Supreme Court Building. (AP images)
Today, the Supreme Court delivered a landmark victory for patients rights’ and a blow against corporate healthcare monopolies by unanimously deciding that human DNA is “a product of nature” and thus “not patent eligible.” The case, AMP v. Myriad Genetics, revolved around Utah corporation Myriad Genetics’ exclusive patents on the BRCA1 and BRCA2 genes, which, when mutated, lead to a very high risk of breast and ovarian cancer. Because Myriad was the first to identify the BRCA genes, it patented them, charged exorbitant prices for BRCA testing, and then aggressively prevented any other labs from offering the same test. In 2009, a coalition of plaintiffs including the ACLU, Breast Cancer Action and a number of scientific organizations, researchers and patients sued Myriad, claiming that it had no legal right to hold patents on the BRCA genes.
In a majority decision written by Clarence Thomas, the court affirmed the plaintiffs’ claim that because DNA is naturally occurring, it “lie(s) beyond the domain of patent protection.” In so deciding, the court effectively reversed decades worth of policy by the US Patent and Trade Office, which has granted thousands of gene patents, many of which should now be rendered invalid.
The Court refuted Myriad’s claim that because it had put a lot of time and money into locating the gene, that it therefore deserved a patent: “extensive effort alone is insufficient” to make something patent-worthy. Basically, just because you tried really hard doesn’t mean that you deserve a multi-billion dollar legal monopoly.
The most immediate effect of this decision is that, very soon, testing for BRCA mutations will no longer cost the nearly $4,000 that Myriad charges because women will have a choice of lower-cost labs. As an important subsidiary benefit of the new testing freedom, women will now be able to seek second opinions on this consequential test. And thinking beyond BRCA, other corporations will no longer be able to monopolize the testing for a particular genetic trait. Myriad, and companies like it, will no longer be able to drive up health care costs by charging the inflated genetic test rates enabled by patent monopolies.
Organizations like Breast Cancer Action—one of the plaintiffs in this case—celebrated today’s decision on all of these grounds, calling it “a watershed health victory for women.”
The decision is also a crucial one for advocates of scientific freedom: Myriad will no longer be able to control the huge data set it has developed from the results of women’s BRCA tests, and scientists—not just those who study breast cancer— will be able to pursue their research unimpeded by genetic patents. The ALCU—who argued this case—maintained that genetic patents have had “a chilling effect on research’; things should now warm up a bit.
Some biotech advocates are liable to raise alarmist cries about how this decision will harm bottom lines, but clearly Wall Street does not agree: Myriad’s stock prices surged 11 percent after the announcement, reaching a four-year high. Indeed, Wall Street’s enthusiasm about the SCOTUS decision should indicate that this is not an entirely unambiguous victory. For while there is certainly much to celebrate here, there are also two issues that need to be followed closely.
First of all, the court ruled that while natural occurring DNA (called gDNA) cannot be patented, the tidied-up, synthetic version of DNA used to actually perform tests (called cDNA) may be eligible for patents. Thomas’ opinion—which is remarkably dense with scientific nuance—distinguished between the types of DNA by explaining that “but cDNA is patent eligible because it is not naturally occurring.” This may seem like splitting hairs (or, in this case, nucleotides), but it does give Myriad something of an out, or, at least, an argument for how it can continue to exercise some of its patents—and retain some of its profits. It remains to be seen how exactly this distinction between gDNA and cDNA will effect the genetic testing and research industry. Some experts have suggested that without the gDNA patent, the cDNA patent isn’t worth much.
Second, the Court declined to comment on the relevance of this ruling for genetically modified products. The court was careful not to offer an opinion about the patentability of modified DNA (GMOs, for example), claiming that “scientific alteration of the genetic code presents a different inquiry.” So this ruling, while important and promising, is quite carefully and narrowly drawn. Still, the unanimous outcome of AMP v. Myriad Genetics suggests that the Court has firmly taken the side of the individual patients and scientists over the unlimited power of corporations to make profits at any price.
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