Patents and Gene-Based Tests

Article I, Section 8, Clause 8 of the United States Constitution empowers Congress to grant authors and inventors exclusive rights in their writings and inventions for a limited time, specifically, “To promote the Progress of Science and useful Arts”. A series of Supreme Court cases have ruled that patent rights cannot be granted over basic tools of scientific and technological inquiry. Monopolization of things such as natural phenomena, laws of nature, and abstract ideas would significantly impede, rather than promote, innovation.

Genes and their mutations are naturally occurring substances, and a unanimous Supreme Court ruling in 2013 held that they should not eligible for patenting. In the United States, genes began to be patented in the 1980s and the practice negatively impacted clinical care through limiting access, jeopardizing quality, and significantly increased cost. As a fundamental element of biology, genes and their sequences are crucial to understanding normal physiology and disease. Discovery of human or pathogen genes can often be translated into gene-based diagnostic test services without the incentive provided by patents or exclusive license agreements. The freedom to test for naturally occurring sequence variants in DNA or gene expression must remain widely accessible for optimal patient care, medical training, and medical research.

Read: A decade after a landmark ruling, gene patents still threaten America’s health

Read: 2019 Comments on Amendments to Patent Act

Read: 2021 Comment letter to U.S. Patent and Trademark Office

Read: 2024 Comment letter S. 2140, the Patent Eligibility Restoration Act

Despite the unanimous 2013 Supreme Court ruling that genes are not patent eligible, there has been relentless commercial pressure to revert to a condition where corporate ownership of disease is legally permissible. Clinical laboratory genomics is a broad field with numerous critical implications for patient care. Gene patents pose a serious threat to patient care, medical advancement, and medical education. Lawsuits, exclusive license agreements, excessive licensing fees, and restrictive licensing conditions were problems that were experienced by clinical laboratories before, and their return would put the provision of genetic-based clinical testing and patient care at risk. Allowing commercial entities to resume patenting natural phenomena, including genes, would reintroduce a significant roadblock to patient care.

We support the current judicially clarified exceptions to patent subject matter eligibility, in that natural phenomena, laws of nature, and abstract ideas are not patentable. This understanding protects the pathologist’s right to freely utilize basic tools of scientific/medical inquiry to care for patients (e.g. correlate genetic changes with disease, generate reference ranges, etc).

• Gene-based test services are important to medical practice. They should be widely available to promote optimal patient care, medical training, and medical research.
• The research, development, and practice of molecular pathology testing in academic and other medical centers is essential to medical progress, the training of physicians, researchers, allied health-care professionals, and for the continued improvement of medical care.
• Discoveries of human or pathogen genes can be effectively translated into gene-based diagnostic test services without the incentives provided by patents or exclusive license agreements.
• Natural phenomena patents have previously led to exclusive license agreements, excessive licensing fees, and lawsuits; preventing physicians and clinical laboratories from providing and/or developing gene-based diagnostic test services. This limits access to medical care, jeopardizes its quality, and raises its cost.
• Exclusive licenses that limit gene-based test services to a single provider are not in the public interest. They interfere with medical training, practice and research, the advancement of medical knowledge, response to public health emergencies (e.g. viral pandemics), and enhancement of the public’s health.

The College supports the current judicially clarified exceptions to patent subject matter eligibility, and legislation that would protect physicians and other providers of clinical laboratory services against enforcement of any patents on genes and against liability for infringement of patents on genes, regardless of the date of issuance of the patents.