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Will inter partes review speed US generic drug entry?

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

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  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 (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.

  10. Shuchman, L. Corp Counsel (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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Correspondence to Jonathan J Darrow.

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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).

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