Supreme Court DNA Ruling: For a Change, US Regulation is Stricter than EU’s

“Separating a gene from its surrounding genetic material is not an act of intervention,” says Justice Clarence Thomas. The US Supreme Court has ruled unanimously that human genes cannot be patented. The case resolves the suit against Myriad Genetics, the Utah-based company that was sued over its claim of patents relating to two types of biological material that they identified and are linked to increased hereditary risk for breast and ovarian cancer.

The case involved two genes, known as BRCA1 and BRCA2, where mutations can indicate significant likelihood of breast and ovarian cancer. Remember when actress Angelina Jolie announced last month that she underwent a double mastectomy? She decided to do it following a genetic test of this kind.

Among the plaintiffs, says CNN, was breast cancer survivor Lisbeth Ceriani. “She faced having to pay thousands for Myriad’s test to see if she had a mutation for ovarian cancer. Because of the high cost, she waited 18 months before she could afford it, learning she carried a mutation, according to the American Civil Liberties Union, which represented plaintiffs,” they wrote. ACLU, one of the civil liberty groups that sued, said that the human gene is a natural product. Myriad company said they have not patented that, but the isolation process. It has been basically an intellectual property case.

The industry is irritated. They say at the end of the day this will increase the costs, and that their investment has to be rewarded, otherwise the huge field will see a big delay in new developments. The R&D system is going to suffer if the income of bio companies that invest is cut, they insist. But some public institutes researchers disagree: the availability to the rest of the community is more important than the incentive to private companies, and that there are more patents by public institutes.

European Union seems to think alike. “The case is different in Europe. It is a different direction both from Europe and what Americans have been doing for the last few years. Here, since 1998, you can patent genes that you have isolated, given that they describe their functioning, a practical application, like a diagnosis of an illness, and of course they have to be new and have a certain inventivity”, said Francisco Fernández Brañas from European Patent Office at Spanish radio Onda Cero on Thursday. The idea is not that genes exist, but that either the researcher or the company have made them available to the public.

But the reality is that most of the patents related to genes have been done in the US. That is why this ruling is so important. “It is expected to quickly expand access to genetic testing while potentially allowing inventors to retain rights to artificially created DNA,” says the WSJ.