Redsey’s “patent dispute” caused a stir, don’t rush to spray!

The new pneumonia epidemic is still escalating, and “the hope of the people” has come! From February 6th, Remdesivir, a hotly discussed antiviral drug, will begin clinical trials at first-tier hospitals such as Jinyintan, Wuhan, and the first batch of pneumonia patients with the new coronary virus infection will begin to receive the drug.

It’s worth noting that Gilead Sciences, the manufacturer of Ridsyway, has recently been embroiled in a “patent dispute” with Wuhan Virus Research Institute, which Gilead Sciences CEO Daniel O’Day says will protect patents but will not get involved in disputes and will provide free clinical trials to research drugs.

For the recent Wuhan Virus Research Institute “grabbing patents” approach, the Internet caused a stir – a time “request to thoroughly investigate” the Sound of Wuhan Virus Research Institute.

Yang Zhanqiu, a professor at the Institute of Virus espresso of Wuhan University’s Department of Medicine, recently told the Global Times:

The Wuhan Institute of Virus Research of the Chinese Academy of Sciences declared “use” rather than the structure of the drug, meaning “a new use of the drug was discovered”, so there is no problem with patent filing.

People’s Hope: A “Potential Unit” to Cure a New Type of Pneumonia

It is reported that the drug Redsie’s English for Remdesivir, according to the harmonic called “the hope of the people.” In fact, Redciewe is a “potential stock” among the many drugs that could succeed in curing new forms of pneumonia.

In the early hours of February 1, 2020, Beijing time, the New England Journal of Medicine (NEJM) reported in a short report on the first successful cure in the United States of a confirmed new type of coronavirus pneumonia. According to the article, the infection with the new coronavirus deteriorated after isolation treatment, and the effect was immediate after the use of Redcivir.

Redciewe is an experimental anti-Ebola virus drug developed by Gilead Sciences, the world’s first antiviral drug research company and one of the largest biotech companies in the United States, to suppress RNA synthetic enzymes (RdRp), which are present in the new coronavirus.

In fact, at the time, Ridsiewe was not yet approved in the United States, based on the principle of “sympathetic medication” (Note: In addition to clinical trials, drugs that are still in the research phase are given to patients with serious or life-threatening diseases). This is a principle commonly adopted by the international community in the face of a major outbreak, and was used by doctors in the treatment of the first confirmed patient, with no significant effect.

With a precedent for successful patient cures, it’s like seeing Sugon.

On February 2, the Drug Review Center of the State Drug Administration formally accepted Redsey’s application for clinical trials. The Chinese team then began clinical trials of the drug.

As Li Taisheng, director of infection medicine at Beijing Concord Hospital, said in an interview with the China Science Daily:

Redcivir is a cell trial of the Ebola virus that is effective, and clinical safety is possible, but clinical results data are not available. China’s emergency start-up of the third phase of clinical, if approved by the relevant state administration, after the ethics committee review, that in a certain range can be done.

From February 3, the Beijing China-Japan Friendship Hospital and Gilead began phase III clinical trials of Ridsiwe (the normal process of using anti-Ebola drugs against new coronaviruses, which need to be re-run in Phase III clinical trials, but given the outbreak, Redsiewe’s clinical trials skip Phases I and II). The main trial sympathies were patients with light and moderate new coronary pneumonia, and a randomized, double-blind, placebo-controlled trial was conducted, led by Professor Cao Bin of the Sino-Japanese Friendship Hospital, with a total sample size of 270 cases.

On the afternoon of February 5, the Ministry of Science and Technology’s emergency attack “Redsiwe Treatment 2019 New Coronary Virus Infection Research” project launched at Jinyintan Hospital in Wuhan City, the opening meeting of relevant experts said that the first batch of new coronary virus infection pneumonia patients will receive medication on February 6.

It is reported that two clinical studies will be conducted this time:

First, to assess the therapeutic effect of Redcivir for patients who were admitted to hospital but showed significant clinical symptoms.

The second is to evaluate the efficacy of Redcivir for diagnosed patients with more severe clinical symptoms.

In addition, the above-mentioned trials will be involved in a total of 761 patients, of which 308 cases of light and moderate patients, 453 cases of severe patients. Professor Cao Bin of the China-Japan Friendship Hospital said the study will carry out rigorous randomized double-blind trials to determine the efficacy and safety of Redsiewe in the new coronary viral pneumonia. Gilead has reached an agreement with the Chinese health authorities to support the two clinical trials , providing drugs for research without compensation and supporting the design and implementation of the research.

Caught in a “patent dispute”: Wuhan virus declared is “use”, not drug structure

We don’t know exactly how Ridsey will behave, but the patent wave surrounding Redsey has already started.

On February 4, the Wuhan Institute of Viruses of the Chinese Academy of Sciences said in a statement on its official website that Chinese scholars have made important progress in the screening of anti-2019 coronavirus drugs. According to the statement, the results of the study were published in Cell Research, an internationally renowned academic journal of China’s independent intellectual property rights, entitled “Reedsieve and chloroquine phosphate can effectively suppress new coronaviruses (2019-nCoV) in vitro.”

Specifically, the Wuhan Institute of Virus research of the Chinese Academy of Sciences found that on Vero E6 cells, Redciewe had an effective concentration of EC50-nCoV for 2019-nCoV EC50-0.77 uM (micromole per liter), with a choice index SI greater than 129; The two drugs are effective at the cellular level to suppress the infection of 2019-nCoV.

It is worth mentioning that the Wuhan Institute of Viruses of the Chinese Academy of Sciences also made it clear in a statement:

For the drug Ridsiwe, which is not yet on the market in China and has intellectual property barriers, we filed a Patent for Chinese Invention (anti-2019 coronavirus for use) on January 21st, in accordance with international practice, and will enter the major countries around the world through the PCT (Patent Cooperation Agreement). If foreign related enterprises intend to contribute to the prevention and control of China’s epidemic, we agree that in the case of national needs, do not require the implementation of the patent claims rights, hope to work together with foreign pharmaceutical companies for the outbreak prevention and control efforts.

And as mentioned above, Redsyway was developed by The U.S. Gilead Sciences, so many people can’t help wondering: Does this mean that Wuhan Virus Research Institute infringes the intellectual property rights of drug manufacturers, and since the current Redsiewe has not proved effective, why should Wuhan Virus Research Institute seize the opportunity to apply for patents?

Therefore, for a time the network scolding a piece, to seek the Wuhan Virus Research Institute to seize the patent, is unethical;

The source knows

Yang Zhanqiu, a professor at the Institute of Virus Esphaly, of Wuhan University’s Department of Medicine, said in an interview with Global Times recently:

The Wuhan Institute of Virus Research of the Chinese Academy of Sciences declared “use” rather than the structure of the drug, meaning “a new use of the drug was discovered”, so there is no problem with patent filing.

It is reported that the “First Finance” reporter to Wuhan Virus Research Institute Redsiwe paper co-author, Wuhan Virus Research Institute Wang Manli e-mail, telephone, have not received any reply.

In fact, on the Wuhan Virus Research Institute’s application for a Chinese patent invention, Gilead said it had filed patents globally for the compound and its use for coronaviruses as early as 2016, including in China, although China’s application has yet to be approved.

According to First Financial, Gilead did not say whether it would challenge the wuhan virus research institute’s patents:

It is too early to discuss any mandatory or other types of licensing at this stage. We have not had any discussions with regulators about Gilead’s production supply costs or financial returns. The current focus is on identifying the potential therapeutic effects of Redciewe for the new coronavirus as soon as possible and accelerating production supply to meet potential future supply demand. In addition, Gilead has no authority to interfere with whether the Patent Office grants patents to Chinese researchers. We can’t comment on the details of a researcher’s patent application because it won’t be published until 18 months later.

吉利德 CEO Daniel O’Day 在公司活动中就相关问题表示,患者是第一位的(原话:I just want to be tremendously clear here that our responsibility is the pa Tients. Andour responsibility is number one… patients first.), also want to promote mass production, and also do not want to be involved in patent disputes (in the current: we will not get into a patent dispute).

In this statement, some people call gilead for the benefit of mankind, pay tribute to it, and even call it “the accumulation of German company”;

Photo Source Pancheng Capital, Fast Taxi Founder Chen Weixing Weibo . . .

According to some professionals in the field of intellectual property, the United States has a compound patent, and Wuhan Virus Research Institute applied for an indication patent, from the perspective of patent law is operational. However, the new patent to be granted must prove that the new use of anti-new coronavirus is novel, creative, and have sufficient experimental data to support, so Wuhan Virus Research Institute to obtain a patent has a certain degree of difficulty.

As Zhao Youbin, senior intellectual property consultant in the direction of intellectual property patent analysis, told the Global Times:

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.

In addition, on why wuhan virus research institute should seize the opportunity to apply for patents, Tsinghua University School of Pharmacy, Ding Sheng pointed out:

There is no excuse for patenting scientific research results, and whether or not to be granted a license is a follow-up need to be discussed and judged. In the prevention and control of the epidemic, coordinated the introduction of overseas drugs, we need to strive for more international cooperation and mutual trust.

However, Tang Jiawei, a patent lawyer for Huiye Solicitors, said the move could also be a “patent competition” under international rules – “Gilead will do everything possible to supplement the application for patents after the invention of the drug, and others will have to use methods of warfare that are in line with national patent laws if others continue to fight in this field.” Only small-scale patent silkworms can be excavated. “

It can be said that if China obtains the relevant patent of Red-thaned this time, the future will be able to make checks and balances on the pricing and supply of the drug.

The editor noted that Gilead was founded in 1987 and entered the Chinese market in 2017, with its headquarters in Shanghai. In 2017, Gilead was ranked 92nd in the world’s top 500. As the global pharmaceutical company TOP10, Gilead is known as “Apple in the Pharmaceutical World” for its innovation capabilities:

2006 listed AIDS treatment single-piece compound;

In 2013, the first launch of “hepatitis C medicine” Sowardi;

Enter the world’s first CAR-T therapy in 2017.

However, even if Gilead’s ability as a well-known pharmaceutical company is strong, we cannot conclude that Redsey, which is still in the clinical trial stage, must be the “god drug” for the new pneumonia. As Wang Chen, vice president of the Chinese Academy of Engineering and an expert in respiratory and critical care, said:

The case is not a true scientific conclusion that is effective or ineffective for drugs, and it is necessary to conduct rigorous clinical scientific experiments.

It remains to be seen how effective the drugs will be.