Tell Congress: Prioritize Patients over Gene Patents

On July 27, molecular professionals from around the United States met with the offices of their elected representatives to express opposition to the Patent Eligibility Restoration Act of 2023. This concerning legislation would allow resumption of patents on naturally occurring DNA that has been isolated from the human body, reversing a unanimous Supreme Court decision that has led to a decade of unprecedented scientific innovations and advances in precision medicine and patient care.

Ten years ago, the U.S. Supreme Court ruled unanimously that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated” in Association for Molecular Pathology v. Myriad Genetics, Inc (2013). As a practicing physician and pathologist who diagnoses patient conditions every day, this case has had a profound impact on my career.  When I started in my field, gene patents were held on some 20% of the human genome. At that time, the patents hampered the ability of the medical and scientific communities to advance research and develop new tests and treatments for conditions such as cancer, muscular dystrophy, Alzheimer’s disease, and heart disease. In addition, they allowed testing monopolies that stifled competition, reduced patient access, and increased costs. By striking down gene patenting, the Court’s ruling significantly improved the ability for healthcare professionals to accurately diagnose conditions and tailor treatments for patients across America, leading to our current exciting era of Precision Medicine. The decision was celebrated by a broad community of physicians, scientists, patient advocates, and industry.

Before the AMP v. Myriad case, a test to sequence two genes associated with hereditary breast and ovarian cancer cost more than $4,000. Today, multiplex gene panels - with dozens of relevant genes included in a single test - are now routine practice, and they are available (and significantly more affordable) to patients regardless of their insurance status. The impact of the Court’s decision is also apparent in the laboratory community’s response to the COVID-19 pandemic, where the decision enabled rapid diagnostic innovation in a very short time period in a fast-moving situation. As soon as the RNA sequence of SARS-CoV-2 was posted publicly on the internet, diagnostic testing developers, including academic laboratories and manufacturers, worldwide began working to develop, validate, and launch high-quality SARS-CoV-2 tests. Had the genomic sequence of SARS-CoV-2 been eligible to be patented, the patent holder could have restricted testing to as little as a single test or test manufacturer, which by no means would have met the testing capacity needs over the past three years. Instead, hundreds of tests were deployed, allowing for an unprecedented scale of testing in the face of unpredictable waves of viral variants and supply-chain disruptions.

While the United States healthcare system remains a work in progress, the 2013 AMP v. Myriad Supreme Court decision deserves enormous credit for helping to break down this major barrier for improved access to laboratory testing in America today. To preserve and build upon existing progress, we must maintain this access to genomic information and their associated health implications. I urge lawmakers to continue listening to and engaging with the medical and scientific community, particularly laboratory professionals, so we may further advance patient outcomes, rather than hinder existing progress.

Eric Konnick, MD, MS, FCAP