Judge Robert Sweet in the U.S. District Court for the Southern District of New York has allowed a challenge to two gene patents owned by Myriad Genetics. The ACLU, on behalf of scientific organizations, researchers, genetic counselors, and individual women, is contesting the validity of gene patents in general, and is challenging the patents on the BRCA-1 and BRCA-2 genes in particular. The complaint alleges that gene patents are unpatentable subject matter under 35 U.S.C § 101, and that such patents violate the First and Fourteenth Amendments.
Are Genes Patentable?
Naturally occurring things, even if newly discovered, may not be patented. The ACLU asserts that the isolated genes in Myriad’s patents are no different from the genes that occur in nature. The ACLU’s lawsuit seeks to invalidate Myriad’s patents. They also argue that the patent covers basic human knowledge or thought (more specifically, the process of comparing the mutated gene to the normal one) and is therefore a violation of the First Amendment. If the court accepts this reasoning, genes will no longer be patentable material under § 101.
Why It Matters: The BRCA Genes and Cancer
The BRCA-1 and BRCA-2 genes are linked to hereditary breast and ovarian cancer. Women with mutations in these genes have a 40-85% chance of developing breast cancer, and suffer an increased risk for ovarian cancer as well. Diagnostic tests can reveal these mutations, allowing women to better assess their risk. Many women who have the mutated genes can undergo screening for the cancers earlier and more frequently than usual; some may even elect to have prophylactic surgeries. Results can also serve to alert female relatives that they are more likely to have the mutation. However, since Myriad holds patents on BRCA-1 and BRCA-2, it currently possesses a right to exclude others from performing these diagnostic tests.
The ACLU’s complaint points out that Myriad has failed to license its patent widely, which carries with it important implications. Given that there are no alternatives, Myriad may freely price their diagnostics; many argue that the current rate ($3000 per test) is too expensive for many of the women who need to be tested. Additionally, without other laboratories conducting similar tests, women are unable to secure second opinions.
The Big Picture
About 20% of human genes are patented. Patent holders can prevent a researcher from studying or testing a particular gene. Many of these genes, like BRCA-1 and BRCA-2, are associated with serious illness, including Alzheimer’s, muscular dystrophy, and colon cancer. The ability to screen for genetic predispositions to these and similar diseases represents a great advance in personalized and predictive care. There is concern, however, that allowing gene patents might slow development in this area. The ACLU claims that, with gene patents, there is no opportunity to invent around the patent or to build upon and improve it. They argue that this produces a disincentive to innovate.
As the court wrote in its opinion denying Myriad’s motion to dismiss, “the resolution of these issues will have far-reaching implications, not only for gene-based health care . . . but also for the future course of biomedical research.”
The ACLU’s complaint is available here.
By Claire Devine and Kyle de Neve.