Bioethics and Patent Law: The Cases of Moore and the Hagahai People.
Bioethics and Patent Law: The Cases of Moore and the Hagahai People
September 2006
Hairy cell leukemia. Dr. Golde patented a cell line established from Mr. Moore’s discarded spleen tissue. Should he have sought consent? (Photo: U.S. National Cancer Institute)
This is the final article in the WIPO Magazine series on intellectual property and bioethics. It looks at questions raised by the Moore and the Hagahai cases, where patents resulting from research based on human genetic material were challenged because prior informed consent had not been sought from the donors.
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 patient of any economic or personal interest in using or studying his tissues; and that if the fiduciary bond of trust is broken, the patient may sue for breach of that duty. This decision notably drew a distinction between the legal context of access to the genetic material, and the legal context of patenting a subsequent invention which made use of that material.
But debate continues over the legal and bioethical linkages between access to genetic resources and downstream patenting on derivative research. If an individual gives consent for basic research, can that consent be assumed to extend to patenting and commercialization activity resulting from the research? Should specific prior information be required as to the researcher’s future inventions? And who exactly should be able to give – or withhold – consent? This question becomes even more complex when the same genetic resources (e.g. a particular gene mutation) are shared between members of a family or community, or even neighboring countries. (Read more)
To Your Health 