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The patentability of medicinal inventions related to personalized medicine in Japan

Nature Biotechnology volume 23, pages 1367–1369 (2005)Cite this article

Several amendments of the examination guidelines for medicinal inventions may be good news for pharmaceutical companies.

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References

  1. Patent Nos. JP H10-506640 and US 6299872.

  2. Intellectual Property Policy Headquarters. “Regarding the state of patent protection for methods related to medical activity.” November 22, 2004.

  3. Japan Patent Office. Examination guidelines for patent & utility model in Japan, Part VII: Examination guidelines for specific technical field, “Medicinal Inventions.” April 15, 2005.

  4. Japan Patent Law, Article 29, Subsection 1.

  5. Article 52 of the EPC was amended on 29 November, 2000. When the amended provisions are implemented, the methods of treatment currently in Article 52(4) EPC will become an exception to patentability under Article 53 EPC, rather than being regarded as not susceptible to industrial application under the present Article 52 EPC.

  6. In re Schoenwald, 946 F.2d 1122 (Fed. Cir. 1992).

  7. G5/83-EISAI/Second Medical Use [1985] O.J. EPO, 64.

  8. Under the new Article 54(5) EPC, patentability will not be excluded on the grounds of lack of novelty for any substance or composition, comprised in the state of the art, for any specific use in a method referred to in the present Article 52(4), provided that such use is not comprised in the state of the art.

  9. T128/82 Hoffmann-La Roche/pyrrolidine-derivatives [1984] O.J. EPO, 164.

  10. UK Patent Office. F. Hoffmann-La Roche AG BL 0/192/04 July 7, 2004.

  11. T51/93 Serono.

  12. T570/92 Bayer (see also T56/97 Takeda).

  13. Bristol-Myers Squibb Company v. Baker Norton Pharmaceutical Inc. [2001] RPC 1.

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Acknowledgements

We thank Toshio Miyake of Kato Patent Firm for advice on this article.

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Authors and Affiliations

  1. Research Priority Committee, RIKEN, 2-1 Hirosawa, Wako-shi, Saitama, 351-0198, Japan

    Itsuki Shimbo, Andrew Cobden & Koichi Sumikura

  2. Resarch Institute of Intellectual Property Management, Waseda University,

    Itsuki Shimbo, Andrew Cobden & Koichi Sumikura

  3. Lovells, 1-4-2 Kasumigaseki, Chiyodaku, Tokyo, 100-0013, Japan

    Itsuki Shimbo, Andrew Cobden & Koichi Sumikura

  4. National Graduate Institute for Policy Studies (GRIPS), 7-22-1 Roppongi, Minatoku, Tokyo, 106-8677, Japan

    Itsuki Shimbo, Andrew Cobden & Koichi Sumikura

Authors
  1. Itsuki Shimbo
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  2. Andrew Cobden
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  3. Koichi Sumikura
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Shimbo, I., Cobden, A. & Sumikura, K. The patentability of medicinal inventions related to personalized medicine in Japan. Nat Biotechnol 23, 1367–1369 (2005). https://doi.org/10.1038/nbt1105-1367

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