On June 13, the U.S. Supreme Court handed down a ruling in Association for Molecular Pathology et. al. v. Myriad Genetics, the outcome of which was considered crucial in the development of genetic research.
In May 2009, the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PPF) sued Myriad Genetics, arguing that two patents the company held on human genes associated with breast and ovarian cancer were unconstitutional and invalid. Myriad, a molecular diagnostic company, discovered the location and sequence of the BRCA1 and BRCA2 genes. Mutations of these genes dramatically increase the risk of breast cancer and ovarian cancer, respectively. Myriad was able to develop a diagnostic test which could determine whether a patient had these mutations.
Since securing the relevant patents, Myriad has tested more than a million women since the late 1990's. For most women, the cost was over three thousand dollars for the breast cancer analysis. In some cases, a supplemental test was required which cost $700 dollars.
Myriad guarded its discovery closely, taking legal actions against other companies who were attempting testing based on the same gene pattern. Myriad has also held the cost of testing at what some consider to be a high level.
The Supreme Court, in ruling against Myriad, held that isolated human genes in and of themselves are not patentable. Separating the gene from its surrounding genetic material is not an act of invention as contemplated by the controlling statute. But the Court found that a synthetic version of the gene created in the lab could be protected by patent. It also hinted that the process employed to isolate the genes could perhaps be patented, though the genes themselves could not.
The results of the Supreme Court's decision are not immediately clear. Myriad's patents are due to run out in a few months. At that point, we'll know more about how generic companies will price these tests and the degree to which they will be covered by insurance.
By William C. Talmadge