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Ruth Marcus: The case of the patented genes

BY RUTH MARCUS Modified: May 21, 2013 at 8:26 pm •  Published: May 22, 2013
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Angelina Jolie's genes threatened to kill her. But, for the time being anyway, she doesn't own them.

Jolie revealed last week that she chose to undergo a double mastectomy after testing positive for the BRCA1 mutation. That genetic glitch meant Jolie's risk of developing breast cancer was as high as 87 percent; her mother died at age 56 of ovarian cancer, which is also associated with the BRCA1 gene.

Jolie's news highlights an arcane but increasingly important question of patent law. As the sequencing of the human genome has expanded the ability to test for such genetic susceptibilities, is the discovery of the gene itself a patentable invention?

The practical consequences are enormous. Would allowing companies that identify such genes to hold patents on them provide an incentive to useful discoveries? Or would it have the perverse effect of impeding research by allowing one patent-holder to lock up work on the gene, and, simultaneously, hurting consumers by driving up costs and availability?

As it happens, the Supreme Court is poised to decide this issue in a case involving a Utah company, Myriad Genetics, and its patents on the BRCA1 and BRCA2 mutations.

Patent law extends protections to “any new and useful process, machine, manufacture, or composition of matter.” But natural products or laws of nature cannot be patented. Think of the difference between gold (not patentable) and a method of extracting gold (patentable).

Those challenging Myriad's patents, the Association for Molecular Pathology and the American Civil Liberties Union, argue that genes are more like gold, or, as Justice Samuel Alito put it when the case was argued last month, a previously unknown plant found in the Amazon. Simply because it took an explorer the effort to find that plant and bring it home does not entitle him to a patent — although a process for extracting sap from the plant, or using it to treat a disease, would be patentable. Similarly, the BRCA genes, yanked from their natural habitat, are not themselves eligible for a patent.

Moreover, they argue, Myriad's patent in this case has frustrated scientific inquiry, not enabled it. Other labs have been blocked from studying the genes. Patients have been harmed because Myriad's monopoly has resulted in false negatives due to the company's decision to exclude certain mutations; the unavailability of confirmatory testing; and higher costs in the absence of competitors in the market. The mutations are “decisions that were made by nature, not by Myriad,” lawyer Christopher Hansen told the court.

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