Soon after the BRCA genes were identified, Myriad Genetic Laboratories obtained the rights to them. Myriad elected to retain all testing exclusively, with the minor exception of testing Ashkenazi Jewish persons for three mutations. Myriad licenses this limited use to several institutions and collects a royalty.
One pathologist whose diagnostic molecular pathology laboratory has a license to test Ashkenazi Jewish patients is Wayne W. Grody, MD, PhD, professor in the Divisions of Molecular Pathology and Medical Genetics in the Departments of Pathology and Laboratory Medicine, Pediatrics, and Human Genetics, UCLA School of Medicine. Dr. Grody admits to feeling “a bit awkward” about discussing the patent issues.
“I have a close relationship with a number of people at Myriad,” he says, “and although they do have exclusive gene patents, which I object to in principle, they have not been as obnoxious about it as a number of other companies. They have allowed my lab to do limited BRCA testing under a sublicense, which many exclusive patent holders will not do. I don’t mind paying a royalty to a patent holder,” he adds, “as long as we still have access and it doesn’t make the test outrageously expensive.”
Dr. Grody says Myriad does “an excellent job” of keeping a database of all mutations and sharing it with the Breast Cancer Information Core.
However, as chair of the Professional Relations Committee of the Association for Molecular Pathology, or AMP, he endorsed a letter sent by the AMP on June 22 to the Secretary’s Advisory Committee on Genetics, Health and Society opposing exclusive gene patents (www.amp.org/News/genepatents06.pdf). “We had been actively working to fight gene patents,” Dr. Grody says. The “we” he refers to is the CAP, AMP, AMA, ASCP, AAMC, and others. “Our goal had been to get rid of them.” However, they realized that the biotechnology industry felt that the ability to patent genes was at the heart of its business. “Since we live in a capitalist society, it was a losing battle,” Dr. Grody says. Now the groups’ objective is to advocate for “nonexclusive arrangements.”
One argument supporting this position is that, in high-complexity laboratories, board-certified directors in molecular genetics and molecular diagnostics often make their own test methods. Such testing is part of the “practice of medicine.” Since the gene sequence is part of the test, this argument contends, it should not be restricted. “We don’t have any objection to patenting a kit,” Dr. Grody says. “But if we are making our own test based on the gene sequence, which is available to anyone, why should that be off limits?”
As precedent, Dr. Grody and his colleagues cite a case in which a court ruled that an ophthalmologist could not patent a procedure for cataract extraction, since it is part of the practice of medicine for a surgeon to have discretion to choose which method to use. “We would like to extend such discretion to the practice of laboratory medicine as well,” Dr. Grody says.
One example of nonexclusive use is InVivoScribe Technologies’ patent on detecting rearrangements of the immunoglobulin gene. A laboratory can either purchase the company’s reagents and method or use its own homebrew kit and pay a royalty.
More upsetting, in Dr. Grody’s view, is the case of Athena Diagnostics, which “very jealously” guards its many patents on disease-related genes. Dr. Grody had to stop testing for spinocerebellar ataxia (UCLA has a large ataxia clinic) and had to stop offering the connexin test for congenital deafness. Athena also owns patents on the genes for ApoE and for Duchenne muscular dystrophy.
“I think Myriad does a fairly good job at what they do,” agrees Victoria M. Pratt, PhD, FACMG, chief director of molecular genetics at Quest Diagnostics-Nichols Institute, Chantilly, Va. But Dr. Pratt, too, is not happy about exclusive patents. “I think when you open up testing to a broader market, you can increase the advances in type of testing and the model for testing,” she says. “Myriad only does sequencing and, as Mary-Claire King showed in an article in JAMA in March, sequencing misses some mutations. I believe they are good people and will eventually make the test better, though with no competition there is not as much pressure to do that immediately.” (Myriad modified its test in response to the JAMA publication; details are in BRCA: What do we know)
Dr. Pratt notes that, when there is no competition, “if you make a mistake there is no way to verify that. If someone makes an accidental miscall, where does the patient go to get confirmation?”
She, too, dislikes Athena’s exclusive licensing policy. “Many lab directors feel that licensing issues make it very difficult to perform testing,” Dr. Pratt says. “Smaller labs may have more of a problem.” She foresees paying licensing fees to gene patent holders becoming an increasing part of the picture. “Medicare and Medicaid do not reimburse these fees,” she points out.
Myriad’s assertion of its patent has met resistance in Canada, Europe, and
Australia, says Diane J. Allingham-Hawkins, PhD, FCCMG, director of molecular
genetics and cytogenetics at North York General Hospital, Toronto. The
Canadian Cancer Society and Canadian
College of Medical Geneticists (CCMG) have issued statements on gene patents.
Dr. Allingham-Hawkins, who is president of the CCMG, says the CCMG’s statement raised issues about access, cost, method, quality, and privacy. “We are a publicly funded health care system in a very big country,” she says. “We are striving for equitable access regardless of geographic location. Any restrictive licensing process could restrict access.” As for method, she says, “No one method can be considered ideal or standard. It is not in the best interest of Canadians to have a patent determine which methodology can be used.” Four resolutions are included in the CCMG document, including the statement that a gene patent “must not be used to enforce commercial monopoly on any use of the protected knowledge.”
Statements were also issued recently by the Organization for Economic Cooperation
and Development (“Guidelines for the Licensing of Genetic Inventions,” www.oecd.org/dataoecd/39/38/36198812.pdf)
and the Canadian Biotechnology Advisory Committee (“Human
Genetics Materials, Intellectual Property and the Health Sector”).
David Magnus, PhD, associate professor of pediatrics at Stanford University School of Medicine and director of the Stanford Center for Biomedical Ethics, summarizes philosophical arguments in opposition to gene patents. In 2002, Dr. Magnus was chief editor of the collection of essays, Who Owns Life (2002, Prometheus Press).
Dr. Magnus distinguishes patents treating a gene or any other complex molecule as a potential therapeutic target for drug discovery, an area that is largely settled, from what are referred to as disease gene patents. “These are very broad patents on any method of detecting a gene for a trait,” he explains. “There are a number of problems with these patents.”
Ethicist Rebecca Eisenberg of the University of Michigan has described the “anti-commons problem”—eager entrepreneurs “racing around” trying to snap up as many patents as possible. As a result, exclusive licensing could tie up so many biological entities that it may make it difficult to do research or provide clinical services because of conflicting patents.
Along with ethicists John Merz, Mildred Cho, and Arthur Caplan, Dr. Magnus has written on issues related to justice and intellectual property (Merz JF, et al. Am J Hum Genet. 2002;70:965–971). They noted two conflicting trends: patient groups becoming increasingly active in genetics research and the significant shift of academic biomedical science toward commercialization.
Dr. Magnus cites the story of Canavan’s disease as a “great example” of this issue. Foundations set up by patients’ families raised money and recruited scientists to find the responsible gene. Most important, they gave tissue samples. Once the gene was discovered, the chief scientist at Miami Children’s Hospital took out a patent on any method of detecting the gene. A settlement was reached following extensive conflict. Many people contribute to such discoveries, Dr. Magnus says, but “in our system, only a small number of people or one entity is identified as discoverers, and they get all the financial benefit. We have been trying to get disease groups to be more careful when they turn over their tissue samples.”
The chief argument in favor of allowing patenting is that private investment could stimulate obtaining products from basic research faster. “That makes some sense for genes as therapeutic products,” Dr. Magnus says, “but it probably doesn’t hold much weight for disease genes.” His reasoning: Once published, a gene sequence is a roadmap for doing genetic testing. “Laboratories are often providing gene testing services by the time the patent issues.”
William Check is a medical writer in Wilmette, Ill.