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Evergreening: a common practice to protect new drugs

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The common strategy of evergreening using patents and other exclusivity periods likely contributes to the total incentives that justify a pharmaceutical company's investment in a new drug.

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Figure 1: Characteristics of patent exclusivities associated with NDAs.
Figure 2: Characteristics of FDA-approval exclusivities associated with NDAs.

References

  1. Kate, K.T. & Laird, S.A. The Commercial Use of Biodiversity: Access to Genetic Resources and Benefit-Sharing (Earthscan, London, 1999).

  2. DiMasi, J.A. & Grabowski, H.G. The cost of biopharmaceutical R&D: Is biotech different? Manage. Decis. Econ. 28, 469–479 (2007).

    Article  Google Scholar 

  3. 35 USC §§ 102–103.

  4. 21 USC § 355(b)(1)(G).

  5. See 35 USC §§ 102–103.

  6. United States Patent and Trademark Office. US Dept. of Commerce, Manual of Patent Examining Procedure § 800 (8th ed., 8th rev. 2010) (hereinafter MPEP).

  7. MPEP § 2701.

  8. 21 USC § 355(j)(5)(F)(ii).

  9. 21 USC § 355(j)(5)(F)(iii).

  10. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Exclusivity Codes (FDA, 2011). http://www.accessdata.fda.gov/scripts/cder/ob/docs/excltermsall.cfm

  11. 21 CFR § 355(c)(3)(E)(iv).

  12. 21 USC § 360(aa)-(cc).

  13. 21 USC § 355a.

  14. Id.

  15. Scherer, F.R. The link between gross profitability and pharmaceutical R&D spending. Health Aff. 20, 216–220 (2001).

    Article  CAS  Google Scholar 

  16. Food and Drug Administration. Drug approval reports. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsMenu

  17. Department of Health and Human Services, Letter to Katherine Gaudry. (Freedom of Information Act Request No. 2010–6543), Jan. 17, 2011.

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Acknowledgements

The author would like to thank B. Roin and P. Hutt for their review of and suggestions for this manuscript.

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Correspondence to Kate S Gaudry.

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The author declares no competing financial interests.

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Gaudry, K. Evergreening: a common practice to protect new drugs. Nat Biotechnol 29, 876–878 (2011). https://doi.org/10.1038/nbt.1993

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