Bringing the gene-patent debate down to earth
In contrast to so many current political debates–climate change, abortion, health care–intellectual property law often appears to occupy a rarefied perch accessible only to patent experts, clerks and judges. Patent policy is unnervingly complicated, with deceptively simple patent laws that are burdened with complicated webs of judicial interpretations. It is little wonder, then, that most of us take for granted our government’s policy of granting and enforcing patents–if only as a cognitive coping strategy. This complexity-induced apathy, by the way, suits patent lawyers just fine, and might be acceptable most of the time because, as in the case of an undersea oil-well blowout-preventer, patents may work pretty well, except when they don’t.
Patents on human DNA sequences (at least 20% of our genes are locked up) are increasingly viewed as deterrents to a new generation of genetic-diagnostic technologies, as well as to basic biomedical research itself. That is the belief held growing number of physicians, researchers and legal experts, as well as this author.
Why do I use the word, “belief”? Simply put, though the specifics of patent law are largely excluded from raucous public debate, the costs and benefits of patent reform are nevertheless as hypothetical, and worthy of argument, as in the cases of health-care reform, climate-change strategy or nuclear disarmament. Proponents of the current system claim that the current patent regime is nothing less than vital to innovation. As in any debate, those in favor of the status quo can point to experience, arguing that current technology would not have arisen without patent protection. The apparent conservatism of this position belies the fact that our current patent regime–and any patent regime–is an artificial, legislated concept. Defending it from alteration by claiming that it is an optimal policy is, thus, rationally unfeasible.
Some of the current momentum behind the reform of gene patent policy results from evidence that future genetic tests will be hamstrung by patents held by universities and companies–patents that give these organizations control over virtually any use of the human genes they claim. That is the conclusion shared by a recent report from the HHS Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS). The prediction that patents will impede progress may not, in itself, be sufficient reason to make changes to the policy. However, the Committee points out the exceptionalism of patient care:
Indeed, in the realm of commodities or consumer electronics it may well be that dramatic harms and a profound lack of benefit should be required to compel any recommendation for change. But genetic tests affect patients’ lives and health. Thus, the current system’s net negative effects on test development and patient access to these tests argue strongly for the narrowly tailored changes that are proposed.
These proposed changes are two-fold: (1) a diagnostic test exemption, allowing human genes to be analyzed even if they are protected from other uses (i.e. as therapeutics) by patents; and (2) a research exemption, allowing any use of patented genes in the pursuit of biomedical research. This second exemption may come as a surprise to many, even to scientific researchers themselves. Many scientists I’ve talked to either assume that common law (or common sense) already exempts their work from violating patents (mostly because it is unbelievable to many genetic researchers that DNA sequences could be patented in this way). However, court decisions have decreased the research exemption to nil. The SACGHS report argues for the clear enunciation of the legality of research on patented genes, if only to promote the rule of law.
Agree or disagree with these proposals–that is their major benefit! They give something concrete to agree or disagree with to those citizens (especially relatively apolitical research scientists) who may have felt sidelined by the complexities of patent law debates. Furthermore, gene patents are a natural starting point for a more general debate over patent policy because they affect anyone who intends to ever get medical care.
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