Let’s say someone offers you a test that will tell you if you’re likely to develop a certain kind of aggressive cancer at a young age. The cancer runs in your family, and there are preventive measures available so you can reduce your risk of developing the disease. The test is only available from one company, though, and you have to take extreme measures to get a second opinion. By the way, if your insurance doesn’t cover the test, it could cost you more than $3,000.
This is a real situation. The company that offers the test is Myriad Genetics, and it owns the patent on the BRCA1 and BRCA2 genes, which, when mutated, can dramatically increase a woman’s chance of developing breast and ovarian cancer as early as her 20s or 30s. (BRCA stands for “BReast CAncer.”) These mutations, or changes in a gene, have increased incidence in the Ashkenazi Jewish population, though they can occur in anyone. Preventive measures include lifelong surveillance, which could mean frequent MRIs and mammograms, and prophylactic mastectomies and oophorectomies — removing your breasts and ovaries before they develop cancer. If your results are inconclusive, meaning you have a mutation but the lab doesn’t know if it’s a harmful mutation, the next nearest option for Americans is Canada, which ignores the American patent.
Last year the American Civil Liberties Union (ACLU), along with hundreds of co-plaintiffs, filed suit against Myriad, claiming the BRCA gene patents were unconstitutional. They framed it both as an issue of access, highlighting the cost of the test, limitations on outside research and a perceived stranglehold on information, and as an attack on the gene patenting system itself. Genetic material, they argue, is a product of nature: it’s like patenting kidneys or oxygen or photosynthesis.
Nearly everyone I talk to about this issue is stunned to learn that 20% of the human genome is already patented. Why would anyone think such a thing was okay?, they ask. The reason for patenting a gene, as with any patent, is economic. Biotechnology companies invest millions of dollars in research and development. They want to be able to recoup that investment and put the money toward future projects. If there was no guarantee that investors would get returns on their investments, no one would give the company money, and no one would be able to develop life-saving technologies and medicines: they couldn’t afford it. Government grant money is nearly impossible to get, especially in this economic climate, and even then, it could never fund the depth of research needed to study something like BRCA.
Patent-holding companies also believe that focusing all their resources on a limited piece of genetic material encourages a consolidation of talent and knowledge. If people want to work on the BRCA gene, and their ideas are good enough, they can come to Myriad and have access to all their research and all their information. Nobody has to start from square one, and whatever good comes of that innovation can go toward funding new work. In refuting allegations made by a variety of consumer, health and research advocates, Myriad insists that its enforcement of its patents has not inhibited competition, shut down labs or projects, or denied women access to their genes, whether by availability or prohibitive costs. The many plaintiffs in the recent federal case, including medical societies, cancer researchers and BRCA-positive women, disagree.
On March 29, the federal judge overseeing ACLU v. Myriad Genetics sided with the ACLU. Myriad’s justification for seeking the patent in the first place is that it was the first to identify and isolate the BRCA gene. It applied to patent the isolated gene in purified form, which requires human processing. According to Judge Robert Sweet’s interpretation of the law, the U.S. Patent and Trademark Office had no business issuing proprietary control over something that occurs in nature, whether in isolation or no. The suit is far from over – Myriad is certain to pursue a higher ruling to protect its patents, even as they begin to expire in 2014 – but the ruling is significant, and, if upheld, could signal a need for innovative thinking among companies that rely on gene patents as protection.
Access to your own genetic information is a good thing. Everyone should be able to make informed decisions about their own health care, and genetic testing can provide important information that may influence these decisions. Does genetic testing only exist because its development has been incentivized? Will the current model evolve or stay intact? We’re on our way to finding out.
• Excerpt: In the Family – Filmmaker Joanna Rudnick visits Myriad’s laboratories and interviews Myriad founder Dr. Mark Skolnick.
• American Medical News: “Gene patents rejected by federal judge” – The newspaper of the American Medical Association, which was a plaintiff in the case, reports on the physician angle of the case.
• The Los Angeles Times: “Are patients misserved by patents on human genes?” – A geneticist and a lawyer offer two interpretations of the ruling.
• The Salt Lake Tribune: “Myriad elicits a genetics tempest” – Myriad’s hometown paper reports on the politics of the case.