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Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Articles
This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …
Biobanks As Innovation Infrastructure For Translational Medicine, W. Nicholson Price Ii
Biobanks As Innovation Infrastructure For Translational Medicine, W. Nicholson Price Ii
Book Chapters
Biobanks represent an opportunity for the use of big data to drive translational medicine. Precision medicine demands data to shape treatments to individual patient characteristics; large datasets can also suggest new uses for old drugs or relationships between previously unlinked conditions. But these tasks can be stymied when data are siloed in different datasets, smaller biobanks, or completely proprietary private resources. This hampers not only analysis of the data themselves, but also efforts to translate data-based insights into actionable recommendations and to transfer the discovered technology into a commercialization pipeline. Cross-project technological innovation, development, and validation are all more difficult …
The Cost Of Novelty, W. Nicholson Price Ii
The Cost Of Novelty, W. Nicholson Price Ii
Law & Economics Working Papers
Patent law tries to spur the development of new, better, innovative technology. But it focuses much more on “new” than “better” — and it turns out that “new” carries real social costs. I argue that patent law promotes innovation that diverges from existing technology, either a little (what I call “differentiating innovation”) or a lot (“exploring innovation”), at the expense of innovation that tells us more about existing technology (“deepening innovation”). Patent law’s focus on newness is unsurprising, and fits within a well-told narrative of innovative diversity accompanied by market selection of the best technologies. Unfortunately, innovative diversity brings not …