Reed & Co., Ltd. Needs To Break Through Patent Licensing For Mass Production.

In the evening of February 11th, Bo Rui medicine announced that the company successfully developed the synthetic technology and preparation technology of Reed Wei Wei raw materials, and has produced batch of Reed West Wei raw materials, and the production of Reed Wei Wei preparations is in progress. Affected by this news, in February 12th, the opening of the medicine was sealed on the daily limit.

However, Bo Rui medicine said Reed Wei Wei finally transformed into the product market, and needed the authorization of Gilead company as a patented person. In February 12th, Shi Lichen, director of Beijing Ding Chen medical management consulting center, told reporters in twenty-first Century economic report that under the current background, patent licensing is not the biggest problem, and whether it can be listed and listed finally depends on the development of the epidemic and the judgement of the regulatory authorities. "One of the core ingredients of chemical drugs is raw material medicine. Since it has been mass produced, it shows that there is little technical problem. Under the current epidemic situation, it can be compulsive imitation under the principle of WTO, and the state can also approve its listing according to conditional listing."

In the evening of February 11th, after the news came out of the development of Reed West, many comments were made in the industry. Some people think that this is the signal coming from the era of high imitation in China. Some people think that when the generic drug comes out, it will help reduce the price of drugs, and some people are also questioning the patent issue. In this regard, Shi Lichen told the twenty-first Century economic report reporter that the existence of generic drugs is an important value to reduce drug prices, but this does not mean that China is already entering the era of strong imitation. At present, there is still a big gap between foreign technology and foreign technology.

De Lian Capital Partners Jiang Yangzhi also pointed out to the twenty-first Century economic news reporter that the development of high-end generic drugs requires a certain strategy and cycle, and there are technical barriers and experience accumulation. "At present, we remain on the sidelines under the condition that the original drug has not yet been clinically validated for the new crown virus."

Research ahead

Gilid's Reed West Wei has received extensive attention after successfully treating a new type of coronavirus pneumonia in the United States. Under the support of the Ministry of science and technology, the national Wei Jian Committee, the State Administration of drug administration and other departments, the antiviral drug Reed West has completed the registration and approval of clinical trials. The first severe coronavirus infected severe pneumonia patients were also treated in February 6th.

Gilid said that, taking into account the urgency of the current situation, Reed, the owner of the West Wei medicine, is taking various measures to speed up production and increase supply.

In order to better solve the problem of drug accessibility, medicine is also developing Reed's medicine.

Up to now, the cost incurred by Reed in the development and production of pharmaceutical raw materials and preparations in the west side of the company is estimated to be about 5 million yuan, and the further expansion of production is expected to cost about 10 million yuan. Mr Bo said that the R & D is independent of other businesses and that other businesses of the company operate normally.

It is understood that after the production of imitation and preparation of Reed's raw material, it is necessary to undergo clinical trials, drug approval and other links. At the same time, there are still some uncertainties in the future, including whether Reed Wei Wei will eventually convert into the market for products and whether he can authorize the company as a patented person. Moreover, the Reed Xi Wei phase III clinical trial is not over. If the relevant clinical trial results are not considered, then Reed's way of imitating technology is of no great value.

Another important aspect is closely related to the development of the epidemic. If the epidemic caused by the new coronavirus infection is rapidly controlled and alleviated in the near future, the number of confirmed cases will continue to decrease. Even if Reed West is approved for the treatment of new coronavirus infection, it will not be of great help to the fight against the outbreak.

Wang Zhengye, director of medicine, told the twenty-first Century economic news reporter that even if the above factors lead to 15 million of investment, there will be no return and no regrets. "In the face of the epidemic, we do not want to wait and do research and development first. If we succeed, we will not issue "national financial difficulties" and will provide drugs to the country to treat more patients.

According to reports, after the outbreak of the disease, Buri medicine started the research and development project at the end of January this year, and in a short period of time, it developed and produced Reed Wei Wei raw material. "We can develop and produce API, as well as the ability to produce pharmaceutical preparations."

Patents span?

One of the most important factors in the success of Reed pharmaceuticals is whether the patent is authorized. According to the analysis of Patentcloud&apos s Due Diligence (patented cloud due diligence solution), gilde has obtained patent approval in the major countries and regions such as the United States, China, the European Union, Japan and Korea, and the patent rights of Reed's Wei Wei compounds and preparation methods are estimated to last for 2031-2036 years.

In Shi Lichen's view, patent licensing is not the main problem for Bo Rui medicine. Shi Lichen said that under the current epidemic situation, according to the relevant principles of WTO, Bo Rui medicine can be compulsive imitation without patent restrictions. Although the three phase of the original research drug has not been completed, if the demand for epidemic prevention and control is available, the state can approve its listing according to the conditional listing.

In November 2001, at the Fourth Ministerial Conference of WTO in Doha, in addition to accepting China as a member of the WTO, another historic decision was to publish the Declaration on trade related intellectual property rights agreements and public health. The declaration clearly states that when developing countries encounter severe public health crises caused by AIDS, tuberculosis, malaria and other infectious diseases, member states can force the imitation of drugs for treating these diseases. "The Doha declaration" points out that the protection of intellectual property rights should not be an obstacle to people's access to life-saving drugs.

In fact, in the past, there were also cases of multinational pharmaceutical companies authorized by Chinese pharmaceutical companies when they had infectious diseases in China. In order to prevent and control the pandemic of influenza, in December 2005, Roche authorized the Shanghai Pharmaceutical Group to produce oseltamivir (Tamiflu); in March 2006, the Roche Group also authorized Shenzhen East Sunshine Industrial Development Co., Ltd. to produce oseltamivir in China.

In addition, in Shi Lichen's view, high quality generic drugs are one of the most important ways to promote drug accessibility, so many foreign governments also encourage companies to do research and development of generic drugs.

It is understood that many generic companies began their R & D and clinical trials after the initial application period.

A senior person in the industry told the economic news reporters twenty-first Century that these are international practices and are not against patent laws, which is also in line with the principle of "Bolar exception".

The principle of "Bolar exception" is a patent infringement exemption principle specially applied to related fields such as pharmaceuticals and medical devices. It was named in the early 1980s when Roche v. Bolar filed a patent infringement case. In practice, it was also referred to as the "clinical trial case" principle or "Bolar clause". The basic meaning of this principle is that in order to carry out clinical trials and declarations of registration of drugs and medical devices, the implementation of related patents shall not be regarded as infringement of patent rights.

Shi Lichen believes that enterprises actively engaged in R & D investment, clinical trials, and so on, will be more conducive to the imitation of high-end drugs, so that only after the patent medicine expires, the first generic drug will be launched, helping the development of generic drugs to high quality.

According to the twenty-first Century economic report reporter, there are many start-ups in the process of combining imitation and innovation. In the industry, over the years, especially in the past 10 years, with the growth of these enterprises and the mastery of new technologies, it will play a great role in promoting the development of Chinese generic drugs and innovative drugs, and will change the pattern of the pharmaceutical industry in the future.