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    Home > Medical News > Medical World News > 2020 DIA site construction drug patent protection system needs to be cut from multiple dimensions

    2020 DIA site construction drug patent protection system needs to be cut from multiple dimensions

    • Last Update: 2020-11-10
    • Source: Internet
    • Author: User
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    Since the reform of the drug review and approval system in 2015, China's biopharmaceutical industry innovation ability has been greatly improved, innovative research and development results continue to emerge, patent protection has become more and more major innovative pharmaceutical companies and even the industry is very concerned about.
    especially for innovative pharmaceutical companies, without timely patent layout, the economic value of innovation results will be significantly reduced, which may be very serious and even devastating blow to enterprises.
    Drug Patent Protection involves multiple dimensions October 29, 2020 at the 12th annual meeting of DIA, Beijing Ruiyang United Intellectual Property Agency Co., Ltd. senior partner Zhang Ying said that the pharmaceutical sector is much more dependent on patent protection than other industries.
    Drug patent protection involves many dimensions, in order to establish the ecological chain of pharmaceutical patent protection, not only to protect the trademark logo, but also to protect compounds, compositions, adaptors, crystals, preparations, intermediates, preparation process patents and so on.
    Taking the chemical drug development process as an example, there are several types of patent protection that may be involved, such as: (1) small molecular compounds and derivatives (core patents) and their synthesis methods; ) Drug dosage range; (5) new preparation methods, new processes; (6) preparations, new dosage forms; (7) pharmaceutical compositions, combinations, compound preparations; (8) analytical testing methods, quality control methods; (9) pharmaceutical packaging design, pharmaceutical equipment, administration devices ... In addition, China's patents are divided into inventions, utility models and design three categories, different types of patents corresponding to the application requirements are also different.
    enterprises need to apply for patent protection and safeguard their rights and interests.
    the construction of the patent protection system needs to be strengthened urgently Zhang Ying introduced, in order to safeguard the interests of enterprise developers and stimulate their enthusiasm for innovation, all countries have established a drug patent protection system in line with their own conditions.
    such as the United States, as early as 1984 took the lead in the establishment of drug patent links, test data protection, patent extension as the core of the complete drug patent protection system, promoting the development of the domestic pharmaceutical market imitation balance.
    , however, China has not yet established a systematic drug patent protection system.
    Patent Act of 1985 does not protect products and products obtained by chemical methods, only the preparation methods are protected, and the Patent Act of 93 begins to protect medicines and chemical substances.
    , however, drug innovation cycles are long, investment costs are high, and risks are high, and if markets do not deliver returns for innovators, the motivation of innovators will not be sustainable.
    patent protection as the enterprise's "armor", in the protection of enterprise intellectual property rights are not infringed at the same time, but also let enterprises get the return of research and development drugs, back-feeding innovation.
    , it is urgent to strengthen the construction of patent protection system.
    , director of the State Intellectual Property Chemistry Department, said at the same time: "Patented technology can be used for reference, its mountain stone can attack jade."
    we need to learn from the experience of the international mature pharmaceutical market and strengthen the construction of China's patent protection system.
    In recent years, the state has realized the importance of drug patent protection, so in 2017 and 2018 has issued three drug patent protection documents, proposed to explore the establishment of drug patent link system, drug patent term compensation system pilot, improve and implement drug test data protection system and other drug patent protection system.
    In recent years, China's domestic pharmaceutical companies continue to rise, international exchanges are also increasing, because of and foreign companies in some areas cross, so we will also face more and more patent disputes, pay attention to patent protection for domestic enterprises to protect independent innovation.
    the future of china's patent protection has a long way to go, Europe and the United States and Japan's mature experience is worth learning.
    To build a systematic drug patent protection system, we need multi-sectoral coordination, policy-making departments should strengthen communication with enterprises, enterprises should also pay attention to the introduction and training of intellectual property talent, and patent examiners more exchanges, familiar with the application of patent law regulations, to safeguard their own vital interests.
    In addition, the China Association for the Promotion of Pharmaceutical Innovation has issued a report on the construction of the patent protection system put forward specific implementation rules: 1. In the drug test data system, appropriate extension of the protection period of orphan drugs, children's drug use, to give reasonable protection period of new adaptations, etc.; Mechanism, set a ceiling on the number of triggers for the approval waiting period, grant a certain market exclusive period for the first generic drug, extend the litigation period, etc.;3. In the case of the patent period compensation system, set up specific compensation time, clarify the calculation method of the compensation period, propose a customized patent period compensation scheme; 4. Improve the construction of intellectual property courts, overall management, and improve the relevant provisions of patent law in the area of patent litigation mechanism.
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