Protecting methods for treatment related to regenerative medicine and gene therapy in Japan

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In light of the Japan Patent Office's revised examination guidelines, what are the potential problems of protecting advanced biomedical methods related to medical activity?

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  1. 1

    Trade-related Aspects of Intellectual Property Rights (TRIPS) Agreement, Article 27.3(a).

  2. 2

    As stated by Art. 52(4) of the European Patent Convention. The EPC was revised in 2000; however, it has not yet been enforced and the Article before the amendment is still applied.

  3. 3

    Murphy, C.D. Nat. Biotechnol. 19, 481 (2001).

  4. 4

    35 USC Sec. 287. (c).

  5. 5

    Case of a diagnostic device, Tokyo High Court, 2000 (Line KE), Decision No. 65 (H14.4.11).

  6. 6

    Japan Strategic Council on Intellectual Property. Intellectual Property Policy Outline.

  7. 7

    Japan Patent Office. Examination Guidelines for patent and utility model in Japan, Part II, Requirements for Patentability.

  8. 8

    This is a view from Armin K. Bohmann on the claim of the example 9.

  9. 9

    Tabata, Y. Pharm. Sci. & Tech. Today. 3, 80 (2000).

  10. 10

    On July 8, 2003, the expert panel was set up in the Strategic Council on Intellectual Property to continuously examine how to protect methods related to medical activity. The outcome would be expected around next spring.

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We are grateful to Armin K. Bohmann of Bohmann & Loosen, Germany, for his helpful views on how Japanese case examples would be handled in Europe. We would also like to thank Hatsushi Shimizu and Scot Ritchey for their critical review of this manuscript and editorial insight.

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Correspondence to Katsuya Tamai.

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Kaneshiro, K., Masuda, S., Tanaka, Y. et al. Protecting methods for treatment related to regenerative medicine and gene therapy in Japan. Nat Biotechnol 22, 343–345 (2004) doi:10.1038/nbt0304-343

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