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Biologic patent challenges under the America Invents Act

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Administrative patent review procedures are an effective way of correcting erroneously granted biologic patents and may help promote timely drug competition for the benefit of patients and the US healthcare system.

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Fig. 1: Number of asserted patents in inter partes review and post grant review proceedings per biologic drug (total patents = 102).
Fig. 2: AIA proceeding outcomes for all patents (n = 102).

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Acknowledgements

National Institutes of Health Care Management (NIHCM). A.S.K. and S.S.T. also receive support from Arnold Ventures and the Commonwealth Fund. The funders had no role in the preparation, review or approval of the manuscript or the decision to submit the manuscript for publication.

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Authors and Affiliations

  1. Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA

    Victor L. Van de Wiele & Aaron S. Kesselheim

  2. West Virginia University College of Law, Morgantown, WV, USA

    S. Sean Tu

Authors
  1. Victor L. Van de Wiele
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  2. Aaron S. Kesselheim
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  3. S. Sean Tu
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Correspondence to S. Sean Tu.

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Van de Wiele, V.L., Kesselheim, A.S. & Tu, S.S. Biologic patent challenges under the America Invents Act. Nat Biotechnol 42, 374–377 (2024). https://doi.org/10.1038/s41587-024-02156-9

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