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.
Which brings us to Monday morning, when the Federal Circuit once again has to figure out what the nature of nature is as it relates to federal patent law. It's dense, technical stuff that belies the fundamental nature of the inquiry -- and the fact that there are millions of people here, there and everywhere who are following this story because it may have a direct impact upon their lives. That story, the legal aspect of it anyway, began in May 2009 when a group of doctors, patients, gene researchers, the American Civil Liberties Union and others challenged the Myriad patents. In their complaint, the group plainly stated their cause:
Ease of access to genomic discoveries is crucial if basic research is to be expeditiously translated into clinical tests that benefit patients in the emerging era of personalized and predictive medicine. The patents make ease of access more restricted. Because of the patents, defendant Myriad has the right to prevent clinicians from independently looking at or interpreting a person's BRCA1 and BRCA2 genes to determine if the person is at a higher risk of breast and/or ovarian cancer. Because of the patents and because Myriad chooses not to license the patents broadly, woman who fear they may be at an increased risk of breast and/or ovarian cancer are barred from having anyone look at their BRCA1 and BRCA 2 genes or interpret them except for the patent holder.
Myriad and its co-defendants in this civil action quickly moved to dismiss the complaint. It's lawyers were also clear. They wrote:
[The] patent system has worked exactly as it was designed to do. Myriad Genetics and the other Defendants have spent considerable time, effort, and money, in competition with other researchers, to discover the BRCA1 and BRCA2 genes, synthesize DNA corresponding to the genes in test tubes, and identify specific gene mutations that are correlated with breast and ovarian cancer.... The plaintiffs accept these facts, but they object to the Defendants' exclusive rights covering the diagnostic tests. Of course, such limited terms of exclusivity is exactly how the patent system rewards the Defendants' landmark discoveries, and encourages the life-saving research that the Defendants have performed. Without such efforts incentivized by exclusivity, there would be a much smaller number of women, if any, tested for mutations in the BRCA1 and BRCA2 genes. Indeed, but for the prospect of the patent exclusivity, Myriad Genetics would not have been established and funded by investors.
The federal government also responded to the gene patenting lawsuit. The U.S. Patent and Trademark Office, which had issued the patents to Myriad in the first place (and thousands more in this field), sought to defend its decision. The USPTO had both the statutory and constitutional authority to issue the patents, federal lawyers argued, and there were good reasons for the severe statutory restrictions on the ability of third-parties to challenge those patents. Science likes certainty -- but capital and the law like it even more. The USPTO essentially told the judge that Myriad had truly "invented" something beyond a "product of nature" worth protecting through patent.