Over the last few months, I have posted several articles about the lawsuit brought against Myriad Genetics by the Association for Molecular Pathology, the College of American Pathologists and other plaintiffs regarding the patents it (Myriad) holds on BRCA1 and BRCA2. The plaintiffs argue the patents should be invalidated and that no one should be able to patent a product of nature. Myriad argues the truncated DNA sequences in question exist only in a laboratory setting and therefore can be patented.
Among other issues raised by critics is the contention that Myriad, by holding these patents, stifles research and clinical testing into hereditary cancers involving BRCA gene mutations. Myriad has always vehemently denied this, but in this recent article from Bloomberg, Myriad’s CEO seems to admit the opposite.
First a little background.
The Myriad case has been in the judicial system for some time now. Originally, a federal court found the patents to be invalid. Myriad appealed to the US Court of Appeals for the Federal Circuit, which found in favor of Myriad.
Following its decision in the Mayo v. Prometheus case, the US Supreme Court vacated the appellate court’s decision and ordered it to re-review the Myriad case using the Mayo decision for guidance. The appellate court upheld its own decision on re-review.
The plaintiffs appealed to the US Supreme Court, which agreed to hear the case on November 30, 2012.
The Bloomberg article discusses how Myriad, despite its denials, allegedly refuses to share data with others in the scientific community. The article points to a consortium of 48 US companies and universities that have all agreed to contribute data to a government-run database that will catalogue genetic mutations.
Myriad has yet to contribute to this database.
And here comes the most important part of the article, at least for me. The CEO of Myriad, Dr. Peter Meldrum, when asked why Myriad has not contributed data to the new database, said the sharing of data “doesn’t make a lot of business sense”.
Before now I had not seen any proof of Myriad’s unwillingness to share data. To me this quote from Myriad’s CEO essentially proves what Myriad’s critics have been saying all along and is one (and perhaps the best) reason why I agree with the plaintiffs that genes should not be patentable.
As I have said before, I believe the US Supreme Court will invalidate Myriad’s patents. We should know its decision by this summer.
Tory Galloway thought her negative result on a widely-used test sold by Myriad Genetics Inc. (MYGN) cleared her DNA as a cause for her fallopian tube cancer.
She happily advised her four sisters that the disease didn’t result from a family trait. The relief from the December 2010 test, though, was short lived. In October, after getting results from a broader scan at the University of Washington that included dozens of genes, she learned the truth: Her cancer was caused by a mutation that wasn’t included in the Myriad product.
“It makes me nuts to even think about it,” said Galloway, a landscape designer in Indianola, Washington.
The broader test, created by University of Washington researchers, uses technology to identify as many cancer risks as possible. There’s one problem: Such a test can’t include the BRCA1 and BRCA2 genes that are the most common inherited causes for breast and ovarian cancer because Myriad owns the patents on them. This prevents other U.S. laboratories from using them in a commercial test.
In the mid-1990s, Myriad helped kick-start the gene-testing revolution by pinpointing the two BRCA genes. Now, the world’s biggest genetic testing company for breast cancer, with a market value of $2.2 billion, is under attack by researchers, genetic counselors, doctors, and their patients.
Besides stifling competitors from offering combination tests including the BRCA genes, critics also said the company won’t share data from decades of testing that could aid research into how best to interpret screening. They said Myriad doesn’t adequately respond when other researchers find added BRCA mutations that address risks their current tests don’t cover.
“What is at stake is the way we want our health-care system to work,” said Robert Cook-Deegan, a professor of public policy, biology, and medicine at Duke University in Durham, North Carolina, who supports limits on gene patents. “The testing has been set up by Myriad to optimize this business model. It is not set up to optimize public health outcomes.”
The dispute, which has grown in intensity as more and more cancer-causing mutations are found, has spilled out of the laboratories and clinics into the U.S. Supreme Court. A ruling next year in a case challenging Myriad’s hold on the BRCA patents could either support the company’s profit-driven motives or redefine a nascent industry in a way that affects millions of dollars in revenue.
Myriad officials reject the criticisms, saying they offer faster, more accurate testing for harmful mutations in breast cancer genes than any other laboratory in the world, and its patents haven’t hindered research or patient care.
Link to entirety of article: Myriad Stymies Cancer Answers by Impeding Data Sharing – Bloomberg.