Who owns the genome? The Human Genome Project was sold to the public on the promise of future health benefits. Its goals, however, promised only to “transfer related technologies to the private sector.” Ten years after its mission was accomplished, many people are wondering when their investment in public science will pay off.
Perhaps this helps explain why tests for BRCA1 and BRCA2 mutations, which predict risk for breast and ovarian cancer, have become a lightning rod for public discontent. They were discovered and patented in the 1990’s, before sequencing for the Human Genome Project began. Today they remain among the very few clinical genetic tests that are relevant to preventing common diseases.
Unlike many gene patents, those on BRCA1 and BRCA2 have been aggressively enforced, creating an effective monopoly for a single company, Myriad Genetics. The Supreme Court has not yet decided whether to hear the case that could decide whether they meet the definition of “invention” under patent law. In the meantime the ACLU, which organized the lawsuit on behalf of multiple plaintiffs, has launched a public information campaign, Take Back Our Genes. The centerpiece is a website inviting people to make videos explaining how gene patents have affected them, while holding a sign saying “I TAKE BACK MY GENES.”
But wait a minute—do we really want to take back our genes? It’s a good slogan for getting attention but it doesn’t do much to frame the issue for public debate. The fact is, a a person’s genes are useful for predicting health or diagnosing disease only to the extent that they can be compared with others. Practically everything we know about using genes to predict and diagnose disease has come from studying genetic variation in families and populations. A single genome reveals few secrets.
As the human genome sequence continues its transformation from shiny object to commodity, the search for value is focused on mining the data. Finding ways to manage, store, analyze, and share data—not just sequences but their annotations, variations, and associations—has always been a priority for genome research. The discovery of BRCA1 itself prompted NIH to establish the Breast Cancer Information Core, an international, open access, online database of mutations found in breast cancer. Its mission is to help ensure that “the detection and interpretation of these mutations is coordinated and that this information is made available to as many qualified investigators as possible.”
Genome policy expert Misha Angrist recently reminded everyone that Myriad Genetics is one of only two laboratories that do not participate in this database, having last contributed data in 2004: the data it continues to compile from clinical tests are proprietary. An analysis published this time last year in the Genomics Law Report suggests that these data could be Myriad’s ace in the hole, regardless of the fate of their gene patents. Opponents of gene patents should note that data sharing isn’t the only available alternative—data can also be entombed as trade secrets.
More than 40 years ago, an ecologist writing in Science introduced the “tragedy of the commons” as a metaphor for the overuse of a shared resource by individuals who act independently out of rational self-interest. A generation later, a pair of legal scholars warned against the opposite:
[T]he recent proliferation of intellectual property rights in biomedical research suggests a different tragedy, an “anticommons” in which people underuse scarce resources because too many owners can block each other. Privatization of biomedical research must be more carefully deployed to sustain both upstream research and downstream product development. Otherwise, more intellectual property rights may lead paradoxically to fewer useful products for improving human health.
Our society’s rules of membership, which apply to corporations as well as to real people, address many types of shared benefits and risks. As affirmed by the Institute of Medicine, government’s role is “striving to achieve a balance between the two great concerns in the American public philosophy: individual liberty and free enterprise on the one hand, just and equitable action for the good of the community on the other.”
The sense that benefits and risks are out of balance sometimes leads to hasty actions, such as the legislation pending in South Dakota and several other states that would create individual property rights in DNA. A new analysis in the Genomics Law Report considers potential implications of such laws that might surprise their authors. For example, would police still be allowed to collect DNA evidence at crime scenes?
Oceans of ink on these issues are free for the surfing by pundits and policy-makers. What may be missing is a way to engage the public in a broader discussion of values to redefine the genome commons. An opinion piece in The Scientist is one starting point:
Do patents promote investment in personalized medicine or stifle innovation by suppressing competition? Do patients benefit from patented therapies, or do they suffer without treatments because they are too expensive?…
At its heart, this debate may be more of a public policy question than a legal one. People deciding this issue must keep in mind that most university research is funded by government grants and that NIH is a federal agency. We may want taxpayer money to support this kind of research, but it raises the same specter of big government and taxpayer burden as health care reform. Is a country that may not be ready to provide universal access to proven therapies willing to invest substantial amounts in research programs that may take years to yield any benefits?