Federal regulators are considering steps to end patent rights for medical tests, often developed by universities, that detect inherited diseases. Ending such rights could make the tests more widely available, regulators have been advised.
But several universities, fearing the change will curtail their ability to sell research to private industry—an enterprise that nets them millions of dollars a year—are joining forces with biotechnology companies to campaign against the change.
The recommendation was approved last month by an advisory panel of the Department of Health and Human Services. The panel, known as the Secretary’s Advisory Committee on Genetics, Health and Society, or SACGHS, described several examples of patents that put the tests outside the reach of patients.
Those examples include an effort by the University of Utah and its corporate partners to maintain patent protections on tests for genes found to signal a woman’s risk of breast and ovarian cancer. That is now being challenged in court by various medical, patient-advocacy, and civil-liberties groups.
In other cases, the panel’s report said, companies abandon production of patented genetic tests for rare diseases, again developed with university research, because the profits prove insufficient.
“Clear harm was demonstrated” in such cases, said James P. Evans, a professor of genetics and medicine at the University of North Carolina at Chapel Hill who served on the advisory panel, “especially to the most vulnerable members of the patient population.”
Yet even his own university isn’t necessarily supportive. Catherine A. Innes, director of the Office of Technology Development at Chapel Hill, said the panel’s recommendations go too far in settling a dispute that the marketplace is largely capable of resolving.
“Universities are somewhat schizophrenic on this,” Ms. Innes acknowledged, a reflection of the fact that they support free inquiry while sometimes behaving “more like industry.”
Staunch Opposition
The advisory panel has recommended that the secretary of health and human services, Kathleen Sebelius, pursue legislation that would withhold patent-rights enforcement from anyone who works with genes to make a diagnostic test or uses patent-protected genes “in the pursuit of research.”
The panel also proposed that the secretary, who oversees the National Institutes of Health, make sure that NIH grants, which usually go to university scientists, prohibit gene researchers from granting exclusive licenses for their inventions to companies.
Pharmaceutical companies are staunchly opposed, calling the idea a short-sighted attack on the university-industry relationship that has grown out of a 1980 federal law called the Bayh-Dole Act. That law, giving universities and other federal-grant recipients the legal right to sell their inventions, has raised U.S. gross industrial output by more than $45-billion a year, the Biotechnology Industry Organization has estimated.
“History has shown that what SACGHS proposes will have a disastrous impact on the American economy,” said one author of the Bayh-Dole Act, former Senator Birch E. Bayh, a Democrat of Indiana.
Also opposed is the Wisconsin Alumni Research Foundation, which generates $45-million a year for the University of Wisconsin by patenting and licensing its research discoveries. The panel’s recommendations should be recognized as a “worrisome” attempt to undermine all forms of scientific patents, said Carl E. Gulbrandsen, the foundation’s managing director.
None of the problems with patient access cited by SACGHS “rise to the level of real empirical evidence,” Mr. Gulbrandsen said.
The panel argues otherwise. It cites examples such as DNA Sciences, a California company given exclusive testing rights by the University of Utah, the same institution involved in the breast-cancer lawsuit, after its researchers in the mid-1990s discovered the genes linked to familial long QT syndrome, a potentially fatal heart condition affecting one in 3,000 newborns. DNA Sciences took legal action against other laboratories that tried to offer the test, even though the company itself didn’t offer the testing for a year or two, the panel’s report said.
Other examples include Athena Diagnostics, which holds the patent or has the exclusive license to 12 patents for identifying genetic mutations that cause types of spinocerebellar ataxia, a degenerative muscle disease. Athena Diagnostics has used legal threats to enforce its exclusive use of those licenses, many obtained from the University of Minnesota and the Baylor College of Medicine, and charges patients $7,300 for a complete set of tests, the report said.
The report estimated that 64 percent of the patented descriptions of the ways to test for particular diseases made it either difficult or impossible for another party to propose a different way of testing for the same disease.
Losing patent protection would not hold back research, the report argues. Academic researchers have strong incentives to invent that are independent of patents, the panel said, such as the desire help patients, fight diseases, advance careers, enhance reputations, and generally increase the store of human knowledge.
Interviews with Alzheimer’s-disease researchers found that none were motivated by the prospect of patent rights, the report said. Patent rights also did nothing to motivate the researchers who discovered the genes for Tay-Sachs disease and cystic fibrosis, it said.
The report also highlighted cases such as the University of Michigan and the Johns Hopkins University, which hold patents for detecting mutations in the gene that cause cystic fibrosis but allow a nonexclusive patent license. As a result, it said, at least 63 laboratories now test for the disease.
Further, the report said, many patient-advocacy groups have shown they are willing to spend money developing tests without requiring the financial protection of an exclusive patent. Such groups have created genetic tests for hearing loss and hereditary hemochromatosis, a genetic disease that causes the body to absorb too much iron, damaging or destroying organs.
Critics, however, contend that the report is based on a few examples of problems with specific genetic tests that mask the overall effectiveness of the patent system.
Detailed examinations of those specific cases often point to solutions that could stop short of upending the Bayh-Dole Act, said Thomas DiLenge, general counsel of the Biotechnology Industry Organization. In many of those instances, Mr. DiLenge said, labs that want to produce a test already under patent by another party have the right to simply ask the government to issue a nonexclusive license.
The Effects of Patents
The few independent studies of the value of patent policies have been largely inconclusive. A commission assembled by the National Research Council, reviewing the question in 2004, found no clear evidence of whether new moves toward patenting “discoveries and tools of research,” which primarily involve the biological field, were fostering innovation or impeding it.
A pair of researchers—Andrew W. Torrance, an associate professor of law at the University of Kansas, and William M. Tomlinson, an associate professor of informatics at the University of California at Irvine—did report last year that the patent system held back scientific discovery.
In an experiment, they created a computer game in which the players, first-year law students, were given a database of potential innovations and allowed to patent them or make them freely available, and then interact with one another to license, assign, buy, infringe, and enforce the patents. The researchers concluded that the modern patent system generates significantly lower rates of innovation, productivity, and societal usefulness than does a system lacking patent protections.
Obama-administration officials said they were reviewing the SACGHS report and had not decided what steps to take. But NIH officials expressed support for the report’s themes, and the NIH director, Francis S. Collins, told The Chronicle earlier this year that universities may be going too far in asserting patent protections.
“Bayh-Dole has the right philosophy, I think, which is that if you want to see public benefit, you need to inspire that kind of public-private partnership in a way that provides an incentive,” Dr. Collins said. “But the way in which it gets applied in individual instances isn’t always, I think, as nuanced as it might be.”
