Patents & the Progress of Personalized Medicine: Biomarkers Research as Lens

Progress toward \u27personalized medicine\u27 remains stymied by several factors. Most glaring is the questionable quality of the data expected to drive this new treatment paradigm. Institutions and firms engaged in \u27biomarkers\u27 research have systematically failed to validate newly discovered molecular variations, be they genomic, proteomic, metabolomic, or dynamic interactions amongst them all, with clinical outcomes as they amass and unfold over time. This is, in part, attributable to deficiencies in the present regulatory framework. Ambiguous standards for evaluating study design and product risk, as well as seemingly redundant requirements from different regulatory authorities have led some, if not driven others, to escape oversight. However, it also reflects a marked failure of coordination, a failure not only to put into place large-scale collections of biological specimens accompanied by longitudinal patient health information, but a failure to ensure continuous data exchange amongst the researchers, clinicians, healthcare providers, and private firms already attempting to commercialize biomarker-related technologies. The argument advanced in this paper is that intellectual property rights (especially patents), and the set of practices that those rights tend to engender, contribute significantly to the paucity of data sharing that currently pervades biomarkers research. Further, these patent-related issues cannot be easily disentangled from other barriers facing personalized medicine, particularly the deficiencies of the present regulatory framework. And the way in which the discourse around the impact of patent rights upon early stage scientific research has been framed helps account for why this dimension of the problem has received minimal attention to date