ACLU Condemns Congressional Bill To Patent Human Genes, Nature, and Abstract Ideas

WASHINGTON — The American Civil Liberties Union today announced its opposition to legislation introduced by Sens. Thom Tillis and Chris Coons. The Patent Eligibility Restoration Act of 2023, which was announced today by the senators, would eliminate the long-standing prohibition on patenting laws of nature, natural phenomena, and abstract ideas from U.S. patent law.

Ten years after the Supreme Court invalidated the patents on two human genes in AMP v. Myriad, the Patent Eligibility Restoration Act of 2023 threatens to reverse that critical ruling, and the 150 years of legal precedent before it. If passed, the Act would allow corporations and other entities to patent laws of nature and products of nature, including naturally-occurring genes, giving them exclusive domain over research, development, and analysis. Such monopolies would result in higher health care costs, deny patients access to their health information, and create new hurdles for developing technologies to fight cancer, pandemics, and much more.

“The government should not be granting exclusive rights to control something as personal and basic to the human body as our genes. Patents on nature and abstract ideas limit research, learning, and the free flow of information that benefits all of us,” said Sandra Park, senior staff attorney at the ACLU’s Women’s Rights Project. “The ACLU is proud to defend the ability of researchers, scientists, and patients to use what should be in the public commons to create true inventions, and we oppose this bill accordingly.”

The ACLU opposes patenting that would authorize exclusive control over access to something as fundamental to humanity as our genes. For decades, the U.S. Patent and Trademark Office granted patents on DNA once it was discovered and “isolated,” authorizing patents that covered at least 20 percent of the human genome. Because isolating DNA is a preliminary step in any type of genetic analysis, Myriad Genetics was able to stop all other laboratories from offering clinical testing of BRCA1 and BRCA2, two genes connected with hereditary breast and ovarian cancer risk, even when they wanted to offer different, cheaper, or more comprehensive testing methods.

In AMP v. Myriad, the ACLU filed a lawsuit on behalf of 20 geneticists, genetic counselors, women patients, cancer survivors, breast cancer and women’s health groups, and scientific associations representing 150,000 geneticists, pathologists, and laboratory professionals. On June 13, 2013, the Supreme Court stopped the practice and unanimously held that human genes, including those that are “isolated,” cannot be patented because they are “products of nature.” Recently, the CEO of Myriad Genetics, the defendant in the AMP v. Myriad Genetics suit, said that the Supreme Court “ruled correctly.”

The bill sponsored by Sens. Tillis and Coons directly overturns this Supreme Court decision by permitting companies to once again patent genes and other natural materials once they are merely “isolated” or otherwise used in some way. The bill would also permit companies to patent the connection between genes and different diseases, blocking efforts in the scientific community to better understand and respond to health conditions. Legislation reversing the Supreme Court precedent was opposed by over 150 groups when Sen. Tillis and others offered draft legislation in 2019.