A PATENT on DNA? Really? As strange as it sounds, the question of whether companies can patent DNA extracted from human cells is a live debate — one that will reach the Supreme Court on Monday.
The case involves the Salt Lake City-based Myriad Genetics, which identified two sections of genetic code that, when abnormal, indicate higher risk for breast and ovarian cancer. In order to scrutinize these genes, scientists must know where to look for them, find them and then remove them from the long strand of DNA in human cells, “isolating” them for lab testing. The company obtained patents on the isolated versions of the two genes it identified. That means if you want to see if you carry a mutated version of one or both of them, you have to ask Myriad to do the testing for you.
Myriad claims that the process of defining these genes — where they stop and start — took time, effort and ingenuity. The company’s geneticists can now isolate genetic material from patients and compare it to the template Myriad developed. In being the first to isolate these genes, the argument goes, the company in effect created a new chemical with novel therapeutic uses. Therefore, the company concludes, it rightly holds patent rights over that chemical — any version of these genes, once isolated.
A New York academic researcher, backed by the American Civil Liberties Union and others, challenged the notion that Myriad invented anything. DNA, the challengers claim, is a substance found in nature. Merely isolating bits of that DNA does not change their essential attributes. All Myriad is doing is examining — however rigorously — what nature created. Worse, the critics claim, Myriad’s patents are so broad that they potentially give the company rights over all sorts of human genetic code after it has been isolated. All that, they say, puts unreasonable restrictions on therapy and research.
The legal precedent stresses that products of nature aren’t patentable, so the justices may well rule against Myriad. But either way, their ruling shouldn’t be the end of it. Balancing the benefits of free-flowing research against the value of mobilizing private money to detangle genetic code is a hard policy call that Congress should make. Myriad mounts a good case that refusing to offer gene patents would endanger billions invested in U.S. genetics research, plowed into the field on the assumption that companies could obtain patents. The company has reason to say that its work, though profit-motivated, has brought major progress to women’s health. That’s why the rest of the industrialized world allows gene patents, too.
Lawmakers should be able to design a system that encourages private investment but also limits the extent to which genetic-research patents can freeze free inquiry, offering patents or some other incentives but snipping their potentially overly broad reach, about which Myriad’s foes are rightly worried.