United States in race to commercialize pluripotent stem cells.
As the battle to create therapeutic stem-cell lines intensifies, Japan is waking up to the fact that the United States could steal a march on it by being the first to commercialize induced pluripotent stem (iPS) cell technology.
Shinya Yamanaka and his colleagues at Kyoto University pioneered the creation of iPS cells, and the technology is seen as something of a national industry — albeit one in its extreme infancy. Like embryonic stem (ES) cells, human iPS cells have the potential to develop into any of the body's cell types, and are expected to have tremendous value in drug screening and for therapeutic purposes. They are easier to produce than ES cells and are not associated with the same controversial source — iPS cells can be derived from adult cells rather than embryonic cells.
On the same day in November 2007 that Yamanaka reported his human iPS cells1, James Thomson's team at the University of Wisconsin-Madison separately published similar results2. The details of any patents applied for by either party are not known — in Japan, as in Europe, a patent is awarded to the researchers who file first; in the United States, the patent goes to the group that can show it invented the technology first (see Broader coverage).
Kyoto University stalled over developing a strategy to protect its patents because of a lack of legal expertise on involvement with industry. This has caused much anxiety in the Japanese media, with pundits fretting over what they see as imminent US ascendancy in the field. The Nikkei Keizai Shimbun newspaper, for example, notes that presentations on iPS cells by non-Japanese groups had arrived "one after the other" at last week's meeting of the International Society for Stem Cell Research in Philadelphia, adding that "Japan should be leading in iPS technology, but things have taken a turn for the worse".
This might be about to change, though, with the launch of 'iPS Academia Japan', a company set up to manage Kyoto University's iPS patents. The company, which is due to start up within a month, will be backed by around ¥1.2 billion (US$11 million) from a fund created jointly in May by Daiwa Securities Group, the Sumitomo Mitsui bank and NIF SMBC Ventures, a private Japanese equity company. A Daiwa Securities representative says that no return is expected, "at least not in the short term. It is a form of corporate social responsibility."
A central purpose of iPS Academia Japan is "to prevent some group or company from monopolizing iPS technology", says Hiroshi Matsumoto, Kyoto University's executive vice-president, who has been heading the dealings between the university and the investors.
It may already be too late. Kazuhiro Sakurada, who led the research arm of drug company Bayer Yakuhin in Kobe, is now chief scientific officer of iZumi Bio in San Francisco, California, a company set up to commercialize iPS cells. In April, reports claimed that Sakurada had created his own iPS cells in April 2007 while at Bayer Yakuhin, even though his results were not published until this January3. There are unconfirmed reports that Yamanaka did not create his first cells until July 2007, and it is not known who would hold the critical patent. Although Yamanaka has patents from his original iPS work in mice, it is not clear whether these patents will cover human iPS cells. Neither Sakurada nor Yamanaka would comment on the issue.
Little is known about iZumi Bio, and this exacerbates Japanese fears. The company is in "stealth mode", according to a spokesperson at Burson-Marsteller, the public-relations firm representing iZumi in Tokyo. It has a skeletal website (www.izumibio.com) that presents only its mission statement: to use "the power of induced pluripotent stem (iPS) cells to transform drug discovery and regenerative medicine". Yutaka Teranishi, who heads Kyoto University's intellectual-property office, says there is currently no formal relationship between the university and iZumi. But he adds: "We would be ready to license the technology to any partner ready to [develop iPS-cell technology for the benefit of patients]."
Thane Kreiner, chief executive of iZumi Bio, told Nature only that the company is funded by Kleiner Perkins Caufield and Byers, the high-powered venture-capital company that helped create Genentech, and Highland Capital Partners. "iZumi is engaging in discussions with various potential partners," Kreiner says, and would not discuss the company's business model further. But on Monday, iZumi announced "a major research collaboration and licensing agreement to focus on applications for iPS cells" with Gladstone Institutes, based in San Francisco. Yamanaka has a joint position there.
Rumours abound in the normally conservative Japanese press. The magazine Nikkei Biotechnology & Business reports that iZumi has been collecting "iPS cell patents from all over the world", and has already licensed ES-and iPS-cell-related patents from Harvard University and the Massachusetts Institute of Technology (MIT) in Cambridge. Representatives of the intellectual-property office at MIT deny the report. Counterparts at Harvard say "we have no news to report" with regard to the patents. Kreiner says the patents in question have not even been issued. "It is clearly too early to discuss," he says.
"iZumi would like to work closely with Japan, and we celebrate Japan's scientific leadership," Kreiner told Nature. "Yamanaka and Sakurada as well as Thomson have made significant contributions," he says, acknowledging that it was Yamanaka's work on iPS cells in mice that was the starting point for the whole field.
Takahashi, K. et al. Cell 131, 861–872 (2007).
Yu, J. et al. Science 318, 1917–1920 (2007).
Masaki, H. et al. Stem Cell Res. 1, 105–115 (2007).
See also Correspondence: Japan should intensify embryonic stem-cell investigations
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Cyranoski, D. Japan ramps up patent effort to keep iPS lead. Nature 453, 962–963 (2008). https://doi.org/10.1038/453962a
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