(1) Protected objects and conditions
The protection objects of medical patents are mainly new inventions in the medical field, that is, technological innovation, including newly developed raw materials, that is, active ingredients, new pharmaceutical preparations or compounds, new preparation processes or their improvements. Among them, the most important authorization conditions are novelty, creativity and practicality. Novelty means that before the filing date, no identical pharmaceutical invention was published in domestic and foreign publications, used in China or known to the public in other ways, and no identical pharmaceutical invention was applied to the patent administration department of the State Council by others and recorded in the patent application documents published after the filing date; Creativity means that the drug invention has outstanding substantive characteristics and remarkable progress compared with the technology before the application date; Practicality means that drug inventions can be made or used and can produce positive effects. It can be seen that drug patents protect the latest drugs or preparation processes developed through creative work in the world, while all domestic generic drugs that fill the gaps do not have novelty in the sense of patent law, so they cannot obtain patent protection. This requirement is obviously much higher than other administrative regulations. However, in terms of practicality, drug patents only require that drugs or preparation processes can be applied in industry, that is, they have industrial prospects. In addition, this industrial application is mainly based on its technical treatment effect on diseases, but its toxicity and safety are not strictly checked. Generally speaking, in order to seize the time, you can apply for a patent after the therapeutic effect of the drug is proved by animal experiments, and you don't have to wait until the clinical trial is completed. In this respect, the requirements of drug patents are far lower than those of other administrative regulations.
(2) the purpose and function of protection
The purpose of patent protection is to encourage inventions, facilitate the popularization and application of inventions, and promote scientific and technological progress and innovation. Therefore, it can be said that the patent system is an effective incentive mechanism to promote scientific research and development under the conditions of market economy. Generally speaking, the patent system has the following functions:
The first is the role of stimulating invention and creation. Inventions and creations require venture capital, especially drug inventions, and require a lot of manpower, material resources and funds, as well as a lot of time and creative labor, in order to obtain the possibility of success. Once a new drug is developed, others can copy it at will, and the inventor will not get any return, which will seriously dampen his enthusiasm, so that no one will take the initiative to develop it. The patent system gives inventors the right to monopolize the market for a certain period of time, so that they can get rich returns, not only to recover the investment paid by R&D, but also to obtain certain benefits, so as to continue to carry out new invention and creation activities and promote the development of science and technology and the upgrading of products. Mansfield, a famous American economist, concluded that 60% of new drugs would not have been invented without patent protection.
The second is to promote the exchange of technical information and the effective allocation of technological innovation resources. If there is no patent system, the research results of new drugs will not be fully protected, and developers will not disclose their own technical information, thus avoiding repeated research by others; In addition, once someone's new drug or technology has achieved good market benefits, everyone will rush headlong into it and compete for low-level imitation, which will also cause a waste of resources. On the one hand, the patent system promotes the disclosure of technical information in advance, enables people to research, develop and update better drugs or processes at a new and higher starting point, and can greatly avoid low-level repeated research; On the other hand, patent protection can effectively prevent imitation, which makes people have to spend limited manpower, material resources and financial resources on the research and development of new drugs and new processes, thus improving the efficiency of resource utilization. The research results of the World Intellectual Property Organization show that more than 90% of the latest inventions in the world were first published through patent documents. Paying attention to the use of patent documents at all stages of R&D can not only improve the starting point of R&D, but also save 40% of R&D funds and 60% of R&D time.
The third is to promote the industrialization of scientific research achievements. In the past, under the planned economy system, scientific research and production were seriously out of touch, and scientific research institutions generally tended to attach importance to papers rather than markets. The state invests a lot of money in research, and successful scientific research results often end in the form of publishing papers or winning prizes, which is often difficult to industrialize and has not really become the driving force for economic development. In this sense, this is undoubtedly a huge waste and loss of state-owned assets. Patent system is the product of market economy. According to the provisions of the Patent Law, inventors and patentees can only get returns after the implementation of their inventions, that is, industrialization, which effectively avoids the unprovoked waste of early investment, and can provide sufficient sources of funds for future research and development, which is conducive to the formation of a virtuous circle of scientific research system.
The fourth is to provide a good legal environment for technology import and export trade. In the past, because there was no patent protection, foreign businessmen often had doubts when exporting advanced technology to China enterprises, or took the opportunity to ask for high additional fees; When China enterprises export technology to foreign investors, because they have not obtained the patent right, their reputation is not guaranteed, and it is impossible to avoid the other party's desperate price reduction. The patent system can provide a better legal environment and effectively promote China's technology import and export trade.
(3) the duration and mode of protection
According to the current patent law, the term of the invention patent right is 20 years, counting from the date of application. In fact, within 20 years from the date of filing the case, it can be divided into three stages, and the protection effect is gradually strengthened. Because of China's early disclosure and delayed review system, after a new drug invention is patented but not made public, others can't actually know the content of the invention, so there is no infringement of patent right. If the same pharmaceutical invention is publicly manufactured during this period, the other party cannot be required to compensate for the losses, because the patent right has not yet been produced, and the other party can neither apply for a patent nor destroy the novelty of the patent application. Therefore, this stage can be regarded as a transitional period of non-interference between the two sides; After the patent application is published but before the patent right is granted, because the public can already know the content of the invention, if someone implements his invention during this period, the applicant can ask him to pay an appropriate fee, which is called temporary protection period; After the patent right is granted, no unit or individual may exploit its patent without the permission of the patentee, that is, it may not manufacture, use, promise to sell, sell or import its patented products for production and business purposes, or use its patented methods and use, promise to sell, sell or import products directly obtained according to the patented methods. During this period, if someone exploits his patent without permission, the patentee or interested party may bring a lawsuit to the people's court, or request the patent management authority to bring a lawsuit against him.
According to the detailed rules for the implementation of the Patent Law, only one patent can be granted for the same invention-creation. Therefore, the patent right is exclusive. In other words, innovative drugs protected by patents are unique, and their exclusiveness can be reflected in the monopoly of market interests, including the monopoly of the production, sale, use and import of innovative drugs, and its huge economic benefits are self-evident.
(4) Judicial remedy
According to the Patent Law, if an applicant for a patent refuses to accept the decision of the State Council Patent Administration Department to reject his patent application, he may request a reexamination to the Patent Reexamination Board within a specified time. Since the date when the patent administrative department of the State Council announced the grant of the patent right, any unit or individual may request the Patent Reexamination Board to declare the patent right invalid if it considers that the grant of the patent right is not in conformity with the provisions of the Patent Law. If a party refuses to accept the decision of the Patent Reexamination Board, he may bring a suit in a people's court within the prescribed time limit.
It can be seen that the patent protection of drugs requires high novelty, but low practicality. Because patent protection conforms to the international rules stipulated in the TRIPS Agreement and must be performed after death, its protection is exclusive and has the strongest legal effect, so it will continue to improve and develop after death.