By Diane Allingham-Hawkins, PhD, FCCMG, FACMG, Senior Director, Genetic Test Evaluation Program and Technical Editing
Yesterday, the 9 Justices of the Supreme Court pondered the question of whether human genes should be patentable as arguments were heard in the case of Association of Molecular Pathology V. Myriad Genetics. The issue is whether or not a gene constitutes a “product of nature,” which would not be eligible for patenting, or once isolated from the body, could it be considered an invention, which is eligible for patenting. On one side of the arguments, patent-holders argue that patents foster innovation and investment, thereby saving lives. On the other side, professional organizations, patient-rights activists, and civil libertarians claim that patents limit access to genetic testing and impede the quality of testing.
You can follow along with the proceedings on the SCOTUS blog, are keeping readers apprised of the arguments.
Although the Justices clearly wrestled with the complex scientific facets of the case, it appears that the Justices are not inclined to relax the position that products of nature not be eligible for patenting. The question remains, however, as to what constitutes a product of nature in the context of human genes. To answer this question, the Justices turned to a number of analogies, including shaping a baseball bat out of a tree limb or using the sap of a plant from the Amazon for medicinal purposes. The analogy that appears to have cut right to the heart of the matter, however, is that of Justice Sonia Sotomayor, who stated that one could not get a patent for the ingredients used to make a chocolate chip cookie, but rather they would be required to show a new or novel process or use for the cookie. "If I combust those in some new way, I can get a patent on that," Justice Sotomayor said. "But I can't imagine getting a patent simply on the basic items of salt, flour and eggs, simply because I've created a new use or a new product from those ingredients."
Although apparently in agreement concerning the fact that a product of nature could not be patented, the Justices also seemed reluctant to say that genes are not patentable in any circumstance. According to Chief Justice Roberts, simply “snipping” a string of DNA out of the body is not an invention, but if one is to do something with that DNA that is new or novel and benefits society, that may be considered an invention. It was here that the baseball bat and sap of the Amazonian plant analogies were useful—while neither the tree nor the plant can be patented, the bat or the medicinal use of the sap may be.
In the end, a compromise seems most likely—genes, as they appear in nature, would not be patentable but a new or novel process based on an isolated gene could be. As for the fate of the wide-reaching Myriad patents, we must await the Supreme Court decision, expected by late June.
As stated in our earlier blog post on this topic, we at Hayes believe that genes are products of nature and therefore should never have been subject to patenting. We would welcome a Supreme Court decision that asserts the same belief.