Back in June, Mike wrote about the important Myriad Genetics judgment from the Supreme Court, which said that naturally-occuring genetic material could not be patented. However, because of some hedging from the judges, there were concerns about how much this would block gene patents in practice. Last week we had an indication that the impact is indeed likely to be significant, as VentureBeat reports:
a District Court judge in California upheld the landmark [SCOTUS] ruling, and struck down a patent held by a San Diego-based diagnostics company called Sequenom. Sequenom offers a non-invasive genetic test for Down's Syndrome, which pregnant women can take as early as 10 weeks.
As Science magazine explained in its report on the case:
Sequenom plans to appeal the decision to the Federal Circuit Court of Appeals. It was highly unexpected, and has caused shockwaves of disbelief in the scientific community. The judge, Susan Illston of the United States District Court in Northern California, ruled against Sequenom after a summary judgement, citing the Supreme Court case "Association for Molecular Pathology v. Myriad Genetics, Inc., 12-398."
In both cases, the judge ruled that a "natural phenomenon" could not be patented.
If this decision stands, "I don’t see how you can maintain a genetic diagnostic claim anymore," says Christopher Holman, a molecular biologist and professor of law at the University of Missouri, Kansas City.
However, that does not mean that biotech is now an area that will be abandoned by investors. As the VentureBeat story notes:
Bryan Roberts, a health-focused investment partner at Venrock, predicts that "real innovation will be patentable and rewarded" while patents on natural phenomena will not. Roberts is a leading investor in Ariosa Diagnostics, the San Jose, Calif. based company that filed suit against Sequenom in 2011.
That connection means that Roberts may be biased in his view of this particular case, but his broader analysis of the ruling's impact remains true:
The ruling "raises the bar to rely on intellectual property as a business defense," said Roberts. "It will drive prices down [and support] the product that is both high quality and efficiently priced."
What makes this latest judgement (embedded below) particularly welcome is that it joins the Myriad Genetics decision, and an earlier SCOTUS ruling that struck down a patent on basic medical diagnostics, to form part of a growing body of US case law that brings some much-needed sanity to the world of gene patents.
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