The U.S. Supreme Court has decided it will hear the appeal of the Myriad, and, it is hoped, settle the issue as to whether or not companies can patent human genes, a decision that could reconfigure the direction of medical care in the United States.
IP Value Wire has been following the story for some time. Myles Jackson, Professor of the History of Science, NYU, writing in Huffington Post, provides excellent background for this historic development.
Since 1982 the United States Patent and Trademark Office (USPTO) has granted patents on human genes, and now there are over 4,000 such patents.
Myriad Genetics owns the patents on BRCA 1 and 2, genes which code for tumor-suppressing proteins. They also own the patent on mutations of these genes and a diagnostic test for any mutations that may impinge the proteins' ability to interact with cancer cells, “thereby increasing the chance of developing breast cancer.”
The overall theory behind patents is that full disclosure with protection stimulates innovation and research. However, as patent owner, Myriad does not permit researchers to perform full sequencing testing on BRCA 1 and 2. Right now, It is legally impossible to get validation of current test results, nor can the test be improved by others.
Not surprisingly, The Association for Molecular Pathology, The American College of Medical Genetics, The American Society for Clinical Pathology, The College of American Pathologists, and other researchers object to Myriad’s legal fortress, and, joined by the ACLU, argue that products of nature cannot be patented. The case has been bounced around, and now the U.S. Supreme Court has decided it should rule on the matter. At stake are the very business models of genetic research companies. Valuators have had to factor in this risk for some time. Soon, hopefully, we’ll have an answer.