The nation�s number one consumer advocate has asked the Clinton administration to investigate a major biotechnology company regarding the possible use of its patent power to suppress an important public health invention.
Ralph Nader and James Love sent letters on Thursday to President Clinton and to Amgen chief Gordon Binder. In the letters, Nader and Love outline concerns over Amgen's apparent refusal to commercially develop a protein that would make the company's prize product, Epogen, more accessible to patients who currently can�t afford the drug.
"All we�re saying [through the letter] is, 'Look, is it your job to protect the public interest, or are you going to sit back and take what randomly comes out of private companies,'" said Love, an economist and director of the Consumer Project on Technology.
At issue in this dispute is what obligation, if any, do biotechnology companies have to act in the public interest when portions of their inventions stem from government-funded research programs.
"EPO results from 30 years of government-funded research -- it�s turned Amgen into a Fortune 500 company," explained Love.
Epogen, or EPO, is Amgen�s brand name for its recombinant human erythropoietin, a synthetic protein that stimulates the body�s production of red blood cells. Red blood cells are key to the transport of oxygen throughout the body, and are in short supply in people who suffer from chronic anemia. According to the National Center for Health Statistics, some 4.7 million Americans suffer from anemia.
Those with immature immune systems, such as infants and children, are particularly vulnerable to anemia. Currently, high dosages of EPO are needed by these patients because their bodies naturally discharge large amounts of the protein through their urine. EPO treatments can cost several thousand dollars per patient per month.
Enter Lawrence Berkeley Laboratory. A researcher in this Berkeley, California-based government laboratory developed a binding protein that would increase the body�s ability to absorb EPO, thereby reducing the amount of EPO needed by a patient. In some cases, the binding protein, which was patented in 1997, could eliminate the need for EPO entirely. According to Love�s letter, the researcher approached Amgen several years ago in an attempt to commercialize the protein but was turned down because, as Love outlined, "it would significantly reduce the demand for EPO."
Officials at Amgen did not return phone calls made by Wired News.
According to documents filed with the Securities and Exchange Commission, Amgen indicated that sales of Epogen accounted for about 48 percent of its total revenues in 1997.
It is also the favorite example of successful biotech patents among industry observers such as James McCamant, editor of the Medical Technology Stock Letter. McCamant points to Amgen�s successes in fending off challenges to its patent by worthy opponents like the Genetics Institute. Through several successful defenses, Amgen has been able to control the EPO market, he noted.
But part of this good defense has come with government help. Love points to the Orphan Drug Act, legislation enacted in 1983 to spur the development of drugs for rare diseases, which generally have a limited market. The act was to give companies -� ideally, small startups -� substantial tax credits for costs incurred during human drug trials. In addition, the act also gave companies seven years to exclusively market their product.
Amgen was awarded orphan drug status for Epogen, which, in Love�s estimation, diminished any incentive for other companies to go forward with any development on their own versions of erythropoietin, simply because Amgen had seven years to build on its patent and gain further exclusivity, he explained.
In the early '90s, the Orphan Drug Act tax credit expired, but was made permanent in 1997 as part of the mid-year Congressional budget bill.
By asking for an investigation, Nader and Love hope Amgen�s actions will become a test case that will ultimately lead to the development of a social responsibility code for the biotech and pharmaceutical sector.
