As one of the pillar industries of great significance to China's national economy, the independent innovation of pharmaceutical industry is not only related to the healthy development of China's economy, but also of vital significance to China's national health. However, there are still many problems in China pharmaceutical enterprises, such as more traditional products, less innovative products, more low-end products and less high-end products, and lack of independent intellectual property rights, which affect the development of pharmaceutical enterprises in China to varying degrees.
Therefore, how to actively and effectively support the technological innovation activities of pharmaceutical enterprises in China, so as to effectively promote the upgrading of products from low-end to high-end and improve the core competitiveness of pharmaceutical enterprises in China is an urgent task before us.
The author believes that in view of the development history and present situation of Chinese pharmaceutical enterprises, it is one of the most important strategies to improve and implement patent protection as soon as possible. Although some pharmaceutical enterprises in China have begun to attach importance to patent protection and made some achievements, on the whole, Chinese pharmaceutical enterprises have not really realized the significance of patent protection to enterprises. There is no sound intellectual property system, no corresponding management department has been established, and there is a general lack of high-level intellectual property engineers, so they cannot skillfully use various patent protection strategies. These factors restrict the patent application and protection level of Chinese pharmaceutical enterprises, and then restrict the maximization of interests.
Therefore, the author combines his own experience and various problems existing in patent protection of pharmaceutical enterprises, analyzes them from multiple angles, and puts forward some specific opinions and suggestions to improve the level of patent protection of enterprises, hoping to help Chinese pharmaceutical enterprises.
Establish and improve the intellectual property system of enterprises
Improve patent awareness
Pharmaceutical enterprises should first improve their patent awareness, that is, establish and cultivate the thinking and concept of using patent protection to promote the development of enterprises. This requires enterprises from top managers to grass-roots employees, especially the consciousness of patent application, patent trading and patent protection, to establish the consciousness of relying on patents to ensure the development of enterprises and ensure that the achievements of enterprises are transformed into patents or other intellectual property rights as much as possible. The ultimate goal of cultivating and creating enterprise patent consciousness is to improve the independent innovation ability of enterprises and continuously realize technological innovation, product innovation and market development of enterprises.
Improve the rules and regulations
Pharmaceutical enterprises should establish and improve patent management rules and regulations, and form norms such as patent management and protection, patent information utilization and patent reward, including the establishment of enterprise patent information system. Good patent management norms and enterprise patent information systems can provide important means and platforms for enterprises, especially decision makers and technicians, in scientific research and market work. Perfecting the patent management norms and information system will help employees to inquire about the latest patent documents in time and understand the latest market demand and technological development frontier. Then combined with the actual situation of this enterprise, we should establish a breakthrough point, better develop new products and technologies, and apply for enterprise patents with independent intellectual property rights.
Establish a patent management department
It is difficult for enterprises to acquire a certain technology. Whether to protect as a technical secret or as a patent involves the core issue of enterprise strategy, which is particularly common in the pharmaceutical industry. If we rely solely on patent agents to handle patent affairs, it will easily lead to the loss of technical secrets. Therefore, enterprises need to establish their own patent management departments, strictly control patent affairs, choose appropriate institutions to cooperate, and avoid leaking technical secrets, which is particularly important in the research and development stage. Patent agents are good at legal affairs and process affairs, but for the pharmaceutical industry with high technology content, most patent agents lack forward-looking judgment on the industry and do not fully understand the demands of enterprises, so there are often deviations in patent writing. This requires the patentee and the agent to strengthen communication and learn from each other.
Due to different professional backgrounds, there will be communication difficulties between enterprise executives and patent agents, which also requires enterprise patent personnel to play a bridge role. Therefore, it is very necessary to set up a patent management department and establish relevant systems. It can also help enterprises keep abreast of patent information and patent protection.
Training enterprise intellectual property engineers
When an enterprise develops to a certain stage, it is particularly necessary to cultivate its own intellectual property talents in order to establish, develop and develop its own patent strategy more effectively. At present, some large pharmaceutical enterprises in China, especially those whose main profit direction is export, have started to set up patent and intellectual property management departments or legal departments one after another, equipped with professionals. However, due to short time, late start and low professional level, they often have no professional background and are often reluctant. The author believes that domestic pharmaceutical enterprises should attach great importance to the following aspects, train their own intellectual property engineers and improve their ability to control intellectual property rights.
Enhance information retrieval ability
Mastering the patent and non-patent technical information of drugs not only provides support for drug research and development, but also provides strong guidance for patent application of technological achievements and enterprise decision-making. Although domestic pharmaceutical enterprises have achieved a certain level of retrieval, there are still some shortcomings.
The retrieval of domestic pharmaceutical enterprises mainly depends on online free database and Scifinder. But many enterprises can't make good use of these databases. Take Scifinder as an example, as one of the most powerful databases in the medical field, it has many advanced retrieval functions, which need to be combined with many retrieval skills to give full play to its functions. But many enterprises can't master these skills well and make full use of these databases. Therefore, domestic pharmaceutical enterprises need to strengthen training, better understand the main characteristics, retrieval strategies and retrieval skills of each database, so that scientific researchers and intellectual property managers of enterprises can make better use of existing retrieval resources, especially tap the advanced functions in Scifinder, and improve retrieval efficiency. When the conditions are ripe, establish the enterprise's own database to realize the resource sharing within the enterprise and avoid duplication of work.
Improve information processing ability
There are many and miscellaneous technical information obtained through retrieval, so it is necessary to classify the obtained information and then make a comprehensive analysis.
In terms of patent classification, domestic pharmaceutical companies have also had a certain foundation. However, it is understood that the classification of patents by domestic pharmaceutical companies is still in the manual stage. Because many databases already have complete classification and statistics functions, automatic classification and statistics can be realized. Therefore, pharmaceutical enterprises should deeply study and make full use of the functions of these databases, focusing on automatic statistical classification of databases, supplemented by manual statistical classification, and improving efficiency. In the aspect of patent analysis, the analysis of patents by domestic enterprises usually stays at the level of a single patent, and it is difficult to sort out a complete three-dimensional map of patent protection. In contrast, the patent analysis level of large foreign pharmaceutical companies is very high. On the basis of analyzing the protection scope of each patent, they can organically combine these patents to form a three-dimensional "patent map" and sort out the existing patent protection system, so as to understand the existing drug patent protection situation relatively comprehensively and accurately.
Therefore, the author suggests learning from the experience of large foreign pharmaceutical companies to improve the classification level of patents. At the same time, it is necessary to comprehensively analyze the patents of the original institute, analyze the research and protection strategies of the original institute in the process of drug research and development, and provide guidance for developing new core patents, peripheral patent technologies and applying for patent protection.
Pay attention to the level of patent writing
The writing of patent application documents is the first step to obtain patent rights. Its advantages and disadvantages are related to the protection level of an invention and the effectiveness of the overall patent layout. According to the communication with R&D personnel and intellectual property management personnel of some enterprises, and the analysis of the writing situation of some patents, the author thinks that the writing ability and level can be comprehensively improved from the following aspects.
The scope of protection of claims should be hierarchical, wide and narrow.
In order to ensure that compounds that have not been fully developed before the filing date can be protected by the original application at least to some extent, the first application usually hopes to obtain the widest protection. However, a wide range may lead to defects such as lack of novelty, creativity or lack of normative support. Therefore, when writing claims, we should pay attention to the construction of a "three-dimensional security, step by step" security system. On the one hand, we can strive for the widest possible scope of protection, on the other hand, we can leave a "retreat" when a large range of claims are not authorized, and we can get a smaller scope.
Generally, in the independent claims of patent applications, a wide range of Markush compounds are claimed, and in the dependent claims, a narrow range of Markush compounds are further claimed. Layer by layer, until it is limited to specific compounds or different material forms of specific compounds, such as isomers, hydrates, crystals, etc.
However, it should be noted that the scope of compounds disclosed in the application documents is not as wide as possible, so it is necessary to leave room for enterprises to apply for patents for subsequent research. It is not allowed to disclose the compounds that the enterprise is conducting but has not yet completed the research, so as not to bury hidden dangers for the subsequent patent application.
Accurately grasp the invention points of the invention
Before writing the application documents, the applicant should fully understand the existing technology and accurately analyze the innovation of this application. When writing a claim, the invention should be recorded in the independent claim to ensure that the independent claim meets the requirements of novelty and creativity. And some features that are not important for realizing the invention (that is, unnecessary technical features) should not be recorded in the independent claim, so as not to limit the protection scope of the independent claim too small. These features can be recorded in the dependent claims. In this way, you can ask for greater protection and ensure that a wide range of claims are authorized. At the same time, there are some small-scale claims as a "retreat". Even if a wide range of claims cannot be authorized or the patent right is unstable, there is still room for revision, so as to maximize their own interests. At the same time, in order to increase the possibility of patent authorization, it is necessary to emphasize the advantages of the technology improved by invention over the existing technology, such as good product activity, high yield, high purity, good shape and no need for further purification. And try to provide more suitable examples or comparative examples that can prove the creativity of the invention.
In short, the writing of application documents is self-evident for patent protection, and enterprises should attach great importance to it. At the same time, enterprises should also realize that patent application documents are legal and technical documents, which are different from ordinary technical articles and have certain writing skills. Enterprises should fully study and learn from it, or actively consult professional agents to effectively improve the writing level of application documents.
Drawing lessons from the patent protection strategy of brand pharmaceutical companies
After decades or even hundreds of years of development, major foreign pharmaceutical companies have become very familiar with the laws and regulations on intellectual property rights. They can not only fully realize the importance of intellectual property protection to enterprises, but also flexibly use these laws and regulations to set up barriers to prevent other companies from copying, so as to maximize profits. However, China's pharmaceutical companies have a short development time, relatively weak research and development capabilities, less accumulation and insufficient experience. Therefore, learning from the experience of foreign counterparts is a shortcut for us to improve our own ability.
Among them, the offensive strategy, defensive strategy, patent risk avoidance strategy, patent authorization and cooperation strategy commonly used by brand pharmaceutical companies are all patent protection strategies that domestic pharmaceutical companies should fully learn and learn from. Only by constantly learning, being familiar with and deeply understanding these strategies can we use them flexibly in the market competition, so as to maximize our own interests.
The author believes that it is very important for enterprises to establish a system and train professional intellectual property engineers, which is the guarantee for enterprises to formulate patent strategies and flexibly use strategies to ensure the efficient development of enterprises. No matter which strategy is adopted in drug innovation and imitation, the ultimate appeal is the same, and efforts should be made to maximize the benefits of products and enterprises. We should constantly master and be familiar with these basic strategies, constantly explore the patent laws, regulations and protection policies in China and the target market, flexibly adopt reasonable strategies and comprehensively apply them according to the development direction established by the enterprise itself, combined with the scale, financial strength and product sequence of the enterprise, and strive to become bigger and stronger in the field of innovative drugs or generic drugs.
(Text/Liu Guiming Huang Chaofeng Liu Qing)
Originally published in China Journal of Medicine.