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Of Thickets, Blocks and Gaps: Designing Tools to Resolve Obstacles in the Gene Patents Landscape

Framing the problem: The current patent landscape for human genomic science has refuelled the debate on human gene patents. Expressed in figurative language, concerns are raised that patent thickets and blocking patents will lead to a tragedy of the anti-commons, and that new genetic inventions might not find their way into products as a translational gap might widen to form a valley of death, thus frustrating new treatments in healthcare. Even though the problems may not paralyse commerce yet, many thoughtful observers - ranging from lawyers, economists, patent experts to geneticists - unison agree that the problems reported in current patent law and practice in the field of genetics are real and merit further attention, especially in the area of genetic diagnostics, which seems to be most prone to suffer from patent discomfort in the near future. The problems in genetic diagnostics are expected to grow with the turn from monogenetic testing to multifactorial testing (multiplex diagnostics) and the availability of bio-chips and micro-arrays. Difficulties might dramatically increase with the paradigm shift from monogenetic and multifactorial diagnostics based on Mendelian causality to diagnostics based on genome-wide association studies driven by the high-throughput of SNP platforms and the next-generation sequencing possibilities. Central Research Question: The central question around which the present paper revolves is what measures should be taken to render patented human genes accessible for further use. This question is constricted to what measures should be contemplated to safeguard research and development in genetic diagnostics, as this area is most prone to fall victim of patent thickets. Underlying Assumptions: When exploring measures, it is assumed in the present paper that the ultimate goals are to maintain the function of patent law as incentive for the production of drugs and therapies important in health care and to remedy some of the adverse effects patent law may have in the field of diagnostics, within a reasonable period of time. Creating tools which optimize the negotiation of a multitude of (blocking) patents in diagnostics has proven to be the best option to meet these goals. In other words, the best way to deal with current obstacles in the genetic patent landscape is to remedy the horizontal regulatory function of patent law by designing formal rules of contract. Research Hypotheses: Four hypotheses have been suggested to make the starting goals more explicit. The first hypothesis is that in the current state of affairs, the problems created by patent law in genetic diagnostics are best served by contractual, collaborative measures. The specific features of the collaborative models and the nature of the subject matter exchanged therein, suggest that patent pools, clearing houses and open source models seem most fit to traverse the patent landscape in genetic diagnostics and thus meet the major objective. Successful as it may be to solve the translation of small molecules, the plasticity of public-private partnerships with optional liability regime appear rather limited in this area and it is difficult to imagine to what extent the model can be applied to other contexts. Consideration of all comparisons of prerequisites, benefits and disadvantages of the various models leads us to believe that the optimal patent pool model in diagnostic genetics might well be a patent platform where individual patent pools are narrowly defined around single genes comprising vertically oriented patents, thereby providing access to horizontally oriented thickets. It will take quite a while before such a platform may be operationalized and meanwhile efforts should concentrate on patent pools set up around single genes or gene panels. The optimal clearing house might well be a fully fletched patent royalty collection clearing house. Since this is probably too far fetched for the time being, major efforts in the coming years should focus on setting up patent standard clearing houses in genetic diagnostics, tuned to the varied needs in this branch of genetics and tailored to the specific characteristics of the biotech business sector. As to open source models, translating open source from software to genetics and introducing copyleft-style open source licence in relation to diagnostic tests based on gene patents seems also feasible, but might not be unproblematic. The first hypothesis is made more exacting by introducing three additional assumptions. Contractual, collaborative models will come into being and function properly in the long run, if they are based on the pre-existence of patent rights, if they prove to be commercially sustainable and economically viable without overriding social motives, and if they contribute to restoring trust in the patent system. Conclusions: First, the pre-existence of patent rights is indeed quintessential for the establishment of patent pools, clearing houses and open source models. Second, all the models display certain benefits in a for-profit, market context. Additional economic research is necessary to provide a more refined and robust assessment of their economically viability and commercial sustainability. Further research is also required to identify incentives for the establishment of such models, and to ascertain that the models attract valuable patents and distribute usage rights efficiently rather then create “markets for lemons�?. Third, the various arrangements also offer a unique opportunity to restore trust in both the private and public interest objectives of the patent system pertaining to economic and social welfare, and to discontinue ignoring the patent norm. Further empirical research would be helpful to test this last assumption. Normative analysis, based on normative intuitions and ethical theory, is also needed to make the underlying goals and values more explicit.