With the development of the new coronavirus epidemic prevention and control, Redsiewe, a new antiviral drug, suddenly attracted attention. The Wuhan Virus Institute of the Chinese Academy of Sciences recently conducted a joint study with the National Research Center for Emergency Prevention and Control Drug Engineering and Technology of the Military Medical Research Institute of the Academy of Military Sciences to conduct a joint study on January 21 stilettos (the use of a new type of coronavirus against 2019), the official website of the Wuhan Virus Institute of the Chinese Academy of Sciences said Thursday.
The news sparked a debate about whether to infringe the intellectual property rights of pharmaceutical manufacturers. Redsywe is a new broad-spectrum antiviral drug developed by Gilead Pharmaceuticals in the United States. Global Times reporter 5 by e-mail contact the Chinese Academy of Sciences Wuhan Virus Institute, as of the evening of the 5th this newspaper did not receive a reply. On the same day, this reporter on the issue of drug patents interviewed a number of domestic experts and lawyers in the relevant fields.
Patent filing is not “infringement” and it is difficult to obtain authorization
Redsiewe was developed by Gilead Pharmaceuticals of the United States and previously used to treat the Ebola virus. According to the official website of Wuhan Virus Institute of the Chinese Academy of Sciences, redsiewe, a drug that has not yet been listed in China and has intellectual property barriers, filed a patent for Chinese invention on January 21st from the point of view of protecting the national interest,’ according to the official website of the Wuhan Virus Institute of the Chinese Academy of Sciences. It will also enter major countries around the world through the PCT (Patent Cooperation Agreement).
The drug developed by Gilead Pharmaceuticals in the United States, patented by our country’s institutions, will it be suspected of “infringement”? In this regard, Wuhan University Medical Department of the Institute of Virus Research Professor Yang Zhanqiu 5 in an interview with the Global Times, said that the Chinese Academy of Sciences Wuhan virus declared is “use”, not the drug structure, meaning “found a new use of the drug”, so the patent is no problem, and after the patent declaration, Ip Offices will also have relevant reviews, and if non-compliance is likely to be rejected, “if the drug development company had already indicated that the drug had anti-new coronavirus effects, it might not have been granted a patent.” “
Chen Yihong, a partner at Zhonglun Law Firm in Beijing, told the Global Times on Friday that the U.S. has a patent for the drug itself, that is, a compound patent, and we are applying for an indication patent, which can be operated in patent law, without problems.
“It’s as if Van Aike was first used to treat cardiovascular disease, and then found that it could treat male sexual dysfunction, and you could apply for a patent for drug use.” Zhao Youbin, senior intellectual property consultant for zito intellectual property patent analysis, told the Global Times that Gilead has patented the compound structure of Ridsyway and the use of the treatment of coronavirus, which has outlined all the uses of anti-coronavirus. Also mentioned is the technical characteristics of coronary virus polymerase inhibition. The new coronavirus also belongs to the scope of the coronavirus, if the Wuhan virus institute of this patent is only the use of Redsiwe originally used to anti-coronavirus further specific to the anti-coronavirus, the mechanism of action is the same, this patent in the licensing of a certain degree of difficulty.
“Therefore, the new patent of the Wuhan Virus Institute of the Chinese Academy of Sciences must prove that the new use of anti-viral virus is novel and creative, and that there must be sufficient experimental data to support it.” However, the patent’s application has not been published in detail, Zhao said, and the patent is more likely to be granted if the patent application is a combination of Redsey and other compounds. I’d
The view of the patent attorney
The official website of the Wuhan Virus Institute of the Chinese Academy of Sciences has such a paragraph: “If foreign related enterprises intend to contribute to the prevention and control of China’s epidemic, we both agreed that in the case of national needs, do not require the implementation of the patent claims rights, hope and foreign pharmaceutical companies to work together for the outbreak prevention and control efforts.” “
Chen Yihong told the Global Times, according to international practice, if the Chinese Academy of Sciences Wuhan Virus Institute patent application signed in China, then the U.S. company really use drugs for the clinical treatment of new coronavirus must obtain our authorization, without our authorization on the infringement, the two sides restrict each other. “China is applying for a patent for use, that is, an extension of other people’s patents, the purpose is to force cross-authorization, to avoid patent holders with the patent to carry the threat and produce wanton price increases and other acts, which is the international practice. “
Zhao Youbin believes that, in view of Gilead has a compound patent, but also applied for a patent for anti-coronavirus use, these two patents belong to the basic patent and core patent, the Chinese Academy of Sciences Wuhan virus applied for the anti-new coronavirus patent if approved will become a peripheral patent. At that time, China’s production of Ridsyway still need to pay Gilead patent fees, but if Gilead produces Redsie drug for the Chinese market and the new coronavirus, also need to get permission from the Chinese side.
The official website of the Wuhan Virus Institute of the Chinese Academy of Sciences also mentioned that “access to major countries around the world will be channeled through the PCT (Patent Cooperation Agreement).” That is to say, through the PCT, the patent application for the virus can be opened to major countries around the world, but the approval of the virus can be made independently of those countries. “As for what the major countries include, it depends on the virus’s own judgment. “
In a statement calling on foreign-related enterprises to contribute to the prevention and control of China’s outbreak, Liu Changqiu, a researcher at the Institute of Law of the Shanghai Academy of Social Sciences, believes that according to previous experience, the greatest help that foreign enterprises can do may be “less patent fees”.
Zhao Youbin also said that in addition to economic value, the application for use patents for Redsie also has scientific and technological value. “The essence of the patent system is to use ‘open’ for ‘protection’: by making patent literature available to the whole society so that more people can be studied, in exchange for the exclusive interestprotection given by state power. Perhaps the public understanding of the patent system is not very thorough, resulting in the ‘Chinese Academy of Sciences Wuhan virus is not to work hard to get other people’s results’ misunderstanding, but in fact this does not exist. The Institute’s patent application is also a common practice in the pharmaceutical industry. “I’d
That’s what Chinese pharmaceutical executives say.
Global Times reporter 5 interviewed a Chinese pharmaceutical company executives, the company has long been subject to the patent protection of foreign pharmaceutical companies, and because of patent licensing and foreign companies to the public.
The executive believes that the Chinese Academy of Sciences Wuhan Virus Research Institute’s practice is not illegal, the United States Gilead did not find that Ridsiewe can be used to treat the new coronavirus, domestic institutions can apply for the drug in the country’s new indications patent. He pointed out that there is also a legal practice called “compulsory licensing”, even if foreign companies have patents, the special period of the state will force the other side to open patents, not to mention to apply for an indication patent. “Some people say that people work hard to develop drugs, but you put people’s patents to register. But assuming there is no outbreak in China, Gilead does not know that the drug can be used in the treatment of the new coronavirus, and since china has agency found it, it can apply under the law. He said, understand the views of netizens, but in the case of the epidemic is more severe, the Chinese Academy of Sciences Wuhan Virus Research Institute’s approach is ultimately beneficial to the people.
What does it mean if the patent is approved by the Chinese government? If the patent is approved, the executive said, it would mean that Gilead’s Ridsiewe, at least until the Chinese market for the treatment of pneumonia for the new coronavirus infection, would have to obtain a patent from the Wuhan Virus Research Institute, known as an indication scarcity patent. But the executive cautioned that “the patent is not a matter of two days a day, and the audit department will also consider the performance of the clinical application of the drug, and it will take some time for the approval to take place.” “
Global Times reporter learned that after SARS in 2003, China’s patent law has a mandatory licensing provisions, in the event of a state of emergency or exceptional circumstances, or for the public interest, the State Council patent administrative department can give the implementation of invention patents or utility model patents mandatory license. In response, the executive said, “In this case, the patents of foreign companies will be forced to open, because this is already a major issue of social stability.” There is no problem with the need to allow domestic companies to copy in the face of a major national outbreak. But China has not used the compulsory permit once. Therefore, at this time, as long as it is beneficial to China’s epidemic, conducive to social stability, we can all consider. “I’d
Gilead responded to this newspaper
The United States Gilead Pharmaceuticals sent an email to the Global Times on the evening of the 5th, said that Redciewe is a broad-spectrum antiviral drug under study, has not been approved in any country in the world. Redciewe has demonstrated the activity of MERS and SARS virus pathogens in in vitro and in vitro animal models, which are also coronaviruses and are structurally similar to the new coronavirus (2019-nCoV). Limited preclinical data on MERS and SARS indicate that the drug may have potential lynoviruses.
The email said Gilead has reached an agreement with Chinese health authorities to support two clinical trials of people infected with 2019-nCoV to determine the safety and effectiveness of Redciewe as a potential treatment for coronavirus. One study assessed the effectiveness of the drug in patients who were diagnosed with 2019-nCoV and were hospitalized but did not exhibit significant clinical symptoms, such as the need for additional oxygen absorption, while the other assessed the efficacy of Redcievir in diagnosed patients with more severe clinical symptoms, such as the need for oxygen absorption. Both clinical trials, led by Chinese researchers, are conducted in Wuhan. Gilead provides the drugs needed for the research free of charge and supports the design and development of the research. ‘We expect the lead research unit for clinical trials to release more details in the near future, ‘ the email said.
The antiviral drug Redsiewe has completed the registration and approval of clinical trials, and the first batch of cases has been put in place, Chinese state media reported On The 5th. The first batch of severe pneumonia patients with the new coronary virus infection will be treated on February 6. The relevant research will be carried out in wuhan Jinyintan Hospital and other clinical first-line hospitals to treat patients with new coronary viral infection pneumonia, and the proposed group of 761 patients were conducted using random, double-blind, placebo-controlled methods. I’d
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