In a closely-watched oral argument Monday at a federal courthouse in Washington, the core questions of the case read like scripts from a college philosophy exam: are isolated human genes and the subsequent comparisons of their sequences patentable? Can one company own a monopoly on such genes without violating the rights of others? They are multi-billion dollar questions, the judicially-sanctioned answers to which will have enormous ramifications for the worlds of medicine, science, law, business, politics and religion.
Even the name of the case at the U.S. Circuit Court for the Federal Circuit -- Association of Molecular Pathology, et al. v United States Patent and Trademark Office, et al -- oozes significance. The appeals court judges have been asked to determine whether seven existing patents covering two genes -- BRCA1 and BRCA2 (a/k/a "Breast Cancer Susceptibility Genes 1 and 2") -- are valid under federal law or, instead, fall under statutory exceptions that preclude from patentability what the law identifies as "products of nature."
In other words, no one can patent a human being. Not yet anyway. But there are plenty of other fascinating items or products, which you might otherwise consider "natural," that may be lawfully patented. Like Harvard's famously patented mouse, for example. The Patent and Trademark Office thought that BRCA1 and BRCA2 fit into this category. And the company which sought and now possesses the patents, Myriad Genetics, heavily markets the results today as one of their "molecular diagnostic products." From the company's website, here is the pitch:
BRACAnalysis® assesses a woman's risk of developing breast or ovarian cancer based on detection of mutations in the BRCA1 and BRCA2 genes. This test has become the standard of care in identification of individuals with hereditary breast and ovarian cancer and is reimbursed by insurance.
But a trial judge last March may have changed the plan. In a ruling with ramifications as large as the publicity it generated, U.S. District Judge Robert W. Sweet, a judge sitting with senior status in the Southern District of New York, declared that the two genes were unpatentable and that the USPTO had violated the constitutional rights of others in accepting Myriad's patents on them. Without valid patents, Myriad no longer would have "exclusive" rights to research the genes it had researched and developed. The field of BRCA1/2 research suddenly would be quite crowded, indeed.