Opinion: A patent on human genes

Written by Daniel Sprockett Monday, 18 April 2011 17:18

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Can you patent life? What about components of life? The U.S. Court of Appeals may soon give us an answer. Earlier this month, it reviewed a case dealing with a company’s ability to patent human genes – a decision that will have far-reaching implications for the relationship between science, medicine and industry.

The case involves a contested patent held by the biotechnology company Myriad Genetics. Myriad sells a genetic test called BRACAnalysis, which detects mutations in two tumor-suppressor genes called BRCA1 and BRCA2. When functioning normally, these genes repair damaged DNA or help destroy the cell if its DNA is irreparable. However, The National Cancer Institute reports that women with mutations in these genes are five times more likely to develop breast cancer during their lives.

In the process of developing these tests, Myriad Genetics was granted seven patents that were later revoked in a decision by U.S. District Court Judge Robert Sweet. In 2009, a group of scientists and patients’ rights advocacy groups, led by the ACLU, filed a lawsuit against Myriad Genetics and the U.S. Patent and Trademark Office. They argued Myriad’s patents on human genes are invalid because genes are products of nature and are therefore not patentable. In March 2010, Sweet agreed.

You might think it’s strange to be granted patents on genes in the first place, considering they already exist inside every one your cells. Human genes are clearly discovered, not invented. However, legal precedent has established that molecules, cells and even whole organisms are subject to patent protection if they represent a human innovation that is not found in nature. This has been true ever since the 1980 Diamond v. Chakrabarty case, when the Supreme Court ruled that a genetically modified bacterium capable of degrading oil slicks was patentable. In fact, upwards of 20 percent of human genes have already been patented in some form.

To be clear, these decisions do not extend to the naturally occurring genomic DNA inside your body.

Patent protection is strictly limited to DNA that has been isolated, purified and/or modified in some way using various molecular techniques. Here lies the crux of Myriad’s argument: The act of isolating DNA sufficiently transforms it enough to make it patentable.

Myriad is now appealing Sweet’s decision, further arguing that patents allow companies time to recover their sizable R&D investments necessary for such advancements. If companies aren’t able to patent their technologies, they contend, then there is no incentive to invest in medical research, and progress will suffer overall.

However, these patents give companies a monopoly on critical diagnostic tests, preventing patients from having their results independently confirmed and allowing testing companies to drive up prices.

Myriad’s BRACAnalysis test costs over $3,000.

Furthermore, these patents also effectively bar other scientists from pursuing certain research areas and stifle innovation. For example, we know that BRCA1 and BRCA2 also play an important role in embryo development. Will these patents prohibit researchers from investigating gene functions that are completely unrelated to the patent holder’s interests? It is too early to tell.

Whatever this court’s decision, it will likely end up at the Supreme Court some time in the coming years. I hope patients’ rights and open scientific advancement are prioritized above corporate interests, but judging from some of the Supreme Court’s recent rulings, things don’t look good.