At present, the pharmaceutical industry in China is at a critical stage of transition from imitation to innovation. Innovation requires policy encouragement. Patents are undoubtedly one of the best incentives.
However, when discussing drug patent protection, one issue has always plagued the pharmaceutical industry: Before the drug is marketed, due to its clinical research and registration approval, it takes several years. Therefore, before the official launch of the market, a considerable part of the patent protection period It has passed. Is this fair to the inventors of the pharmaceutical industry?
At a forum on “Using Intellectual Property Rights and Encouraging Pharmaceutical Innovation†co-organized by the International Association of Pharmaceutical Manufacturers Association and the China Pharmaceutical Industry Association for Foreign Investment Enterprises Association, the participating experts will pay attention when discussing the incentives of patents for innovation. The emphasis was placed on the extension of the patent protection period.
What is the significance of such a system for China, a large producer of generic drugs, and a developing country with the largest population? Is it time to discuss the introduction of this system?
Does China introduce
According to Saito Aimei, examiner of the Division of Pharmaceutical Compounds at the Japan Patent Office, the patent protection period extension system can really solve the problem of the long period of research and development and the long time for approval of drugs, resulting in a significant reduction in the time for patent owners to benefit from patented inventions. Contradictions to promote innovation in the pharmaceutical industry.
From this point of view, the patent owners of pharmaceutical products have proposed an extension of the patent protection period, which should be said to be reasonable. The extended period of patent protection in Europe, the United States and Japan is based on this starting point and gives "special treatment" to the pharmaceutical-related industries.
However, for a developing country such as China, with a large population and extremely limited medical and health resources, the extension of the patent period will inevitably lead to an increase in the cost of medical care for the government. When people need it, they cannot use or can not afford expensive patented drugs and equipment. . What is the meaning of extending the patent period when China's national pharmaceutical industry is currently small in size, lacks strength, lacks innovation, and is mainly imitation?
“For economically underdeveloped developing countries, whether the protection of drugs is too advanced. This is also a question raised by the World Health Organization after its inspection in China.†Zhang Qingkui, Minister of the Department of Pharmaceutical Biology Invention Review of the Patent Office of the State Intellectual Property Office, takes a cautious view. .
He said that the dependence of pharmaceutical inventions on intellectual property rights is relatively high. When formulating relevant policies and laws, the government must consider the protection of right holders and also consider social factors. From the perspective of public health, from the 2003 “SARS†to the epidemic of bird flu in recent years, and the prevalence of chronic diseases and AIDS; coupled with the difficulty of access to medical services and high drug prices in rural areas, if the patent period is extended, it is bound to lead to drugs. The price is high. On the other hand, there is insufficient experience. So far, the EU, such as France and the United Kingdom, have insufficient reports to extend the period of patent protection, and the statistical data are incomplete, setting a threshold for the establishment of a patent protection extension system.
Yao Huanqing, a researcher at the Civil and Commercial Law Research Center of Renmin University of China, believes that perfecting the intellectual property system will help regulate the development of the entire industry. He said that the approval process of new drugs in China is relatively simple compared with developed countries and has not been adequately tested. Therefore, the establishment of an intellectual property protection system can enable companies to spend more time on quality in R&D, and objectively help ensure product quality in the R&D phase. .
In Yao Huanqing's view, this is not only a drug issue, but an important part of the entire intellectual property system. “This is the tuition we must pay.†It can help raise the awareness of domestic intellectual property protection, and further development and innovation. product. For the pharmaceutical industry with high input, high risk, high output, and high profitability, it is possible to stimulate venture capital investment and promote the process of drug innovation and transformation. "China is in a rising period. Establishing a system in advance is more effective than establishing when it is needed. From the perspective of the laws of social development, we should pay more attention to long-term interests than to immediate interests."
Gradual or suspended
Although all sectors in the country recognize that the long-term trend is that such a system should be introduced, the current timing is not the right time. How do domestic pharmaceutical companies in the company view this issue?
Hou Quanmin, general manager of Beijing Baiao Pharmaceutical Co., Ltd., believes that it takes more than 10 years to discover a new compound and get a new drug certificate, and the benefit of the patent is only 5 to 10 years old. Patents for inventions should be given a "relatively fair" extension. After joining the WTO, China and other countries should follow the same rules of the game. At present, imitation medicines have imitations in China. Now we will discuss extending the period of patent protection and will not have too much impact on the industry. From the perspective of the state, we should look at the longer term. In the future we must focus on innovation. Extending the patent period can promote innovation. However, Hou Quanmin believes that whether or not to extend the protection period should be treated differently, and those newly discovered small-molecule monomer drugs, new sequence proteins, etc., should be extended, and process patents are not necessarily prolonged.
Beijing Kexin Bicheng Pharmaceutical Technology Development Co., Ltd. is a new drug R&D and technology innovation company specializing in the development of new drug preparations and has more than 50 patents for pharmaceutical preparations. The general manager of the company, Wang Jingang, believes that the general trend is to gradually introduce a patent protection extension system, but this is not the time. Because China's pharmaceutical industry is very weak in innovation, there is no accumulation of innovation in the first 20 years, and there is currently no newfound compound. If this system is implemented now, it will be impossible to copy patent-due drugs, which will be very unfavorable to China's industrial production enterprises, especially to raw material drug companies, and indirectly affect the supply of new drug substances to drug manufacturers, and to the development of the entire industry. It is unfavorable. Wang Jingang believes that the system should be implemented gradually or temporarily, and it should be promoted on the basis of formulating an overall strategy.
Oil Tank
Henan Zonghai Plastic Industry Co., Ltd. , https://www.hnzonghai.com