Nobel Prize winner filed a lawsuit against Ono pharmaceutical, demanding a settlement of 22.6 billion yen for the PD1 project
Last Update: 2020-06-19
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Tasuku Honjo, an immunologist at Kyoto University and the winner of the 2018 Nobel Prize in physiology or medicine, recently announced that he would file a lawsuit against Ono Pharmaceutical Co., requiring Ono to pay 22.6 billion yen (US $207 million) in settlement to opdivo, its PD-1 anticancer drugBefore that, Ben Shuyou testified in a patent dispute case for Ono pharmaceutical, which shares a patent with him, and helped the company win a huge amount of compensation, but he has not received his own part of the compensation< br / > about this lawsuit, we should start from the discovery of PD-1, the relationship between bensuyou and Ono pharmaceutical, the relationship between medarex, an American biotechnology company, and BMS, and the patent war between opdivo and keytruda between BMS and Merck< br / > in 1992, bensuyou first found an immunoglobulin receptor on the lymphocyte membraneAt that time, it was thought that it was related to programmed cell death, so it was named pd-11994Bensuyou first found human PD-1 gene and protein, and in 1999, he first proposed that PD-1 was a negative regulator of the immune systemThen bensuyou successively published the research on the immune mechanism transduction of PD-1, It was found that PD-1 expressed by programmed death T cells could be used in cancer treatment< br / > Ben Shuyou suggested to a researcher of Ono pharmaceutical who went to Kyoto University to cooperate in the development of anti-cancer drugsAt that time, Ono pharmaceutical was also in urgent need of breakthrough, so the two sides jointly launched cooperation< br / > around June 2001, bensuyou and Ono Pharmaceutical Co., Ltdsubmitted an international patent: substance specific to human PD-1Under the protection of this patent, any substance, as long as it is specifically combined with human PD-1 protein, infringes the patents of bensuyou and Ono pharmaceutical< br / > in July 2003, benshuyou and "Ono pharmaceutical industry" applied for Patents according to the distribution ratio of 1:1< br / > in May 2005, bensuyou, Ono pharmaceutical and medarex announced a cooperation agreementOno pharmaceutical obtained the global rights and interests of PD-1 antibody except North America, while medarex retained the commercial rights and interests of PD-1 antibody in North America< br / > in June 2006, bensuyou, Ono pharmaceutical and medarex jointly developed opdivo, an anti-PD-1 single antibody, which is one of the anti-PD-L1 and anti-PD-1 single antibody for human use, and submitted an application for a new investigational drug (ind) to the U.SFDA In the same year, they began to conduct clinical trials on patients with relapsed and refractory solid tumor (non-small cell lung cancer, colorectal cancer, melanoma, etc.) < br / > in October 2006, bensuyou signed a contract with Ono pharmaceutical to pay patent fees, but the patent fees paid to bensuyou were less than 1% of the sales volume < br / > in 2009, medarex was acquired by BMS, and the clinical trials, intellectual property rights and subsequent development rights of opdivo were dominated by BMS So far, the patent rights of opdivo include Ono pharmaceutical and bensuyou, and BMS has the exclusive license to implement the patent rights < br / > in June 2014, opdivo was approved to treat melanoma in Japan, becoming the first approved PD-1 in the world However, it is suffering from patent cliff and generic competition Ono pharmaceutical rapidly gained new growth In the spring of that year, the total market value of Ono pharmaceutical reached about 3 trillion yen, ranking the second in Japanese pharmaceutical manufacturing industry < br / > on September 4, 2014, keysruda was approved by FDA That night, BMS filed a lawsuit against MSD, claiming that MSD's keytruda violated BMS / Ono's series of patents on PD-1 antibody for cancer treatment < br / > later, the two companies waged a long-term tug of war on the patent rights of the two PD-1 drugs, during which Ben Shuyou went to the United States to testify and provided other support for the lawsuit < br / > on January 20, 2017, BMS / Ono announced and signed a settlement and global patent license agreement with MSD on the patent lawsuit of PD-1 monoclonal antibody: MSD will pay a down payment of $625 million to BMS / Ono, 6.5% of keytruda's sales in 2017-2023, 2.4% of keytruda's sales in 2024-2026, and BMS and Ono will be divided by 75 / 25 It is roughly estimated that MSD will pay more than $6 billion (642 billion yen) in total < br / > in April 2019, Ben Shuyou asked to restart contract negotiations with Ono pharmaceutical at a press conference Bensuyou and his lawyer said that they refused to accept the offer of about 2.6 billion yen from Ono pharmaceutical When the agreement was signed in 2006, Ono pharmaceutical did not give a full explanation for bensuyou's remuneration Bensuyou could only obtain less than 1% of the sales and licensing income of the drug, which could not reflect its contribution Lawyers say a reasonable level is 5% to 10% At the same time, Ben said he hoped to negotiate directly with Ono to avoid litigation < br / > in June 2020, Ben Shuyou announced that he would file a lawsuit against Ono pharmaceutical company < br / > Benye said that at the time of signing the compensation agreement with him, he didn't expect Benye's role in the patent case, so he promised to pay 40% of the settlement to him, no matter how much the settlement was, but later, he said that he would only pay 1% of the compensation to him; but up to now, Ono has yet to pay him anything < br / > after three years of fruitless negotiations with Ono, he decided to bring the matter to court The lawsuit will be filed in Osaka District Court in mid June < br / > at that time, bensuyou wanted to apply for a patent for his PD-1 research results, but Japanese universities including Kyoto University "did not have any ability to manage or apply for a patent, or even could not pay for the patent application fees", so bensuyou turned to Ono pharmaceutical, "I did not have any cooperation with Ono pharmaceutical in scientific research, but they helped me apply for a patent", Japanese companies are still benefiting from the research of scientists, "we believe that this lawsuit is not only against my own situation, but also supports many other scientists in the academic community," he said < br / > prior to that, bensuyou has promised to donate part of the compensation he received in the settlement to Kyoto University to establish a foundation with a fund of 100 billion yen to support young researchers.
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