By Kevin E. Noonan --
Speaking of Oakland, Gertrude Stein famously said "There is no there, there." The quote comes to mind when reading much of the academic literature on patenting genes and diagnostic method claims, which continues to follow the pattern of "there could be a problem, there should be a problem, in the future there might be a problem, so the fact that there is no evidence that there is a problem is irrelevant to my theory about the best way to solve the problem."
The latest example of this genre is by Geertui Van Overwalle (at right), from the Centre for Intellectual Property Rights, University of Leuven, Belgium, in an article in Science entitled "Turning Patent Swords into Shares." The article sets forth the "usual suspects" of premises: claims that "genes are difficult to design around," and that patents could hamper research and development, clinical access and availability of high-quality tests." This portion of the article raises the first (of many) red flags in its citations: the threat to "clinical access and availability of high-quality tests" is supported by no citation (representing the problem that "should exist"), and the statement that "genes are difficult to design around" is supported by a citation that reads (in very small type at the end of the article) "[i]n some empirical studies, a negative impact of patents could not be found (citing Walsh et al., 2005, "Science and Law: View from the Bench: Patents and Material Transfers," Science 309: 2002-03)" -- really, there are several such studies, all with the same message. In other words, despite the empirical evidence that there is no current problem, the Professor postulates that there is, and then devises ways to address the non-existent problem. This portion of the article also cites the SACGHS report, another example of an attempt to identify and address a problem that proved elusive at best.
The article similarly cites the possibility of a "patent thicket" caused by gene and diagnostic method patenting, but then supports the argument with the now thoroughly discredited (except in academia) "tragedy of the anticommons" idea (see "The Tragedy of a Bad Idea"). The article even admits that the problem does not exist:
Empirical data do not yet confirm existence of a patent thicket in genetics at large . . . . However, thicket problems in genetic diagnostics could grow with shifts (i) from monogenetic to multifactorial testing (multiplex diagnostics) and (ii) toward diagnostics based on genome-wide association studies driven by the high-throughput of single nucleotide polymorphism platforms and next-generation sequencing possibilities.
Although not an illustrative example of this phenomenon, the Myriad decision has invigorated concerns about potential negative effects of a dense and dispersed patent landscape.
Having arrived at this description of the problem, Professor Van Overwalle proposes solutions, most taking as their starting point practices prevalent in Europe. These include compulsory licensing, as has been instituted in France, Belgium, and Switzerland (despite the fact that "they have not yet been put to work"; but, the Professor informs us, "they may have an indirect, preventive effect on unduly restrictive licensing behavior by patent owners"). Another possibility is the exercise of "march-in" rights by the National Institutes of Health under provisions of the Bayh-Dole Act (35 U.S.C. §§ 200-213). Also mentioned is a "diagnostic use" exemption, as proposed in the SACGHS report.
The Professor does recognize that a ban on gene patents could be as detrimental to "development of drugs and therapies" as it could be beneficial to "upstream" research, although there is no evidence that gene patents have affected such "upstream," non-commercial research at all, and ample evidence that basic research is unaffected by patents on genes (see "The Fantastical Economics of the Gene Patenting Debate"). Nevertheless, the article proposes that gene patents be limited only for those uses appreciated at the time the patent application was filed. While seemingly a "reasonable" compromise, in reality such a restriction would result merely in prophetic disclosure on the one hand, and would (paradoxically) make it easier to obtain patent rights on newly discovered applications or uses of a claimed gene sequence -- such as a diagnostic method relating change or mutations in the gene to disease or the propensity for disease. Of course, this is not much different from the current situation, and in addition it is unlikely that patent claims for genes (which are overwhelmingly limited to isolated, full-length copies thereof) are infringed or even necessary to practice such diagnostic methods (patented or otherwise).
Turning to less coercive possibilities, the Professor proposes patent pools or clearinghouses, using as examples the American Society of Composers, Authors and Publishers (ASCAP) for copyright and MPEG LA, the latter group organized to promote distribution of gene sequences in such a manner. Unfortunately, the article cannot stay true to the concept that such an arrangement can be voluntary, and thus posits that the government may need to force such collaborations.
There certainly exists the possibility that any or even many of the possible problems identified in this and other academic articles could one day exist. Of course, it is equally (if not more) likely that gene patents will have expired before the technology advances to a point where a patent thicket would have developed. The history of the past thirty years reflects that possibility: from an initial glacial pace of gene patenting (due in part to the focused effort to isolate particular genes that encode therapeutically useful molecules, and in part to the need for development of biotechnology) to the flood of genetic sequence unleashed by the Human Genome Project and it commercial counterparts. It is certainly the case that success in deciphering the relationship between disease and genetic markers thereof has proceeded much more slowly than expected, and it is unlikely that the pace will quicken in the near term. But patents -- i.e., exclusive rights -- to genes will expire more or less "all at once" in about 2020, being twenty years from the end of the HGP and about 20 years (or more) from the filing date of most gene patents from that time. Thus, just when the potential for a patent thicket might become relevant (if we are lucky enough that robust genetic markers for disease have been so rapidly developed), the thicket will disappear.
There is a greater potential for diagnostic method patents to raise the kinds of issues referenced in the article, but the complexity of ascertaining these types of genetic relationships, and the potential for these relationships to remain undisclosed if diagnostic methods are unprotected by patenting, is likely to result in a public calculus that trades the relatively short period of exclusivity to the patentee for the economic incentives needed to develop commercial embodiments of these tests. Perhaps the most frightening prospect set forth in Professor Van Overwalle's article is that diagnostic method patents would be unenforceable against "clinicians using their own 'homemade' gene-based tests." To the extent that such tests are compared with tests by companies like Myriad, which has never had a reported false positive, it seems that women would be better served having researchers do research (clinical or otherwise) and commercial clinical labs perform such clinical tests. For diagnoses as important as the propensity to develop cancer, patients deserve no less.
Perhaps the most dangerous aspect of such articles, however, is the tendency for policymakers and even courts (who are not immune to the blandishments of academic "research") to base their decisions on the persistent argument that there is an existing problem that needs a solution. Darwin said that "[f]alse facts are highly injurious to the progress of science, for they often endure long; but false views, if supported by some evidence, do little harm, for every one takes a salutary pleasure in proving their falseness." The non-existent problem becomes the unquestioned premise, and as any student of elementary logic can tell you, a syllogism is only as strong as its premises. Thus can well-intentioned leaders promulgate policies that have harmful unintended consequences, all in the service of solving a problem that simply does not exist.