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Will inter partes review speed US generic drug entry?

Nature Biotechnology volume 35, pages 1139–1141 (2017)Cite this article

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A new extra-judicial pathway for challenging pharmaceutical patents has intensified patent challenges and helped to clear the way for earlier generic entry.

Patents are ubiquitous in the pharmaceutical industry and are used by brand-name drug manufacturers to prevent low-cost generic competition and maintain high drug prices. Patents are granted by the US Patent and Trademark Office (USPTO), and it is the job of the more than 8,000 examiners within the USPTO to ensure that patents are granted only when they are deserved: namely, when the drug, formulation, or method of use is new, useful, and sufficiently “non-obvious” over existing products. Despite their best efforts, however, examiners have limited time and resources, and, as a result, it is well documented that some of the more than 300,000 patents issued each year are granted in error.

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References

  1. Leahy-Smith America Invents Act, Pub. L. No. 112–29, 125 Stat. 284 (2011).

  2. 21 USC § 355(j)(2)(vii)(IV) (2017).

  3. Grabowski, H. et al. J. Med. Econ. 19, 836–844 (2016).

    Article  Google Scholar 

  4. Goldstein, R.W. & Pentcheva, D.P. 2015 Report of the Economic Survey. AIPLA (June 2015).

  5. Gleaton, A.V. et al. Finnegan http://www.finnegan.com/resources/articles/articlesdetail.aspx?news=ef284b32-7634-4bc3-b718-7d387a8bc57f (7 March, 2014).

    Google Scholar 

  6. 37 CFR § 42.100(b) (2016).

  7. Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc).

  8. Duffy, J.F. George Washington Law Rev. 83, 28–46 (2015).

    Google Scholar 

  9. Unified Patents. https://www.unifiedpatents.com/join

  10. Shuchman, L. Corp Counsel http://www.corpcounsel.com/id=1202751772701/In-a-Win-for-Crusaders-Bass-and-Spangenberg-PTO-Agrees-to-Reconsider-Pharma-Patents?slreturn=20160628073542 (9 March, 2016).

    Google Scholar 

  11. Judgment on request for adverse judgment, Lupin Limited v. Vertex Pharm. Inc., IPR2015–00405, Paper No. 28 (PTAB 3 November, 2015).

  12. Final written decision, Lupin Limited v. Vertex Pharm. Inc., No. IPR2016–00558, Paper No. 39 (PTAB 2 August, 2016).

  13. Allergan, Inc. v. Teva Pharm. USA, Inc., No. 2:15-cv-1455-WCB, 2017 WL 4619790 (E.D. Tex. 16 October, 2017) (Bryson, J.).

  14. Lewis v. Clarke, 137 S. Ct. 1285 (2017).

  15. S. 1948, 115th Cong. 1st Sess. (5 October, 2017).

  16. Oil States Energy Servs., LLC v. Greene's Energy Grp., LLC, 137 S. Ct. 2239 (2017).

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Authors and Affiliations

  1. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Jonathan J. Darrow, Reed F. Beall and Aaron S. Kesselheim are at the Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.,

    Jonathan J Darrow, Reed F Beall & Aaron S Kesselheim

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  1. Jonathan J Darrow
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  2. Reed F Beall
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  3. Aaron S Kesselheim
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Correspondence to Jonathan J Darrow.

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Competing interests

A.S.K. work is supported by the Laura and John Arnold Foundation, with additional support from the Harvard Program in Therapeutic Science and the Engelberg Foundation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Darrow, J., Beall, R. & Kesselheim, A. Will inter partes review speed US generic drug entry?. Nat Biotechnol 35, 1139–1141 (2017). https://doi.org/10.1038/nbt.4036

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