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The Mayo Framework Is Bad For Your Health, Christopher M. Holman
The Mayo Framework Is Bad For Your Health, Christopher M. Holman
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This Article begins by providing a brief historical retrospective of the development of the patent eligibility doctrine, and then delves into the related questions of: (1) what are the Supreme Court’s policy objectives for the recent reinvigoration of the patent eligibility doctrine; and (2) has it achieved those objectives? The article then discusses three important out-standing questions regarding the application of the new test for patent eligibility: (1) what constitutes a natural phenomenon; (2) what constitutes an inventive step; and (3) what, if any, role does preemption play in the analysis? The article then provides four examples of recent lower …
The Critical Role Of Patents In The Development, Commercialization And Utilization Of Innovative Genetic Diagnostic Test And Personalized Medicine, Christopher M. Holman
The Critical Role Of Patents In The Development, Commercialization And Utilization Of Innovative Genetic Diagnostic Test And Personalized Medicine, Christopher M. Holman
Faculty Works
Arguments in favor of reining in the availability of effective patent protection in the area of genetic diagnostic testing are based largely on two fundamental misconceptions regarding the role of patents in this important area of technological innovation. The first is the mistaken assumption that patents negatively impact patient access to genetic diagnostic testing by preventing research that might lead to new or improved versions of a genetic test and by increasing the cost of testing services. The second is the failure to appreciate the substantial positive role patents play in in the development and utilization of genetic diagnostic tests. …
Patent Eligibility Post-Myriad: Reinvigorated Judicial Wildcard Of Uncertain Effect, Christopher M. Holman
Patent Eligibility Post-Myriad: Reinvigorated Judicial Wildcard Of Uncertain Effect, Christopher M. Holman
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In the 1970s and early 1980s the US Supreme Court issued several landmark decisions establishing the contours of patent eligibility, a judicially created doctrine that serves as a gatekeeper to prevent the patenting of subject matter deemed so fundamental as to be better left unpatented. Over the course of the next 25 years the Court of Appeals of the Federal Circuit oversaw a progressive expansion in the scope subject matter deemed patent eligible, highlighted by the adoption in the 1990’s of a “useful, concrete and tangible” test for patent eligibility that for all practical purposes seemed to subsume the patent …
Mayo, Myriad, And The Future Of Innovation In Molecular Diagnostics And Personalized Medicine, Christopher M. Holman
Mayo, Myriad, And The Future Of Innovation In Molecular Diagnostics And Personalized Medicine, Christopher M. Holman
Faculty Works
Contrary to popular perception, the Supreme Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc., finding certain patent claims reciting isolated genomic DNA molecules patent ineligible is likely to have a relatively minor impact on the patenting of diagnostics and personalized medicine. Method claims generally play a much more important role than isolated DNA claims in the patenting of innovations in this important technological sector, and the Court’s earlier decision in Mayo v. Prometheus Labs that held claims directed towards non-genetic methods of personalized medicine to be patent ineligible will likely prove significantly more problematic in this …