Disease Gene Patents: Overcoming Unethical Constraints on Clinical Laboratory Medicine

Abstract

The rapidly growing number of disease gene patents—patents that claim all methods for diagnosis of a particular genetic condition—threatens the ability of physicians to provide medical care to their patients. In the past, patented diagnostic tests were made broadly available 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 standard 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 require compulsory licensing of physicians providing medical services is recommended. Vatican City (Reuters). The Vatican announced today that it has entered into an agreement with Dr. Mark Bogart of Honolulu, Hawaii, which grants to the Vatican exclusive rights to United States Patent no. 4,874,693. That patent, granted to Dr. Bogart in 1989, covers the human chorionic gonadotropin part of the maternal serum triple test for Down syndrome when performed between 18 and 25 weeks of pregnancy. Dr. Bogart, who was collecting royalties of several million dollars per quarter from hospitals, health maintenance organizations, and testing laboratories throughout the US, sold his interests in the patent for an undisclosed sum. The Vatican’s statement made clear that the Church intends to enforce its patent and prevent further use of the test in the US.