• Ritalin to Roundup: Expanding the Pharmaceutical Industry Statutory Experimental Use Exception to Agriculture

    Author(s):
    Jennifer Carter-Johnson
    Date:
    2016
    Group(s):
    MSU Law Faculty Repository
    Item Type:
    Article
    Permanent URL:
    https://doi.org/10.17613/zybq-qd88
    Abstract:
    The modern agricultural biotechnology industry developed from a small cottage industry based on selective crop breeding into a multi-billion dollar industry based on the isolation and insertion of genes that code for commercially valuable crop traits. As it grew, the industry relied on patent protection to recoup its investment into new research and development of genetically engineered (GE) crops. A recent billion dollar patent infringement damage award to Monsanto based only on research activities of its competitors testifies to the importance of that patent protection. Had the Monsanto patent infringement case been between two pharmaceutical companies creating genetics-based drugs, the outcome would have been different. Instead of a one billion dollar award, the patent verdict would have been one of noninfringement. The difference between the two patent infringement cases lies with the Hatch-Waxman Act's statutory experimental use exception. The Hatch-Waxman Act controls the regulation of generic drugs by the Food and Drug Administration (FDA). Along with an abbreviated generic drug approval process, the Hatch-Waxman Act includes a statutory experimental use exception to patent infringement allowing pharmaceutical companies to conduct research on patented drugs if the research might be used in a regulatory submission to the FDA.
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    Published as:
    Journal article    
    Status:
    Published
    Last Updated:
    3 weeks ago
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