Perfecting operation mechanism and constructing protection pattern of pharmaceutical industry

[editorial perspective of chinapharma.com] refers to the license approved and published by the government to grant exclusive right to a certain product or use method of a certain product within a specific period of time The importance of the system for the pharmaceutical industry is due to the particularity of the pharmaceutical industry The information resource is an important scientific and technological information source, which is an important reference resource that the majority of scientific researchers and scientific and technological information workers often need to search in the actual work Due to the particularity of the pharmaceutical industry, information resources are also of great importance to pharmaceutical enterprises (picture source: Baidu picture) the development of pharmaceutical industry in the era of pharmaceutical industry is a highly technology intensive industry with high R & D investment, high risk and high income On the one hand, technically speaking, the reduction and analysis of a drug is less difficult than the research and development, and the cost is much lower; on the other hand, the ingredients of the drug must also be made public to inform doctors and patients for convenient use All of these lead to the fact that new drugs are easy to be imitated and manufactured Therefore, it becomes a powerful means to protect new drugs As early as the early 20th century in the United States, the pharmaceutical technology at that time was basically like a day for decades, with little change In 1938, the FDA act was promulgated In order to prevent the drugs with potential safety hazards from appearing on the market, the FDA requires that any new drug must be approved and registered by the FDA before being put on the market With the development of technology, it began to play an increasingly important role in the pharmaceutical industry After that, new drug R & D enterprises began to stop granting equal licenses to other manufacturers Instead, they began to use the "legal monopoly" granted to them to build competitive barriers and gain competitive advantages The new rules of the game in the pharmaceutical industry are also emerging, that is, to obtain the right through technological innovation - to obtain the ticket to enter the player club by mastering one or more rights - and then the members of each club compete for market share through their own advertising skills Protection makes it possible for high profits of drugs, which also brings rapid development for pharmaceutical enterprises and industries It can be said that it is precisely because of the "legal monopoly" position brought by the system to drugs that pharmaceutical enterprises that have successfully kept up with this tide have gradually grown from simple raw material manufacturers or drug packaging and sales manufacturers to today's highly vertically integrated large-scale enterprises The frequent occurrence and operability of drug standard necessity cases need to be implemented in the practice of intellectual property rights There are often people talking about technicalization and standardization There is a popular saying in the pharmaceutical industry that "the third-class enterprises do products, the second-class enterprises do brands, and the enterprises do standards." The so-called standard refers to the necessity of having a standard The standards must be included in international standards, national standards and industrial standards, and must be used in the implementation of standards Some experts say that there is a sense of excessive and suspected monopoly here In recent years, with the emergence of a number of anti-monopoly cases involving the necessity of standards, the necessity of standards has attracted much attention because of its high commercial value in the industry Recently, Qilu Pharmaceutical Co., Ltd (hereinafter referred to as "Qilu pharmaceutical") sued Beijing Sihuan Pharmaceutical Co., Ltd (hereinafter referred to as "Sihuan pharmaceutical") for monopoly and unfair competition, which caused heated discussion in the pharmaceutical industry The author has learned that the dispute between Qilu pharmaceutical and Sihuan pharmaceutical is centered on guipizide maleate, which was introduced into China from Sihuan pharmaceutical in 2002 and has become one of the most important varieties of cardiovascular and cerebrovascular drugs Qilu Pharmaceutical Co., Ltd pre manufactured the same kind of drugs and sought the relevant implementation license from Sihuan Pharmaceutical Co., Ltd., but was refused In June 2015, Qilu pharmaceutical obtained the production approval and was shortlisted in the drug purchase list, and Sihuan pharmaceutical sued Qilu pharmaceutical for violating its rights Qilu pharmaceutical then filed a claim for invalidation of the right related to the drug, and initiated a lawsuit on the grounds of monopoly and unfair competition For the necessity of standards, there must be a licensing process between the owner and the implementer In accordance with the provisions on the administration of national standards (Provisional) (hereinafter referred to as the "provisions"), if the compulsory national standards do involve, and the owner or applicant refuses the license declaration, the National Standardization Administration Committee, the State Intellectual Property Office and relevant departments may consult with the owner or the applicant for handling However, it is very difficult in the actual operation stage In this regard, some experts believe that the handling mechanism of disputes in drug standards in China is still imperfect Although the regulations regulate the relevant issues involved in the national standards, they still can not solve the infringement disputes arising from the implementation of mandatory standards Therefore, the relevant departments need to establish, in-depth and operable terms, improve relevant mechanisms, and build a good pattern, so as to promote the pharmaceutical industry to develop well and rapidly, so as to create a good pharmaceutical environment for the people.