Patenting Personalized Medicine
Résumé
The histories of patent law and medical practice in the United States have intersected in various ways over the past 150 years, beginning with the professional campaign against "patent medicines" in the late nineteenth century, and culminating, for now, in attempts to patent the diagnostic procedures discussed in this article. The patenting of diagnostic procedures provokes a set of fundamental questions about the episteme of patent law. These questions are not new. They emerged at the very origins of patent jurisprudence, centered on the question of what distinguished an invention from a law of nature, and this question of patentability has persistently reemerged over the past century in the contexts of plant breeding, biotechnology, and now diagnostic medicine. So far, the question has been addressed in terms that imagine the invention as a machine, understood in the figurative sense of a transfor-mative organization of forces and elements. But diagnostic procedures, because they address the body informationally, as a system based on the recursive patterning of signals rather than a linear transformation of inputs into outputs, stretch the figure of the machine to the point at which it ceases to be effective. How then should one define and delimit invention? The role of patents in medicine is intriguing not so much because of their predictable ability to expand and intensify the commodification of medical knowledge and technology , but rather because of the extent to which their uses and functions have qualitatively changed over time across medical and biomedical disciplines. These developments hinge on the increasingly complex relationship between medical objects and the concepts of patent law, the different patent-based business and research models that have shaped the recent culture of biomedical research, and the way patent law itself has changed over time-changes that have generally expanded but also constrained the protection of medical innovations. It is the specificity of the multilevel interaction between patents and medical cultures and businesses that interests us here. In the last two decades, significant cracks have developed in the stable long-term alignment between the objects of medicine and the concepts of patent law-an.