As biotech nerds around the world celebrate International DNA Day (in case you forgot, that's this Thursday, April 25 — the 60th anniversary of the day James Watson, Francis Crick, and their colleagues published papers on the structure of deoxyribonucleic acid), and the Maine legislature considers a bill that would require genetically engineered foods to be labeled as such, the US Supreme Court is getting ready to rule on the seemingly sci-fi question of whether private companies can obtain patents on genes, the molecular units that comprise our DNA.
Last week, the court heard oral arguments in Association of Molecular Pathology v. Myriad Genetics, a case that pits scientists, breast cancer survivors, and women's health advocates against a Utah-based biotechnology company that offers diagnostic tests for hereditary breast and ovarian cancer genes. Since the 1990s, Myriad has held patents on what are known as the BRCA1 and BRCA2 genes, which are linked to both types of cancer.
In their lawsuit, the American Civil Liberties Union and the Public Patent Foundation contend that Myriad's patents are unconstitutional and should be invalidated. "Our main constitutional argument is that patenting genes impedes scientific freedom and inquiry, which is protected under the First Amendment," says Rachel Healy of the ACLU of Maine.
In their statements, plaintiffs (who represent dozens of research institutions, as well as affected patients) describe many ways in which gene patenting is problematic. First, it creates a diagnostic monopoly. If a woman wants to test her own DNA for mutations on the BRCA genes, she must go through Myriad, because by virtue of its patents, it is the only provider of this genetic test. This precludes the common practice of getting a second opinion, and does little to promote affordability (the Myriad test costs more than $3000) or to further innovation.
"Myriad's monopoly of the genes prevents others from conducting diagnostic tests on the BRCA genes and from developing alternative tests," says Judy Norsigian, executive director of the Boston-based Our Bodies Ourselves health-care advocacy organization. "This means there is no way for a woman to know if the test has been done properly, to confirm whether the results are accurate, or to get a second opinion. Because it has no competition, Myriad can charge exceptionally high rates . . . which many women cannot afford."
Experts say gene patents have a chilling effect on research and development. As it stands now, about 20 percent of human genes — including others connected to Alzheimer's disease, muscular dystrophy, and colon cancer — are patented; researchers who want to study a patented gene must obtain permission to do so from the patent holder, who has the right to prevent others from experimenting with that gene.
"I became a scientist because of the endless possibilities for discovery and progress in my field, but now so much research is blocked by the legalities of patents," Arupa Gaguly of the Penn Medicine Genetic Diagnostic laboratory says in her plaintiff's statement. "This seems to me to go against the spirit of my work."
Some even argue that gene patents put ethnic minorities at a particular disadvantage. According to doctors, African Americans, Hispanics, and Asian Americans are disproportionately likely to show what Myriad refers to as "variants of unknown significance" — ambiguous test results. Due to limitations imposed by gene patents, researchers have been unable to study and interpret such results to gain a better understanding of relevant genetic mutations.