Posted January 18, 2011
Genes and the relationships between genetic variants and clinical phenotypes are naturally occurring substances and phenomena, and should not be patented. Gene patents limit access to medical care, discourage innovation and research hence jeopardizing quality of care, as well as raise the cost of care. Most 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. Genetics-based tests should be widely available to promote optimal patient care, medical training, and medical research.
The College of American Pathologists believes that genes, their variants, including mutations, and the relationship between these variants and clinical phenotypes, are naturally occurring substances and natural phenomena, and should not be patented. The College supports legislation and judicial decisions that will accomplish this and protect physicians and other providers of clinical laboratory services against the enforcement of patents on genes, and against liability that results from the infringement of gene patents.
- Genetics is the study of how biological traits and characteristics are transmitted to us by our parents. Molecular medicine examines how illness and disease occur or can be prevented at the cellular or molecular level.1 This includes heritable genetic conditions as well as acquired genetic diseases, such as cancer.
- Many, if not most, diseases are rooted in our genes. More than 4,000 diseases are thought to stem from mutated genes inherited from at least one parent.2
- Genetic variation also plays a role in the metabolism of drugs, and therefore can be related to optimal dosing, clinical response, and the development of side effects for some medications.
- Mutations that arise in cellular DNA over an individual’s lifetime, either spontaneously or in response to environmental stimuli, often influence the development of diseases like cancer. Analysis of mutations within tumors can aid in establishing a diagnosis, estimating prognosis, and predicting the responsiveness of tumors to therapeutic drugs and monitoring progression or resolution of the disease.
- A gene patent is a patent issued for a specific nucleic acid (DNA or RNA) sequence of a particular organism.
- To date, more than 4,000 patents on human genes have been granted in the United States and 47,000 that involve genetic material.3
- The topic of gene patenting has provoked much controversy in political and medical ethics arenas.
- A concern is that gene patents will limit the availability of genetic tests, increase their cost, and reduce innovation, decreasing access to medical care and jeopardizing its quality.
- The College of American Pathologists (CAP) believes genes and their variants, including mutations, and the relationships between genetic variants and clinical phenotypes are naturally occurring substances and phenomena and should not be patented.
- The CAP supports legislation and judicial decisions that will accomplish this and protect physicians and other providers of clinical laboratory services against the enforcement of patents on genes or the relationships between genes and clinical phenotypes, and against the liability that results from the infringement of patents on genes or the relationships between genetic variants and clinical phenotypes.
- The College of American Pathologists is a medical society serving more than 17,000 physician members and the laboratory community throughout the world. It is the world’s largest association composed exclusively of board-certified pathologists and is widely considered the leader in laboratory quality assurance. The College is an advocate for high-quality and cost-effective patient care.
- American Medical Association, Copyright 1995-2010, American Medical Association. All rights reserved.
- The Hastings Center