3. Drug production license system
The drug production license system widely practiced at home and abroad shall be implemented in accordance with the following provisions of the Drug Administration Law of People's Republic of China (PRC):
"Article 7 ... No medicines may be produced without a Pharmaceutical Production License."
Article 9 Pharmaceutical production enterprises must organize production in accordance with the good manufacturing practice formulated by the pharmaceutical supervisory and administrative department of the State Council in accordance with this Law. The pharmaceutical supervisory and administrative department shall, in accordance with the provisions, certify whether the pharmaceutical production enterprises meet the requirements of good manufacturing practice; If the certification is qualified, a certification certificate will be issued. "
"Article 29 Development of New Drugs ... New drugs that have completed clinical trials and passed the examination and approval shall be approved by the drug supervision and administration department of the State Council and issued with new drug certificates."
"Article 31 The production of new drugs or drugs with national standards must be approved by the drug supervision and administration department of the State Council, and a drug approval number shall be issued. A pharmaceutical production enterprise can produce the drug only after obtaining the drug approval number. "
In addition, after the protection period, other enterprises need to copy and produce the new drug, and they also need to go through a series of drug declaration and production processes. It takes 1 year for generic new drugs to go on the market, which has won a certain market time for the original manufacturers.
As can be seen from the above rules and regulations, the state has always attached great importance to the supervision and management of drugs, which is a special commodity and related to the life safety of the broad masses of people. Therefore, drugs have a higher market access threshold than the production and operation of ordinary commodities. Drug production license, good manufacturing practice (GMP) and drug approval number (including new drug certificate and production approval) are necessary conditions for drug production, and it takes a lot of time and money to obtain them.
4 know-how protection
Proprietary technology refers to undisclosed technology, which is not protected by special intellectual property law (such as patent law), but can be protected by contract law, anti-unfair competition law, criminal law, general principles of civil law and other relevant provisions. Only by keeping secrets can all people maintain their existence and value and possess them. Once the proprietary technology is leaked and made public, it becomes public technology and anyone can use it.
In the research and development of drugs, the screening and synthesis of pharmaceutical chemical components is a very expensive process. Most domestic new drugs are copied from foreign patented drugs. Although the screening process of drugs is omitted, the synthesis of chemical components of drugs is an essential link, which requires not only laboratory tests, but also pilot scale-up until large-scale production, in which a large number of proprietary technologies will be used. To successfully realize commercial production, we should not only ensure the stability of drug production quality and quantity, but also reduce the production cost. Usually, more and higher-level technical support is needed in the production of chemical raw materials and biological products. During or after the patent/administrative protection period/monitoring period, we must rely on proprietary technology to ensure quality and cost advantages to participate in market competition and continuously obtain excess profits.
In addition, the undisclosed test data of the new drug original drug registration applicant will be protected for six years, and the undisclosed test data here is proprietary technology. The protection period of 6 years is longer than the monitoring period of less than 5 years, which reflects the importance and protection of proprietary technology.
5 trademark protection
According to the Trademark Law, drugs for human use are subject to compulsory trademark registration. All drugs for human use (including ordinary drugs and new drugs) have registered trademarks, and new drugs can also have trade names (they can be used only after being approved by the State Pharmaceutical Administration); In addition to the generic name (generally referring to the international non-proprietary name, that is, there is a generic name all over the world, such as aspirin), each new drug also has a trade name (that is, the manufacturer or enterprise often registers a trade name for its products to show the difference, such as bamir is one of the trade names of aspirin). Consumers are familiar with trade names, and will pay attention to choosing brands with good quality and high reputation when purchasing drugs; After the end of the patent/administrative protection period, pharmaceutical production and operation enterprises often need to protect their drugs with their trade names to distinguish them from other similar products, so as to obtain sustained profits and extend the economic life of drugs.
6. The comprehensive protection of intellectual property rights of new drugs affects their economic life.
The economic life of general technology patents is much shorter than the patent protection period. For example, the patent protection period in Germany is 20 years, but statistics show that the actual patent protection period is only 9 years on average, and only 3.7% of all patents remain to 18 years. The economic life of patents rarely reaches the protection period, and the products produced by patents often lose their market value before the protection period.
As a special commodity, new drugs have high research and development cost and long cycle. The combination of these two factors makes the protection of intellectual property rights very important. Western developed countries have a perfect intellectual property protection system for drugs, and have formed a complete protection system and business model with patent protection as the core and trademarks and trade secrets (including proprietary technology and trade secrets) as the supplement. Therefore, creating a new drug category means the monopoly of pharmaceutical companies, which can provide necessary protection for pharmaceutical companies based on research, so that they can make up for R&D investment and generate returns. Compared with other industries, patents are particularly effective in the pharmaceutical industry. Practice shows that the economic life of most patented drugs can not only reach the protection period, but also obtain excess income through comprehensive protection of other non-patented intellectual property rights after the protection period, thus prolonging their economic life.
Because China's pharmaceutical industry has always been dominated by imitation, there are very few drugs with independent intellectual property rights. Statistics show that more than 97% of drugs produced in China in recent 20 years are imitations. The so-called new drugs recently introduced by many companies are almost all new drugs before 1993 when the China government implemented administrative protection for foreign patent applications. Therefore, at present, most new drugs in China are mainly based on administrative protection of new drugs. Similar to the situation after the expiration of foreign drug patent protection, after the expiration of administrative protection, domestic new drugs get excess income through the comprehensive protection of other intellectual property rights, extending their economic life. According to general experience, it should be 1~3 years, and the economic life of special new drugs may be more than 3 years.
To sum up, the comprehensive protection of intellectual property rights of new drugs is much stronger than the general technical intangible assets. Therefore, the development experience of new drugs at home and abroad shows that the technological renewal cycle of drugs is longer than that of ordinary high technology, and the corresponding economic life is longer. The economic life of most drugs can generally last until the expiration of patent/administrative protection. After the expiration of patent/administrative protection, although its ability to bring excess profits will be greatly weakened, it can still be effectively extended through trademark protection and proprietary technology protection. That is, after the patent/administrative protection expires, the drug still has a certain residual economic life.
In the evaluation practice, as an intangible asset, a new drug is usually defined according to proprietary technology or general new drug technology, which easily ignores that a new drug is a special technical intangible asset and is comprehensively protected by various intellectual property rights. It is necessary to attach importance to and correct the administrative protection period for machinery to determine the economic life of new drugs, so that they are underestimated.