The Reed West Wei Patent In The Vortex: Bargaining Weight Under The Cross License?

Reed Wei Wei is the "net red" that has been published this week. From the new England Journal of Medicine (NEJM) papers, the efficacy of China-Japan Friendship Hospital, the clinical trials of China-Japan Friendship Hospital, and the Wuhan Institute of virus research of the Chinese Academy of sciences have been declared patent.

In January 31st, the new England Journal of Medicine published a paper on the medical treatment, diagnosis, treatment and clinical manifestations of the first new coronavirus in the United States. In January 26th, the patient received Remdesivir (Reed Wei Wei) injection after the condition worsened, and the symptoms improved significantly the next day.

In the evening of February 4th, the Wuhan Academy of Chinese Academy of Sciences issued a research progress: it is found that reed Wei Wei and chloroquine phosphate can effectively inhibit the new coronavirus in vitro. The research results are published in the Cell Research, a leading international academic journal of intellectual property rights in China.

What sparked controversy was the patent declaration operation and a key time point for rreid Wei Wei, "Reed Wei Wei, which is not yet listed in China and has intellectual property barriers. In accordance with international practice, we declared China's invention patent (anti 2019 new coronavirus use) in January 21st from the perspective of protecting the interests of the state, and will enter the world's main countries through the PCT (patent cooperation agreement)".

In February 5th, the economic report reporters interviewed Wuhan virus on twenty-first Century. As of press release, no reply was received. And the other side of the vortex, Reed, the patent owner of the science of Geoff science, issued a statement on the same night, saying that Gilead is actively cooperating with the Chinese government and medical institutions to support clinical trials for 2019-nCoV infected people. We also maintain regular communication with government agencies to update our latest progress in expanding production scale.

Defense of patent declaration

According to the results of the Wuhan virus research, "on Vero E6 cells, the median effective concentration of EC50=0.77 (uM) per EC50=0.77" (Remdesivir, GS-5734) of EC50=0.77 (GS-5734) is higher than 129. The EC50=1.13 index of chloroquine phosphate (Chloroquine) is more than 88, indicating that the above two drugs can effectively inhibit the infection of cells in the cell level, and its role in the human body remains to be verified clinically.

Zhang Hongtao, an associate professor in the Department of pathology and experimental medicine of University of Pennsylvania School of medicine, in February 5th, told an interview with the twenty-first Century economic report reporter: "Reed and chloroquine have good effects, but the key is in vitro activity."

According to the insider response to the Chinese Journal, it is confirmed that Reid Wei, a patent declared by the Wuhan virus, is Reed West by Gillie.

The principle of Reed's Remdesivir is to inhibit RNA dependent RNA synthetase (RdRp), which was first developed by eild gilid in connection with Ebola virus. Because coronavirus also has RdRp, it is presumed that it is effective against coronavirus. But its effect on Ebola is not good enough. Gilid has started a preclinical study of other coronavirus infections, including SARS and MERS.

At the same time, gilid also applied for a series of patents around the world for Remdesivir, from compound structure to drug use. In twenty-first Century, the economic report reporters interviewed the announcement of the website of the State Intellectual Property Office. It showed that in September 16, 2016, gilid applied for a patent for the treatment of the virus infection of the virion and coronavirus family. The application number is CN108348526A. "It provides a way to treat the infection of the virion and coronavirus family through the application of the nucleoside and its prodrug of the application type I, in which the nucleoside sugars 1&apos is replaced. The compounds, compositions and methods provided are particularly useful for the treatment of Lassa virus and Hu Ning virus infection. And published relevant chemical formula, this use patent summarizes the scope of the coronavirus.

In the voice of public opinion, people familiar with the above-mentioned Wuhan virus said, "this is a basic requirement for scientific research. The scope of this patent is the use of Reed Wei Wei in the fight against new coronavirus. This is also to protect the interests of the state, if we do not rush to register the use of drugs, the supply and price of this drug will not be guaranteed, and will be subject to foreign companies. If China has a patent for Reed's medicine and other patents, we can cross license with foreign companies, which is also a negotiation method.

In response, Zhang Xi, lawyer of Shanghai Shang Bao law firm, told the economic report in twenty-first Century that the behavior of Wuhan virus was lawful. The patent application for the new use of the licensed product patent is in conformity with the relevant provisions of the patent law and other relevant laws and regulations [reference patent law second and Review Guide 2010 Edition second part tenth chapter 6.2 the invention of chemical products use inventions (2), which is equivalent to the new technical proposal put forward by the method. As long as there is a significant difference between the patent and the previous use, the patent can be applied, but whether the patent is authorized or depends on the examination of its three nature (novelty, practicality and creativity).

Authorization and value

The declared use patent does not mean that the Wuhan virus can now be used, "the relevant person familiar with the matter said." it has not been approved yet. There is a process of patent examination and approval. Generally speaking, it takes about a year to make the approval. Whether it can be approved or not, we must first have the priority of patent declaration. Because the data can not be disclosed before the declaration, so the publication of the paper is after the patent application.

Zhang Xi said the authorization of the use patent does not require gilid's authorization. "But when producing and using drugs, they need permission from gilid. Usually, the licensee needs to sign a patent licensing contract with gilid. "

Another focus of public opinion is the declaration time point in January 21st. On the timeline of the development of Wuhan's epidemic, in January 20th, academician Zhong Nanshan said the new crown virus was transmitted by humans. In January 21st, the Wuhan virus declared a patent for "Reid".

However, the informed persons of the above-mentioned Wuhan virus did not respond to the date of declaration in January 21st.

In his statement in January 31st and February 5th, Gilead stressed: Remdesivir Reed is developing drugs and has not been approved in any country in the world. "We are using Remdesivir's raw material inventory to meet the demand for" sympathetic medication "and the two clinical trials currently planned in China.

In addition, Gilead said in a February 5th statement that if the results of the preliminary study indicate the potential safety and effectiveness of Remdesivir in the treatment of 2019-nCoV infection, we will work hard to develop various plans to open up the Remdesivir test drug to more patients through appropriate channels. We are also discussing with many agencies the possibility of future clinical trials.

In February 4th, Sun Yanrong, deputy director of the Biotechnology Center of the Ministry of science and technology, told the news conference of the national health and Health Committee, "the State Food and drug administration has informed applicants that China-Japan Friendship Hospital and the Chinese Academy of medical sciences can carry out clinical trials." Wang Chen, vice president of the Chinese Academy of engineering and President of the Chinese Academy of Medical Sciences, said in a February 5th news 1+1 interview that we have great hopes for Reed. But clinical trials are needed to prove its efficacy. In February 5th, Professor Wang Chen and Professor Cao Bin of China-Japan Friendship Hospital of Capital Medical University announced the clinical research of the drug in Wuhan golden Yin Tan Hospital. According to the plan, the trial will be divided into mild and moderate patients in 308 cases, severe cases in 453 cases.

If the future patent of the Wuhan virus was approved, Zhang Hongtao said that all the patents in Wuhan were Geely's molecular patent. "In fact, the Wuhan virus can not produce itself, because it can not infringe the patent of the Gillie molecular structure, but it has this use but myrrh. If Gillie does not authorize, no one will give up. Finally, the patient will be unlucky because he can not sell in China. From a commercial point of view, the two sides may reach cooperation. "

Zhang Xi believed that gildor could ask Wuhan to grant the patent license to Gillie and produce a proprietary medicine for the treatment of the new coronavirus. But authorizing the production of Chinese enterprises is likely to affect Geely's profits. "If jild does not agree with the licensing authority, according to the forty-ninth provision of the patent law, the State Council's patent administration department may grant a compulsory license for the invention patent or utility model patent in case of a state of emergency or unusual circumstances, or for the purpose of public interest. At the same time, the compulsory license will grant Geely the corresponding patent licensing fee. (Editor: Bao Fang Ming)