Name: Jiangxi Biological Products Research Institute Co., Ltd.
Address: National Jinggangshan Economic and Technological Development Zone, Ji'an City, Jiangxi Province
Chinese medicine: the patent dilemma under the "copy" system
In the third year after joining the "World Trade Organization", this year was called the beginning of the "transition period after the accession to the WTO". After the first two years of running-in period, the deep-seated problems in China's integration with the international are gradually emerging, and intellectual property rights have gradually become an inevitable focus.
Just this year, the dispute between the multinational pharmaceutical giant Pfizer and more than 10 domestic pharmaceutical companies, in the eyes of the industry, is a landmark event that has plagued the Chinese pharmaceutical industry's intellectual property bottleneck for many years. In fact, it is an intellectual property right. Big battle.
It is understood that in order to invent Viagra, Pfizer has gone through a 10-year research process, which was listed in the US in March 1998 and has been sold in 112 countries around the world with a prescription of 30 million US dollars. As early as 1994, Pfizer applied for intellectual property protection in China, with a term of 20 years. If this patent battle is won by Pfizer, it means that before 2014, Chinese pharmaceutical factories can only watch the use of sildenafil citrate, which is not difficult to synthesize. And more than ten domestic pharmaceutical companies that have invested huge amounts of manpower, material resources and financial resources to conduct the same research will face significant losses, and the domestic market share of about 200 billion yuan will also be handed over.
This possible outcome is only one of the bitter fruits of China's pharmaceutical companies accustomed to copying drugs from other countries for decades, lacking motivation for innovation, and indifferent intellectual property protection concepts.
The biggest feature of the pharmaceutical industry is the high degree of patent dependence of the industry and the high degree of monopoly of developed countries in patented drugs. Intellectual property protection is particularly important. After China's accession to the WTO, it has achieved international standards in the field of pharmaceutical intellectual property. According to the relevant WTO agreements, China will implement the provisions on intellectual property protection for more than 100 member states. According to the relevant provisions of intellectual property protection, the developer has the right to claim compensation of 4 to 1 billion US dollars during the patent period. If the production license for a new patent is bought out, it will also cost 5 to 6 million US dollars.
However, a piece of information provided by the Ministry of Health indicates that there are few medical patent applications, fewer invention patents, and low patents in China's medical field. However, foreign patents applied in China, especially invention patents, are coming. more. At present, 80% of China's more than 10,000 drug patents are owned by foreign research institutions and enterprises, and more than 90% of them are invention patents.
Obviously, China's pharmaceutical companies that use imitation new drugs as a means of development are facing the dual dilemma brought by intellectual property rights: self-developed new drugs, facing many problems such as capital and scientific research; while the imitation of foreign patents has passed the road of drugs, but it is full of fierce competition. The profit is meager. In the face of intellectual property rights, China's pharmaceutical industry is facing a severe test.
Patent unconscious under the "imitation" system
The lack of innovative motivation and pressure in Chinese pharmaceutical companies is the main reason for the current situation.
For a long time, under the highly centralized planning system, Chinese pharmaceutical companies are unable to arrange production independently and lack the necessary market awareness. Although the long-term imitation method saves a lot of funds for the development of new products, the imitation system formed by the enterprise is “successful and good”, but it has stifled the innovation ability of the enterprise.
At present, there are not many enterprises capable of high-tech development research in China. Even those capable of high-tech development research are weak. Some enterprises have insufficient understanding of the importance of enterprise R&D, or rely too much on imitation, or rely too much on introduction. The ability of secondary development. The data shows that 97% of the chemicals produced by Chinese enterprises are imitation.
It is under this system that there is a widespread problem of patent unconsciousness in Chinese pharmaceutical companies.
Many companies prefer to spend huge amounts of manpower, resources and funds to promote their products. They spend huge sums of money to use various media for advertising, but they are reluctant to invest in scientific research and intellectual property protection. For example, in the field of Chinese medicine, patent applications are mainly from individual applications, while companies have few applications. For example, at the Canton Fair in 2002 and 2003 after the accession to the WTO, the intellectual property management department still investigated 120 cases and 127 cases of suspected infringement of patent rights and 25 cases and 23 cases of alleged infringement of trademark rights, which was higher than before the accession to the WTO. No reduction.
In China's universities and research institutes that undertake the heavy responsibility of scientific research, due to management systems, incentive mechanisms, etc., they have received research on state-funded projects, and there are widespread cases of patents. Although the government departments at all levels have taken measures such as issuing patent application indicators, this tendency has not fundamentally changed. In fact, published papers are limited to basic research; for scientific research results with industrial prospects, if you only pre-emptively publish papers without applying for patents, it will result in the loss of intellectual property rights, which is equivalent to giving the scientific research results exchanged by the state investment to others.
Due to the lack of knowledge of patent law and the influence of past passive protection and the traditional concept of traditional Chinese medicine ancestors, many pharmaceutical companies are reluctant to apply for patents on the grounds that they are afraid of leaking their technical secrets after disclosure, and prefer to protect their intellectual property rights through confidentiality. However, because drugs are related to public health, the public has the right to know about the drugs they take or use. Therefore, when applying for a drug production license, it is necessary to disclose their prescriptions and processes, and meet the standards for safe and effective drug quality approval and quality control. Therefore, it is difficult to keep confidential; in addition, even if confidentiality measures are taken, once the self-developed person has successfully developed and applied for patent protection, the secret manufacturer has the right to use it first, but can only produce and use it within the original scope, and cannot permit others to produce and expand. The scope of production has constrained the development of confidential technology and related companies.
At the same time, the ability to create new drugs in China was not strong, and only a few innovative achievements, due to weak patent awareness, did not obtain patent protection in a timely manner.
The most typical ones, which are also the most criticized in the industry, are the following two examples:
First, after more than ten years of arduous research, China's medical science and technology personnel developed a new antimalarial drug, artemisinin, in the 1970s. This medicine is a major invention in the field of medicine in China, and it is also the only new chemical drug recognized by the world in the field of medicine in China. However, because we did not have the necessary conditions for intellectual property protection at the time, when the research papers on artemisinin were published, foreign companies immediately carried out some structural transformations and applied for patents, which led to the invention of China becoming a foreign patent. As a result, our country will suffer an export loss of 200-300 million U.S. dollars per year.
The second is the invention of the preparation technology of vitamin C two-step fermentation method in China. This is an invention with international advanced level, but because of the lack of awareness of intellectual property protection, a foreign company that had to buy the preparation technology for $5 million would not hesitate to say no after applying for a patent. A few dozen yuan to buy the paper back. A few years later, the vitamin C produced by this low-cost technology abroad has been sold to the international market in large quantities, causing great losses to China's vitamin C export enterprises.
At the same time as the patent awareness is indifferent, there is still a case of patent application in the pharmaceutical industry, which also reflects the current impetuousness of the industry. For example, in the field of human genes, a company in the south rushed to apply for more than 3,700 patents more than a year before and after 2000. Since then, it has suddenly died down. In the nano-field, in recent years, there have been nearly one thousand consecutive applications from the same person. In the case of patents; for example, after the SARS epidemic last year, there were also cases in the medical field where people competed to apply for anti-SARS drug patents.
Insiders pointed out that in the above-mentioned patent applications filed by the assault, quite a number of applications did not make any scientific experiments, but it was a very immature preliminary idea. It was not tested by experiments and could not meet the requirements of the Patent Law. A clear and complete description of the invention or utility model technology should be made, which can be achieved by a person skilled in the art, and therefore cannot obtain effective patent protection. In addition, due to the limitation of the first application system, such defects of insufficient disclosure cannot be compensated by supplementing the experimental data after the application date. The result is that some invention ideas are disclosed in vain, and it is possible to “make clothes for her”, but Can not change the "fame and fortune" pursued.
The Chinese medicine field is the area with the highest proportion of domestic patent applications in all technical fields. It remained at around 96% until 1997, which shows that China has a large advantage in traditional Chinese medicine research. However, Chinese medicines apply for patent protection abroad, but the number of patent applications abroad is only 0.35% of the number of domestic applications. Even after China's accession to the WTO, the awareness of patents in the Chinese medicine industry has generally improved. In 2002, the proportion of patent applications filed abroad to domestic applications for patents was only 0.6%, which was lower than the average of 2.4% in various technical fields.
In sharp contrast, foreign companies, especially multinational pharmaceutical companies, in order to occupy China's domestic market and fully enjoy the national treatment promised after China's accession to the WTO, the use of PCT Patent Cooperation Treaty and other means to enter China's patent applications is increasing, It even extended its tentacles to the Chinese medicine field where domestic applications have always been dominant.
Can pharmaceutical companies rebuild the patent innovation system?
China's patent system started late. In the field of medicine, the patent law before 1993 only protected the pharmaceutical production process, and excluded the pharmaceutical substances and varieties from patent protection. Coupled with the weak patent awareness, the emphasis on and training of patent professionals is not enough, resulting in a serious shortage of patent talents in the pharmaceutical field in China. There are fewer professionals such as patent attorneys or patent attorneys in pharmaceutical companies, and there are few specialized patent management agencies.
However, some pharmaceutical companies in some developed countries have specialized patent agencies, and patents are usually undertaken by patent attorneys and patent attorneys. For example, the well-known American pharmaceutical company Merck has an intellectual property department with a large number of patent attorneys and dozens of patent attorneys; Pfizer has a patent law department, of which the patent department has dozens of patent attorneys. Their functions include patent intelligence research, mining inventions, processing patent applications, handling patent disputes, and trading patent licenses. In China, there are very few specialists in this area, and there are only a handful of companies with these departments.
For a long time, the research and development of China's medicine is mainly based on imitation, and the funding for new drug innovation is seriously insufficient. The pharmaceutical industry is known as the high-tech industry, and it has the basic characteristics of high-tech industries with high knowledge and technology, high capital intensive, high added value, good social benefits, high risks, fast growth, and short product life cycle. At present, it takes 800-100 million US dollars to develop a new chemical drug, and only 3 kinds of drugs can be profitable for each 10 new drugs listed. Only one of them is profitable, and from drug screening to final product. Listings often take more than a decade. Foreign large multinational companies invest 15%-20% of their annual sales of new drugs. China's pharmaceutical companies usually only have 1%, and can't guarantee 1% of special funds, at the expense of the connotation of the pharmaceutical industry to expand reproduction. For example, the North China Pharmaceutical Factory, which has a greater impact in China's pharmaceutical industry, has a research and development fee of only tens of millions of yuan a year.
Behind the lack of research and development funds, there is a lack of risk investment mechanisms in China's pharmaceutical industry. China's long-term investment in research and development, especially in the early stage, is mainly based on the state and lacks the support of venture capital funds. Because there is no venture capital investment, some companies have no funds to commercialize them even if they have good technology; even if they have good products, they have no financial resources to keep them updated.
On the one hand, research funding is very scarce. On the other hand, valuable research funds have not produced the greatest benefits. The scientific research results obtained by concentrating a large amount of manpower, material resources and financial resources are somewhat shelved and some disappear on their own, resulting in long-term investment and low output. At present, China's high-tech commercialization rate is 25%, and the industrialization rate is only 7%.
The relevant price authorities have adopted a “one size fits all” policy on the profit rate of drugs. There are also many drawbacks – not only the ordinary drugs that do not need to be researched and developed are maintained at high prices, but also the normal profits of innovative drugs cannot be effectively Encourage companies to invest in innovation.
Even in the field of imitation, what China lacks is a clever imitation. In fact, independent intellectual property rights can also be generated in the imitation process. Japan is constantly updating and improving the imported technology, and thus it has derived many subordinate patents (dependent patents) with Japanese characteristics around the basic patents of foreign countries, and it is called the “Encroaching Policy”. Through wise introduction and intelligent imitation, Japan not only succeeded in promoting the rapid growth of the economy, but also made itself one of the world's recognized patent powers. The huge number of patents accumulated in turn has laid a solid foundation for Japan to become a world economic power. Foundation. Chinese pharmaceutical companies should learn from Japan's experience. In the process of copying, they should combine their own advantages and acquire independent intellectual property rights in re-creation. They should stand on the shoulders of giants instead of lying on giants.
There are indications that after the completion of the large-scale entry into China by international pharmaceutical giants, it is now shifting from past industrial investment to R&D investment in China. On July 1 this year, the Novo Nordisk China R&D Center, which has a dominant position in the world of treatment of diabetes, was completed in the Zhongguancun Life Science Park. At the same time, Roche, another multinational pharmaceutical company headquartered in Basel, Switzerland, also set up a research and development center in Zhangjiang Hi-Tech Park in Pudong, Shanghai.
Experts in the industry believe that multinational pharmaceutical companies have targeted China's "good quality and low price" scientific research personnel, strong scientific research base in certain fields and rich and unique disease resources. Multinational companies set up R&D institutions in China mainly to save costs, because recruiting the same level of researchers in China is much lower than those recruited abroad, and China's clinical costs are much lower.
China has not taken advantage of good technology research and development and is being smashed by international pharmaceutical companies.
On the occasion of China’s third anniversary of China’s accession to the WTO, some media have issued questions about “China’s intellectual property rights have become a public hazard?” There are signs that the international community has begun “liquidation” of China’s intellectual property issues. Just want to move. In this context, the dilemma facing China's pharmaceutical industry will be even more difficult, and it will usher in a big test of life and death.