Bioethics and Patent Law: The Cases of Moore and the Hagahai People

Informed consent

The doctrine of prior informed consent derives from medical ethics, where it concerns the patient’s right to agree to, or refuse, certain medical treatment after being informed by the practitioner about the risks and benefits. The concept extends increasingly to other fields, notably to medical research using human tissue. The 2005 UNESCO Declaration on Bioethics and Human Rights provides that both scientific research and medical interventions "should only be carried out with the prior, free, express and informed consent of the person concerned." This approach would appear to require a patient’s express consent in the event that samples taken in the course of the medical intervention are used for research purposes.

But a further issue then arises. What if genetic materials, taken from the human body and used as inputs for research, subsequently lead to biotechnological inventions, which are then patented? Should consent over use of research inputs also extend to the patenting of research outputs? Should separate consent then be obtained for each stage?

John Moore’s spleen

Mr. John Moore suffered from hairy-cell leukemia. In 1976, Dr. David Golde of the University of California Medical Center, recommended that his spleen be removed in order to slow the progress of the disease. Mr. Moore signed a written consent form authorizing a splenectomy, and surgeons removed his spleen. Dr. Golde and his research assistants extracted tissue from the discarded spleen, having recognized its value for research to develop possible ant-cancer treatments. In the next three years they established a cell line from the extracted T-lymphocytes. Mr. Moore was not informed about the research work or the potential of the cell line. In 1984 Dr. Golde was granted US patent 4438032 on the cell line, which generated substantial revenue through commercial arrangements with two biotech firms.

John Moore sued, claiming an ownership interest in the patent, as well as redress from Dr. Golde for breach of his professional obligations. On appeal, the Supreme Court of California rejected Mr. Moore’s claim to ownership interest in the patent - he was not one of the inventors. Nor, it concluded, could a patient exercise property rights over discarded body tissues. But the Court did rule that a physician has a ''fiduciary duty'' to inform a...