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BIOETHICS AND INNOVATION

Your Genes Not for Sale

What the Myriad Case Means for the Future of Biotech Research

SOURCE: BigStockPhoto/DNA Science

In a unanimous ruling last week, the U.S. Supreme Court rejected that a patent can be granted to a gene sequence that describes the risk of a disease. Simply stated, you cannot own a piece of the human genome. Praise to the scientists whose hard work discovered the gene, but their discovery is like the periodic table of the elements—not an invention of human creation, but an art of nature. With this decision, the Court has said that information about how genes describe risks of diseases such as breast and ovarian cancer is free for all to use and no one to own.

That it took the highest court of the United States to step into the world of desktop medicine and proclaim “stop” to the armies of entrepreneurs racing to stake a claim on the human genome illustrates how the zeal to fulfill both ambition and wealth have seized the biomedical scientific imagination and enterprise.

For nearly two decades, biomedical science and ethics have debated whether ownership of gene sequences was permissible, and much of the debate was the biotech industry’s and academic investigators’ steamrolled agenda of collectively insisting that only with patent protection could they invest their money, time, and hard work to discover genes that explain who is more or less likely to develop diseases such as breast cancer or Alzheimer’s disease.

The promise of a period of exclusive ownership was their incentive to risk time and money. Yet bioethics and some investigators as well argued that owning a gene that explains why Angelina Jolie is at such a high risk of breast cancer that she should have a double mastectomy seems like owning how to read a radar map to deduce that a rainstorm is coming. You can invent radar and patent it, but surely you can’t patent how to interpret it.

With this ruling and its similarly unanimous 2012 Mayo v. Prometheus Laboratories ruling, the Supreme Court has decided that the medical mind cannot be owned. The ruling is a call for a reboot on the encroachment of the business model on medicine and medical science.

In Mayo v. Prometheus, the Court ruled that you cannot own a biomarker test that involves measuring a metabolite of a drug to then infer how to dose that drug to treat patients with inflammatory bowel disease. During that case’s oral arguments, Justice Stephen Breyer suggested that such a patent would be like owning how to fertilize a garden. When the lawyer for Prometheus—a biotech company named after the titan who stole fire from the Gods and gave it to humans so they could live better lives—replied that how to think about fertilizing a garden was patentable, that was perhaps the moment when the collective justices decided “enough!” With their Myriad ruling, the Court now places bookends on an issue that will define 21st century biomedical-industrial science. Observing and thinking about the risks of the world of health and disease are not inventions. Euclid can’t own his geometry.

What are the lessons of this case that mark the end of a Wild West free-for-all era of owning nature?

First, biomedical science—the scientists—showed that as a profession, they couldn’t agree on a professional ethic that said such ownership is simply not part of being a scientist. Once upon a time, they believed that. In the late 1970s, Eugene Goldwasser, the discoverer of the hormone erythropoietin that drives red blood cell production, didn’t bother to patent his discovery. But by the late 20th century, many researchers accepted and even embraced as part of being a scientist that they should own their discoveries. And no doubt this change in their ethic was at least in part because they, as well as their academic institutions, could profit mightily from a claim as evident as describing a correlation between a gene and a risk of cancer. To them, this was an “invention” akin to a motor part or chemical assay. As is too often the case in research ethics, society—this time the Supreme Court—had to step in and say to the scientists, unequivocally, “enough!”

Second, we see the power of patient disease advocacy groups. At the heart of the Myriad case were informed, motivated, and fired-up women who argued that no one could own their ability to learn their genetic risk for breast and ovarian cancers. Yet again, we see the power of the patient.

Like the HIV community that in the 1980s transformed FDA drug testing and approval regulations, the breast cancer community is a model for disease advocacy. Among the lessons: Stick to your guns and don’t simply become a patient-based extension of the private sector. Let the PR firms cheerlead the scientists and corporations. Your role is to responsibly collaborate and advocate with them, but also to be prepared to act up and fight back. This is a powerful lesson for the groups who represent the patients who suffer from the killers of the 21st century, especially Alzheimer’s disease and frailty.

Third, the case shows how, despite the relentless march of science that all but banished nature from its textbooks, laboratories, and clinics, the appeal to nature and the natural still evoke deep convictions in the nonscientists. Few scientists would dare to describe themselves using once-upon-a-time common 18th century monikers such as a “steward of God’s Creation,” and no one dies of “natural causes.” And yet Justice Clarence Thomas’s argument and the Federal Circuit ruling that preceded it read like a strange synthesis of Biology 101 and Aquinas 101.

Justice Thomas writes how “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring,” and “The nucleotides on the DNA strand pair naturally with their counterparts, with the exception that RNA uses the nucleotide base uracil instead of thymine.” Such nature engages in creation as when Thomas writes: “The pre-RNA is then naturally ‘spliced’ by the physical removal of the introns. … The exons-only strand is known as messenger RNA (mRNA), which creates amino acids through translation.” All of these events “occur naturally within cells.” Why? Because “The location and order of the nucleotides existed in nature before Myriad found them.” Amen.

In contrast, cDNA, which the justices ruled a patentable invention, is not of nature but of man. “Because the natural creation of mRNA involves splicing that removes introns, the synthetic DNA created from mRNA also contains only the exon sequences. This synthetic DNA created in the laboratory from mRNA is known as complementary DNA (cDNA).”

Association for Molecular Pathology v. Myriad Genetics, Inc. illustrates that although by the late 19th century, science dismissed nature as a concept worthy of even mention, society still cares deeply about nature.

Finally, the case is a call to order. Biotech and its compatriots argued in Myriad and as well in last year’s Mayo v. Prometheus that patents on biomarkers and genes are essential to support their business model. And yet, in the aftermath of the Myriad ruling, the free market gave Myriad the corporation a boost. Its stock went up. If we believe that free markets are nature’s invisible hand that aggregates information, then we can conclude that the Supreme Court has managed to balance competing commitments. Some discoveries are inventions worthy of private ownership and others are simply part of the laws of nature.

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