The 2012 Nobel Prize in Physiology or Medicine was awarded to Sir John B. Gurdon, a professor at the University of Cambridge, and Dr. Shinya Yamanaka, Director of the Center for iPS Cell Research and Application (CiRA) at Kyoto University, for their discovery that “mature cells can be reprogrammed to a pluripotent stem cell state”.

Dr. Yamanaka developed a new type of pluripotent stem cells, known as induced pluripotent stem cells (iPS cells), which are similar to embryonic stem cells (ES cells) and are created by artificially introducing certain genes into somatic cells. iPS cells are characterized by the theoretic ability to differentiate into any kind of organ or tissue of the human body.

Patent Strategies for iPS Cell Technology

In order to protect such breakthrough scientific technology, it is important to develop a farsighted patent strategy taking practical uses of the technology into consideration. Dr. Yamanaka’s strategy is to file patent applications promptly in an attempt to obtain patents on the basis of fundamental research, which can lead to expedition of the establishment of license agreements between companies and research organizations around the world, resulting in the achievement of practical uses of clinical applications. According to CiRA, “the acquisition of iPS cell-related patents by Kyoto University prevents any domestic and foreign companies from dominating licenses for iPS cell technology, and ensures that iPS cells are widely available at reasonable and appropriate licensing fees”. This patent strategy of CiRA is vastly different from those of many companies trying to obtain patents to protect their technologies. In addition, CiRA focuses on another point in their patent strategy with regard to license agreements. CiRA aims to avoid IP disputes with regenerative medicine enterprises and instead promotes the creation of license agreements with them. For example, CiRA has been assigned two iPS cell-related patents filed by iPierian, Inc., a U.S. venture company. In return, iPierian was given permission to use CiRA’s basic patents relating to a method for preparing iPS cells through a license agreement with Kyoto University. Although a conflict between CiRA and iPierian was initially expected, their issues were settled through dialogue and agreement on practical use of each of their patents.

CiRA Patent Information

According to CiRA, Kyoto University was granted four patents this year relating to CiRA’s basic iPS cell technology, one in Japan and three in the U.S. Prior to this, Kyoto University had already obtained three Japanese patents relating to basic iPS cell technology. In addition to newly-granted patents, there is a total of four Japanese patents and six in the U.S. Kyoto University has obtained patents relating to basic iPS cell technology not only in the U.S. but also in Europe, Singapore, South Africa, and the Eurasian region.

The first patent was issued in September 2009 (Japanese Patent No. 4183742). This patent is related to a method of creating iPS cells comprising the step of introducing four kinds of genes into somatic cells, for example, skin cells. The patent covers the cells created by this method. The following is the granted claim of Japanese Patent No. 4183742:

“A method for preparing an induced pluripotent stem cell from a somatic cell, comprising the step of introducing the following four kinds of genes into a somatic cell: Oct3/4, Klf4, c-Myc, and Sox2.”

CiRA Licensing Situation

According to iPS Academia Japan, Inc., an IP management company entrusted by CiRA, a wide range of sublicensing rights has been granted to iPS Academia Japan not only from Kyoto University but also from several other universities and research institutions. The number of patent applications licensed to iPS Academia Japan has reached about 60 patent families (approximately 220 patent applications), of which 41 applications have been issued as patents in Japan, the U.S., Europe, and others.

Conclusion

In moving to the next step, it is necessary to promote the development of R&D strategies, to secure financing, and to prepare a sufficient R&D environment for iPS cell technology. More importantly, as far as intellectual property is concerned, in order to promote such breakthrough studies in Japan and to encourage the filing of patent applications from many industries, the establishment of a legal framework for IP enforcement has come to be an urgent necessity.

The Japanese Patent Office has begun to reconsider how to examine and protect inventions related to stem cell technologies and in the process has called for opinions from intellectuals. As a result, the Examination Guidelines for Patents and Utility Models in Japan were revised in 2003. In accordance with the revised Examination Guidelines, medical inventions relating to “methods which separate or purify stem cells removed from the human body”, “methods which cultivate stem cells”, “methods which differentiate stem cells into tissue cells”, and “methods which carry out processing before transplanting a tissue or organ removed from the human body” are now patentable. It should be noted that there are some who strongly feel that “methods for removal of cells from the human body” and “methods for transplantation of a processed tissue or organ into the human body” should also be patentable.