Can Wuhan virus Institute win the patent for radcivir? Experts say so

category:Finance
 Can Wuhan virus Institute win the patent for radcivir? Experts say so


Core patents are still in Gilead

Xu Bo, a former judge of Beijing Intellectual Property Court and consultant of Beijing Longnuo law firm, told the first financial reporter: from the perspective of patent law, based on the relevant data and technical information it has, Wuhan Virus Research Institute has no fault in filing patent applications for new medical purposes. Moreover, between the patent application and the final authorization of the patent, a series of examination is needed to ensure that the application meets the requirements of the patent law of our country. Even after being authorized, anyone can apply to the State Intellectual Property Office for invalidation of the patent. In addition, the patent right of the core compound of radcivir is still in the hands of Gilead. As long as Gilead does not authorize it, neither party can produce the drug, even if it has a patent for a specific indication.

Li Jiabo, a former patent examiner and senior patent agent of Anjie law firm in Beijing Patent Examination cooperation center of the State Intellectual Property Office, told the first finance and economics reporter: the new use of radcivir, a known compound applied by Wuhan Virus Research Institute, is actually to circle a small scope within the scope of Gileads patent layout, specifically for the coronavirus The indication of new coronavirus. Whether we can apply for it depends on whether there is obvious difference between the treatment mechanism of the new coronavirus and the coronavirus, and whether the test data exceeds the expectation in the original patent application.

Li said that new use patents are very important in the field of pharmaceutical patents. Whether there are indications in the drug manual directly determines what medicine the doctor can prescribe to the patient. He also pointed out that the examination and approval of the patent office and the drug administration are two different standards. The patent office needs to judge whether a drug is novel and creative according to the experimental data provided in the application documents and the technical level of the existing technology, and the drug administration is responsible for the safety and effectiveness of the clinical trials of drugs. In theory, the quality of the data provided to the Patent Office is far lower than the quality of the data provided to the drug administration.

Although we cant see the specific content of the patent of Wuhan Virus Research Institute at present, a paper entitled rhetcivir and chloroquine phosphate can effectively inhibit new coronavirus (2019 ncov) in vitro was published online on February 4 in cell research, an international well-known academic journal with independent intellectual property rights in China.

Chinese researchers have shown that on veroe6 cells, the half effective concentration EC50 of remidesivir (gs-5734) to 2019-ncov is 0.77um (micromol / L), and the selection index Si is greater than 129, indicating that the drug can effectively inhibit 2019-ncov infection at the cell level, and its effect on human body remains to be clinically verified.

Li Jiabo told the first financial reporter that if ridcivir is similar to the previous coronavirus treatment mechanism in terms of the treatment mechanism of the new coronavirus, the patent office is likely to reject the application of Wuhan Virus Research Institute on the grounds that it does not have creativity. However, if the mechanism of drug treatment of new coronavirus proposed by Wuhan Virus Research Institute is significantly different from that proposed by Geely de in 2016, and the test data provided has unexpected effect, there is still a certain possibility of obtaining patent approval.

Or trigger cross authorization negotiation

Li Jiabo also told the first financial reporter that the patent applied for by Wuhan virus research institute belongs to the use patent, and how much of the right depends on the situation. He said that the patent right belongs to exclusive right, that is to say, to obtain a patent right is only to have the right not to allow others to enter the scope of patent protection, but does not mean that it can be used by itself. In this case, even if Wuhan Virus Research Institute has obtained the relevant patent, whether it can use the patent right is still subject to Geely, because the compound patent right of the drug is owned by Geely, which will lead to a series of cross licensing and commercial negotiations in the future.

Similar cases have occurred in the United States. In June 2018, Suoyuan bio, a precision medical technology company, announced in San Diego, California that it has reached a global exclusive license agreement with Stanford University. Suoyuan bio will have the global exclusive right to develop and commercialize its leading compound, enzastaurin (db102), for the new indications of pulmonary hypertension (PAH) and emphysema.

At that time, researchers at Stanford University found that db102 could prevent and reverse the development of experimental pulmonary hypertension in preclinical models. Db102 can regulate a potential therapeutic pathway by targeting a previously unknown drug target. This target is different from db102 in the treatment of malignant cancer. According to the PCT patent law treaty, Stanford University registered the discovery with an international patent. We bought the patent back from Stanford. Luo Wen, the founder and chairman of Suoyuan biology, told the first financial reporter.

However, the case of Gilead and Wuhan Virus Research Institute is more complicated this time, because Suoyuan biology acquired the patent of Stanford team, aiming at two completely different targets of the same drug, while the patent of radcivir is aimed at two different subdivisions of the same virus, namely, coronavirus, which makes the scale of trade-off more difficult to grasp.

On the other hand, in the context of new coronavirus pneumonia, major public safety factors may also be considered. In a statement issued on February 4, Wuhan Virus Research Institute said: from the perspective of protecting national interests, on January 21, it declared Chinas invention patent (the use of anti 2019 new coronavirus), and will enter major countries in the world through PCT (patent cooperation agreement). 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. In response, lawyer Xu Bo told the first financial reporter: in the case of major public security, the patent law provides for compulsory licensing of patents, but no similar cases have yet appeared in China. But he also said it was too early for Wuhan virus to claim no patent. Patent has not been authorized. Whats the claim? He said. Source: First Financial Editor: Guo Chenqi, nbj9931

On the other hand, in the context of new coronavirus pneumonia, major public safety factors may also be considered. In a statement issued on February 4, Wuhan Virus Research Institute said: from the perspective of protecting national interests, on January 21, it declared Chinas invention patent (the use of anti 2019 new coronavirus), and will enter major countries in the world through PCT (patent cooperation agreement). 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.

In response, lawyer Xu Bo told the first financial reporter: in the case of major public security, the patent law provides for compulsory licensing of patents, but no similar cases have yet appeared in China. But he also said it was too early for Wuhan virus to claim no patent. Patent has not been authorized. Whats the claim? He said.