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PATENTS

The characteristics of patents impacting availability of biosimilars

The large number of biologic drug patents in the United States has contributed to delays in biosimilar availability.

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Fig. 1: Claim types among litigated biologic patents.
Fig. 2: Priority, application and grant timing of litigated biologic patents.

References

  1. Biosimilars in the United States: Competition, Savings, and Sustainability (IQVIA, 2020); https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/iqvia-institute-biosimilars-in-the-united-states.pdf

  2. Ferris, L. K., Gellad, W. F. & Hernandez, I. JAMA Dermatol. 156, 1136–1138 (2020).

    Article  Google Scholar 

  3. Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals (FDA, accessed 6 August 2021); https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process

  4. Sarpatwari, A., Barenie, R. & Curfman, G. Clin. Pharmacol. Ther. 105, 92–100 (2019).

    Article  Google Scholar 

  5. FDA approvals. Big Molecule Watch (accessed 29 December 2021); https://www.bigmoleculewatch.com/fda-approved-ablas/

  6. Biosimilar approval status. Biosimilars Review and Report (accessed 23 December 2021); https://biosimilarsrr.com/us-biosimilar-filings/

  7. Medicines (EMA, accessed 23 December 2021); https://www.ema.europa.eu/en/medicines

  8. Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving up Drug Prices (IMAK, 2018); https://www.i-mak.org/wp-content/uploads/2018/08/I-MAK-Overpatented-Overpriced-Report.pdf

  9. Druedahl, L. C. et al. Nat. Biotechnol. 38, 1253–1256 (2020).

    Article  CAS  Google Scholar 

  10. Van de Wiele, V. L., Kesselheim, A. S. & Sarpatwari, A. Health Aff. 40, 1198–1205 (2021).

    Article  Google Scholar 

  11. Price, W. N. & Rai, A. K. Iowa Law Rev. 101, 1023–1063 (2016).

    Google Scholar 

  12. Drug Pricing and Pharmaceutical Patenting Practices (Congressional Research Service, 2020); https://fas.org/sgp/crs/misc/R46221.pdf

  13. BPCIA Litigations (Big Molecule Watch, accessed 13 May 2021); https://www.bigmoleculewatch.com/bpcia-patent-litigations/

  14. Patent Term Calculator (USPTO, accessed 6 August 2021); https://www.uspto.gov/patents/laws/patent-term-calculator

  15. Beall, R. F., Darrow, J. J. & Kesselheim, A. S. Value Health 21, 1382–1389 (2018).

    Article  Google Scholar 

  16. Vilcek, J. Nat. Immunol. 10, 555–557 (2009).

    Article  CAS  Google Scholar 

  17. Pelechas, E., Voulgari, P. V. & Drosos, A. A. Expert Opin. Drug Discov. 16, 227–234 (2021).

    Article  CAS  Google Scholar 

  18. Hemphill, C. S. & Sampat, B. Science 339, 1386–1387 (2013).

    Article  CAS  Google Scholar 

  19. Rai, A. K. & Price, W. N. II Nat. Biotechnol. 39, 20–22 (2021).

    Article  CAS  Google Scholar 

  20. Bergman, M., Patel, P., Chen, N., Jing, Y. & Saffore, C. D. Rheumatol. Ther. 8, 109–118 (2021).

    Article  Google Scholar 

  21. Chung, A. Europe issues better patents than US – Europe patent boss. Reuters (15 September 2016).

  22. Picard, P. M. & van Pottelsberghe de la Portterie, B. J. Public Econ. 104, 14–25 (2013).

    Article  Google Scholar 

  23. Moorkens, E., Vulto, A. G. & Huys, I. MAbs 12, 1743517 (2020).

    Article  Google Scholar 

  24. Feldman, R. Drugs, Money, and Secret Handshakes (Cambridge Univ. Press, 2019).

  25. Bloomfield, D. & Kesselheim, A.S. Biden can lower drug prices without Congress doing anything. Washington Post (5 January 2021).

  26. Frakes, M.D. & Wasserman, M.F. Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination (NBER, 2020); https://www.nber.org/papers/w27579

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Acknowledgements

This work was supported by Arnold Ventures.

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Correspondence to Ameet Sarpatwari.

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Van de Wiele, V.L., Beall, R.F., Kesselheim, A.S. et al. The characteristics of patents impacting availability of biosimilars. Nat Biotechnol 40, 22–25 (2022). https://doi.org/10.1038/s41587-021-01170-5

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