This is a long-lasting tug-of-war. The disparity in innovation ability makes it difficult for domestic enterprises to lose their intellectual property resources in a short period of time. Under the profit-oriented mechanism, no one is willing to give up the vested interests. Drug patents are an important source of cash flow for pharmaceutical companies. Once the patent expires, the price of the drug usually drops by 80%, making many companies face the pressure of a sharp decline in sales. In order to maintain a monopoly position in the market, multinational companies often obtain new drug patents through mergers and acquisitions, or increase the market share of drug sales through mergers and acquisitions. The difficulty in research and development of new drugs is alienating the industrial ecology. The core competitiveness of many large pharmaceutical companies is not the ability of independent research and development of drugs, but the ability to obtain and maintain patent rights through various means. The revised Patent Law of the People's Republic of China is expected. In the face of the patented edge of the multinational giants, we are taking a more proactive stance. Through the use of intellectual property systems and functions, seeking a favorable position in the market competition - this may be a direct and pragmatic approach to the current Zui. In fact, even in a large patent country like the United States, the “positiveness†of using the flexibility provisions of the TRIPS Agreement is no worse than that of developing countries. The United States has a complex "patent exception system" that covers many case law and statutory law. The “Bolar Exception†clause applies to patents used for drug registration or experimental purposes; the “Sovereign Immunity†clause stipulates that government and colleges cannot be defendants in patent infringement proceedings; the Special Compulsory License Act applies to clean air and civilian nuclear energy Technology, etc. In addition, there are jurisprudence for the use of compulsory licensing in conjunction with the injunctive procedure in the judicial process for the protection of the “public interestâ€. The “Bolar Exception†has always been regarded as a safe haven for patent risk prevention in drug development. The US courts have adopted an increasingly loose explanation for the scope of application of the "Bolar Exception". Expanding “patented products†to Medical Devices other than pharmaceuticals; as long as it is used to collect data required for FDA approval, whether it is for commercial purposes, it is “reasonable to be relevantâ€; even considering the high probability of failure in drug screening Even if the information collected in the preclinical study is not submitted to the FDA, the Bolar Exception can be applied as long as the information is suitable for submission in the FDA's formal procedures. In addition, the US Zui High Court also ruled that the “Bolar Exception†is not limited to experiments conducted on humans, and experiments on animals are equally applicable. The essence of the patent system is to grant inventions and creators a monopoly on their inventions and creations, but respecting intellectual property rights does not mean giving up competitiveness and dominance. Although the patent knife light is fierce, the flaws still flash from time to time. "Bolar exception" or compulsory license, for local companies, in addition to the resilience of the courage, there must be patents against the killing.
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Prominently enclosing the patented drugs also requires counter-institutional "killing"
The difficulty of patents is the long-term pain of local pharmaceutical companies. While monopolizing core technologies, multinational corporations have adopted various means to suppress Chinese enterprises on patent issues. According to previous data, in the world, the United States has 59% of biotechnology patents, 51% of pharmaceutical patents, and 40% of human genetics patents, and all developing countries including China have in these three areas. The patents are 5%, 4% and 3% respectively. In balancing the relationship between public health and patent protection, the interests of developing countries and developed countries are very different: one side needs low-cost medicine to save people, maintain public health and national security; the other side invests heavily in research and development to make the majority of patented medicines developed. The state requires zui to protect its own interests to a large extent.