These patent wars are also taking place behind the Nobel Prize winner's lawsuit of $22 billion in arrears
Last Update: 2020-06-19
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UKU Honjo, 80, a Nobel Laureate in physiology or medicine, recently announced that he would sue Ono Pharmaceutical Coto pay 22.6 billion yen ($207 million) in arrears for patent fees for the PD-1 cancer drug opdivo< br / > Ono pharmaceutical didn't do anything scientific, they just helped me apply for a patent Ben Shuyou announced to the media< br / > this famous immunologist, who first found an immunoglobulin receptor on the lymphocyte membrane in 1992 and named it PD-1 (programmed cell death 1), started to work with Ono pharmaceutical in 2003, until BMS joined in 2007, gradually bringing this heavy-duty PD-1 drug to the market< br / > nowadays, it's hard to avoid that the two sides in the same boat are trapped in the mire of torn interestsHowever, as a favorable weapon to seize the market, patent frictions in the field of medicine have become normal in recent years, especially in the hot target and heavy drug patents, big pharmaceutical companies are fighting endlessly, which can be described as "one wave is not flat, another wave is rising again"< br / > it is worth mentioning that in 2020, only half of the patents will be contested in the pharmaceutical industryWe have taken stock of some of the more important "patent disputes", some of which are twists and turns, some of which can be described as "textbook" level cases, and some of which are atypical events in special periods< br / >< br / > in December 2014, the PD-1 drug opdivo, which was held by bensuyou and Ono pharmaceutical and developed by Ono pharmaceutical and BMS, was approved by FDA for listingIn September 2014, the heavyweight PD-1 drug approved for listing was keytruda of MSD< br / > before that, BMS and MSD have been competing with each other in clinical trials and marketingUntil keytruda went public, BMS and Ono filed a lawsuit to the federal court, accusing keytruda of infringing the patent rights of its PD-1 antibody used to treat cancer in the United States, Europe, Australia, Japan and other countries and regions< br / > in the face of BMS holding the powerful weapon of patent monopoly, MSD chose reconciliationIn January 2017, MSD and BMS / Ono pharmaceutical signed a patent litigation settlement and a global patent license agreementAccording to the agreement, MSD will pay US $625 million patent license fee in the first phase, and 6.5% of keytruda's global sales from January 1, 2017 to December 31, 2023, and 2.5% of global sales from January 1, 2024 to December 31, 2026 as patent license feeBMS and Ono will share the proceeds in a 3:1 ratio < br / > and what role does Ben Shuyou play in this patent dispute? Why did he initiate this lawsuit? < br / > let's go back to the beginning of the 20th century At that time, he wanted to use his PD-1 discovery patent to treat cancer, but at that time, including Kyoto University, Japan's University had almost no knowledge and ability to apply for a patent Until 2003, Ono pharmaceutical, which was in urgent need of new drugs to change its business status, delivered olive branch to benshuyou The two sides applied for patent according to the distribution ratio of 1:1 However, when the patent license agreement was signed in 2006, due to unclear research prospects, benshuyou's distribution ratio was less than 1% < br / > in May of last year, when Ono pharmaceutical paid 2.6 billion yen of patent payment according to the original agreement, Ben Shuyou refused to accept the payment and entrusted the fund to the legal bureau, proposing that the distribution proportion should be 5-10% according to the international practice < br / > secondly, in the patent dispute between BMS / Ono pharmaceutical and MSD, Ben Shuyou went to the United States to testify and provided other support for the lawsuit It is reported that at that time, Ono pharmaceutical promised to provide 40% of the total compensation to benshuyou Then three years later, benshuyou said that he did not receive the payment < br / > this is the case of "Nobel laureate brings Ono to court to sue the patent fee of 22 billion yen in arrears" On the whole, 1% of the patent fee is much lower than the international practice Secondly, from the sales volume of K medicine in 2020, which has exceeded 10 billion US dollars, what bensuyou should get is a large amount of revenue < br / > but Ono seems to be right First of all, according to the agreement of 2006, both in black and white, and with the signature of Ben Shuyou, as a listed company, no matter from the perspective of legal affairs or in the attitude of being responsible to shareholders, it is indeed unable to pay the patent fee 5-10 times of the original agreement Secondly, Ono also said that in the deepening cooperation between the two sides after professor benshuyou won the Nobel Prize in medicine in 2018, he had donated more than 20 billion yen to Kyoto University < br / > it's the tearing up of interests after all < br / > < br / > < br / > recently, the patent dispute between Sanofi and Amgen on PCSK9 also has staged results < br / > May 13, according to the Japanese medicine website jiho.jp Sanofi's PCSK9 cholesterol lowering drug, praluent, will be withdrawn from the Japanese market after losing a patent lawsuit with Amgen in April, the report said The drug was launched in Japan in June 2016, and repatha, a competing product of Amgen, was launched in Japan in April 2016 It is the first PCSK9 inhibitor launched in Japan < br / > in fact, in October last year, the Japanese court judged Amgen to win the case, but Sanofi challenged the decision and appealed to the Supreme Court Until this year, the Supreme Court rejected its appeal and upheld the decision of the lower court < br / > according to the data, in 2019, repatha's sales volume in Japan is about 3 billion yen, accounting for 70% of the market share of PCSK9 inhibitors in Japan, and the rest 30% is held by praluent In the lawsuit against Sanofi, Amgen claimed that Sanofi violated its PCSK9 antigen binding protein related patent and tried to prevent the sale of praluent < br / > in fact, the patent dispute between Amgen and Sanofi on PCSK9 started as early as 2014, and the protracted patent fight seems to have no intention of stopping The following is the litigation progress of Amgen and Sanofi in the U.S market: < br / > from injunction to re judgment, from the local court to the federal court, it is not difficult to see that the patent litigation of Sanofi and Amgen in the U.S market is in twists and turns The wonderful game between them even provides an excellent research case for antibody patent < br / > at the beginning of April this year, Sanofi and jayuan completed the restructuring plan related to praluent According to the restructuring plan, Sanofi will be solely responsible for the sales of praluent in the market outside the United States, while zaharan will be responsible for the U.S market < br / > it's just outside the U.S market that more patent disputes are waiting for Sanofi For example, in July 2019, a German court ruled that Sanofi praluent infringed the patent of Amgen repatha and granted Amgen the right to allow competitors' drugs to withdraw from the German market Of course, Sanofi filed different claims, and the fight is not over < br / > Sanofi and Amgen have independently developed PCSK9 antibodies, which are not identical in structure and are unlikely to be involved in patent disputes in theory However, the epitopes of praluent and repatha binding to PCSK9 are overlapped, and the overlapped epitopes are protected by us 8829165 and us 8859741 < br / > it can be seen that an Jin, a law firm with "biopharmaceutical business", attaches great importance to PCSK9, a potential heavy fat reducing target, and has carried out a strict patent layout Unlike the traditional "structure is the king", Amgen's epitope patent is of great significance in the field of intellectual property rights of antibody drugs, and its final judgment has an important reference role in the patent litigation of antibody drugs < br / > < br / > < br / > in April, Gilead / kit was identified as "intentional" by Philip Gutierrez, a judge in California, in the patent infringement case related to car-t therapy yescarta The ruling result is: to increase the USD 752 million compensation paid by Gilead / kit to USD 1.2 billion < br / > the time goes back to December 2019, when Gilead / kit and BMS / Juno filed a lawsuit in California on car-t patent dispute The review result ruled that Gilead / kit needs to compensate BMS for a total of $725 million After that, in order to overturn the decision, Gilead made a lot of arguments to try to invalidate the patent held by BMS / Juno < br / > now, Geely Germany insists once again that yescarta was independently developed by kit and has taken all the risks of discovery and development, and plans to appeal the decision < br / > the core products and technologies involved in this infringement case are yescarta of kite Pharma Department of Geely and car-t technology targeted at CD19 by Juno therapeutics Department of BMS Behind the two giants' confrontation, the key lies in the competition for the technology named "190 patent" < br / > and if the verdict is true, Gilead's profit through car-t therapy is almost 0 ", according to some analysts, the latest verdict < br / > so in this lawsuit, does Gilead have a chance to turn over? You should know that as early as 2015, Novartis and Juno reached a settlement on a patent for car-t therapy Finally, Novartis paid Juno a patent fee of US $12.25 million, as well as subsequent milestone payments and sales commission after kymriah's listing, which calmed the patent storm < br / > < br / > 2 4, China China novel coronavirus Reed Institute announced its official website: it has declared China's invention patent on the use of Reed's "2019 anti coronavirus" < br / > after the news was made public, there were many questions The first focus of public opinion is: does Wuhan Virus Research Institute violate Geely's intellectual property rights? < br / > some experts have given a clear interpretation of this, "what Wuhan Institute of Virology, Chinese Academy of Sciences declared is' use ', not drug structure, which means' a new use of the drug has been found', so there is no problem in patent application." This is also a common practice in the world " < br / > in response to this, Gilead also said that it has no right to interfere with whether the Patent Office grants patents to Chinese researchers So the second question: what's the benefit of applying for the use patent of radcivir 2019-ncov? According to all parties, the key advantage of the move is that the Chinese government does not need to pay a sky high patent fee when purchasing readcivir for the treatment of new coronavirus, and there will be some bargaining chips in the price negotiation with Gilead science < br / > at present, the third question that the market pays attention to is: how likely is Wuhan virus to apply for success? At present, novel coronavirus patents are required to be innovative, creative and patent specifications open enough to be licensed by the patent for use The Wuhan virus is a bit difficult to win the patent of Reed's new anti 2019 coronavirus < br / > it is worth mentioning that a person familiar with the matter disclosed to China Science Daily that "our plan is to apply for the Chinese invention patent of ridacivir for anti new coronavirus first, then apply for PCT (patent cooperation agreement) and enter the United States, European Union, Japan and other countries and regions within 18 months At present, China's invention patents have not been made public, and may be made public within half a year, and then enter the stage of patent substantive examination and authorization "
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