The Future of Genetic Research
Myriad's patent-authorized monopoly on BRCA gene testing may have ended, but its legacy will continue. Beginning in late 2004 the company chose to withhold information on variations of the BRCA gene from public databases. "Myriad has more data on BRCA mutations than anyone else," explains Robert Cook-Deegan, a research professor in the Institute for Genome Sciences and Policy and the Sanford School of Public Policy at Duke University. He fears that proprietary databases like Myriad's could hinder the progress of genetic medicine. "Databases and trade secrets," he notes, "don't expire like patents do."
In most cases, BRCA analysis clearly shows whether an individual is at increased risk of breast and ovarian cancer. But some patients' BRCA genes possess what are called "variants of unknown significance" (VUS). In such cases, deciding whether a patient is at elevated cancer risk is a tough call. Because it has access to information on rare BRCA variants in its proprietary database, Myriad claims that only 3% of its analyses are returned with a diagnosis of VUS, as opposed to about 20% for most European laboratories.
Myriad has recently expanded its business into Germany, Switzerland, France, Italy, and Spain. The company claims it can offer a better standard of BRCA testing than any European lab thanks to the information in its proprietary database.
Because those data are held as a trade secret, Myriad's analyses of different BRCA mutations have not received clinical peer review; to protect the company's trade secret, the company expects medical providers and patients to take its conclusions on faith. In the United States, Myriad has agreements with numerous health plans that have accepted those terms. Cook-Deegan hopes European health plans and providers will push Myriad to share its data—perhaps by refusing to cover its tests until the data are made public.
Myriad has more data on BRCA mutations than anyone else. … Here's a case where patents are giving rise to a huge body of trade secrets. The patent system is not a solution to trade secrecy in the case of genetic diagnostics. It looks like it's the cause of the problem.
Robert Cook-Deegan, Duke University
Cook-Deegan acknowledges that the value of Myriad's database will dissipate with time, as other labs compile data on BRCA variations. But he points out that the information should belong to the patients from whom it was gathered, not to Myriad. A group of medical professionals have launched an effort to reconstruct Myriad's database by crowdsourcing data—having patients submit the results they obtain from Myriad to a public database.
Patents are meant to serve as a bargain between inventors and the public: The workings of the invention are disclosed in the patent, and in return, the inventor gets 20 years of exclusive rights to his idea. The theory is that patent rights ultimately make scientists more willing to share their useful results. But that's not how things have worked out in the case of Myriad and BRCA, according to Cook-Deegan. "Here's a case where patents are giving rise to a huge body of trade secrets," he notes. "The patent system is not a solution to trade secrecy in the case of genetic diagnostics. It looks like it's the cause of the problem."
That matters in the aftermath of the Myriad decision, because other nations, including Australia and members of the European Union, still allow patents on isolated DNA. Myriad is one of only three companies that refuse to share their information in public databases, but in this case, Cook-Deegan fears that the actions of a single corporation may cause a bottleneck in the progress of genetic medicine. The Supreme Court decision in the Myriad case is historic, but the tension between profit and scientific freedom lives on.
Myriad's Legacy: Proprietary Data
Myriad's patent-authorized monopoly on BRCA gene testing may have ended, but its legacy will continue. Beginning in late 2004 the company chose to withhold information on variations of the BRCA gene from public databases. "Myriad has more data on BRCA mutations than anyone else," explains Robert Cook-Deegan, a research professor in the Institute for Genome Sciences and Policy and the Sanford School of Public Policy at Duke University. He fears that proprietary databases like Myriad's could hinder the progress of genetic medicine. "Databases and trade secrets," he notes, "don't expire like patents do."
In most cases, BRCA analysis clearly shows whether an individual is at increased risk of breast and ovarian cancer. But some patients' BRCA genes possess what are called "variants of unknown significance" (VUS). In such cases, deciding whether a patient is at elevated cancer risk is a tough call. Because it has access to information on rare BRCA variants in its proprietary database, Myriad claims that only 3% of its analyses are returned with a diagnosis of VUS, as opposed to about 20% for most European laboratories.
Myriad has recently expanded its business into Germany, Switzerland, France, Italy, and Spain. The company claims it can offer a better standard of BRCA testing than any European lab thanks to the information in its proprietary database.
Because those data are held as a trade secret, Myriad's analyses of different BRCA mutations have not received clinical peer review; to protect the company's trade secret, the company expects medical providers and patients to take its conclusions on faith. In the United States, Myriad has agreements with numerous health plans that have accepted those terms. Cook-Deegan hopes European health plans and providers will push Myriad to share its data—perhaps by refusing to cover its tests until the data are made public.
Myriad has more data on BRCA mutations than anyone else. … Here's a case where patents are giving rise to a huge body of trade secrets. The patent system is not a solution to trade secrecy in the case of genetic diagnostics. It looks like it's the cause of the problem.
Robert Cook-Deegan, Duke University
Cook-Deegan acknowledges that the value of Myriad's database will dissipate with time, as other labs compile data on BRCA variations. But he points out that the information should belong to the patients from whom it was gathered, not to Myriad. A group of medical professionals have launched an effort to reconstruct Myriad's database by crowdsourcing data—having patients submit the results they obtain from Myriad to a public database.
Patents are meant to serve as a bargain between inventors and the public: The workings of the invention are disclosed in the patent, and in return, the inventor gets 20 years of exclusive rights to his idea. The theory is that patent rights ultimately make scientists more willing to share their useful results. But that's not how things have worked out in the case of Myriad and BRCA, according to Cook-Deegan. "Here's a case where patents are giving rise to a huge body of trade secrets," he notes. "The patent system is not a solution to trade secrecy in the case of genetic diagnostics. It looks like it's the cause of the problem."
That matters in the aftermath of the Myriad decision, because other nations, including Australia and members of the European Union, still allow patents on isolated DNA. Myriad is one of only three companies that refuse to share their information in public databases, but in this case, Cook-Deegan fears that the actions of a single corporation may cause a bottleneck in the progress of genetic medicine. The Supreme Court decision in the Myriad case is historic, but the tension between profit and scientific freedom lives on.
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