Should patents be allowed for human genes? That is the question currently before the Supreme Court. Oral arguments heard on Monday, April 15, however, gave little insight into which way the Court may be leaning.
The case, Association for Molecular Pathology v. Myriad Genetics (12-398), concerns patents held by Myriad Genetics (Myriad) on human genes it isolated that are linked to increased hereditary risk of breast and ovarian cancer. Myriad is the only company that can test for abnormalities with the genes it has patented, and it requested that researchers refrain from infringing by working in this area. Researchers and institutions sought a declaratory judgment that the patents were invalid, but the Federal Circuit in a split decision held that human genes are patentable subject matter.
At the heart of the matter is whether the isolated genes are “products of nature” or “human-made inventions,” with only the latter being eligible for patent protection. In exploring the boundaries of patent law to determine whether Myriad actually invented something, the justices used several hypotheticals, including whether baseball bats, leaves from Amazon River plants or the basic ingredients in a recipe could be eligible for protection. For example, Justice Sotomayor equated the isolated gene to an ingredient in a chocolate chip cookie, arguing that while combining the ingredients in a new way is eligible for protection, the simple ingredients themselves are not. While the Association for Molecular Pathology (Association) argued Myriad did not actually invent anything, Myriad countered that there was human invention in deciding where to begin and end the gene.
Representing the federal government, Solicitor General Donald B. Verrilli Jr. argued that Mayo Collaborative Services v. Prometheus Laboratories, decided last year by the Court and holding that medical tests relying on correlations between drug dosages and treatment are not eligible for protection, suggests that merely isolating a gene is not enough. Rather, to be eligible for protection, the gene must be manipulated to create something not found in nature.
Of further concern to the Court was ensuring that companies are incentivized to continue to invest in medical research. Some argue that the patents save lives by encouraging medical innovation and investment which can ultimately be rewarded financially. Others, however, argue that the patents reduce innovation as researchers won’t invest in these areas for fear of being sued. The ruling, expected by late June, is sure to have a profound impact on the medical research and pharmaceutical industries.