Research Tool Patents

June 26, 2009
HARAKENZO World Patent & Trademark Intellectual Property Law Firm
Patent Attorney: Kentaro TSURUTA

In April of 2009, the research tool patent database was released on the website (*1). The database contains information as to research tool patents owned by private businesses, universities, and the like. The information includes patent ownership and licensing conditions of such research tool patents. The research tool patent database allows a user to easily access such information, and is expected to facilitate the use of research tool patents by providing a condition where a user can use such patents smoothly.
Although there are several definitions for the term “research tool patents”, here, the term “research tool patents” refers to Japanese patents granted to products or methods which are used as tools for conducting research in the life science field. For example, “research tool patents” includes patents as to test animals and plants, cell lines, monoclonal antibody, and screening methods.
As of June 24, 2009, the number of registration is 62 (private businesses account for 6, and universities and research institutions (such as the Japan Science and Technology Agency, and the Institute of Physical and Chemical Research) account for 56). The number of the registered patents is 875 (private businesses’ patents account for 34, and universities’ patents, etc. account for 841). In terms of a sort of the target technology, the numbers are reasonable.
The operation of the database has been just begun, and it is unknown how often the database will be used. However, depending on how the operation will be, there is a possibility that the database will has an influence on the future patent system. This is because the database is one of strategies for solving a patent system problem which has been deliberated internationally from more than a decade ago, and, depending on a situation, another approach may be adopted in order to solve the problem.
The problem is, to put it briefly, a possibility that research tool patents become an obstacle to free research or development. Further, research tool patents include patents as to techniques that cannot be substituted (disease-related genes, for example). This creates uneasiness about high license royalties, mainly in the pharmaceutical industry. In addition, there was such a case that a U.S. biotechnology venture filed a lawsuit against Hamamatsu University School of Medicine for patent infringement on a patent of test mice for a cancer metastasis research (Tokyo District Court, October 10, 2002).
In order to solve such problems, the following approaches have been taken into consideration.
(1) Limitation in Patent Right
With the definition in Article 69 of Japanese Patent Act, “patent right shall not be effective against the working of the patented invention for experimental or research purposes”, the right of a research tool patent can be limited by construing the range of “experimental or research purposes” broadly. However, in the present situation, it is generally considered that the definition is limited only to the experiments and research for the patented inventions themselves.
(2) Setting of Compulsory License (Ruling)
The ruling under Article 93 of Japanese Patent Act can be applied to research tool patents that cannot be substituted.
(3) Use of Guideline, Patent Pool, Patent Clearing House, etc.
In order to solve the problems, a mechanism such as the patent pool in the IT field can be established, or, as a standard for entering into a license agreement, a guideline can be established.
As to the approach (3), “Guidelines for Facilitating the Use of Research Tool Patents in the Life Sciences” was announced at the Council for Science and Technology Policy, March 1, 2007. The guidelines demand, regarding research tool patents, that the grant of a license, a setting of a license royalty, etc. should be smoothly carried out as much as possible. Particularly, the guidelines mention it is desirable to set no license royalty between universities. Further, for such facilitation of license agreements, the guidelines mention the establishment of the integrated database for providing information relevant to research tool patents. It is highly possible that the research tool patent database mentioned at the beginning was established in accordance with the guidelines.
It should be noted that the other approaches have been still taken into consideration. For example, at the 2nd Patent System Seminar held March 27, 2009, it seemed that the approach of the ruling was denied, but there were comments demanding the range of the “experimental and research purposes” should include the use of research tool patents.
As mentioned above, it has not been decided how research tool patents should be dealt with. However, in my private opinion, it is believed that research tool patents are also an incentive for the research and development, as seen from the fact that a lot of universities and research institutions are registered in the research tool patent database. Therefore, it is desirable that the patent system will be the one that does not fail to retain the incentive. In view of this point, it is hoped that the research tool patent database will be broadly used.


*1 http://www.ryutu.inpit.go.jp/RTPatents/

References
• Institute of Intellectual Property, “Investigation Research Report Regarding Exception and Limitation of Effects of Patent Right” (JPO Industrial Property Right System Problem Investigation Research Report, 2004)
http://www.jpo.go.jp/shiryou/toushin/chousa/pdf/zaisanken/165kouryoku.pdf
• Koich SUMIKURA, “Standard and Patented Inventions in Field of Biotechnology” (Intellectual Property Management Vol.59, No3, 2009)
• Hiroshi ISHIKAWA, “Use of Patented Inventions for Research and Development in the Field of Life Science from Industrial Side” (Patent Studies No.43, March 2007)
• Council for Science and Technology Policy, “Guidelines for Facilitating the Use of Research Tool Patents in the Life Science” (March 1, 2007)
http://www8.cao.go.jp/cstp/project/bunyabetu2006/life/4kai/siryo3-2.pdf
• Industrial Structure Council, Intellectual Property Policy Committee, Patent System Subcommittee, “Problems of Non-substitutable Research Tool Patents” (distributed documents at the 7th Patent Strategy Planning Related Problem Working Group, March 3, 2004)
http://www.jpo.go.jp/shiryou/toushin/shingikai/pdf/strategy_wg07/paper03.pdf
• JPO, “The 2nd Patent System Seminar, Summary of Proceedings” (March 27, 2009)
http://www.jpo.go.jp/shiryou/toushin/kenkyukai/tokkyoseidokenkyu02_giji.htm