The U.S. National Library of Medicine defines a gene as a unit of heredity that is transferred from a parent to offspring and is held to determine some characteristic of the offspring. Often times, genes act as instructors to make proteins. Genes also hold DNA, the building blocks of humans and all other animals.
Geneticists, laboratories, and investors have all been grappling with the intersection between intellectual property and genetics for decades. For example, is it appropriate for a corporation to own the right to your genetics? How do we ethically navigate patenting a living organism? Do gene patents incentivize or limit medical research? To date, the U.S. Supreme Court has applied a “Laws of Nature” approach to these issues, denying patents to multiple entities.
Article 1 of the U.S. Constitution requires our patent system to “promote progress in science and the useful arts.” According to the Supreme Court, genes are a “Natural Phenomena” and subject to the “Laws of Nature.” The Manual for Patenting Examining Procedure (MPEP) defines both of these concepts. A patent’s asset must fall outside of these parameters or “have markedly different characteristics compared to what occurs in nature” to be issued by the US Trademark and Patent Office. The rationale is that simply discovering things that already exist does not “promote progress in science and the useful arts.”
There are many examples of controversial attempts to patent genes and the topic has been brought before the Supreme Court many times. In the 1980’s, scientist Dr. Malcolm J. Simons found a certain relationship between DNA and non-coded DNA, otherwise known as “Junk DNA” for its apparent uselessness. Using this relationship, Dr. Simons discovered a method to analyze human DNA using Junk DNA, which he attempted to patent. In Genetic Technologies Ltd. v. Merial LLC, the Supreme Court found Dr. Simons’ discovery to be a “Natural Phenomena” and therefore considered ineligible for patent protection.
Genetic Engineer Ananda Mohan Chakrabarty created a microorganism capable of digesting crude oil. Mr. Chakrabarty filed a patent for the organism for use in minimizing the damage of oil spills. The patent was rejected by a patent officer because it was considered common knowledge you could not patent living things. The dispute was then brought to the Supreme Court, which ruled in favor of Chakrabarty in Chakrabarty v. Diamond. They justified the ruling, arguing, “the fact that microorganisms are alive is without legal significance for purposes of the patent law.” In the end, the Supreme Court found that because Chakrabaty had created a new organism, his discovery could be patented. Many critics have claimed that under this ruling Chakrabarty has effectively patented DNA because he now has a monopoly on an application of certain DNA sequences, and that now the genes in Chakrabarty’s organism are no longer public goods.
Up until June 13, 2013, approximately 20% of your DNA was patented. Various corporations and individuals held patents on isolated genes after Chakrabarty allowed an indirect approach to do so. Then, Myriad Genetics Inc. tried to patent the isolation of genes BRCA1 and BRCA2 based on a test they developed to predict the presence of breast and ovarian cancer in women. The case was brought to the Supreme Court, which ruled against Myriad Genetics because their discovery was considered a “law of nature”; they had not developed anything new but rather analyzed what was already there. This decision voided all previous claims to isolated DNA sequences except in cases where a new organism (and new DNA) was created. As a result, patent claims could no longer cover the genetics of humans (or animals).
Looking to the future, there is a bipartisan bill on the House floor which would overturn all Supreme Court decisions based on the doctrines of “laws of nature” and “natural phenomena.” The new bill disallows any “implicit or other judicially created exceptions to subject matter eligibility”, specifically eliminating consideration of “laws of nature” in new patent applications. The press release promoting the bill focuses on restoring “integrity, predictability, and stability to our nation’s patent system.”
Industry representatives, inventors, and investors,also believe that more genetic research would be funded if genes were patentable. They argue that such research would be healthy for the economy and the medical industry. They contend that individuals do not need patents for their own genes because they do not use them in a commercial sense. They justify their position by saying that using an isolated gene for a specific function makes a new entity different than the gene itself.
Many others, including the ACLU and prominent genetic researchers, agree with the Supreme Court. Some even argue that the Chakrabarty case was decided incorrectly because it resulted in a monopoly over the use of certain genes. In a letter of opposition to the proposed bill, these groups argued that it “would pave the way for businesses to own exclusive rights to genes, giving them the right to prohibit all others from providing and developing genetic testing and pursuing research.” Their concerns center on the constraints imposed by genetic patents on further related research and testing. They point out that in a world of whole body genetic sequencing, allowing any one entity exclusive ownership of genes would reduce innovation.
The issue of gene patenting is sure to cause more and more controversy on the court as gene-editing technology advances further. The line here is thin, with few precedents, and contradictory ones at that, to base it on. Both the Supreme Court and the people’s representatives in Congress must decide how far companies can go in monopolizing genes they spent the time investing in, and how much of gene research should be available for the common good.