No one should own your genes

Patents on human genes stifle science and innovation

November 09, 2010|By Steven L. Salzberg

A battle is under way over who owns our genes.

Each of us has about 25,000 of them, stored in every cell in our body. Our genes are 99 percent identical from one individual to the next. The small differences in the remaining 1 percent of our DNA account for all the remarkable diversity in the human race.

Thanks to advances in biotechnology, in the not-too-distant future we'll be able to carry our DNA sequences around with us, perhaps stored on a mini-flash drive or on our smartphones. The great promise of modern genetics is that as we learn more about genes and disease, we'll be able to use this information to improve our health.

But most people don't realize that the U.S. Patent and Trademark Office has been issuing patents on human genes for many years. These patents give private companies the exclusive rights to any diagnostic test involving the genes they have patented. Furthermore, if anyone develops a treatment for any disease involving the patented genes, the developer must first obtain permission from the patent holder.

According to current patent law, you can't even look at your own genes without paying thousands of dollars in licensing fees.

The notion that you don't have the rights to your own genes might seem absurd, but that's not how the patent office lawyers viewed it. Once the door was opened, biotechnology companies, pharamaceutical companies and universities began filing thousands of patent claims. By one recent estimate, patents and related intellectual property claims now cover over 4,000 human genes.

The most well-known cancer genes, called BRCA1 and BRCA2, were patented by Myriad Genetics in the 1990s. Mutations in these genes are associated with an increased risk of breast and ovarian cancer, and Myriad sells a diagnostic test for these mutations. The test, which costs nearly $4,000, is offered exclusively by Myriad, and no one can offer a competing test without a license from Myriad.

Earlier this year, the ACLU challenged the BRCA gene patents on behalf of patients and doctors, arguing that patenting genes violates the Constitution. Some patent experts expected the judge to throw the case out, but last March, U.S. District Court Judge Robert Sweet ruled in favor of the ACLU and declared the patents invalid. In June, Myriad filed an appeal.

Many scientists applauded Judge Sweet's ruling. Most of us felt that gene patents had never made sense. New genes have been the basis of many exciting discoveries, but they are not inventions. No one should have exclusive rights to a gene that occurs naturally in humans, animals, plants or any other living species. My own lab has participated in the discovery of thousands of genes, but we've never attempted to patent any of them, nor should we be allowed to do so.

The newest and most surprising development came just a week ago, when the Department of Justice filed a friend-of-the-court brief in the ongoing case. In its brief, the DOJ declared for the first time that the U.S. government does not support the patenting of naturally occurring human genes. The justice department wrote that a gene "is a product of nature" and is not a "human-made invention." Even though these statements are glaringly obvious, lobbyists for the biotechnology industry are fighting back, claiming that the DOJ lawyers misunderstand the science and that gene patents are essential to the growth of industry.

But the DOJ didn't misunderstand the science. On the contrary, the federal government finally got this one right, and the implications go far beyond the BRCA gene patents: If the initial court ruling and the justice department's position hold up, then virtually all gene patents, on human genes and on many other species' genes, will become invalid. As a result, a host of new avenues for promising biomedical research will be freed up, unimpeded by the prohibitive costs of licensing fees or the threat of crippling lawsuits.

No one — not the scientists who discovered them, and certainly not the lawyers trying to defend gene patents — invented the genes in the human genome. And none of us should have to pay a licensing fee before we can take a look at our own genes. Such a ruling will help the cause of science, not hurt it.

Steven L. Salzberg is the Horvitz Professor of Computer Science and the director of the Center for Bioinformatics and Computational Biology at the University of Maryland- College Park. His e-mail is salzberg@umd.edu.

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