Perhaps it was inevitable. What began as a dispute between scientists at the Paris-based Institut Curie and Myriad Genetics Inc. of Salt Lake City over testing rights in France for the putative breast cancer genes BRCA1 and BRCA2 has spilled over to much of Western Europe.
The mounting opposition to the patents, which Myriad owns, now includes scores of scientists, dozens of laboratories, and several genetics societies in countries such as France, Belgium, the United Kingdom, the Netherlands, Sweden, Spain, and Germany. The French government and the European Parliament also joined the fray.
In early October, Curie and the nearby Institut Gustave-Roussy filed a formal opposition with the European Patent Office protesting the patent. At stake is the right to test for genes to determine risk for hereditary breast and ovarian cancer. Researchers estimate that alterations in BRCA1 and the related gene BRCA2 may be responsible for approximately half of all inherited cases of breast cancer.
Since 1999, Myriad has held the U.S. patents on the genes and the exclusive rights to perform diagnostic testing; in January 2001, Myriad won the European patents, but the patents have not been enforced yet by the European Patent Office. Myriad wants all clinical testing samples sent to the companys laboratories in Salt Lake City and evaluated for a fee, which is more than $2,600.
Genetics societies in Belgium, The Netherlands, Germany, Denmark, and the United Kingdom have also filed an opposition to the European patent.
In reality, the Curie challenge represents an increasingly shared sentiment across Europe, said Gert Matthijs, Ph.D., associate professor of human genetics at the University Hospital in Leuven, Belgium.
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The latest flap began when a team of scientists led by Curie geneticist Dominique Stoppa-Lyonnet, M.D., Ph.D., published a report in June in the Journal of Medical Genetics describing a new mutationa deletion of three exons, or coding regionsin BRCA1 in a woman at Cedars-Sinai Medical Center in Los Angeles who had been diagnosed with breast and ovarian cancer. The woman had already been tested by Myriads automated test, which scans for mutations and deletions. But the test fails to pick up large DNA deletions or rearrangements, and it did not pick up any BRCA1 mutations.
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Stoppa-Lyonnet claims Myriads test misses some 10% to 20% of the expected BRCA1 mutations, and as a result, the patent is too broad. The companys BRCA patents cover all methods of diagnosing the risk for hereditary breast and ovarian cancers based on comparing an individuals sequence with the companys BRCA sequences.
Myriad contends that it has poured millions of dollars into research and development and has every right to charge a fee for its service and to protect its investment. "We believe we have a very strong intellectual property," said Bill Hockett, vice president of corporate communications for Myriad.
However, Stoppa-Lyonnet said she thinks the patent is too restrictive. "Myriad has what amounts to a monopoly [on testing], and monopolies arent good to maximize the benefits of genetic testing," she said. "Its clear that the Myriad test is not the gold standard. It only detects small mutations and deletions but not large rearrangements of the gene. There are many different techniques that can be used."
She argues that a Myriad monopoly hurts patient care and clinical research. The patent allows Myriad to stop the distribution of alternate tests by Curie. Whats more, requiring that all test samples be sent to Salt Lake City will deny French and European scientists important opportunities to study the gene, she said.
"In the long run, the patent is dangerous," said Hakan Olsson, M.D., professor of oncology and head physician at the University Hospital in Lund, Sweden. "It gives Myriad the sole right to do the analyses and other companies and laboratories will lose the know-how involved." Olsson opposes the Myriad patent for several reasons, including the fact that sending blood samples to Myriad could give the company an unfair advantage in finding new BRCA mutations.
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Broader issues
Gene patenting, to be sure, has become a fixture in the biomedical landscape. Many contend that the dispute between Myriad and the Curie-led contingent points up larger issues. "There are important scientific and medical issues at stake here," said Mary-Claire King, Ph.D., the American Cancer Society Research Professor of Medicine and Genetics at the University of Washington in Seattle. King predicted the presence of BRCA1 in 1990.
Among these issues are the familiar arguments for and against patenting genes. (See News, Jan. 19, 2000, p. 96, and Feb. 2, 2000, p. 184.) Those in favor say that drug patents developed from gene discoveries are needed to recoup investments in research. Those opposed worry about the effects on research and patient care when ceding control of gene patents and diagnostic tests to companies charging what they want.
"Gene patenting complicates genetic testing," said Linda Wasserman, M.D., director of the molecular genetics lab in the department of medicine at the University of California in San Diego and director of clinical cancer genetics at the UCSD Cancer Center. "Every new gene getting patented means that whatever lab has the patent is the only one that can afford to do gene testing. It has a negative effect on developing quicker, more efficient ways to do a genetic test and it raises costs. The question is, should anyone have sole possession of a genetic test?"
Some, like Olsson and Kathy Helzlsouer, M.D., associate professor of epidemiology and oncology and director of the Breast and Ovarian Surveillance Service at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore, have a difficult time accepting the notion of patenting natural products such as genes.
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Myriad has had its share of challenges in the past, King noted, and "has aggressively pursued its rights to keep the BRCA1 patent."
No one knows how the current challenge will ultimately play out. Curie scientists were able to challenge the patent months after it was awarded because the European system allows a special nine-month window to do so. Matthijs expects the opposition to probably take about 2 years to be resolved.
In the meantime, the French government has said if Myriad will not license its tests in France, it will introduce legislation to extend compulsory licensing laws to cover diagnostics, meaning the courts would decide which laboratories would be able to conduct testing.
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