Last Thursday the US Supreme Court ruled unanimously that natural human genes, even isolated from the human body, cannot be patented, a decision that scientists, doctors, patients and civil rights campaigners celebrate because it removes a major barrier to medical care and innovation.
The court said that human DNA is a “product of nature”, a basic tool of scientific and technological work, thereby placing it beyond the domain of patent protection. The resolution strikes down patents held by Myriad Genetics Inc, a Utah based company, on two BRCA1 and BRCA1 genes linked to a higher risk of breast and ovarian cancer.
The ruling represents a major shift in the law and will have a profound effect on the biotechnology and drug industry. It will allow new companies and laboratories to enter the market on genetic testing reducing the costs and making easier to develop new combinations of tests and therapies tailored to each person’s unique genetic makeup.
However, the court limited its’ ruling. It held that synthetic DNA, forms of DNA that have been manipulated in the lab in a way that modifies their natural state, could be patented.
The decision resolves one of the most important and complex disputes in a generation involving the intersection of science, law and commerce. The issue has gained increasing importance as scientists make progress in identifying specific genes, or mutations, linked to a variety of diseases. The full text of the decision is available here [in English] and here an in deep feature about the resolution and the decade-long conflict with human genes patents [in Spanish].