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16 J. Marshall Rev. Intell. Prop. L. [i] (2016-2017)

handle is hein.journals/johnmars16 and id is 1 raw text is: 


                 THE jOHN MARSHALL

REVIEW OF INTELLECTUAL PROPERTY LAW


  THE  PATENTING   OF GENE  BASED  DIAGNOSTIC   ASSAYS  IN A POST MAYOAND MYRIAD
                                        WORLD

                                  MICHAEL   A. 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.















                        Copyright 0 2016 TheJ ohn Marshall Law School




        Cite as Michael A. Sanzo, The Patenting of Gene Based Diagnostic Assays in a Post
             Mayo and Myriad Work, 16J . MARSHALL REV. INTELL. PROP. L. 1 (2016).

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