Ridacivir, a broad-spectrum antiviral drug, was developed by Gilead pharmaceutical company and used to treat Ebola virus. According to the information on the official website of Wuhan virus Institute, according to the international practice and from the perspective of protecting the national interests, ridcevir, a drug that has not yet been listed in China and has intellectual property barriers, applied for a Chinese invention patent (the use of anti 2019 new coronavirus) on January 21, and will enter major countries in the world through PCT (patent cooperation agreement).
Will the drugs developed by Gilead pharmaceutical company in the United States be suspected of infringement if they are patented by Chinese institutions? In response, Yang zhanqiu said that Wuhan Institute of Virology, Chinese Academy of Sciences, applied for use rather than drug structure, which means a new use of the drug has been found, so there is no problem in applying for a patent. Moreover, after applying for a patent, the Intellectual Property Office will also have relevant examination. If it does not meet the requirements, it may also be rejected, if the drug development company has earlier It is noted that the drug has the anti coronavirus effect, so it may not be patented. Chen Jihong, a partner of Beijing Zhonglun law firm, told Global Times global.com on Friday that the United States has a patent for the drug itself, that is, the compound patent right, while we are applying for an indication patent, which can be operated in the patent law without any problem.
Its like Viagra was first used to treat cardiovascular disease, and later found that it can treat male sexual dysfunction, so it can apply for a patent for drug use. Zhao Youbin, senior intellectual property consultant for patent analysis of Wisterias intellectual property, said in an interview with global times global network that, however, it may be difficult for ridacivir to obtain authorization for its anti-2019 new coronavirus new use patent. Zhao Youbin explained to reporters that Gilead has applied for a patent for the compound structure of ridacivir and the use of ridacivir in the treatment of coronavirus, which has summarized all the uses of anti coronavirus, and also mentioned the technical characteristics of the inhibition of coronavirus polymerase. The new type of coronavirus also belongs to the scope of coronavirus. If the patent of Wuhan virus institute only uses ridacivir for the purpose of anti coronavirus, and further specifies the aspect of anti coronavirus, the mechanism of action is the same, so it is still difficult for the patent to be authorized.
Therefore, if the new patent of Wuhan virus Institute is to be authorized, it must prove that the new application of anti new coronavirus has novelty and creativity, and at the same time, it must have sufficient experimental data support. However, the content of the patent application has not been disclosed in detail at present, Zhao said. If the content of the patent application is the combination of ridacivir and other compounds, the patent is more likely to be authorized.
Patent lawyer: compulsory cross licensing to avoid arbitrary price hike by patent holders
It is worth noting that there is a message on the official website of Wuhan virus Institute of Chinese Academy of Sciences: if relevant foreign enterprises intend to make contributions to the prevention and control of epidemic in China, we both agree that, in the case of national needs, we will not require the implementation of the rights claimed in the patent for the time being, and we hope to cooperate with foreign pharmaceutical companies to do our best as epidemic prevention and control.
Chen Jihong told the Global Times - global network reporter that according to international practice, if the patent application of the Institute of viruses is approved in China, then the US company must obtain our authorization when it really uses drugs for the treatment of new crown virus. Without our authorization, it involves infringement, and the two sides restrict each other. What our country applies for is the use patent, which is the extension of other peoples patents. The purpose is to force cross licensing, and avoid arbitrary price hike and other behaviors of patent holders with the threat of patent, which is a common practice in the world.
Zhao Youbin believes that, in view of Gileads compound patent and application for anti coronavirus patent, the two patents belong to basic patent and core patent, and the anti new coronavirus patent applied for by Wuhan virus will become a peripheral patent if approved. At that time, Chinas production of ridcivir still needs to pay a patent fee to Gilead, but for example, Gileads production of ridcivir drugs for the Chinese market and new coronavirus also needs to obtain the license from Wuhan virus Institute.
Liu Changqiu, a researcher at the Institute of law, Shanghai Academy of Social Sciences, believes that according to previous experience, the greatest help foreign enterprises can achieve may be a little less royalties.
Zhao Youbin also said that in addition to its economic value, it also has scientific and technological value to apply for the use patent of ridceway. The essence of patent system is to exchange publicity for protection : by opening patent documents to the whole society so that more people can study them, we can get exclusive benefit protection given by the state power. In essence, this is to encourage more people to stand on the shoulders of previous research results to create new ones and avoid repeated research. Perhaps the publics understanding of the patent system is not very thorough, which leads to the misunderstanding that Wuhan virus is robbing others achievements without any effort, but in fact, this does not exist. The patent application of Wuhan virus Institute is also a common practice in the pharmaceutical industry.
Why not use it on Chinese patients in advance?
According to several foreign media reports, the first patient diagnosed with the new coronavirus in the United States received ridacivir injection in a hospital in Washington State on January 26, and achieved remarkable results. However, according to a January 31 statement issued by ridcivir manufacturer Gilead, there are limited clinical data on ridcivirs emergency use in the treatment of people infected with Ebola virus. At the same time, Gilead said that remdesivr has not been approved for listing in any country, and its safety and effectiveness have not been confirmed.
According to reports, this is based on the principle of compassionate medication. According to the regulations of the FDA, CompassionateUse is also known as ExpandedAccess, Named-patientUse, which refers to patients with serious or life-threatening diseases At the time of effective treatment, an application may be made for the use of experimental drugs other than clinical trials without marketing permission.
The patent application of Wuhan virus Institute of Chinese Academy of Sciences was filed on January 21, and some people questioned why it was not used in China? Yang zhanqiu told reporters that according to relevant laws, a new drug should be used in patients. First, cell experiments, that is, in vitro experiments, then animal experiments, and finally clinical trials. Instead of using the patient as soon as the effect is found.
Global Times - global network reporters refer to the newly revised Drug Administration Law of 2019, which also has provisions similar to compassionate drug use. Article 23 shows that drugs that are being used in clinical trials to treat diseases that are seriously life-threatening and have no effective means of treatment may benefit from medical observation and conform to ethical principles after examination and informed consent To be used for other patients with the same condition in the institutions where clinical trials are conducted.
It is worth mentioning that on February 2, China Japan Friendship Hospital announced that it led the clinical research on the treatment of 2019 ncov new coronavirus with remdesivir in Wuhan. On the same day, the drug approval center of the State Drug Administration accepted and undertook the application for clinical trial of ridacivir. This means that when the patent was filed on January 21, the clinical trial of ridacivir had not been carried out, so it did not conform to the relevant provisions of the drug administration law on compassionate drug use.
Drug companies comment on drug patents applied by Wuhan virus Institute: Chinese people once suffered from the price of drugs rush injection should not be criticized
Wuhan Virus Research Institute rush to register domestic invention patent of ridceway, causing public outcry. Many people on the internet think that it is against morality for Wuhan Virus Research Institute to rush to inject the patents of drug invention enterprises at this time. So is the practice of Wuhan Virus Research Institute in line with the relevant laws, and is there any special consideration for doing so in a special period? Global Times - a reporter from global network interviewed a senior executive of a pharmaceutical company, which has long been subject to the patent protection of foreign pharmaceutical companies, and has been in court with foreign companies for patent licensing. According to the executive, the practice of the Wuhan Virus Research Institute is not against the rules. He also said that the vast number of patients in China have suffered from the price of drugs, so the practice of the Wuhan Virus Research Institute is not critical.
Wuhan Institute of Virology issued a notice on its official website on February 4: for remdesivir, a drug that has not yet been listed in China and has intellectual property barriers, we applied for a Chinese invention patent (the use of anti 2019 new coronavirus) on January 21 in accordance with international practices and from the perspective of protecting national interests, and will enter the world through PCT (patent cooperation agreement) Country. If relevant foreign enterprises intend to contribute to Chinas epidemic prevention and control, we agree that we will not require the implementation of the rights claimed in the patent for the time being if the country needs it.
According to the executive, the practice of Wuhan Virus Research Institute is not against the rules. When Gilead did not find that ridacivir can be used to treat new coronavirus, domestic institutions can apply for its new domestic patent for indications. He pointed out that there is also a legal practice called compulsory licensing. Even if foreign companies have patents, countries will force them to open patents in special periods, let alone apply for an indication patent. Some people say that you have registered their patents for the drugs they have worked hard to develop. However, if there is no outbreak in China, Gilead does not know that the drug can be used for the treatment of new crown. Since an institution in China has found it, it can apply according to the law. He said that he understood the opinions of netizens, but in the severe situation, the practice of Wuhan Virus Research Institute is ultimately beneficial to the people.
If the patent is approved by the Chinese government, what does that mean? The executive explained that if the patent is approved, it means that ridacivir produced by Gilead, at least in the Chinese market, cannot be used for the treatment of pneumonia caused by new coronavirus. At this time, it needs to obtain the patent license of Wuhan Virus Research Institute, which is called the indication patent. But the executive cautioned that the approval of the patent is not a matter of two days a day. The audit department should also consider the performance of the clinical application of the drug, and it will take a while for the approval to come down.
The executive reminded the Global Times - global network reporters that because of the patent problem of the original research drug, the vast number of patients in China have suffered from the high price of drugs. And one of the most famous is Greaves. Gleevec is used for the treatment of blood diseases, and its patent is in the hands of Novartis, a Swiss pharmaceutical company. However, Gleevec is also suitable for the treatment of gastrointestinal stromal tumors. However, Novartis Switzerland has no patent to open this indication in China, which leads to the vast number of gastrointestinal stromal tumor patients in China can only take drugs of high price. Until the patent of Novartis for gastrointestinal stromal tumor expired, domestic enterprises were allowed to copy it, which was very troublesome. It used to cost more than 300000 yuan for a patient to take Novartis in Switzerland. Later, after domestic pharmaceutical companies copied the drug and allowed it to be used for the treatment of the disease, the patient only needs more than 20000 yuan a year.
Given these past situations, netizens should not criticize Wuhan Virus Research Institute at this time. After all, they are good for China, the executive told the Global Times - global network. Of course, you have to say that Wuhan Virus Research Institute gains without pains. This is another perspective. Different people have different opinions.
Global Times - global network reporters learned that after the SARS period in 2003, Chinas patent law had provisions for compulsory licensing. In case of a state of emergency or emergency, or for the purpose of public interest, the patent administration department under the State Council could grant compulsory licensing for the implementation of the patent or utility model patent. In response, the executive said, in this case, patents of foreign companies will be forced to open up, because this is a major period of social stability. Under a major national epidemic, it is no problem that domestic companies must be allowed to copy it. But China has not used the compulsory license at one time. Therefore, at this time, we can consider as long as it is beneficial to Chinas epidemic situation and social stability. Based on this, there is nothing to criticize about the practice of Wuhan Virus Research Institute.
Recently, the Wuhan Institute of virology / biosafety research center of Chinese Academy of Sciences and the National Center of emergency prevention and control drug engineering and technology of Military Medical Research Institute of Chinese Academy of military sciences have carried out joint research, making important progress in inhibiting drug screening of 2019 new coronavirus (2019 ncov).