ACLU and gene patents

Although this is not related to plants, this certainly has implications for plant genetics. I have just received notice that th ACLU has filed a lawsuit against Myriad Genetics, the company that owns the patents on the BCRA1 and BCRA2 breast and ovarian cancer genes in humans.

According to this press release, the ACLU charges “that the patenting of two human genes linked to breast and ovarian cancer will inhibit medical research. The organization also claims that the patents are invalid and unconstitutional.”

It continues:

“This is going to turn into one of the watershed events in the evolution of the bioindustry,” says John Sterling, Editor in Chief of GEN. “The pros and cons of patenting genes have been an ongoing, and often acrimonious series of debates, since the in re Chakrabarty decision in 1980. But this particular case seems to have taken on a life of its own with over fifteen plaintiffs. For while the lawsuit specifically centers on the patentability of two cancer-related genes, the ACLU says it plans to challenge the entire concept of patenting genes. What we have here is one group, the ACLU and its allies, contending that gene patents stifle life science research and potentially harm the health of thousands of patients. On the other side are biotech companies who maintain that without gene patents research incentives are seriously diminished and innovation is smothered.”

Kenneth I. Berns, M.D., Ph.D., Editor in Chief of the peer reviewed journal, Genetic Testing and Molecular Biomarkers (http://www.liebertpub.com/gtmb), which is the official journal of the Genetic Alliance, says the “patenting of human genes is a bad idea and that healthcare in the U.S. would be enhanced if the ACLU suit prevails.” Dr. Berns is also Director of the University of Florida Genetics Institute in Gainesville.

William Warren, partner at the Sutherland law firm, thinks the ACLU, in this case, is barking up the wrong tree. “The ACLU unexpectedly based its invalidity challenge on claims to unpatentable subject matter,” he says. “The ACLU might have instead considered challenging the Myriad patents for obviousness.” Warren and Sutherland colleague, Lei Fang, Ph.D., M.D., have authored a legal article, which will be published in the June 1 issue of GEN entitled “Patentability of Genetic Sequences Limited.” It is now available online. (http://www.genengnews.com/news/bnitem.aspx?name=54504126&source=genwire)

Genetic Engineering & Biotechnology News also has an article about the lawsuit.

I’m interested to see what the legal arguments will entail, so I’ll try to follow this as it develops.

Here’s a bit of background into the issue at hand. When you make a genetic discovery, such as figuring out the gene (or allele) that causes X, whether it be a predisposition to breast cancer, added sweetness in sweet corn, etc. Under U.S. Patent law you are allowed to patent that genetic sequence, which gives you certain rights as I understand it.

For a period of time, you are allowed a monopoly on profiting from the specific information of that discovery. In the case of Myriad Genetics, they get to charge people if they want to conduct research on the patented versions of the gene, do a diagnostic test based on that sequence, etc. The idea behind this is that it gives people a financial incentive to not only make these discoveries but also to publish them. Without such a financial incentive, it might be much longer before either public institutions discover it and publish, or companies will keep this information secret in order to protect their investment. Without patents, Myriad may still be charging for a ‘breast cancer predisposition’ screen test – without telling anybody what the gene is.

On the other hand, as a monopoly, it restricts the ability for people to find out such information about themselves, and restrict the ability of public researchers (and other companies) to conduct research on these genes. They would have to arrange a licensing agreement with the patent holder in order to do so. In the case of a crop gene, it might be annoying from the perspective of a breeder that wanted to use a molecular marker to ‘precision breed’ this gene into their crops. But when it comes to public researchers studying diseases like breast cancer, patent restrictions can go from beyond annoying to potentially dangerous.

Now to address a common myth about patents in the life sciences. Some people believe that the patents on BCRA1 and BCRA2, and other patents of this type, mean that the patent holders ‘own’ the genes, and even the organisms that contain them. This is not true. As I understand it (and I’m not a patent law expert!) they own the use of the information about that gene, for example, the specific sequence of the mutant breast-cancer gene. They do not own any part of men or women who possess this gene!

In plants, if one were to patent a gene that gives a desirable trait, then you would own the ability for a breeder to use the sequence of that gene to screen their different plant lines for that gene directly. This is known as a molecular marker, which is a tool for more accurate breeding. If, however, there was a way to screen for the gene that was based upon phenotype, such as a wrinkly seed in a test cross, the patent would have no effect on that.

In fact, there would be absolutely no restriction on such a patented gene being bred into whatever cultivars anyone so chooses. The gene existed before its discovery, and so the patent cannot touch that. You cannot take some native landrace, find a few genes in it, and claim that you own the plant – as is often implied about such patents.

This is distinct from the kind of patent that comes into play with transgenic crops, where a gene is assembled from various components and inserted into the genome of a plant. In this case because the gene itself is owned, people or organizations that generated this new gene own your ability to use the gene and breed it into other crops.

Because these two kinds of patents are different, I don’t think the ACLU lawsuit will affect GE crops, however, if they are successful, it may affect other patents related to plant genetics. Patents are a human construct, not a biological one, and when you apply human concepts to biological realities there may always be conflicts. It will be interesting to see how this plays out.

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Karl is a Ph.D. Candidate in Plant Breeding and Plant Genetics at UW-Madison. In addition to his research on the genetics of sweet corn, he is also completing a minor in science communication and is working on several media projects about plant breeding. His favorite produce might just be squash.


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