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Full-Text Articles in Law
Diagnostics Need Not Apply, Rebecca S. Eisenberg
Diagnostics Need Not Apply, Rebecca S. Eisenberg
Articles
Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions from …
Law, History And Lessons In The Crispr Patent Conflict, Jacob S. Sherkow
Law, History And Lessons In The Crispr Patent Conflict, Jacob S. Sherkow
Articles & Chapters
Predicting the outcome of the ongoing patent disputes surrounding genome-editing technology is equal parts patent analysis and history.
Genome-editing technology based on clustered, regularly interspaced, short palindromic repeats (CRISPR) and CRISPR associated protein 9 (Cas9) has generated great excitement in both academia and industry. But a potential patent dispute between two sets of inventors has left the biotech community pondering its fate. Understanding several facets of patent law and history may provide some lessons about the probable — and best — outcome for the dispute.
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. …
The History Of Patenting Genetic Material, Jacob S. Sherkow, Henry T. Greely
The History Of Patenting Genetic Material, Jacob S. Sherkow, Henry T. Greely
Articles & Chapters
The US Supreme Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc. declared, for the first time, that isolated human genes cannot be patented. Many have wondered how genes were ever the subjects of patents. The answer lies in a nuanced understanding of both legal and scientific history. Since the early twentieth century, “products of nature” were not eligible to be patented unless they were “isolated and purified” from their surrounding environment. As molecular biology advanced, and the capability to isolate genes both physically and by sequence came to fruition, researchers (and patent offices) began to apply …