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Tertiary patenting on drug–device combination products in the United States

Drug–device combination products are becoming increasingly prevalent, with many lasting years beyond the expiration date of primary and secondary patents on the drug itself.

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Figure 1: Changes in prevalence of primary, secondary, and tertiary patents over time.
Figure 2: Duration of unexpired primary, secondary, and tertiary patents for drug–device combination products in 2000 and 2016 (relative to FDA approval date).

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Acknowledgements

A.S.K.'s work is supported by the Laura and John Arnold Foundation and Harvard Program in Therapeutic Science, with additional support from the Engelberg Foundation. The authors are grateful to J.W. Nickerson, W.A. Kaplan, and A. Attaran for their feedback on developing this idea, as well as to J.J. Darrow and M.S. Sinha for their insights on earlier drafts.

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Correspondence to Aaron S Kesselheim.

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Supplementary information

Supplementary Table 1

Products listing tertiary patents in 2000, 2005, 2010, and/or 2016 (XLSX 19 kb)

Supplementary Table 2

Products listing tertiary patents in 2000, 2005, 2010, and 2016 (XLSX 74 kb)

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Beall, R., Kesselheim, A. Tertiary patenting on drug–device combination products in the United States. Nat Biotechnol 36, 142–145 (2018). https://doi.org/10.1038/nbt.4078

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