Global Intellectual Property Center

Research Report on Establishing System of Linking New Drug Application and Patent Protection

Research Report on Establishing System of Linking New Drug Application and Patent Protection

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Drug is a necessity for human beings to sustain life and ensure life dignity. Research and development of new drugs and decrease of drug price have been the everlasting topics. The drug research and development is characterized by long cycle, vast investment and extremely low success rate. Hence, by making use of design and formulation of relevant system, which aims at providing sufficient protection for drug-related R&D achievements as well as guaranteeing high benefits, on one hand, the continuous R&D activities with respect to new drugs carried out by pharmaceutical enterprises can be encouraged, while on the other hand, funds for R&D support can also be available. By such means, the sustainable development of drug-related R&D can be realized. According to statistics of the World Health Organization, among 315 kinds of essential drugs, only 3-5% of them are currently still under patent protection. Yet 312 of them were once under patent protection. It shows that patent protection makes great contribution to the development and research of new drugs and the patent system is a essential system to guarantee the new drug developers to get repaid from its R&D activities. The drug price is another factor in realizing accessibility, and decrease of drug price requires development of generic drugs. Providing patent protection for drugs, namely, exchanging disclosure for monopoly, is not only the requirement of drug accessibility, but also lay a foundation for manufacturing of generic drugs. The most typical case is penicillin. Penicillin was discovered in as early as 1928. At that time, its discoverer, Franklin, announced that he would like to contribute the relevant achievements, rather than seeking for patent protection. Yet the unfortunate result came out as the fact that penicillin was not put into use for the first time until 1942, while during the 14 years between 1928 and 1942, countless people died of the bacterial infection. It was a “tragic” case in which drug accessibility was not facilitated by patent protection.

Intellectual property system is an exotic for China and China’s intellectual property system is primarily set up by taking reference of experience of foreign jurisdictions. When considering how to deal with drug-related issues, a system appropriate to China’s situation can also be established by taking reference of foreign experience. In view of the international trends of promoting development of biopharmaceutical industry, Chinese authorities have enacted a series of policies in succession in the recent decade, aiming at propping up the development of pharmaceutical industry. In recent years in particular, China has, by keeping up with international trends, prioritized development of the biopharmaceutical industry as significant industry, encouraged and guided development and research of brand drugs, and accelerated industrial transformation, in order to try every effort to march from a generic drug nation towards a brand drug nation. In the general orientation of national overall planning on pharmaceutical industry, the implementation of all specific measures has become essential power for the pharmaceutical industry to achieve considerable development.

Taking account of weighing the interests between encouraging drug development and research and reducing drug price, currently, there are primarily three models with respect to drug protection throughout the world: (i) the patent linkage system represented by the United States, balancing the development of both brand and generic drugs, (ii) strong data protection system represented by Europe, focusing on protection of brand drugs, and (iii) the Indian Model. In determining what kind of system to establish in China so as to realizing the balance of the aforesaid two kinds of interests to the largest extent, a comprehensive consideration of international practices and the national situations per se should be taken into.

In view of the above, Beijing Intellectual Property Institute (hereinafter referred to as BIPI) has founded a research group to conduct a monographic study on the system of linking new drug application and patent protection.

Read the full report here.