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Will inter partes review speed US generic drug entry?

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A new extra-judicial pathway for challenging pharmaceutical patents has intensified patent challenges and helped to clear the way for earlier generic entry.

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Authors and Affiliations

  1. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Jonathan J. Darrow, Reed F. Beall and Aaron S. Kesselheim are at the Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.,

    Jonathan J Darrow, Reed F Beall & Aaron S Kesselheim

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  1. Jonathan J Darrow
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  2. Reed F Beall
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  3. Aaron S Kesselheim
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Corresponding author

Correspondence to Jonathan J Darrow.

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Competing interests

A.S.K. work is supported by the Laura and John Arnold Foundation, with additional support from the Harvard Program in Therapeutic Science and the Engelberg Foundation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Darrow, J., Beall, R. & Kesselheim, A. Will inter partes review speed US generic drug entry?. Nat Biotechnol 35, 1139–1141 (2017). https://doi.org/10.1038/nbt.4036

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