TOKYO -- A noted Japanese stem cell researcher has asked Fujifilm Holdings to keep fees in check for using patented technology related to induced pluripotent stem cells, he told The Nikkei on Wednesday.
Shinya Yamanaka, director of the Center for iPS Cell Research and Application at Kyoto University, intends to negotiate with Fujifilm. Yamanaka -- who won the Nobel Prize in physiology or medicine in 2012 for his work on iPS cells -- sees the relevant patents as crucial to the field of regenerative medicine and fears that steep licensing fees will hinder progress. Attention will now be on how the Tokyo-based company responds.
Japan's government is investing more than 100 billion yen ($891 million) over a decade into research of iPS cells -- adult cells "reprogrammed" into an embryo-like state. With the government's backing, CiRA is building a stock of the cells that businesses and other bodies could use to create cells for medical transplants.
A licensing company called iPS Academia Japan manages the basic patents on iPS cell technology held by Kyoto University. For businesses, it sets royalties at just 1.5% of product sales. The low price is aimed at promoting the technology's use, in accordance with Yamanaka's approach.
Fujifilm subsidiary Cellular Dynamics International of the U.S. has patented iPS cell production technology critical to modifying the cells for transplanting. Fujifilm has not disclosed its licensing fees.
"Stockpiling iPS cells is a public service project," Yamanaka says. "Prices ought not to be raised."
Fujifilm has "no intention of impeding research," it has said in past interviews. "Should businesses seek to commercialize" iPS cell operations, "there would naturally be patent negotiations just as in drug manufacturing," the company said. It has shown a willingness to act in a way that is not at odds with future market expansion, so it may find points of agreement with Yamanaka.
Another problem for CiRA is funding its stockpiling efforts. Government support and private donations have allowed it to proceed so far, but continued government backing will be indispensable if it is to continue on.
"If support from the government wanes, we'll carry on with support from regular donors," said Yamanaka. "I intend to look for businesses that will cooperate with us."
Government regulations present another hurdle. To receive official approval to work in regenerative medicine, businesses must undergo safety and other screenings for each type of cell they use. Under current rules, some companies may have to gather certain data all over again, such as from animal testing.
"If safety testing could be simplified, costs would fall," Yamanaka said. "We will keep accumulating data and proceed with comprehensive talks with regulatory authorities."