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Patent office backlog adds billions to national drug expenditure

Nature Biotechnology volume 32, pages 436–439 (2014)Cite this article

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US patent term adjustments for newly approved and blockbuster drugs result in nearly $20 billion in added costs to society.

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Figure 1: Occurrence of delays and patent-term adjustments (PTAs).
Figure 2: Magnitude of delays and patent-term adjustments.

References

  1. Centers for Medicare & Medicaid Services. National health expenditures. http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/tables.pdf (CMS.gov, 2013).

  2. Morgan, S. & Kennedy, J. Prescription drug accessibility and affordability in the United States and abroad. Commonwealth Fund pub. 1408, vol. 89. http://www.commonwealthfund.org/∼/media/Files/Publications/Issue%20Brief/2010/Jun/1408_Morgan_Prescription_drug_accessibility_US_intl_ib.pdf (2010).

    Google Scholar 

  3. Office of the Inspector General. Generic drug utilization in state Medicaid programs. http://oig.hhs.gov/oei/reports/oei-05-05-00360.pdf (July 2006).

  4. Dicken, J.E. Drug pricing: research on savings from generic drug use. http://www.gao.gov/assets/590/588064.pdf (31 January 2012).

  5. 35 USC § 154.

  6. Alazraki, M. The 10 biggest-selling drugs that are about to lose their patent. DailyFinance http://www.dailyfinance.com/2011/02/27/top-selling-drugs-are-about-to-lose-patent-protection-ready/ (27 February 2011).

    Google Scholar 

  7. US Patent and Trademark Office. Performance and Accountability Report, Fiscal Year 2012. http://www.uspto.gov/about/stratplan/ar/USPTOFY2012PAR.pdf (USPTO, 2012).

  8. 37 CFR § 1.702.

  9. US Department of Health and Human Services. Approved Drug Products with Therapeutic Equivalence Evaluations. 33rd edn. ADA 1–227 (HHS, 2013).

  10. Hemphill, C.S. & Sampat, B.N. J. Health Econ. 31, 327–339 (2012).

    Article  Google Scholar 

  11. Hemphill, C.S. & Sampat, B.N. J. Empirical Legal Studies 8, 613–649 (2011).

    Article  Google Scholar 

  12. Gaudry, K.S. Nat. Biotechnol. 29, 876–878 (2011).

    Article  CAS  Google Scholar 

  13. US Patent and Trademark Office. President's Budget Submission Fiscal Year 2014. http://www.uspto.gov/about/stratplan/budget/fy14pbr.pdf (USPTO, 2013).

  14. Gaudry, K.S. A look at the results of the USPTO's interview program. Law360 (9 January 2014).

    Google Scholar 

  15. US Patent and Trademark Office. US Dept. of Commerce, Manual of Patent Examining Procedure § 708.02(a), 8th edn., 9th rev. (USPTO, 2012).

  16. America Invents Act (H.R. 1249).

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Acknowledgements

The authors would like to thank D. Stephenson for his assistance in data-collection efforts.

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Authors and Affiliations

  1. Kate S. Gaudry is at Kilpatrick Townsend & Stockton LLP, Washington, DC, USA,

    Kate S Gaudry

  2. Daniel E. Cummings is studying at Creighton University School of Law, Omaha, Nebraska, USA.,

    Daniel E Cummings

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  1. Kate S Gaudry
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  2. Daniel E Cummings
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Correspondence to Kate S Gaudry.

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Gaudry, K., Cummings, D. Patent office backlog adds billions to national drug expenditure. Nat Biotechnol 32, 436–439 (2014). https://doi.org/10.1038/nbt.2894

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