BOX 7-4
Myriad Problems in International Gene Patenting

Through several patents, Myriad Genetics, Inc., legally owns a DNA sequence associated with an increased risk of developing breast cancer. The Salt Lake City, Utah-based company was awarded “composition of matter” and “method-of-use” patents on the BRCA1 and BRCA2 breast cancer susceptibility genes from the U.S., European, and Canadian Patent Offices. However, as of this writing, Myriad has granted only a few limited licenses to other companies, effectively making Myriad the only legal source for BRCA testing in Europe and North America. This business strategy has created international controversy, because it restricts others from testing for BRCA mutations even with superior methods. For example, several cheaper tests with similar effectiveness have been developed, yet the broad scope of Myriad’s patent prevents health care systems worldwide from adopting other technologies.21 For instance, a faster and cheaper genetic test cannot be offered locally within a system of care that is linked to genetic counseling services and the other testing services offered by the system, thus restricting access to care.25

Testing begun in the Canadian province of Ontario for a third of the cost of Myriad’s test and with results available eight weeks sooner, was threatened with legal action by Myriad against the province of Ontario in late 2002. However, under the direction of Ontario’s Health Minister Tony Clement, regional hospitals have disregarded the patent and continue to offer BRCA gene testing services. Clement opposes Myriad’s patent saying, “We do not accept their claim and we are disregarding that claim.” In response to threats from Myriad Genetics to enforce their patent, Clement stated that he was willing to take the issue to the highest court.16

However, care may be affected by the cost of the test, the length of time it takes for samples to be mailed and processed, and the inability of Myriad to test for every possible breast cancer mutation, resulting in false negatives. Only 10 to 20 percent of the potential BRCA1 mutations are tested by Myriad, and their testing has missed mutations.11

nation of new technologies. Although the patent system was designed to “promote the useful arts,” the ability of patent holders to restrict access to their technologies can create obstacles, as has been the case for BRCA testing7 (Box 7-4).

Coverage Matters More for Some Technologies Than Others

As with FDA approval, the decision by health care payers (insurance companies, health maintenance organizations, and Medicare) to reimburse health care providers is usually an important driver of technology adoption. Gaining coverage is still no guarantee of adoption, nor is it required for the successful adoption of an innovative technology into routine practice. For example, testing for BRCA mutations was widely done even in the absence



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