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Health Law and Policy Commons

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Full-Text Articles in Health Law and Policy

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

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

Marquette Intellectual Property Law Review

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 ...


Note: Exclusive Licensing Of Dna Diagnostics: Is There A Negative Effect On Quantity And Quality Of Healthcare Delivery That Compels Nih Rulemaking?, Edward Weck Jan 2005

Note: Exclusive Licensing Of Dna Diagnostics: Is There A Negative Effect On Quantity And Quality Of Healthcare Delivery That Compels Nih Rulemaking?, Edward Weck

William Mitchell Law Review

This comment surveys the costs of deoxyribonucleic acid (DNA) diagnostic tests and argues in favor of non-exclusive licensing as a means to provide broad access to affordable DNA diagnostic testing. Part II provides background information on genetic testing, patenting genes as applied to genetic testing, the Bayh-Dole Act, and technology transfer. In addition, Part II summarizes academic commentary regarding the implications of exclusive licensing for biotechnology. Scholars propose a number of solutions, including expanding the experimental use exception. Part III details proposed rulemaking for DNA diagnostics. Part IV reviews anecdotal examples of genetic testing for breast cancer, hereditary hemochromatosis, and ...


Reproductive Genetics 1991-2002: A Selected Annotated Legal Bibliography Of Genetic Testing, Gene Transfer And Reproductive Cloning, Gail H. Javitt Jan 2003

Reproductive Genetics 1991-2002: A Selected Annotated Legal Bibliography Of Genetic Testing, Gene Transfer And Reproductive Cloning, Gail H. Javitt

Journal of Health Care Law and Policy

No abstract provided.


Index To The Bibliography Jan 2003

Index To The Bibliography

Journal of Health Care Law and Policy

No abstract provided.


Before It's Too Late- Addressing Fear Of Genetic Information, Karen H. Rothenberg, Sharon F. Terry Jan 2002

Before It's Too Late- Addressing Fear Of Genetic Information, Karen H. Rothenberg, Sharon F. Terry

Faculty Scholarship

No abstract provided.