Disease gene patents: Overcoming unethical constraints on clinical laboratory medicine

The rapidly growing number of disease gene patents— patents that claim all methods for diagnosis of a partic-ular genetic condition—threatens the ability of physi-cians to provide medical care to their patients. In the past, patented diagnostic tests were made broadly avail-able to the medical community in the form of test kits or licenses to use the patented test. Disease gene tests, however, are being monopolized by a small number of providers. Monopolization of medical testing services: (a) threatens to restrict research activities; (b) creates unacceptable conflicts of interest; (c) may reduce patient access to testing; (d) may lead to inequitable extensions of patent terms on tests and related discoveries; and (e) grants to patent holders the ability to dictate the stan-dard of care for testing, and to otherwise interfere with the practice of medicine. Because of the risks raised by monopolization, amendment of the patent law to re-quire compulsory licensing of physicians providing medical services is recommended