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Distinguishing and predicting drug patents

Drug patents are different. To improve their quality ex ante, regulators can use predictive models.

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Fig. 1: Distinguishing and predictive traits of drug patent applications.
Fig. 2: Visualization of our results.


  1. Congressional Research Service. Drug Pricing and Pharmaceutical Patenting Practices (11 February 2020);

  2. Letter from Janet Woodcock, Acting Commissioner of FDA to Andrew Hirshfeld, Director of the USPTO (10 September 2021);

  3. Letter from Katherine Vidal, Director of the USPTO to Robert Califf, Commissioner of FDA (6 July 2022);

  4. Request for Comments USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights, 88 Fed. Reg. 9,492 (14 February 2023).

  5. American Intellectual Property Law Association. 2021 Report of the Economic Survey (September 2021).

  6. 21 U.S.C. 355(b)(1)(A)(viii)

  7. 21 C.F.R. § 314.53(b)

  8. US Patent and Trademark Office. Patent Examination Research Dataset (PatEx); (accessed 4 October 2021).

  9. US Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations; (accessed February 2022).

  10. National Bureau of Economic Research. Orange Book Patent and Exclusivity Data—1985–2016; (accessed July 2022).

  11. U.C. Law San Francisco. Evergreen Drug Patent Database;

  12. Chien, C. Tex. Law Rev. 90, 283–329 (2011).

  13. Marco, A. C. & Miller, R. D. Int. J. Econ. Bus. 26, 65–91 (2019).

  14. Korstanje, J. The F1 score. Towards Data Science (31 August 2021);

  15. US Patent and Trademark Office. USPTO - FDA Collaboration Initiatives; (accessed March 2023).

  16. Tu, S. S. & Lemley, M. A. Wash. U. Law Rev. 99, 1673–1731 (2022).

  17. Shah, J. J. Marshall Rev. Intell. Prop. Law 14, 453–475 (2015).

  18. Lowe, D. In the Pipeline blog (9 May 2019);

  19. Krajec, R. How much does a patent cost? Blue Iron IP (16 January 2022);

  20. US Patent and Trademark Office. USPTO Fee Schedule (2021);

  21. In re: Humira Antitrust Litigation, No. 19-cv-1873 (J. Shah) (N.D. Ill. June 2020).

  22. US House of Representatives Committee on Oversight and Reform. Drug Pricing Investigation: Majority Staff Report (December 2021).

  23. Kazhdan, D. Akron Law Rev. 53, 1017–1051 (2019).

  24. Letter from Patrick Leahy, U.S. Senator, et al. to Katherine Vidal, Director of the USPTO (8 June 2022);

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For C.C., any opinions, to the extent reflected herein, are her own and do not represent those of the Patent Office, where she serves as a part-time expert advisor and Edison Fellow. For N.H., any opinions, to the extent reflected herein, are his own and do not represent those of Wilson Sonsini Goodrich & Rosati. For J.K., any opinions, to the extent reflected herein, are his own and do not represent those of Polygon IP. The authors thank Bhaven Sampat and Arti Rai for their comments on previous drafts.

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Correspondence to Colleen V. Chien.

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Chien, C.V., Halkowski, N. & Kuhn, J. Distinguishing and predicting drug patents. Nat Biotechnol 41, 317–321 (2023).

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