO needed by current anemia patients.
We would like to know from you if Amgen is indeed resisting the deployment
of a valuable public health invention simply to protect the revenues it
receives from EPO patients. If Amgen is not trying to suppress this invention
in order to protect its profits, then what is Amgen doing to further develop
this important discovery?