A U.S. Federal Appeals Court determined on August 16 that Myriad Genetics may keep its patent on the BRCA1 and BRCA2 genes, variants of which show heightened risk of breast and ovarian cancer in women.
The previous July 2011 Federal Circuit’s ruling in favor of Myriad’s patent had come under scrutiny after the U.S. Supreme Court ruled against Prometheus Laboratories five months ago, on the grounds that companies cannot patent observations about natural phenomena.
The Prometheus ruling had been hailed as a step in the right direction by many across the country. However, the Federal Appeals Court’s new decision on Myriad marks a significant backtrack.
The American Civil Liberties Union filed a lawsuit in 2009 against Myriad on behalf of plaintiffs including women’s health groups, research organizations, and breast cancer patients. They argue that human gene patents violate the First Amendment because genes are “products of nature.” Myriad and other defenders of gene patents argue that because they isolate the genes, changing their chemical structure, they have transformed genes from elements of our bodies to “products of human ingenuity.” Circuit Judge Alan Louris voiced his agreement last week, writing that, “The compositions here are not natural products. They are the products of man.”
The court did not grant Myriad everything it wanted though. It determined that Myriad’s processes for analyzing the genes, its “method claims”, cannot be protected under its patent. This means that other biotech companies can study the BRCA genes without infringing on Myriad’s patent, but it doesn’t benefit patients, who still can’t be informed what other companies’ tests have found.
As some journalists have noted, patents do not result in literal ownership of a gene, but they do lead to effective ownership for the duration of their patent agreement. Myriad now maintains its monopoly on all BRCA testing in the United States; its BRACAnalysis test is the only tool available to women who want to look into their genetic risk of breast and ovarian cancer.
Besides the obvious pitfalls of monopolies, including the likelihood of higher prices and less accountability, the court’s ruling perpetuates other problems. Myriad’s test itself is limited; it looks at only a few rearrangements of the BRCA genes so it cannot test for all of the potential causes of hereditary cancer. Though Myriad has developed an extra test, the BRAC Analysis Rearrangement Test (BART), it offers it for free only to a small proportion of patients. The majority have to pay an extra $700 for it, though it ought to be part of the overall test as it simply provides more accuracy.
Myriad and its advocates have denied that its patents will result in restricting women’s access to care. Runi Limary would disagree. After being diagnosed with invasive breast cancer at age 28, she wanted to know whether she had the BRCA variation in order to decide whether to have a prophylactic mastectomy on her left breast. The $3,000 for the Myriad test required her to wait several years to be able to afford it. When she finally received her long-awaited results, she learned that she did have an unusual variant of the BRCA1 gene, but that Myriad could not tell her whether the variant was dangerous or benign.
Because of Myriad’s patents on the genes, there was nowhere else Limary could turn for a second (or actually helpful) opinion.
“I was dumbfounded,” Limary said. “I understand that companies take out patents on things they create, but it seemed really weird that they could patent something in my body – and everyone else’s... My health is largely in Myriad’s hands – it feels really unfair to be in this position.”
Previously on Biopolitical Times:
Posted in Biotech & Pharma, Jessica Cussins's Blog Posts, Patents & Other IP, Personal genomics, Sequencing & Genomics, US Federal
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