In what is being hailed as a victory for both scientific research and patients' rights, the Supreme Court ruled unanimously yesterday that human genetic material cannot be patented. The case, Association for Molecular Pathology v. Myriad Genetics, has been working its way through the court system for a number of years now, led by plaintiffs including the ACLU, the American College of Medical Genetics, the American Society for Clinical Pathology, and numerous prominent genetic research scientists. The verdict invalidates the patents Myriad Genetics has held on breast cancer genes BRCA1 and BRCA2 since the 1990's and allows other labs besides theirs to test for mutations in those genes which, when present, strongly indicate a genetic predisposition to cancer. It also means that scientists can move forward in their genetic research without threat of being sued for copyright infringement. While the case was brought against Myriad specifically, the decision to disallow human gene patenting has profound implications for both scientific discovery and individual rights of ownership over our own genetic material.
[Human DNA image above courtesy of NASA]
[The ACLU's case against Myriad and gene patenting, produced before the trial]
The original argument for patents such as Myriad's was that genetic material was significantly altered by being isolated and removed from the body, thereby introducing an element of unique invention to the process. At the time, 20 years ago, it did require a heavy investment in initial research to be able to sequence those genes, and the company exercised its legal option to be the sole producer of diagnostic tests for them. Ten years later, however, that same genetic testing could potentially be done by any number of labs (since we can now sequence the entire genome), for much less money than Myriad was charging, and both patients and doctors were complaining that they wanted a second opinion on those lab results, which they couldn't get.
Proponents of genetic patenting, including companies like Myriad and Monsanto (who did win out in a recent challenge to their patents) but also universities with multiple gene patents such as Harvard, MIT, and the University of California, have argued that overturning those patents would send the wrong message to innovators and would stifle future invention because they would lack the means to recoup their research investment. In a radio program yesterday on KPBS, technology journalist David Wagner asked about the possible effects of the ruling on San Diego's vibrant biotech industry. His assessment was that business was not alarmed. He quotes Joe Panetta, president of the San Diego trade group BIOCOM:
"I think biotech in San Diego isn't particularly surprised by the ruling. I don't think there was any expectation that it was going to be anything different and that there would be any significant negative impact as a result."
Interestingly, Wagner goes on to note that one of the reasons biotech business interests are not more concerned is that genetic research is moving in the direction of synthetic genes, which are patentable. Of course, while losing some traction with specific patents, many companies will also benefit from the ruling by being able to venture into profitable areas such as competing diagnostics where they were locked out before.
For earlier discussions of the gene patenting debate on this blog, read:
Georgetown Cancer Research Links High Estrogen Levels in Womb to BRCA1 Silencing
Will Life Science Research Benefit from Court Rulings against Human Gene Patents?
Genome Sequencing Research Moving at Warp Speed -- What to Expect
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