June 13, 2013 – The U.S. Supreme Court today in a unanimous decision ruled that companies cannot patent human genes, a decision with broad ramifications for research companies and the general public. University of Houston Law Center Professor Barbara Evans, co-director of the Health Law & Policy Institute, and Assistant Professor Sapna Kumar, both experts in the field of biotechnology, offer their explanation and reaction to the court ruling.
The Supreme Court's decision today in Association for Molecular Pathology v. Myriad Genetics resolves a question that has been a sore spot since the dawn of the genomic era back in the early 1990's: Should a person be able to patent a gene merely because the person was the first to identify it? The Supreme Court said "no." The gene, of course, was there all along, like a star that was twinkling in the sky long before an astronomer happened to come along and notice it. The gene itself is a product of nature, a part of God's creation that no human hand invented. The fact that somebody came along and discovered the gene should not give that person a right to patent the gene and block others from using it in their own scientific and medical pursuits. That, in essence, was what the Supreme Court held today.
Today's decision makes sense, but it is a major change that has the potential to upset business expectations of biotech firms that have structured their businesses on the assumption that genes are patentable. One hears dire forecasts that invalidating gene patents will put a halt to biotechnology investment and innovation. Frankly, those fears seem overblown. Merely discovering that genes are there is not a particularly useful form of innovation--anybody with the right equipment can discover genes nowadays. Finding genes may have been innovative in the early 1990s but it is not innovative now. What is useful today is for people to invest in discovering what genes do: How does a particular gene variant affect a person's health, and how can we harness that information to make people healthier? The sort of gene patents that the Supreme Court invalidated today do not necessarily promote that sort of useful innovation and, indeed, they may actually hinder it by blocking the ability of scientists and doctors to use and study genes.
A 2012 case, Mayo Collaborative Services v. Prometheus Laboratories, actually had a more profound impact on useful innovation than today's case does. The Mayo case makes it hard to patent discoveries of the useful relationships between genes and human health. Together, these two cases may simply be telling us that the patent system was never the right legal framework for promoting useful innovation in the genomic sciences. Genomic medicine is informational medicine, and for information to be useful it needs to be shared.
The core challenge is to promote information sharing while still making sure that the innovators who create information can make a living doing so. The patent system has not struck that balance in the right way in the case of genomic medicine. Other areas of law -- including infrastructure law and antitrust law -- seem better equipped to meet that dual challenge. Following today's decision, the debate about genomic innovation policy may move away from patents and focus instead on other areas of law that offer a better set of tools for striking the right balance between information generation and information sharing.
Q.) What did the Supreme Court rule today?
The Supreme Court held that isolated genes are not patentable because they are products of nature. This means that the first company to determine which genes are associated with a particular disease, and to successfully isolate the relevant portions of the genes, will no longer be able to patent the gene.
Q.) Why does this matter to the general public?
Gene patents allowed companies such as Myriad Genetics and Athena Diagnostics to get a monopoly over tests for a variety of diseases, including breast cancer and Alzheimer's disease. Now, many companies will be able to offer genetic testing, meaning that genetic testing will become more affordable to patients. It also means that patients will be able to confirm a test result with another laboratory, allowing them to have more information before making major medical decisions.
Q.) How will this affect future innovation in genetic research?
I don't think that this decision will have a negative impact on new discoveries of genes that are linked to diseases. For example, Myriad wasn't the only one to discover the correlation of BRCA2 with breast cancer—in the European Union, not-for-profit Cancer Research UK secured the patent. Numerous laboratories at universities work in this area.
Moreover, the real advances to be made are not in genetic testing, but in developing new methods of treating diseases that target or even alter our DNA. The Supreme Court's decision leaves the door open for patents on such novel treatments.
Q.) Will this be the end of the gene patent debate?
Unfortunately, no. The Supreme Court merely ruled that under the current Patent Act, isolated genes cannot be patented. Congress is free to amend the Patent Act to allow such patents to be issued. I believe that the Supreme Court should have raised sua sponte constitutional concerns that gene patents may violate the due process rights of patients wishing to make informed health care decisions and may violate the First Amendment rights of researchers who wish to communicate findings to research participants. What we are seeing is only the tip of the iceberg.
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