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Drug patent link is a system for dynamic protection of original research drugs and generic drugs, which can effectively curb patent abuse, while encouraging challenges, stimulating competition, and creating and protecting an environment for innovation
The implementation process of my country's drug patent policies and regulations
The implementation process of my country's drug patent policies and regulationsThe "Healthy China 2030" Planning Outline released in 2016 pointed out that "Drugs are unique and must be protected by the system so that R&D results can be fully guaranteed, so as to achieve the sustainable development of drug innovation and the development of generic drugs.
In 2019, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the "Opinions on Strengthening Intellectual Property Protection", which pointed out that "the establishment of a drug patent linkage system and a drug patent term compensation system should be explored to clarify the specific direction for the next system construction work
With the formal implementation of the "Patient Law of the People's Republic of China (2020 Revision)" on June 1, 2021 and the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" on July 4, innovative pharmaceutical companies can also actively refer to and learn from The patent layout strategy of well-known pharmaceutical companies at home and abroad is to build a multi-point layout around core products, and use advanced technology and patent systems to enhance the core competitiveness of enterprises
Characteristics of my country's drug patent linkage system
Characteristics of my country's drug patent linkage systemChina's drug patent linkage system and drug patent term compensation system have largely borrowed from the relevant regulations of the United States, but in practice, they have made adjustments to local conditions based on national conditions
According to the report on the IP trial work of courts in Beijing, the average trial time of patent cases in courts is approximately equal to the waiting period.
The most basic function of the drug patent linkage system is to resolve patent disputes in a timely manner, guarantee the legitimate rights and interests of patentees, and avoid the risk of delisting generic drugs after they are marketed
It is foreseeable that in the future when China's intellectual property system becomes more and more perfect, more multinational companies will invest their core technologies in the Chinese market, and China's innovative drugs will continue to emerge
Patent linkage system in European and American countries
Patent linkage system in European and American countriesThe United States, Japan, Europe and other countries have established relatively mature drug patent linkage and patent term compensation systems and have experienced many years of practice.
Concluding remarks
Concluding remarksThe drug patent linkage system stimulates the innovation vitality of pharmaceutical companies while avoiding disputes caused by patent infringement, and to a large extent promotes orderly and healthy competition in the entire pharmaceutical industry
China’s pharmaceutical patent system has been in place for more than a month.