First pluripotent stem cell patent granted in Japan

The Japanese Patent Office has granted the first patent for induced pluripotent stem cells (iPS cells) to Kyoto University, where researcher Shinya Yamanaka produced both the first non-human iPS cells in 2006 and, using the same process, the first human iPS cells in 2007.The Japanese patent, a limited version of a much broader international patent application covering all forms of iPS cell (excluding germ cells) across all species, covers only human iPS cells created using Yamanaka's process based on reprogramming adult cells using four gene factors.

The granting of the patent in Japan was fast-tracked by Patent Office officials so as to make clear the University's claim while the broader patent goes through lengthy processing across the world's other major patent institutions. The urgency in part reflects the contemporaneous progress of a US team headed by James Thomson at the University of Wisconsin which published its own successes in producing human iPS cells on the same day as Yamanaka in 2007.

The international patent applications, some of which are in Yamanaka's name solely (including the potentially lucrative US patent), may eventually cover a huge range of therapeutic applications and future avenues of research. Uncertainties have been raised, however, about whether the patent phrasing does enough to preclude others (such as Thomson's group who used a different set of genetic factors to create their iPS cells) from pursuing patents for their own distinct methods of preparation.

Hideya Hayashi of Kyoto University's iPS Cell Research and Application office is quoted in the journal Nature saying that the aim of the patent is not to restrict others from pursuing iPS technologies but instead to ensure that Yamanaka's group are not tied by other future patent applications. 'We want to remove any potential obstacles to the quick clinical application of IPS technology', Hayashi told Nature, adding that 'we are not trying to confine its use'.

The university has claimed it plans to grant licences and assistance in replicating Yamanaka's technology to institutions and non-profit organisations across Japan. The main concern, preventing a large pharmaceutical company from taking out a patent and then forcing universities to pay for the right to employ the technology, has been partially allayed by this first patent, which secures Yamanaka's basic process until 6 December 2026. However, it will be an anxious wait over the coming year while the rest of the international patents finish being scrutinised.