The Supreme Court’s BRCA Decision is Good News

But the future of testing for the gene mutation is uncertain

The Supreme Court decided today that genes cannot be patented, a measured victory for the plaintiffs in Association for Molecular Pathology vs Myriad Genetics, who argued that genes, which are products of nature, cannot be patented. SCOTUS agreed.

The genes in question were BRCA1 and BRCA2 which, when they have certain mutations, can drastically increase a woman’s chance of getting breast and ovarian cancer. (Angelina Jolie recently opted for a prophylactic mastectomy based on the results of BRCA testing).The defendent, a company called Myriad Genetics, discovered the locations and sequences of the genes using standard scientific procedures (don’t ask me), and used those discoveries to develop a test, the BRACAnalysis, to check for known mutations.

Other companies also tested for the gene mutation after the discovery, according to the SCOTUS decision, but Myriad sent them letters “asserting that the genetic testing infringed Myriad’s patents.” So those other companies backed off, and the upshot of all this is that when women want to learn if they carry a BRCA gene mutation, they have to do the testing through Myriad, a pricey proposition for patients without health insurance (Jolie said it costs about $3,000). Or, as articulated by the Court: “Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes.” The implications for price fixing and research stifling were disturbing, and breast cancer advocacy groups spent the months since oral arguments publicizing that.

Since the Court has ruled that the discovery of already-existing natural phenomena are not patentable, Myriad ostensibly can no longer prevent others from using the BRCA genes’ sequences in testing or research. But that doesn’t mean the company won’t find a way to reassert its dominance.

This is because the Justices also wrote in their decision that, though DNA sequences may not qualify for patents, complementary DNA—a synthetic version of DNA that excludes inactive segments—can qualify, as can methods for manipulating genes or new ways of using them. That is, if I’m understanding this all correctly, a company that creates a test-tube version of a gene can monopolize its use, essentially handing the patent holder all related innovation and research discoveries and stifling clinical breakthroughs spurred by a sense of competition. In Myriad’s press release reacting to the Court’s decision, the company notes that “the Court ruled that five of Myriad’s claims covering isolated DNA were not patent eligible. Following today’s decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test.”

Being the only option for an expensive, important test isn’t something a for-profit company executive in his right mind would give up without a fight. So, while today’s decision was a (limited) victory for scientific inquiry, it may not end up being a win for women who need a BRCA test to make a medical intervention plan.

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