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What happens when law intersects with technology and bioethics? Often, there's heated disagreement. However, the Supreme Court justices recently agreed unanimously on a high-profile matter of great significance to medicine, biotechnology, and bioethics: in Association for Molecular Pathology v. Myriad Genetics (June 13, 2013), it ruled that the human genome cannot be patented.
The origins of the case go back to the mid-1990s, when a company called Myriad Genetics successfully identified two genes linked with breast cancer, BRCA1 and BRCA2. The company obtained patents on these genes, giving it a monopoly on research with them. Such monopolies protect patent holders, who may spend millions of dollars on research and development for the chance to discover a "gold mine"—or a "dry well."
Myriad's monopoly meant that no university, company, or other entity could conduct research or diagnostic tests on the two breast cancer genes without Myriad's permission—which came, if at all, with a prohibitively high royalty fee. Over the years, Myriad sued various researchers and labs for performing tests without permission, and it won, effectively consolidating its monopoly on the breast-cancer genes.
Meanwhile, critics claimed that research in personalized genetic medicine was being stymied. Genetic testing labs had to tiptoe around BRCA1 and BRCA2, and the convoluted testing procedures they had to devise to avoid patent infringement claims drove up patient costs. Research into entire genome sequencing was hamstrung.
Apart from these effects, Myriad's patents on BRCA1 and BRCA2 raised fundamental ethical questions about patenting the human genome. How could a corporation hold exclusive rights to a segment of DNA, something that is inside each one of us? To be sure, the Supreme Court had previously upheld a patent on a biological organism—a genetically engineered oil-devouring bacterium designed to clean up oil spills—in a controversial 5–4 decision (Diamond v. Chakrabarty, 1980). But a patent on an organism engineered in a lab is a far cry from a patent on a human gene—especially when the patent bars a researcher from developing a cheaper and more accurate breast-cancer test, or prevents a woman from finding out if she has the breast-cancer gene unless she uses a Myriad Genetics test (currently priced at nearly $4,000).
In Europe, where the genome is regarded as part of our universal heritage, human-gene patents have been rejected as ethically unacceptable and contrary to the ordre public. For example, the Council of Europe's 1997 Convention on Bioethics prohibits financial gain from the human body and its parts, a prohibition that extends to patents on the body "in its natural state." A summary of the European view might read: "It is not yours to patent; it is not mine to hoard; it belongs to all of us."
The U.S. Supreme Court, in an opinion written by Justice Clarence Thomas, agreed that the BRCA1 and BRCA2 genes, in their "naturally occurring state," are not patentable. Simply finding the location of these genes on the human genome did not constitute an invention, even if it was a groundbreaking or brilliant discovery. The Court did hold, however, that Myriad might patent complementary DNA (cDNA), isolated segments with the non-coding portions removed.
In this case, the Court appears to have struck the right balance. Naturally occurring DNA, even if removed from the body, is not patentable. It is a product of nature. But DNA that is modified in the lab might be patentable.
Here are some practical implications of the Court's decision: One company has announced a much cheaper breast-cancer test, and Myriad Genetics is dropping its price, anticipating the effects of a competitive marketplace. Companies that want to sequence the whole genome, including the breast-cancer sequences, may be able to do so. Research on better diagnostics and therapeutics can move ahead, not only for breast cancer, but also for other genetically linked diseases.
This time, when law, ethics, and biotechnology met, the outcome was a happy one. •
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