Did you know that the U.S. Supreme Court is currently considering a case with wide ramifications, a case involving whether genes—human genes in this case—can be patented? (For longer analyses, see the NPR story here and the New York Times story here).
At issue is the patenting by a Utah Company, Myriad Genetics, of two genes involved in breast cancer, BRCA1 and BRCA2. Mutations of these “tumor-suppressor” genes account for between 10% and 15% of both breast and ovarian cancers, and a woman carrying a mutation in either is about five times more likely to develop breast cancer than a woman lacking those mutations. Determining whether one carries these mutations, then, is important in how one is monitored for cancer, particularly if a woman has a family history of the disease. To avoid worry, some women with such a history, or who carry the mutant BRCA genes, get prophylactic mastectomies to forestall cancer.
For the past 18 years, the only company that has the right to test for these mutations—indeed, to allow any research on the BRCA1 and BRCA2 genes, has been Myriad, which in effect patented the two genes. It charges $3000 for its test (the test costs the company about $200), and claims that both its patent—and its exorbitant fee—are needed to recoup the costs of discovering that the gene was associated with cancer and developing a way to assay mutations. Myriad claims it spent $500 million to develop the test (I have doubts about that), but they recouped $405 million of that in the last year alone. As the NYT notes, BRCA testing accounts for 80% of Myriad’s income.
Here’s some background from NPR:
Myriad Genetics, a Utah biotechnology company, discovered and isolated two genes — BRCA 1 and BRCA 2 — that are highly associated with hereditary breast and ovarian cancer. Myriad patented its discovery, giving it a 20-year monopoly over use of the genes for research, diagnostics and treatment. A group of researchers, medical groups and patients sued, challenging the patent as invalid.
There is no way to overstate the importance of this case to the future of science and medicine. In the view of Myriad and its supporters in the biotech and pharmaceutical industries, patents are the keys to making these medical discoveries possible. Their opponents, including leading medical groups and Nobel Prize-winning scientists, contend that Myriad’s patent improperly puts a lock on research and medical diagnostic testing.
The U.S. patent system, authorized in the Constitution, gives temporary economic incentives to inventors to advance science. The general rules of the patent system have been established in statutes and Supreme Court case law for over 150 years. You can’t patent a product of nature or a law of nature. It doesn’t matter that the task was difficult or costly. Nature is immune to patents. So, even though it may have taken Einstein a long time to figure out that E=mc2, he couldn’t have patented that law of nature.
Until relatively recently, much of the medical profession disdained patents, except as a means to ensure quality. When Dr. Jonas Salk, the inventor of the revolutionary polio vaccine, was asked in 1955 whether he had a patent on the vaccine, he replied, “There is no patent … could you patent the sun?”
Myriad Genetics, however, contends that the genes it isolated are not like the sun. Mark Capone, president of Myriad Genetics Laboratories, notes that the 20,000 genes in the human body are part of a 6-foot-long molecule that’s “coiled and compacted and stuffed into each cell.” And, he says, “What Myriad was able to do is sort through all those 20,000 genes and find the two that were highly linked to hereditary breast and ovarian cancer.”
Although Myridad has the right to impede straight research on these genes, they say they haven’t done so, though they still retain a monopoly over diagnostics and treatment. And the Yale case, described below, could be seen as an obstruction of research.
Because of the high cost, some insurance companies won’t cover the testing, and so a woman who worries about familial breast cancer must often pay out of her own pocket—or, if she’s impecunious, not be tested at all. In that way, and others, Myriad certainly has impeded medical treatment. In one case, described in the Times, a woman who had breast and ovarian cancer was given the Myriad test and came up clean. But Yale University Medical Center, where she was treated, wanted to look for other mutations in the BRCA genes not covered by the initial Myriad test, for the woman had a daughter. Myriad wouldn’t allow it. While the insurers haggled over whether to pay for additional testing from Myriad, the daughter developed breast cancer.
Myriad, in other words, owned not only the ability to detect specific mutations in the BRCA genes, but all mutations in the BRCA genes, and wouldn’t let anybody else could look for them. It owned the gene and everything to do with it.
That’s exploitative, greedy, and unfair. No company should own a gene, and this is an explicit violation of patent law, which argues that natural substances cannot be patented. The tumor-suppressor genes are natural, and the DNA in patients is exactly the same as the DNA tested by Myriad. It has to be, or the test wouldn’t work. Yes, Myriad discovered that these genes were associated with cancer, and developed a way to assay mutations, but what should be patented is the diagnostic process, not the gene itself. Others can—and have, in the case of cystic fibrosis—developed and patented tests without patenting the gene, so several companies offer diagnosis for that gene.
When Jonas Salk developed the polio vaccine, which was something that could have been patented, he refused to do so, saying that patenting it was like trying to patent the Sun, and that the vaccine belonged to the whole world. Salk and the University of Pittsburgh could have made millions, but he saw that as unethical.
Well, we no longer live in Salk’s world, and everyone’s trying to get rich from genetic. One could argue that Myriad has jeopardized people’s lives with its unjustifiable patent on a gene itself.
Here, from the New York Times, are those on either side of this issue:
Briefs in support of the plaintiffs were submitted by the American Medical Association, AARP, and various consumer and patient advocacy groups. Supporters of Myriad include drug companies, biotech seed companies and venture capitalists. Diagnostic companies appear split.
The Obama administration, breaking with longstanding policy of the Patent and Trademark Office, says isolated genes should not be patentable. They are medically useful, it says in its brief, “precisely because isolated DNA operates in exactly the same way in a laboratory as it does in its natural environment.”
Genes are products of nature, pure and simple. They should not be patented, and companies, no matter how venal, cannot prevent others from working on these genes or developing their own diagnostic tools should the genes be associated with disease. I can see no justification for a company owning a gene, no matter how much money it takes to determine whether that gene is associated with disease or to develop a test for the relevant mutations.
Yes, by all means let companies develop their own diagnostics, which, if sufficiently novel, can be patented, just as any novel medical test can be patented. But DNA is DNA, whether in a patient or in the sticky hands of greedy biotech companies. Let’s hope the Supreme Court strikes down this unconscionable process of patenting genes, an issue that will become increasingly pressing as DNA-based medicine goes forward. In the meantime, Congress needs to make laws that clarify the situation.