Li Mingde: The competition in the innovative drug research and development track is fierce, and the patent should be applied for in time

Source: People's Daily News

On August 20th, the seminar on "Giving Play to the Main Role of Enterprise Innovation and Strengthening the Support for Pharmaceutical Science and Technology Innovation" sponsored by People's Daily and People's Health was held in Beijing. At the meeting, Li Mingde, doctoral supervisor of the Graduate School of the Chinese Academy of Social Sciences and member of the National Intellectual Property Expert Advisory Committee, explained the supporting role of the intellectual property system on drug science and technology innovation from three aspects.

Li Mingde said that to promote the research and development and innovation of drugs, not only need supporting elements such as policies, capital, talents and land, but also the support of the intellectual property system is also crucial.

First of all, in the scientific research and innovation of drugs, pharmaceutical companies should apply for patents in a timely manner. Pharmaceutical innovation and research and development is a high-cost track, and pharmaceutical companies will pay high capital, manpower and time costs. At the same time, innovative drugs of the same category will be developed by multiple companies at the same time. Therefore, while encouraging pharmaceutical innovation, China also encourages pharmaceutical companies to apply for patents in a timely manner, and within 20 years of obtaining patent protection, the research and development and income of the patentee are protected and have exclusive rights.

Secondly, invention patents must meet the criteria of novelty, inventive step and practicality. The so-called novelty, in accordance with the provisions of China's Patent Law, is not recorded in the public literature, and no invention that has been known or used can be patented. In the actual research and development process, it is necessary to avoid the problem of "boring head and innovation", to do first query, then scientific research, and avoid the existence of relevant patents when applying for patents.

Inventive step refers to the fact that a new invention has outstanding substantive characteristics and significant progress compared to the prior art. "The so-called creativity is not a small change, but a qualitative leap. In the field of pharmaceutical innovation, it is also very important to improve inventions, and it is also creative to improve inventions so that their original functions are increased and side effects are reduced. Li Mingde said.

The standard of practicality means that the invention can be actually manufactured or used and can produce positive results. Starting from the practicality, Li Mingde suggested that inventors should fully disclose their own technical solutions when applying for patents, so that other R& D companies can fully understand the development process and scientific research depth of the entire industry.

Li Mingde specifically pointed out that patent rights are also a property right. This property right is as important as the tangible property rights we own, such as land, plant and equipment, and should be paid attention to and respected by the whole society and the whole industry. From the perspective of improving the patent system, cutting-edge inventions are encouraged to go hand in hand with improved inventions. "Taking innovative drug research and development as an example, after a cutting-edge invention is made, its marketization and functional improvement need to be tried by a large number of other pharmaceutical companies, and there must be different levels of pharmaceutical companies to further improve, perfect, optimize and promote the marketization of cutting-edge inventions." Li Mingde said.

According to reports, the newly revised Patent Law of the People's Republic of China came into effect on June 1. Li Mingde said that in order to fully mobilize the enthusiasm of enterprises to develop innovative drugs, the Patent Law of the People's Republic of China clearly stipulates that the time occupied in the process of drug review and approval is extended for a maximum period of not more than 5 years. This new revision is a response to the patent protection of innovative drugs in China. However, there are still some different debates in the academic community about how to define the scope of the drugs applied, such as whether new drugs approved before the revision of the new law can enjoy this extension system. How to implement this new system, there are still some details that need to be further clarified and implemented. In his view, this issue should take the market rules as the starting point, in accordance with the principle of encouraging innovation, fully consider the huge cost investment in new drug research and development and the high risk borne by enterprises, and specifically implement the extension system of new drug patents.