This is particularly true when the United States Patent and Trademark Office grants extremely broad patents on genetic discoveries. The field of Molecular Pathology uses genes and their mutations to predict or diagnose disease in the fetus, the newborn, children and the adult. Physicians and scientists can easily and rapidly translate the fundamental information derived from mapping the human genome into diagnostic genetic tests and use these tests for patient care. Because information about gene sequences is so fundamental to understanding specific diseases, patent holders can essentially gain ownership of diseases through patents. Exclusive or restrictive license agreements on gene-based tests have been used to prevent physicians and clinical laboratories from performing these tests as diagnostic medical procedures.
Patients suffer because diagnostic test services are less readily and affordably accessible.
Medical education and research related to laboratory testing are also threatened. Forty eight percent had decided not to develop or perform a test for clinical or research purposes because of patent restrictions. Thousands of gene patents have been granted and over 10,000 patents are pending. Physicians should not be further restricted from medical practice and providing quality care. Throughout history, medical discoveries have progressed from the discovery of basic anatomy to histology and cytology, none of which are patented, to the more recent discovery of genes.