Human Gene Patents at the Supreme Court: Does it Matter if Genes are Patentable?

CATEGORIES: Bioethics in Brief

Clark Wolf, Iowa State University Director of Bioethics

In the struggle to distinguish ourselves from others, genetics offers some comfort: unless you have an identical twin, your genetic code is absolutely unique. No other human being has ever carried the same genes you carry. Your genetic identity automatically distinguishes you from everyone else who lives and from every human being who ever has lived.

Sometimes people speak of genetic identity as if it were the core of the soul or the essence of individuality. Surely this is a mistake since we don’t know much about our individual genetic identities. The features of ourselves that matter most—those that are the basis for our relationships with others—are complex. Some of them are very strongly shaped by our genetic makeup, but they cannot be reduced to genetics. And many of our most important characteristics are those we have in common with others, rather than those that distinguish us as individuals. To fall in love, to form a friendship, to be a parent—these activities all involve capabilities we possess because of our genes, but most of these capabilities are common to humanity.

The genetic precursors responsible for the fact that we possess certain capabilities are not the things that make us unique. Of course, some of the features that distinguish us have a source in specific unique genetic precursors. Of these, there are features we value (like musical or mathematical talent, which are both thought to have a genetic component) and others we don’t value (like nearsightedness or susceptibility to disease). Some researchers spend their lives studying the relationship between our genes (genotype) and the physical characteristics (phenotype) that are linked to them. Such research can provide tremendous benefits, such as finding a genetic marker that indicates susceptibility to disease or disability. People may choose to use the knowledge that they are at risk to take preventive measures that save their lives.

The discovery of the BRCA1 and BRCA2 genes was exactly this kind of valuable breakthrough discovery. These genes indicate susceptibility to breast and ovarian cancer. Their discovery facilitated the development of a reliable genetic test.

Many women have had this test and have taken preventive steps to protect themselves. The actress Angelina Jolierecently announced that she tested positive for the BRCA mutations. Relatives had lost their lives to breast cancer, but, due to the knowledge gained by genetic testing, she could take steps to avoid this. Like many others, she chose to have a preventive double mastectomy that may have saved her life.

Myriad Genetics, the company that discovered the BRCA genes, patented their discovery and developed and marketed a test to diagnose cancer susceptibility. Not a surprising thing to do, since companies typically file patents on valuable research results. But in this case, the patents covered the discovery of human genes and claimed the genes themselves as private intellectual property. The American Civil Liberties Union challenged this patent claim in court. The ACLU argued that the valuable BRCA testing should be made available to women who cannot afford Myriad’s price and that Myriad’s patent covered unpatentable human genes. The challenge rose to the Supreme Court during the 2013 term. In support of the ACLU position, Nobel prize winning economist Joseph Stiglitz wrote a “friend of the court” brief and a New York Times editorial arguing that patents often impede innovation and promote pernicious inequalities.

I have written about the BRCA genes in two earlier columns, first in 2010 and then earlier this year after the Supreme Court accepted the case. We now have a judgment: In April, the court unanimously ruled that human genes are products of nature and that they cannot, therefore, be patented. The court clarified that altered DNA sequences are still covered under US patent law. This clarification limits the effect of the ruling for biotech companies but may well call into question the validity of other patents on antibodies and other biotech products.

It’s worth considering whether this ruling undermines the motive to pursue research that aims to discover and isolate other useful genetic markers like the BRCA genes. If research results can’t be patented, their market value will be lower. Of course, companies pursue research because they hope to be able to market a product and make money. If the results can’t be patented, why would they bother with the expensive and time-consuming process of discovering and marketing new genetic tests? This question was raised by Supreme Court Justice Antonin Scalia during the oral argument with James Hansen, the ACLU lawyer arguing the case before the court. Justice Scalia asked, “Why would a company incur massive investment if it cannot patent?” Hansen responded that scientists might simply be curious or might hope to get a Nobel prize. Later in the session, Scalia pressed the question further. “To profit from — from that recombinant DNA, you have to not just isolate the gene, but then you have to do something with it afterwards,” he said. “So you really haven’t given us a reason why somebody would try to isolate the gene. (…) What advantage do I get from being the person that or the company that isolated that — that gene? You say none at all.” Hansen replied “No, I think you get enormous recognition, but I don’t think…” and Scalia cut him off saying, “Well, that’s lovely.”

Recognition for research accomplishment is nice, but it won’t replace Scalia’s concern that overturning the BRCA patents might undermine the motive to pursue research in these areas. The concern is a legitimate one, but the answer is not obvious. The purpose of the patent system is to provide an added incentive for people to pursue socially valuable research and innovation. As Abraham Lincoln put it, “The patent system… secured to the inventor, for a limited time, the exclusive use of his invention; and thereby added the fuel of interest to the fire of genius, in the discovery and production of new and useful things.” (Abraham Lincoln, Second Lecture on Discoveries and Inventions.) Should we be worried that the Supreme Court ruling in this case will undermine this motive?

But as Justice Kagan pointed out, perhaps such questions are not within the purview of the court: U.S. patent law does include specific exceptions for “products of nature,” which are not patentable. So if the court was right to conclude, as it did, that the unaltered DNA is a product of nature, then the court was correct to rule that it cannot be patented under U.S. law.

There are at least two good reasons to think that concerns about the research motive are premature. First, many different researchers were looking for the BRCA markers. The BRCA gene was simultaneously discovered by University of Washington geneticist Mary-Claire King, although the Myriad researchers at the University of Utah were the first to clone the genes and first to file for patent protection. Maybe there are adequate motives after all. King applauded the court’s ruling, saying that it is “splendid for patients, their families, their physicians, scientists, and common sense.”

Second, the court ruling leaves substantial portions of the BRCA patents firmly in place, even though other pieces have been overturned. After the ruling was issued, several companies announced their intention to offer BRCA screening at a much lower price than Myriad, which charges about $4,000 for a full screening of BRCA1 and BRCA2 genes. Hours after the decision was issued, Abry Genetics and another company named Gene by Gene announced their intention to offer tests for these two genes. Early in July, Myriad sued both of these companies for patent infringement. This throws back to the courts the question of whether Myriad’s effective patent protection has changed at all. Maybe, after all the fuss, it doesn’t matter whether human genes are patentable.