Women at risk for hereditary breast cancer—caused by two telltale genetic mutations—should be closely watching a gene-patent case under appeal in U.S. courts. At stake: who owns our genes.
The case, commonly referred to as ACLU v. Myriad Genetics, is the first of its kind to address whether genes are patentable. Plaintiffs are arguing that genetic information should not be the sole possession of corporations, and people shouldn’t have to pay exorbitant fees to research their own DNA. The defendants say that without patent protection, private industry won’t invest in genetic testing and patients will suffer.
Earlier this year, a district court judge ruled that the breast-cancer genes—BRCA1 and BRCA2—are not patentworthy on the basis that they’re products of nature. Late last month, the Justice Department backed up this interpretation, breaking ranks with 30 years of precedents at the U.S. Patent Office. (The office has been issuing gene patents on the assumption that isolating genes requires human intervention, as well as substantial financial investment.) Myriad Genetics, the company with the patents, has had sole control over testing for BRCA1 and BRCA2. The tests can cost thousands of dollars, and patients have not had the option to get tested by a second source.
Myriad is appealing the ruling, but if it fails, patents on thousands of human genes—constituting about 20 percent of the human genome—may become invalid in the U.S. Some patent attorneys claim this will scare biotech firms away from ongoing research. “Without the incentive of patent protection, the investment by private industry would never occur,” says Sean Tu, a patent lawyer who specializes in biotech. Myriad estimates that so far, it has spent approximately $500 million on research and development of the gene (that figure also includes money spent commercializing and marketing the diagnostic testing). As of April, the company had not yet made a profit on the project.
But critics of gene patenting argue that companies could end up stymieing academic research on gene mutations. Even though Myriad maintains it has not stopped purely academic research, not all patent holders might be similarly inclined.
As for the profitability question, opponents also say that genetic research will continue out of curiosity alone, pointing to an international race to isolate the BRCA gene in the 1990s in which many of the research groups promised to not seek a patent.
Problem is, unlike with the Human Genome Project, gene patents often blur the line between public and private entities invested in a race for scientific discovery. For example, Myriad shares its patent on the BRCA genes with the publicly funded University of Utah. And while Myriad itself has not received government funding, one of the company’s founders, Mark Skolnick, initially worked with the National Institute of Health and the University of Utah on isolating the genes. “It does cost a fortune to find a gene, but much of the fortune was paid by the U.S. government,” says Michael Watson, the executive director of the American College of Medical Genetics, one of the plaintiffs.
ACLU v. Myriad will be a milestone for U.S. biotech companies who seek to become profitable off genetic-patenting—and for those scientists and patients who think our genetic heritage should belong free of charge to anyone who cares to research it.