Looking at the development of Chinese medicine from the reform of the patent system

July 06, 2021

Patent right is an intangible property right, and the essence of the patent system is to protect innovation. With the evolution of the international and domestic economic situation, my country's patent system has gradually improved and matured after decades of development. The patent system has brought our society into a new era of "innovation protection", and the whole society has increasingly formed a new pattern of innovation and development with patents as a link.

Patent law from scratch

For decades, my country's patent system has gone through the process of starting from scratch, advancing with the times, and driving innovation. In 1950, my country promulgated the Interim Regulations on the Protection of Invention Rights and Patent Rights. However, in 1952, only 4 patents were examined and approved. In 1954, the "Interim Regulations on Rewarding Inventions, Technological Improvements and Reasonable Suggestions" (hereinafter referred to as "Inventions, Technological Improvements and Incentives Regulations") was promulgated in 1954, which replaced the previous "Interim Regulations on the Protection of Invention Rights and Patent Rights." my country also abolished the "Regulations on Inventions, Technological Improvements and Rewards" in 1963. The Third Plenary Session of the Eleventh Central Committee of the Party in 1978 opened the prelude to reform and opening up. From this period, my country's patent system entered a real preparatory stage. On March 12, 1984, the "Patent Law of the People's Republic of China" was finally discussed and passed at the fourth meeting of the Standing Committee of the Sixth National People's Congress, marking that my country's protection of inventions and creations has entered a new historical period. In the 1980s, the international patent system entered a higher level of protection, and its important sign was the promulgation of the TRIPS agreement. In order to achieve integration with international standards as soon as possible, my country made the first amendment to the Patent Law in 1992. This amendment was developed around the topic of strengthening patent protection, expanded the scope of application of patent rights, and deleted the relevant medicines in the original patent law. , Food, beverages, and condiments are not granted patent rights.

In August 2000, my country's patent law was revised for the second time. This amendment introduces many provisions in the TRIPS Agreement, which further enhances the level of patent protection. Finally, my country officially joined the World Trade Organization on December 11, 2001, becoming the 143rd member country. In 2008, my country's patent law ushered in the third revision. If the previous revision of my country's patent law was more to meet the requirements of WTO accession, then the third revision of the patent law in 2008 was more derived from the needs of my country's own rapid economic development. This revision did not create too many new systems, but on the basis of summarizing the operating effects of the existing systems, the patent law was comprehensively upgraded and improved. The revised patent law has more stringent and pragmatic protection for patent rights. On June 1 this year, the newly revised "Patent Law of the People's Republic of China" in 2020 was officially implemented. The purpose is to safeguard the legitimate rights and interests of patentees, enhance the confidence of innovation subjects in patent protection, and fully stimulate the innovation vitality of the entire society.

New patent law escorts innovative drugs

According to GlobalData forecasts, by 2025, China's pharmaceutical industry is expected to reach US$300.9 billion, with a compound annual growth rate (CAGR) of 12.2%. Although China has historically dominated the main market by generic drugs, a series of reforms in recent years are promoting the rapid development of domestic innovation research. With the introduction of the Marketing Authorization Holder (MAH) system in the newly revised "Pharmaceutical Administration Law of the People's Republic of China" in December 2019, the State Administration for Market Supervision announced the new "Administrative Measures for Drug Registration" in March 2020, July 2020 The Drug Evaluation Center of the State Food and Drug Administration first proposed a breakthrough therapeutic drug review procedure. The new patent law was implemented on June 1 this year, and my country's drug R&D and industrial environment also ushered in a brand new situation. These reforms will further enhance enterprises' innovation competitiveness, prevent unfair competition from generic drugs, and facilitate regional and international innovation research companies to enter the Chinese market. Domestic innovation and R&D have promoted a substantial increase in the number of patent applications and authorizations in China. In the first half of 2021, the State Intellectual Property Office of China authorized 16,983 drug-related patents, ranking first in the world in terms of number.

Source: Reference 1

As domestic pharmaceutical companies increase their global cooperation and transactions based on new therapies and occupy an increasingly important position, it is imperative to formulate strong patent laws to protect innovation. The latest Chinese patent law has attracted much attention in Article 42 and Article 76, namely the "new drug patent right period compensation system" and the "pharmaceutical patent linkage system". This reform proposes a new drug patent term compensation system for the first time at the legislative level, and the original research drugs and generic drugs are also protected in accordance with the law.

Patent system helps domestic innovation to deliver beautiful transcripts

According to the 2020 Drug Evaluation Report released by CDE, the National Drug Administration Center for Drug Evaluation has reviewed and passed 208 NDAs (New Drug Listing Applications) in 2020, an increase of 26.83% over 2019. Among them, 4 TCM NDAs passed the review, the highest number in history. The "Report" shows that in terms of IND (New Drug Clinical Trial) applications, the Center for Drug Evaluation passed 1,435 applications in 2020, an increase of 54.97% over 2019; 208 NDAs passed the review, an increase of 26.83% over 2019; Center for Drug Evaluation The review passed the review of 20 varieties of innovative drugs NDA, and the review passed the review of 72 varieties of overseas-produced original research drugs (including varieties with new indications). Innovative drugs have a long research and development cycle and large investment. Internationally, an innovative drug has a research and development cycle of more than 10 years and an investment of more than 2 billion yuan. Without strong institutional support, the achievements of my country's drug innovation can not be exchanged. The newly amended "Patent Law" has newly added provisions regarding the maximum five-year compensation period for drug patents, which also brings significant benefits to the research and development of new drugs.

summary

Looking back at the history of the development of the patent law, my country's patent system has gradually improved and matured after decades of development along with the evolution of the international and domestic economic situations. In the future, we hope that under China's increasingly complete innovation protection system, we can move from imitation to true innovation, and that a major pharmaceutical country will become a powerful pharmaceutical country.

Reference source:

1.Latest patent reforms to further bolster innovative pharma research in China, says GlobalData

2. Yang Yanchao: Retrospect, Reflection and Prospect of my country's Patent System in the Past 40 Years of Reform and Opening Up

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