TOKYO -- The Japanese government has solidified plans to extend patents on regenerative medicine to a maximum of 25 years from the current 20 years, aiming to encourage R&D and catch up with rivals abroad.
Skin, corneas, muscle, cartilage and other tissue cultured for transplant surgery are expected to become subject to patent. These and other regenerative medicine products will be placed into their own patent classification, separate from pharmaceuticals.
As a rule, Japanese patents last 20 years. The only exceptions are pharmaceuticals and agricultural chemicals, which are granted a maximum of 25 years due to the lengthy approval process.
Extending the patent term would allow companies to more easily recoup development costs even after time-consuming clinical trials on humans. The term on other medical products, such as artificial hearts, would remain 20 years.
The U.S. already has such an exception in its patent law, which provides for a maximum term of 25 years for regenerative medical products.
The Japan Patent Office will convene a committee of experts Thursday which will make a decision this spring. An enforcement order will be issued as early as this fall, making the longer patent term official.
The Japanese government will also support efforts to make Japan's cell culture process the global standard. Industry groups, backed by the government, will submit a request to the International Organization for Standardization.
Japanese companies hold a combined 70% share of the global cell culture market. Making the Japanese process an international standard would give a lift to the country's biotechnology industry.
Japan is a leader in basic regenerative medicine research. Japanese researchers discovered both induced pluripotent stem cells and stimulus-triggered acquisition of pluripotency, another method of stem cell production.
But the country lags behind Europe, the U.S. and South Korea when it comes to implementing these discoveries. The number of clinical trials run in Japan is less than 10% that of the U.S., according to the Ministry of Economy, Trade and Industry.