When Gert Matthijs, Ph.D., complained to an audience of geneticists in October about an American companys monopoly in Europe involving testing for mutations in the breast cancer gene BRCA1, he apparently found sympathetic ears. Those attending the session at the American Society of Human Genetics meeting in Baltimore heard Matthijs, associate professor of human genetics at the University Hospital in Leuven, Belgium, outline the reasons behind the European discontent with several patents held by Myriad Genetics Inc., of Salt Lake City, Utah. Then members of the audience did something that surprised even Matthijs: They applauded for several minutes.
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Round 1 began in October 2001, when the Paris-based Institut Curie and its neighbor, Institut Gustave-Roussy, filed formal oppositions with the European Patent Office against Myriads pair of European patents on the sequence of BRCA1. The patents effectively give the company exclusive rights to test for alterations in BRCA1, which are believed to account for as many as half of all inherited cases of breast cancer.
Myriad recently won a third patent covering use of the gene and protein in the development of therapeutics or products involved in the prevention of breast and ovarian cancer. In late August, several scientists, genetic testing laboratories, and genetics societies in nations such as France, Belgium, The Netherlands, Sweden, the United Kingdom, Spain, and Germanynot to mention the governments of France, Austria and The Netherlandsjoined together to file yet another opposition with the European Patent Office.
Myriad has held their U.S. patents since 1999, which include exclusive rights to perform diagnostic testing. In January 2001, the company snared European patents on BRCA1. As a result, Myriad requires that all patient samples be sent to their Salt Lake City headquarters for analysis at a substantial feenearly $3000.
Patents notwithstanding, most European laboratories continue to use their own genetic tests rather than pay expensive fees to Myriad, said Matthijs. Many geneticists and others question the thoroughness of Myriads tests. One of the main complaints against the tests is the technologys inability to find all of the BRCA1 mutations.
According to Curie geneticist Dominique Stoppa-Lyonnet, M.D., Ph.D., Myriad tests can miss many genetic deletions and rearrangements. In a report published in June 2001 in the Journal of Medical Genetics, she and her colleagues at Curie and Pasteur described a new mutation in BRCA1 in a woman diagnosed with breast and ovarian cancer. Myriads test failed to pick up the deletion in the gene. The authors argued that other testing methods should be available in addition to Myriads.
Myriad contends that it is merely protecting its investment and patent rights, and it also sees a ripe European market. The company said that it offers the most cost-effective, accurate testing available.
"Myriad would like to expand the availability of its BRCAnalysis predictive medicine product for breast and ovarian cancer to Europe, where there is currently a hodge-podge of mostly low sensitivity inaccurate testing," said William Hockett, vice president of corporate communications at Myriad. According to Hockett, current European methods are all too often missing mutations in the BRCA genes, giving women false negative results. Inaccurate testing, he added, then means repeated testing and ultimately, higher health care costs.
The Europeans dispute Myriads patents on several grounds. Matthijs argues, for example, that the Myriad gene patent does not meet the proper criteria for patenting. Matthijs suggests that for a gene to be patented, it must meet several criteria, including "novelty" and "inventive step." The latter means that an invention cannot be obvious. He argues that in the case of BRCA1, thanks to the early work by University of Washington geneticist Mary-Claire King, Ph.D., who predicted the genes existence four years before its identification in 1994, the genes location was "obvious." It was only a matter of time before it was identified, he said.
Whats more, he said, "A patent on something uniquein this case, the genetic codemeans no one else can invent around and improve on the product. In classical diagnostics, a company makes a kit and another company tries to make a better kit. In this case, a monopoly on the sequence means I cant invent a better technology to sequence the gene because the gene itself is patented. This is the major problem with gene patents in general. Eventually, progress will slow down."
There are other problems. Matthijs contends that in the short term, a Myriad monopoly will "cost the European medical community expertise" in looking at mutations in BRCA1. "Myriad says anyone is allowed to use the sequence for research, but no one is interested in sequencing patient samples unless you can return the result to the patient or publish in a journal."
Geneticists should be "concerned for future genetic testing and diagnostics," Stoppa-Lyonnet said. If Myriad succeeds in its monopoly, it will encourage others with patents to do the same.
"Patenting of genes and monopolies are limiting the optimization of genetic testing by various laboratories," Stoppa-Lyonnet said. "Laboratories are not encouraged to develop new methods for the [detection] of BRCA1 because they know their patent will be linked to the Myriad patent. We want to optimize the genetic testing, reduce its cost and not be under obligation to any private company," she said.
"Scientists and the medical community on both sides of the Atlantic are sick of this Myriad patent," said cancer geneticist Charis Eng, M.D., Ph.D., professor of medicine and Director of the Clinical Cancer Genetics Program in the James Comprehensive Cancer Center at Ohio State University in Columbus. "As clinical cancer geneticists with patients who need this testing, we dont appreciate a monopoly." She has no quibble with Myriads work. "Myriad does high quality testing, but it is very expensive in a [American] society that doesnt have nationalized health care," she said. "We simply would like to have options.
"Its more the future implications that frightens both us and the Europeans," she said. "The costs of doing clinical genetics could skyrocket from such a comprehensive patent."
Eng sees the patent challenge as setting a precedent for future gene discoveries. "[The patent challenge] is a test case for all other disease genes," she said.
Funmi Olopade, M.D., professor of medicine and director of clinical cancer genetics at the University of Chicago, sees both sides of the issue. Myriads test is very expensive because the company poured in millions of dollars in research and development, she said. "On the other hand, there are patients in this country and in Europe, with socialized medicine, who would benefit from this testing but cant afford the cost of the test.
"It comes down to how science is funded and how things come to the market," she said. "Unless there is a middle ground, I dont know how it can be resolved fairly." The result may be that companies will leave the genetic testing arena because they cannot recover investments in technology.
"The question is, if you can make a generic BRCA1 test, at what point should other laboratories be able to make that test and be able to benefit from it? We have to find a middle ground," she said.
Licensing to various European laboratories may ultimately be an optionalbeit an expensive oneto at least allow the testing to remain in Europe, said Stoppa-Lyonnet. In the meantime, a ruling on the first two oppositions is not expected for at least another year.
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