In its unanimous ruling Thursday that human genes cannot be patented, the US Supreme Court removed a worrisome source of uncertainty hanging over the biotechnology industry. Myriad Genetics, a Utah-based biotech firm, discovered and isolated BRCA1 and BRCA2, two genes that are highly associated with breast and ovarian cancer. Myriad went on to patent that discovery, but other researchers objected. The high court invalidated that patent on the grounds the company “did not create anything.” The landmark ruling frees up endless amounts of genetic material for the free use of science. It sets a significant precedent that will ultimately benefit researchers, business, consumers, and, most importantly, patients.
Legally, this was not a difficult case for the justices. Supreme Court case law had long held that patents can protect products of human ingenuity but not a product or law of nature. Human genes are clearly natural phenomena. Myriad had argued that it wasn’t patenting nature, but instead the process of isolating those genes from the body. But the American Medical Association, in a brief submitted to the court, effectively countered that that was like saying the first surgeon to remove a kidney should be able to get a patent on all “isolated” kidneys going forward.
Medicine doesn’t happen for free, and patents do have an important place in medical science. Such protections — and their payoffs — encourage companies to invest in much-needed scientific research and development. The court acknowledged this with its decision, which was especially narrow, while also ruling that Myriad could patent a synthetic form of the genes it created. That leaves the door open for other ways the company can still profit from its research, evidenced by the fact its stock soared Thursday on the news.
Yet in the central question of the case, Myriad wasn’t merely asking to patent a new process for determining the presence of the BRCA genes. If it had been, then other biotech firms could work to develop their own tests, and the market would reward the cheapest or most effective. Instead, Myriad’s patent reached much farther, protecting the DNA sequences of the mutated genes, which it also refused to license.
That stance potentially interfered with sick people’s ability to get the tests and treatments they needed to save their lives. Myriad was allowed to set monopoly prices — $3,000 for a test that, experts suggest, costs less than $200 to conduct. It also meant any woman who wanted to find out if she had the mutation had to go to Myriad, and no other lab could even offer a second opinion or confirm the test’s accuracy. That is too much power to grant a single corporation and may have compromised patient safety.
The court removed roadblocks to clinical advancements that may revolutionize patient care.
What’s more, allowing this kind of patenting can stand in the way of future breakthroughs. Myriad has not invoked its right to block academic research, with thousands of journal articles having been published on these two genes. Other firms with similar patents, however, might have been less generous. As the era of personalized medicine approaches, the biotech industry will need access to genetic research in order to determine the appropriate course of treatment. With this ruling, the court removed roadblocks to clinical advancements that may revolutionize patient care.