Patents and Gene-Based Tests
Genes and their mutations are naturally occurring substances and should not be patented. Gene patents limit access to medical care, jeopardize quality of care, and raise the cost of care. Most discoveries of human or pathogen genes can be effectively translated into gene-based diagnostic test services without the incentive provided by patents or exclusive license agreements. Testing for naturally occurring sequence variants in DNA or gene expression should be widely available to promote optimal patient care, medical training, and medical research.
The College of American Pathologists believes:
- Gene-based test services are part of medical practice. As such, 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 and health-care professionals, and the continued improvement of the quality of medical 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.
- When patents, exclusive license agreements, or excessive licensing fees are used to prevent physicians and clinical laboratories from providing 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 because they interfere with medical training, practice and research, the advancement of medical knowledge, and enhancement of the public's health.
The College of American Pathologists believes that DNA and RNA sequence information derived from living organisms, including naturally occurring variation in these sequences and gene expression (to include mutations) should not be patented. Given the existing patents and pending applications, the College supports legislation that will accomplish the above and 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.
Adopted February 2000
Revised February 2009
Revised September 2013