Bioethics and Patent Law: The Cases of Moore and the Hagahai People
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.
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.
The Hagahai case – genetic resources from indigenous peoples
The Hagahai are an indigenous group in Papua New Guinea. They lived an isolated existence until 1984, when they sought help because of a disease that was afflicting the community. Researchers found that the members of the tribe carried a gene that predisposes humans to leukemia, yet they did not themselves manifest symptoms of the illness. Further analysis of blood samples identified a T-lymphotrophic virus, with potential for development into a vaccine for certain types of leukemia. In 1991, the National Institutes of Health in the U.S. sought patent protection for a cell line developed from the DNA of a Hagahai donor (US patent 5397696). The invention related to a cell line infected with a Papua New Guinea Human T-Lymphotropic Virus (HTLV) variant, and to vaccines for humans against infection with and diseases caused by HTLV-I and related viruses.
The patent – which was later abandoned – sparked controversy over whether the Hagahai donor’s consent had, or should have, been obtained before the resulting cell line was patented. Reports of what actually happened vary greatly. But the fact that the genetic material came from an indigenous group made the case particularly sensitive, and gave rise to accusations of biopiracy. Nor was it ever determined whether in this case consent should have been obtained solely from the individual, or from the Hagahai people, or from the state.
Bioethical issues of consent are now being considered in a number of different fora and legal contexts. The focus extends beyond the use of genetic material of human origin, to plant and animal resources, and to biological resources linked with community-held traditional knowledge. Relevant international legal instruments include the Convention on Biological Diversity (CBD), which makes informed consent a condition of access to genetic material of plant or animal origin. A number of countries have introduced specific legal measures that draw a direct linkage between prior informed consent and subsequent patenting activities. The Andean Community has developed regional rules to the same effect. The CBD has commissioned two detailed studies from WIPO on this question, and some countries have proposed a revision of the WTO TRIPS Agreement to mandate a nexus between consent and the patent system. These measures tend to focus on biodiversity-related genetic resources, rather than genetic material of human origin.
Free, prior and informed consent is a cross-cutting theme, touching biotechnological innovation that ranges from medical research to bioprospecting. While the UNESCO Declaration sets prior informed consent in the context of human dignity and autonomy, the CBD links it to the sovereignty of nations over their resources, and the interests of indigenous and local communities. The appropriate linkages between consent arrangements and the patent system are the subject of intense debate and of several international processes.
As with the other issues discussed in this series of articles, policymakers are weighing the boundaries and linkages between bioethical questions and legal measures, including IP laws. These articles have sought to flag up some of these much-debated issues, while recognizing the diversity of views that are brought to these important, ongoing debates.
Series by Anja von der Ropp and Tony Taubman, WIPO Global IP Issues Division