To bring innovative new drugs to market, excellent basic research and development capabilities for commercialization are indispensable. It is vital to create an environment in which researchers and companies can collaborate with a sense of reassurance to enhance Japan’s international competitiveness.
Nobel laureate Tasuku Honjo, a distinguished professor at Kyoto University, and Ono Pharmaceutical Co. have reached a settlement in a lawsuit at the Osaka District Court. Honjo, who shared the Nobel Prize in Physiology or Medicine for his involvement in the development of the anti-cancer drug Opdivo, demanded partial payment of patent royalty income from Ono Pharmaceutical, which manufactures and sells the drug.
In addition to paying Honjo a nominal settlement of ¥5 billion, Ono Pharmaceutical will donate ¥23 billion to a fund newly set up at Kyoto University. The money reportedly will be used to employ young researchers and fund research.
Opdivo is a new drug that activates the human immune system, paving the way for immunotherapy that attacks cancer cells. Sales have reached more than ¥1 trillion worldwide since it was commercialized in 2014.
Flaws in the contract between Honjo and Ono Pharmaceutical were an issue in the trial. It is said that in 2006, when they signed a contract on patent royalties, the university’s intellectual property management system was inadequate, and Honjo had no choice but to handle the negotiations himself.
In recent years, an increasing number of universities have established a technology licensing organization (TLO) to handle intellectual property for the purpose of supporting negotiations between researchers and corporations.
However, there are many cases in which the system is fragile. For example, some universities have no specialized staff members to deal with the issue and others hire fixed-term employees to handle such matters.
Employees in charge of intellectual property are required to have a high level of expertise to be familiar with the content of research and also to understand the issues involving commercialization. There is an urgent need for the government to support the development of human resources for that purpose so that such individuals can work in a stable environment.
Drugs under development are said to have an about 1 in 25,000 chance of hitting the market. Drug manufacturers risk incurring huge losses if they fail.
It is also necessary to devise ways to benefit both companies and researchers, through such measures as setting up a mechanism to review contracts if the developed drugs are promising, to ensure they reflect the contributions of the researchers during the development process.
In the United States, intellectual property strategies are positioned at the core of university management. According to the University Network for Innovation and Technology Transfer, profits from patent-related revenues at Japanese universities and public research institutes were ¥6.6 billion in total in fiscal 2019, less than one-thirtieth of the revenues in the United States.
New drug development technologies are becoming more advanced year by year, and the importance of collaboration between industry and academia is increasing. In the fight against the novel coronavirus, vaccines were developed using genetic technology produced at U.S. universities, and they have been effective around the world.
In Japan, it is also important to ensure that research results are appropriately shared between industry and academia, and to create a virtuous cycle in which research and development progress further.
— The original Japanese article appeared in The Yomiuri Shimbun on Dec. 17, 2021.