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  • Title: The effect of Paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms.
    Author: Panattoni LE.
    Journal: J Health Econ; 2011 Jan; 30(1):126-45. PubMed ID: 21074873.
    Abstract:
    This purpose of this paper is to investigate the impact of Paragraph IV patent infringement decisions on brand drug pharmaceutical firms. Paragraph IV decisions determine whether a generic firm can enter before the period of exclusivity ends. I construct a novel dataset of all Paragraph IV decisions and find that they disproportionately involve the highest revenue drugs, significant periods of patent protection, and a non-trivial portion of all brand drugs facing generic entry. I also estimate the impact of Paragraph IV decisions on brand firm profitability and find they have large value consequences.
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