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Patents

Has the PTAB made a difference in drug settlements and generic entry?

Nature Biotechnology volume 40, pages 1569–1572 (2022)Cite this article

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Legal barriers are preventing generic drug makers from being able to utilize the Patent Trial and Appeal Board for its intended purpose — to serve as a faster and less cumbersome alternative to district court litigation.

Generic drug makers can challenge the patents on brand-name drugs as a means of potentially entering the market before patent expiration. Consequently, patent settlements between brand-name and generic drug makers frequently determine the timing of generic entry. In these settlements, the companies agree that generic entry will be delayed until some later point in the patent term. Until that time, the patentee will retain exclusivity and will charge supracompetitive prices. The companies’ negotiations over the delay period are driven mainly by their expectations about how patent litigation would play out.

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References

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Acknowledgements

The authors thank B. Sampat and K. Shadlen for helpful comments and A. Kesselheim for input on data sources. They are also grateful to A. Jakubow for assistance with coding and data gathering, and to A. Stewart for excellent research assistant work. This research was supported by a grant from the Arnold Foundation.

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Authors and Affiliations

  1. University of Southern California Gould School of Law, Los Angeles, CA, USA

    Erik Hovenkamp

  2. Department of Economics, University of Illinois Urbana-Champaign, Champaign, IL, USA

    Jorge Lemus

  3. Duke University School of Law, Durham, NC, USA

    Arti Rai

  4. Benjamin N. Cardozo School of Law, New York, NY, USA

    Saurabh Vishnubhakat

Authors
  1. Erik Hovenkamp
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  2. Jorge Lemus
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  3. Arti Rai
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  4. Saurabh Vishnubhakat
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Correspondence to Arti Rai.

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The authors declare no competing interests.

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Supplementary Information

Supplementary Data and Figs. 1 and 2.

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Hovenkamp, E., Lemus, J., Rai, A. et al. Has the PTAB made a difference in drug settlements and generic entry?. Nat Biotechnol 40, 1569–1572 (2022). https://doi.org/10.1038/s41587-022-01526-5

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  • DOI: https://doi.org/10.1038/s41587-022-01526-5

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