Article 93 of the Japan Patent Law stipulates that a party who wishes to practice a patented invention in the public interest may request arbitration from the Minister of Economy, Trade and Industry in regard to the granting of a non-exclusive license to practice said invention.
 

Article 93(1) If the working of a patented invention is particularly necessary to the public interest, a person intending to work the patented invention may request the patentee or the exclusive licensee to hold discussions toward an agreement to grant the person a non-exclusive license.
 
(2) If the agreement referred to in the preceding paragraph is not reached or if discussion toward such an agreement cannot be held, the person intending to work the patented invention may request the Minister of Economy, Trade and Industry for arbitration.

 
While there had not previously been any such cases of arbitration in the public interest, Vision Care Inc. and VCCT (VC Cell Therapy) Inc. filed a request for arbitration with the Minister of Economy, Trade and Industry on July 13, 2021, contending that a non-exclusive license to practice Japanese Patent No. 6518878 should be granted based on Article 93(2) of the Patent Law.
 
The patent in question is jointly owned by Healios K.K., the national research and development agency Riken, and Osaka University, and relates to a method of differentiation induction of retinal pigment epithelium (RPE) cells from human pluripotent stem cells such as human iPS cells. The main claims of the patent are as follows.
 

1. A method of producing retinal pigment epithelial cells, the method comprising a step of adhesion culture of human pluripotent stem cells on a culture substrate coated with a laminin 511 E8 fragment, the step of adhesion culture being performed in the presence of a differentiation inducer.
 
2. The method according to claim 1, wherein the human pluripotent stem cells are human iPS cells.

 
The patent relates to an invention having, for example, improved differentiation inductivity of retinal cells, and improved substrate adhesion, as a result of culturing iPS cells, for example, on a substrate coated with a laminin 511 E8 fragment.
 
Vision Care Inc. and VCCT Inc., who requested the arbitration, are both companies of which Masayo Takahashi is President and CEO, and Takahashi is one of the inventors of the patent at issue. In 2014, Takahashi achieved the first transplant of retinal cells to a patient suffering from age-related macular degeneration, using a technique of creating retinal cells from iPS cells while at Riken. Subsequently, the joint research was discontinued owing to differences in direction, and Takahashi attempted to begin negotiations with Healios K.K., who owned an exclusive license, for use of the patent. After this, Takahashi, having moved from Riken to Vision Care Inc., requested the arbitration noted above.
 
While the case was observed with much interest and the outcome greatly anticipated, being the first of its kind, the request for arbitration was ultimately withdrawn on May 30, 2024, as a result of a settlement having been reached. Under the terms of the settlement, Vision Care Inc. and VCCT Inc. are now able to work the patent under certain conditions. The conditions are that during the term of the patent (which expires on October 9, 2034), for up to thirty implementation subjects (with the possibility of increase in the event that the upper limit is reached), in medical treatment at self-expense targeting RPE defects, production of the like of RPE cells derived from private iPS cells may be implemented.
 
Following the settlement, Takahashi published this statement: "This settlement is extremely significant as a case that can now be widely made public in which, for what is likely the first time in our country's history, as a result of a request for arbitration, a party that did not own the patent right has been allowed use of a patented invention, and I am hopeful that it will also have the effect of encouraging inventors who have been struggling in similar circumstances, given the current backdrop of promotion of industry-academia collaboration."
 
<News release from Vision Care Inc. (Japanese)>
https://www.vision-care.jp/news/20240530/
<News release from VCCT (VC Cell Therapy) Inc. (Japanese)>
https://www.vcct.jp/news/20240530/

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Summary prepared by the International Information Group
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