Posted on behalf of David Cyranoski.
On 5 August, the United States Patent and Trademark Office approved its first patent for the induced pluripotent stem (iPS) cell technology developed by Kyoto University’s Shinya Yamanaka. The patent is based on the technique Yamanaka used in 2006 to reprogram fully differentiated somatic mouse cells to an embryonic state, but Akemi Nakamura a university spokeswoman says it will broadly cover variations of the technology developed since then in laboratories around the world for human cells.
The university will not try to restrict research using iPS cells for non-profit purposes. “Kyoto University allows any academic researchers who do research for non-profit purposes to use our iPSC techniques free of charge, so we will not enforce the patent to stop researchers from using iPSCs,” says Nakamura. But university spin-off company, iPS Academia Japan, may ask companies that use iPS cells for a licensing fee.
Kyoto University now has patent rights for iPS cell technology in six nations and two regions: Israel, Japan, New Zealand, Singapore, South Africa, the US, Eurasia and Europe. The European Patent Office granted a patent on 30 May.
In February, the university signed a deal with US-based biotech firm iPerian to share patent rights.
Just how well that patent will defend Kyoto University’s ability to use the technology and prevent others from doing so remains to be seen. Researchers around the world have discovered dozens of variations on Yamanaka’s original and they might challenge the breadth of the patent.
Kyoto University’s press release claims broad coverage: “The US patent covers combinations of nuclear reprogramming family factors comprising an Oct family gene, a Klf family gene, and Myc family gene, or an Oct family gene, a Klf family gene and a cytokine. This means that if companies use a combination of the nuclear reprogramming genes and generate iPSCs, regardless of the kinds of vectors, they need to get the patent license.”
“We believe that many labs use these genes to make iPSCs, so we think the coverage is broad,” says Nakamura.
The patent could also be challenged on the grounds of priority. In February 2010, the USPTO approved San Diego-based Fate Therapeutics’ 2003 patent application describing the potential to reprogram cells. The company claims the patent covers iPS cell technology.
Kyoto University thinks otherwise. “The Fate patent was based on the 2003 application, long before Dr. Yamanaka announced the generation of mouse iPSCs for the first time in 2006. Examining the content of their claims, we think that this Fate patent does not relate to iPSC technology,” says Nakamura. It will be a matter for courts to decide.