Part III of the book periodically broadens its scope beyond Henrietta’s case to include other controversial instances of scientific testing and the commercialization of results. In particular, Skloot talks about the 1984 case Moore vs. Regents of University of California, which involved patents awarded on a cell line derived from the plaintiff, John Moore. This case addressed two interesting issues that have arisen throughout the book. First, to what extent can we own biological material and its products; second, are we entitled to compensation for or control over the use of our own biological material.
Just as in Henrietta’s case, Moore was not informed that his tissue was being experimented on nor that it would be shared with other researchers or put to any use other than his own personal treatment. In fact, he seems to have been told by the physician Golde that it would not be used in any work of commercial value, even though Golde later patented the cell line and entered into an agreement with a biotechnology company to develop marketable products from it. The first question here whether the biological entity — the cell line — could be “owned” at all. Normally, US patent law states that naturally occurring biological entities cannot be owned for the purposes of patent protection. However, the Supreme Court case Diamond v. Chakrabarty determined that biological entities that are not naturally occurring and “only existed because they had been altered using ‘human ingenuity’” could be patentable inventions, referring in this case to a genetically engineered strain of bacteria that was unique in its ability to consume petroleum waste. Similarly, since cell lines must be cultivated through complex procedures and do not occur naturally outside the body, they can be patented as new and useful inventions, according to the Moore case. As a consequence, the doctor who developed Moore’s cell line held property rights in the line that he could sell for profit.
The other question in Moore was whether the original human source for the tissue also possessed property rights in it. Certainly, tissue that is part of a person’s body is her possession, but once it leaves the body, the issue becomes more difficult. The California Supreme Court ultimately ruled against Moore, and stated that although the doctor was wrong not to inform Moore of the university’s intentions, Moore still did not have any ownership in his tissue after it left his body.
Skloot tells us that this remains the law since no legislation has since adjusted these criteria. Clear requirements of informed consent or disclosure of future use have not been established, and the failure to do so does not undermine a research team’s patent rights of a. Interestingly, in the afterword, Skloot points out another patent case that seems to be slightly different from Moore and Chakrabarty. She mentions a lawsuit brought in the year she published the book (2009), against Myriad Genetics, which possessed the patent on two genes crucial to breast and ovarian cancer diagnosis. Skloot points out that these patents have given Myriad a monopoly on genetic testing for these genes that has artificially inflated the prices and inhibited outside research and the advancement of competing analyses. This would seem to violate the medical researcher’s ethical responsibility to facilitate the possible treatment for patients.
Interestingly in 2013, the Supreme Court decided against Myriad (see below link), though not because of the ethical concerns above. Instead the Court found that unlike the bacteria in Chakrabarty, the DNA sequences isolated by Myriad were not patentable inventions because they had not been altered using human ingenuity. The sequences were identical to those that could be found in a human chromosome in nature and were not altered as a consequence of being isolated from the rest of the DNA on the chromosome. It’s would be interesting to see what impact this decision might have on cases like Henrietta’s; it removes one type of biological entity from patent protection but seems to very much recognize other rights, like those in a cell line. Also it didn’t seem to address any of the ethical and public policy issues that are so relevant to Skloot’s book. For those who might seek real long term reform in this area, the courts don’t seem to offer a tremendous amount of hope even though Myriad had a relatively positive outcome. Might the attention that seems to be growing for these issues eventually lead to further regulation by Congress on the questions of ownership and consent?