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Combination therapy patents: a new front in evergreening

Nature Biotechnology volume 39, pages 1504–1510 (2021)Cite this article

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As pharmaceutical companies seek patent protection for combinations of cancer therapeutics, it is worthwhile to assess what constitutes an ‘unexpected result’ for the purpose of an appropriate patent and whether randomized, controlled trials of drug combinations have the ability to generate them.

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Fig. 1: Patent search strategy.
Fig. 2: Identification of clinical trials evaluating the combination of VEGF inhibitors and IO agents from ClinicalTrials.gov.

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Acknowledgements

The authors wish to thank L. Yang for assistance with patent research, as well as N. Brown and M. Dorji for assistance with legal research. G.W.S. is an employee of the US Federal Government; the views expressed in this manuscript do not reflect the views of the US Federal Government and are his personal views.

Author information

Author notes

  1. Garth W. Strohbehn

    Present address: Veterans Affairs Center for Clinical Management and Research, Ann Arbor, MI, USA

  2. These authors contributed equally: Garth W. Strohbehn, Robin Feldman.

Authors and Affiliations

  1. Section of Hematology/Oncology, Department of Medicine, University of Chicago, Chicago, IL, USA

    Garth W. Strohbehn, Alec J. Kacew & Mark J. Ratain

  2. Optimal Cancer Care Alliance, Ann Arbor, MI, USA

    Garth W. Strohbehn, Daniel A. Goldstein & Mark J. Ratain

  3. Tel Aviv University, Tel Aviv, Israel

    Daniel A. Goldstein

  4. Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel

    Daniel A. Goldstein

  5. Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC, USA

    Daniel A. Goldstein

  6. Center for Innovation, University of California Hastings College of the Law, San Francisco, CA, USA

    Robin C. Feldman

Authors
  1. Garth W. Strohbehn
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  2. Alec J. Kacew
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Contributions

All authors meet International Committee of Medical Journal Editors criteria for authorship in the presented work.

Corresponding authors

Correspondence to Robin C. Feldman or Mark J. Ratain.

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Competing interests

The authors declare no competing interests.

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Strohbehn, G.W., Kacew, A.J., Goldstein, D.A. et al. Combination therapy patents: a new front in evergreening. Nat Biotechnol 39, 1504–1510 (2021). https://doi.org/10.1038/s41587-021-01137-6

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