The latest document: the drug patent link system is coming

Recently, the general office of the CPC Central Committee and the general office of the State Council issued the opinions on strengthening the protection of intellectual property rights, which made it clear that we should continue to reform and improve the protection system of intellectual property rights, comprehensively use legal, administrative, economic, technological and social governance means to strengthen protection, and promote the overall improvement of protection capacity and level Highlight 1: opinions and requirements, and improve the protection system of new formats and new fields To explore the establishment of drug patent link system and drug patent term compensation system Highlight 2: research and formulate measures for the protection of traditional culture, traditional knowledge and other fields, and strengthen the protection of intellectual property rights of traditional Chinese medicine Highlight 1 This system is an important reform measure in the pharmaceutical intellectual property system, which shows that China is committed to strengthening the intellectual property protection of innovative drugs and promoting the innovative development of the pharmaceutical industry As early as 2017, the general office of the CPC Central Committee and the general office of the State Council issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices （16） To explore the establishment of drug patent link system In order to protect the legitimate rights and interests of patentees, reduce the risk of patent infringement of generic drugs, encourage the development of generic drugs, and explore the establishment of drug review and approval and drug patent link system When submitting an application for registration, the applicant for drug registration shall state the relevant patents involved and their ownership status, and inform the relevant drug patentee within the prescribed time limit Where there is a dispute over the patent right, the parties concerned may bring a suit before the court, and the technical evaluation of drugs shall not be stopped during the period For the drugs passing the technical review, the food and drug regulatory department shall make a decision on whether to approve the listing according to the effective judgment, ruling or mediation document of the court; if the effective judgment, ruling or mediation document is not obtained within a certain period of time, the food and drug regulatory department may approve the listing （17） We will launch a pilot program on the compensation system for the duration of drug patents Select some new drugs to carry out the pilot, and compensate for the delay in listing due to clinical trials and review and approval According to Article 18 of the current measures for the administration of drug registration in China, the applicant for drug listing license shall submit a statement that the patent of another person does not constitute infringement In case of patent disputes in the process of drug registration, they shall be settled in accordance with the laws and regulations on patents In practice, if there is a dispute between the patentee of the original research drug and the imitated drug enterprise, the approval procedure of the imitated drug will be suspended until the expiration of the patent term, which may cause unfair situation to the imitated drug enterprise In 1984, the United States passed the drug price competition and patent Recovery Act (also known as the hatch Waxman act), which established a set of legal system of drug intellectual property In order to promote the development of generic drugs, the bill provides a simplified new drug approval process (anda) and a Bolar exception (also known as the Bolar exemption "Exemption" refers to the exceptional provision in the patent law that a person imports, manufactures or uses a patented drug before the expiration of a drug patent without the consent of the patentee, so that the act of obtaining the data and other information required by the drug administration department is regarded as not infringing the patent right.) , greatly simplify the approval process of generic drugs, reduce their costs and promote their listing as soon as possible In order to promote the development of the original research drug, the Act provides for drug data protection and patent protection period compensation to make up for the adverse effects of strict drug approval procedures on the original research drug In the approval process of generic drug listing, if there is a patent infringement dispute, the drug approval process will be suspended for 30 months, waiting for the court's decision on the dispute If a court decision is obtained before the expiration of the suspension period, it shall be decided whether to approve the listing of generic drugs If no court decision is obtained at the end of the suspension period, the patent dispute will not be considered and the approval process will continue The drug patent link system in the United States provides a set of complex rules, including orange book system, generic patent declaration, approval suspension period and first generic market monopoly period system Europe and Japan have not established a drug patent link system similar to that of the United States According to the European Commission, the task of drug regulatory agencies is to verify the safety and effectiveness of drugs, and other factors such as whether the product infringes the patent right should not be taken into account, otherwise, it violates the provisions of the Patent Law on the Bolar exception For potential patent infringement disputes in the process of approval of generic drug listing, the patentee can apply to the court for "temporary injunction" to solve them In order to prevent the approval process of generic drugs from going on the market in Europe, drug patentees first need to obtain the temporary injunction of the court, which is obviously much higher than the threshold of the United States In order to solve the potential patent disputes before the generic drugs go on the market, Japan has adopted another way: One is not to approve the listing of generic drugs when the patent period of new drugs' active ingredients has not expired; Second, for generic drugs involving patents other than the active ingredients of new drugs, after the issuance of the listing license, the original research drug enterprise and the generic drug enterprise can conduct "prior consultation" on whether there is patent infringement, but the consultation result has no legal effect From the implementation of drug patent link, the vast majority of patent disputes are for follow-up improved drug patents, and new active ingredient patents are indeed difficult to bypass Therefore, Japan simply prohibits the application of generic drugs before the expiration of the patent for active ingredients of new drugs Canada, Australia and South Korea have all introduced drug patent linkage system through free trade agreements with the United States However, there are some differences in the specific provisions such as the suspension period India made clear through court cases that in the case of Bolar exception stipulated in the patent law, the drug listing approval authority only needs to review the safety and effectiveness of drugs, without considering the factors of patent disputes Strengthening intellectual property protection of traditional Chinese Medicine Current situation of intellectual property protection of traditional Chinese medicine in China The current legal system of intellectual property rights is far from meeting the needs of the protection of intellectual property rights of traditional Chinese medicine, resulting in the loss of a large number of intellectual property rights, traditional knowledge and biological resources of traditional Chinese medicine According to statistics, at present, more than 900 kinds of Chinese herbal medicine projects in China have been applied for patents by enterprises from Japan, South Korea and other countries Nearly 30% of the domestic Chinese herbal medicine market and more than 90% of the international market share have been occupied by foreign enterprises The state has promulgated the law of traditional Chinese medicine to strengthen the protection of intellectual property rights of traditional Chinese Medicine In December 2016, the law of the people's Republic of China on traditional Chinese medicine (hereinafter referred to as the law of traditional Chinese Medicine) was issued, listing a variety of ways to protect intellectual property rights of traditional Chinese medicine: Including encouraging the protection of geographical indication products and other measures to protect authentic Chinese herbal medicines; The state establishes a database, directory and system for the protection of traditional Chinese medicine knowledge; The holders of traditional Chinese medicine knowledge have the right to inherit and use the traditional Chinese medicine knowledge they hold, and have the right to informed consent and benefit sharing for others to acquire and use the traditional Chinese medicine knowledge they hold; the State exercises special protection for the composition and production process of traditional Chinese medicine prescriptions recognized as state secrets according to law In October 2019, the opinions of the CPC Central Committee and the State Council on promoting the inheritance, innovation and development of traditional Chinese medicine pointed out that accelerating the scientific research and innovation of traditional Chinese medicine: "strengthening the protection and application of intellectual property rights of traditional Chinese medicine industry We will improve the management system that gives more autonomy to scientific research institutions and personnel of traditional Chinese medicine, and establish a mechanism to guarantee the rights and interests of intellectual property rights and the transformation of scientific and technological achievements " Improve and strengthen the protection of intellectual property rights of traditional Chinese medicine, people's court, written by Ding Wenyan Zhang Yonghua Interpretation and suggestions on drug patent link system [J] China food and drug administration, June 2018 (173): 34-41 Chinese medicine law of the people's Republic of China