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The Uncertain Future of Gene Patents

The first genes were patented in the early 1980s, and the practice has been controversial from the start. A patent is essentially a monopoly, giving its owner the right to exclude others from using the thing that is patented – conducting research, performing tests, or developing therapies involving it – without obtaining a license or paying royalties.

Concerns about the effect of gene patenting have to do with access, costs, and quality. They are vividly illustrated in the case of the patents associated with the BRCA1 and BRCA2 genes which belong to a class of genes known as tumor suppressors. Certain harmful mutations of these genes have been linked to an increased risk of breast and/or ovarian cancer.

A coalition headed by the Public Patent Foundation and the American Civil Liberties Union, on behalf of breast cancer and women’s health groups, individual women, geneticists and scientific associations, representing approximately 150,000 researchers, pathologists, and laboratory professionals, filed suit against the University of Utah’s Research Foundation and Myriad Genetics, which hold the patents on BRCA1 and BRCA2, and the United States Patent and Trademark Office in the U.S. District Court for the Southern District of New York.

In the case, Association for Molecular Pathology, et al., Plaintiffs, v. United States Patent and Trademark Office, et al., the plaintiffs argued that that these patents are illegal and restrict both scientific research and patients’ access to medical care. The plaintiffs contended that patents on human genes are unconstitutional “because they cover products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.”

On March 29, the court invalidated seven of Myriad’s 23 patents associated with the genes. The decision was based on the ground that these patents had been “improperly granted” – that an isolated and purified version of the gene is nothing more then a “`lawyer’s trick’ that circumvents the prohibitions on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”

Not surprisingly, the decision will cause turmoil in industries associated with gene patenting. Although it is possible that the decision will be overturned on appeal, a multitude of questions require thoughtful examination.

For instance, if the decision is upheld, can we expect to see changes in the business practices of firms and universities engaged in genetic research, which in turn may affect commercial and clinical development? If they can no longer apply for patents, researchers are likely to feel increased pressure to protect their inventions through competition and secrecy, which would slow the overall pace of research.

Timothy Caulfield and colleagues argued in a 2006 essay in Nature Biotechnology­  that genetic researchers were inclined toward secrecy anyway; removing patents would exacerbate tendency. Moreover, a 2005 essay in Science­ estimated that about 20 percent of human genes are associated with at least one United States patent. The research associated with these patents, as well as the diagnostic tools made available as a result, represent billions of dollars. How will the industry’s ability to raise capital be affected? How will the direction of research be affected? Will competition mean lower costs to eventual consumers? The answers to these questions will affect all of us as actual and potential consumers of health care tests and products associated with gene patents.

Given the stakes involved, the effect of the decision on both private industry and universities engaged in genetic research should be closely studied.

Ann Mills is co-director of the Program in Ethics and Policy in Healthcare, and Patti Tereskerz, an attorney and epidemiologist, is an associate professor of the Programs in Biomedical Ethics at the Center for Ethics and Humanities at the University of Virginia. They have consulted for the Biotechnology Industry Organization.

Published on: April 1, 2010
Published in: Emerging Biotechnology, Medicine & Business

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