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Authors

Michael Sanzo

Abstract

Recent advances in biotechnology have given researchers the ability to comprehensively examine the genetic basis of disease in unprecedented ways and will undoubtedly result in many new and valuable gene based diagnostic assays in the near future. These advances came during a period of roughly thirty years during which the patent eligibility of such assays was essentially unquestioned. Then, beginning in 2010, the Supreme Court embarked on a series of decisions that will, in almost all cases, preclude the patenting of diagnostic assays that rely on genetic mutations or gene expression patterns. This article suggests that reason that the issue of patent eligibility went unquestioned in the biotechnology industry for so long is due to early Supreme Court decisions that took conflicting approaches to analyzing patent eligibility. It also examines why the patent eligibility test that has now been adopted by the Supreme Court is so devastating to the patenting of gene based assays