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Articles

University of Michigan Law School

2019

Research and development

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Full-Text Articles in Law

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg Jun 2019

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 …


Grants, Nicholson Price Ii May 2019

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 …