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Patent term extensions for biologic innovators in Japan

Nature Biotechnology volume 29, pages 34–37 (2011)Cite this article

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The Japanese Intellectual Property High Court recently issued two decisions that bolster the market exclusivity period for brand biologic manufacturers.

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Figure 1: Calculation of patent term extension periods.

References

  1. Tessensohn, J.A. & Yamamoto, S. World Intell. Prop. Law Rep. 23, 31–32 (2009).

    Google Scholar 

  2. Connolly, C. & Shear, M.D. Discord on health care dulls luster of new pacts. Washington Post 9 July 2009, A1.

    Google Scholar 

  3. Anonymous. Biotech bottleneck. Washington Post 29 July 2009, A16.

  4. Pollack, A. Costly drugs known as biologics prompt exclusivity debate. New York Times 22 July 2009, B1.

    Google Scholar 

  5. Belsey, M.J., Harris, L.M., Das, R.R. & Chertkow, J. Nat. Rev. Drug Discov. 5, 535–536 (2006).

    Article  CAS  Google Scholar 

  6. Anonymous. Merck to storm Japan with generic biologics. Nihon Keizai Shimbun 3 March 2010.

  7. Anonymous. Nichi-Iko eyes biodrug sales in 3 years with Sanofi-Aventis' help. Nihon Keizai Shimbun 1 June 2010.

  8. GlaxoSmithKline acquired the ex-Japan development and marketing rights to JCR's biosimilar JR-013, a FOB recombinant human erythropoietin kappa that has been approved for renal anaemia in kidney dialysis patients and premature infants, JCR Pharmaceuticals Co. Ltd., Press Release: Comprehensive Agreement on Biopharmaceuticals Business, Dec. 18, 2009.

  9. Anonymous. Teva-Kowa, Nippon Kayaku to develop generic for chemotherapy. Nihon Keizai Shimbun 20 April 2010.

  10. Immunex Corp. v. Commissioner of Japan Patent Office, H-21 (gyo-ke) No. 10092 and H-21 (gyo-ke) No. 10093 dated Dec. 3, 2009, Intellectual Property High Court of Japan.

  11. Wyeth, K.K. & Takeda Pharmaceutical Co. Ltd. Press release: announcing launch of ENBREL, treatment of rheumatoid arthritis. http://www.takeda.com/press/article_1097.html (29 March, 2005).

  12. Jacobsen, T.M. & Wertheimer, A.I. Modern Pharmaceutical Industry: A Primer (Jones and Bartlett Publishers, Sudbury, MA, USA, 2010).

    Google Scholar 

  13. Tessensohn, J.A. & Yamamoto, S. World. Intell. Prop. Law Rep. 19, 21–22 (2005).

    Google Scholar 

  14. Tessensohn, J.A. & Yamamoto, S. World. Intell. Prop. Law Rep 2010/1 18–19 (2010). http://www.wipo.int/wipo_magazine/en/2010/01/article_0007.html.

    Google Scholar 

  15. Japan Patent Office. Annual Report 2006 (Japanese Version) (JPO, Tokyo, 2006).

  16. Japan Patent Office. Annual Report 2009 (Japanese Version) (JPO, Tokyo, 2009).

  17. Schellekens, H. & Moors, E. Nat. Biotechnol. 28, 28–31 (2010).

    Article  CAS  Google Scholar 

  18. US Department of Health and Human Services et al. Guidance for industry Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128076.pdf (June 2005).

  19. Tessensohn, J.A. Modified-Release Drug Delivery Technology. (Rathbone, M.J. et al., eds.) 45–51 (Informa Healthcare, New York, 2008).

    Google Scholar 

  20. Wyeth v. Kappos, 93 U.S.P.Q. 2d 1227 (Fed. Cir. 2010).

  21. Tomomi, A. et al. Nat. Biotechnol. 25, 533–535 (2007).

    Article  Google Scholar 

  22. Tessensohn, J.A. & Yamamoto, S. Biotechnol. Law Rep. 28 483–496 (2009).

    Article  Google Scholar 

  23. Tessensohn, J.A. & Yamamoto, S. Nat. Biotechnol. 27, 815–818 (2009).

    Article  CAS  Google Scholar 

Download references

Acknowledgements

The views and considerations of this article reflect only those of the authors and should not be attributed to Shusaku Yamamoto Co. or to any of its past, present or future clients.

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Authors and Affiliations

  1. John A. Tessensohn & Shusaku Yamamoto are at Shusaku Yamamoto Patents, Chuo-Ku, Osaka, Japan.,

    John A Tessensohn & Shusaku Yamamoto

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  1. John A Tessensohn
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  2. Shusaku Yamamoto
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Correspondence to John A Tessensohn.

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Tessensohn, J., Yamamoto, S. Patent term extensions for biologic innovators in Japan. Nat Biotechnol 29, 34–37 (2011). https://doi.org/10.1038/nbt.1743

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