Published Online: August 26, 2014
Mary K. Caffrey
If anyone thought Myriad Genetics’ legal battles were over when it lost at the US Supreme Court in 2013, that person would be wrong. In many ways, the ruling in Association for Molecular Pathology v. Myriad Genetics
, which found that a naturally occurring DNA sequence cannot be patented, was just the beginning for the Salt Lake City-based testing company.
Myriad has spent the 14 months since the ruling in court with its competitors, asserting that other patents are sufficient to keep its grip on remaining market share. In turn, some labs, including those in academia, have countersued. The most recent litigant is GeneDx, which filed 11 petitions to invalidate Myriad patents, according to a report in Bio-IT World.
The GeneDx filing regarding Myriad goes beyond a mere business dispute and reveals a broader philosophical divide, one that genetic counselors, led by Ellen T. Matloff, MS, CGC, outlined last May in Evidence-Based Oncology,
a publication of The American Journal of Managed Care
: On one side are those who believe strongly that data gathered from patients belong to them. Thus, this side argues, scientists who gather patients’ genetic data are ethically bound to share it on public databases for the advancement of the field and, ultimately, the increased likelihood of tracking disease-causing mutations.
This is the position that GeneDx’s Sherri Bale co-founder and managing director asserted. “If we cannot share our data, talk about what we find, and come to conclusions on what things mean, the whole genomics area is going to fall flat on its face,” she told Bio-IT World. “We have to share the data.”
On the other side is Myriad, a publicly traded company, which in earnings calls forcefully presents its many years of patent protection, and data on 1.3 million patients, as an advantage not only over data in public databases but in the market more broadly. During its fourth-quarter earnings call on August 12, 2014, Myriad CEO Peter Meldrum pulled no punches in comparing the company’s data to public databases when discussing Myriad’s myRisk
panel, a multi-gene diagnostic test that assesses risk for eight major cancers.
“Myriad has classified more than 25,000 mutations, and this database is rapidly expanding as we continue to classify mutations in other genes in the myRisk panel. In fiscal year 2015, we are projected to test over 100,000 patients with myRisk.
“To make significant progress in variant classification for cancer panel testing, a competitor … would have to test hundreds of thousands of patients and spend tens of millions of dollars on variant classification. Thus, our competition will have to rely on the noncurated, unvalidated public databases that are not only small but fraught with errors. This public database accuracy problem was highlighted recently by the American College of Medical Genetics, and I quote, ‘Few, if any, variant databases are curated to a clinical grade. It is well known that many databases contain misclassified variants, particularly benign variants misclassified as disease-causing.’ The result of such a misclassification would be absolutely devastating to patients.”
Andy Batts, writing about the dispute for the investment website Seeking Alpha
, said he “remained bullish” on Myriad but noted that GeneDx’s filing was the first against Myriad’s patents under the America Invents Act of 2011.
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