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Not Playing Well With Others?

Despite the criticism Myriad Genetics receives for its business practices regarding BRCA testing, the company has stayed on message about two things. One, that its exclusive licenses and patents on BRCA 1 and BRCA 2 mutations, which essentially give it a monopoly over the BRCA testing market for hereditary breast and ovarian cancer, is good for business. And two, that the enforcement of its IP rights hasn't been harmful for patients or for researchers looking to develop better tests.

Researchers and patients are, of course, challenging Myriad on these very points in Association for Molecular Pathology et al. v. USPTO et al. In the case, slated for the Supreme Court this year, plaintiffs are challenging patents on BRCA 1 and BRCA 2 mutations held by the University of Utah and exclusively licensed to Myriad, alleging that Myriad's patents are invalid because they claim gene sequences in the body, which are naturally occurring substances and cannot be patented under US law.

While the plaintiffs in AMP v. USPTO assert that Myriad's patent position is stifling research and patient access to innovative tests, industry observers say that most diagnostic companies don't enforce their patents in the manner Myriad has. In the latest article painting Myriad to be a bad industry player, Bloomberg's Robert Langreth highlights the stories of patients who haven't been able to access the most accurate test results and researchers who aren't able to develop and offer the best test science allows because of the company's business practices.

One patient with fallopian tube cancer, Tory Galloway, received a negative result for disease-linked mutations by Myriad's test, and told her four sisters that the disease was unlikely to be hereditary. However, after being tested by the BROCA Cancer Risk Panel at the University of Washington, Galloway found out that her cancer was due to a gene mutation that wasn't part of Myriad's test.

Daily Scan's sister publication Clinical Sequencing News previously reported that the inventors of BROCA — breast cancer genetics pioneer Mary-Claire King and UW's Tom Walsh — excluded BRCA1 and BRCA2 from the panel of genes the targeted sequencing test gauges. The researchers will not add these genes to their test until "the patent situation is regularized," King told CSN.

The Bloomberg piece also discusses what many breast and ovarian cancer clinicians have been saying for some time, that Myriad is not playing nice with other researchers as it keeps its data on variants of unknown significance in a proprietary database. The impact of this practice is illustrated by the example of Runi Limary, who found a cancerous lump in her right breast at the age of 28. Limary had the breast removed and received months of chemotherapy and antibody treatment and, eventually, was able to get Myriad's test after her employer-provided insurance agreed to cover it.

Testing revealed Limary had an extremely rare BRCA1 mutation and Myriad could not tell her definitively if it was harmful or not. Limary, a plaintiff in AMP v. USPTO, believes that if Myriad’s proprietary database was public and more companies were offering BRCA testing, then she might have had more information on what her BRCA mutations meant for her health.

Our sister publication Pharmacogenomics Reporter recently detailed the disagreement among researchers and industry players about whether or not to share gene-disease association data for rare or uncertain markers. Some clinicians and industry players say that sharing of such databases is critical as next-generation sequencing technologies become more commonplace in research and patient care. Others are of the view that the personalized healthcare revolution will be led by those that can interpret patients' molecular data and, therefore, making public the kind of database Myriad has amassed would be foolish from a competitive standpoint.

Unsurprisingly, Myriad falls in the latter camp. Characterizing Myriad as an "unabashed financial success," the Bloomberg piece also quotes CEO Peter Meldrum defending the company's efforts to keep its VUS database secret. Sharing "doesn't make a lot of business sense," Meldrum says.