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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 …
Artificial Intelligence In The Medical System: Four Roles For Potential Transformation, Will Nicholson Price Ii
Artificial Intelligence In The Medical System: Four Roles For Potential Transformation, Will Nicholson Price Ii
Articles
Artificial intelligence (AI) looks to transform the practice of medicine. As academics and policymakers alike turn to legal questions, a threshold issue involves what role AI will play in the larger medical system. This Article argues that AI can play at least four distinct roles in the medical system, each potentially transformative: pushing the frontiers of medical knowledge to increase the limits of medical performance, democratizing medical expertise by making specialist skills more available to non-specialists, automating drudgery within the medical system, and allocating scarce medical resources. Each role raises its own challenges, and an understanding of the four roles …
Grants, Nicholson Price Ii
Grants, Nicholson Price Ii
Articles
Innovation is a primary source of economic growth and is accordingly the target of substantial academic and government attention. Grants are a key tool in the government’s arsenal to promote innovation, but legal academic studies of that arsenal have given them short shrift. Although patents, prizes, and regulator-enforced exclusivity are each the subject of substantial literature, grants are typically addressed briefly, if at all. According to the conventional story, grants may be the only feasible tool to drive basic research, as opposed to applied research, but they are a blunt tool for that task. Three critiques of grants underlie this …
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 …
Patents For Sharing, Toshiko Takenaka
Patents For Sharing, Toshiko Takenaka
Michigan Technology Law Review
Spurred by the Internet, emerging technologies have changed the way commercial firms innovate and have made it possible for individuals to play an important role in that innovation. Producers in the Information Communication Technologies (ICT), and other sectors dealing with complex technologies with many separately patentable components, find it increasingly difficult to make products without infringing on patents held by others. Numerous overlapping patents often cover such products. Producers have developed a new way to use patents: as inclusive rights for sharing their technologies with others through cross-licensing and other private ordering arrangements in order to ensure the freedom to …