Today, a divided appellate court upheld patents on two human genes associated with hereditary breast and ovarian cancer. The ruling partially reverses a landmark decision by a federal district court in March 2010 that concluded that human genes cannot be patented. The appellate court did affirm the district court’s invalidation of several claims on methods for comparing two genetic sequences.
The decision today allows companies like Myriad Genetics, which controls the patents on the BRCA1 and BRCA2 genes, to exclude others from testing and conducting research on patented genes. Patients who want to obtain genetic testing to determine whether they are at risk for hereditary breast and ovarian cancer have only one option for full genetic sequencing: Myriad Genetics. Myriad decides what tests are offered, which mutations are included, at what cost, and what research can be conducted without fear of patent infringement liability.
The Supreme Court, the court that would hear any appeal, has long held that products of nature are not patentable subject matter. A gene, even once removed from the cell, remains a product of nature. The patentholder did not “invent” the genetic information it embodies, and we will continue to fight for that principle.