Discovery is not invention. That is the final decision of the Supreme Court over whether human DNA can be patented. Utah-based Myriad had come to the court seeking to establish that it held a patent on a breast cancer gene the company had isolated; it has tested over 1 million women since the 1990s, with a breast cancer analysis costing $3,340 with a potential follow up test costing $700. But now other companies will be allowed to make similar tests and further their research on the same gene.
Justice Clarence Thomas wrote the unanimous decision: “Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”
The two genes in question are therefore fair game for whoever wants to research and test them. The news also means that any genes the company does invent, such as cDNA, which is not naturally occurring, can be patented, and so the company said that 24 patents with 500 claims remain in effect.
“More than 250,000 patents rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall health care costs,” said the company’s president and CEO, Peter Meldrum.
Many people are celebrating the Supreme Court’s decision, nevertheless, including Mary-Claire King, the geneticist who discovered the abnormality on chromosome 17, the breast cancer gene (BRCA). She told USA Today “It is splendid news for patients, for physicians, for scientists and for common sense. The marketplace will now be open.”
While Myriad claimed that patent protection was needed to keep research and development funded, other geneticists and health groups claim that competition will lower prices and will allow for more discoveries.
“Ensuring equal access to genetic testing is one of the key aspects of this ruling,” said Harry Ostrer, the medical geneticist who was the last remaining plaintiff on the case.
The decision is a bit of a compromise in that, as Thomas said, “We merely hold that genes and the information they encode are not patent-eligible … simply because they have been isolated form the surrounding genetic material,” but artificial genes, would be, a point relevant to agricultural science, among other fields that are making designer DNA. The idea that the discoverer of a gene could not patent it makes common sense, but as for the tricky business of patenting created DNA, such issues will be the topic for further court decisions.