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Wilder gene

13 June 2013 By Reynolds Holding

The U.S. Supreme Court has managed to square the helix on human gene patents. The justices ruled on Thursday that companies can hold exclusive rights to synthetic DNA molecules but not naturally occurring ones. The unanimous decision should allow biotechnology companies to reap rewards for their work without stifling the research of others.

The controversial case involved Utah-based Myriad Genetics’ claim that isolating human genes linked to breast and ovarian cancer was a novel invention deserving of legal protection. The company’s research includes work on the BRCA1 and BRCA2 genes, recently in the news after a genetic test led Hollywood actress Angelina Jolie to decide to undergo a double mastectomy. Doctors, medical researchers and others argued that Myriad was attempting to monopolize natural substances crucial to finding cures for diseases.

The justices seemed on the critics’ side last year. They ruled in another case that observations of natural processes couldn’t be patented and asked the Federal Circuit Court of Appeals to reconsider its decision upholding Myriad’s patents. But the appeals court confounded expectations by again finding the patents valid, and the case landed back at the high court.

This week’s decision is notable for its clarity. Writing for the court, Justice Clarence Thomas explained that the Patent Act bars patents on “natural phenomena,” meaning only Myriad’s man-made genes deserve protection. Case closed.

It’s a setback for Big Pharma and the roughly $90 billion biotech industry. They argued that changing the rules would threaten investments made in drugs and tests in reliance on DNA patents. But these concerns always seemed overblown, what with all the patents, trade secret rules and other protections covering proteins, antibodies and other substances required for medical research.

The Supreme Court has defused the controversy, leaving nature’s handiwork available to all while protecting biotech companies’ genuine innovations. It has also delivered a needed slap to the Federal Circuit, whose tendency to uphold overbroad patents has helped make a mess of America’s intellectual property system. With the decision, science, industry and the rule of law have all been well served.


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