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    Home > Medical News > Medical World News > Predicting the future development of some issues in China's drug management from the Sino-US trade negotiations

    Predicting the future development of some issues in China's drug management from the Sino-US trade negotiations

    • Last Update: 2020-01-17
    • Source: Internet
    • Author: User
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    Text: zulikou431 With the promulgation and entry into force of the new revised version of the drug administration law on August 26, 2019, China's drug administration has entered a new historical stage In the near future, the State Food and drug administration has successively issued Measures for the administration of drug registration (Draft for comments), measures for the administration of drug production supervision (Draft for comments), measures for the administration of drug trade supervision (Draft for comments) and other documents With the release of these documents, a new situation of drug supervision in China is gradually forming On January 15, 2020, the first phase of the Sino US trade negotiations (full name is the economic and trade agreement between the government of the people's Republic of China and the government of the United States of America) was published in full, which inevitably involves some drug management provisions This important international agreement will also have a lot of impact on China's drug administration, and on the above-mentioned laws and regulations being revised Now I will sort out the main points and analyze the text for you, hoping to provide reference for pharmaceutical colleagues In Section III of the economic and trade agreement between the government of the people's Republic of China and the government of the United States of America on pharmaceutical related intellectual property rights, it is mentioned that: pharmaceuticals are related to people's life and health, and the need to find new methods to treat and cure diseases persists, such as cancer, diabetes, hypertension and stroke In order to promote innovation and cooperation between China and the United States in the field of medicine and better meet the needs of patients, both parties shall provide effective protection and enforcement for pharmaceutical related intellectual property rights, including patents and undisclosed test data or other data submitted to meet the conditions of market approval Analysis: from the above content, the agreements reached between China and the United States focus on pharmaceutical intellectual property rights It is expected that this policy will be of great benefit to enterprises with strong intellectual property team and profound patent layout, while for some innovative pharmaceutical enterprises, if the intellectual property rights of their products are not very clear, or there are potential infringement problems, it is estimated that they will be suppressed Of course, in the long run, it is beneficial to enhance the awareness of property rights protection of Chinese pharmaceutical enterprises and increase the cultivation of innovation Section 1.10 consideration of supplementary data 1、 China should allow drug patent applicants to rely on supplementary data to meet the requirements of patentability in patent examination, patent reexamination and judicial procedures, including the requirements of full disclosure and creativity Analysis: this part of terms means that patent applicants have many opportunities to supplement data in the process of work In the judicial process, multiple supplementary opportunities will be more beneficial to patent holders, and it is estimated that patent litigation will be prolonged 2、 The United States confirms that the measures in force in the United States give equal treatment to the provisions of this article Article 1.11 effective mechanism for early resolution of patent disputes 1、 As a condition for approving the listing of drugs, including biological drugs, if China allows others other than the person who originally submitted the safety and effectiveness information to rely on the evidence or information of the safety and effectiveness of previously approved products, such as the evidence of listing approval in China or other countries or regions, China shall: (I) stipulate the system to notify patent rights Persons, licensees or holders of marketing licenses who are seeking to market the approved products or their approved methods of use within the patent validity period; (II) providing sufficient time and opportunity for the patentee to seek the remedies provided in paragraph (III) before the alleged infringing products are listed; and (III) providing judicial or administrative procedures and expeditions Remedies, such as action preservation measures or equivalent effective interim measures, to resolve disputes in a timely manner over the validity or infringement of patents applicable to approved drugs or their approved methods of use Analysis: from the above content, in view of these patent disputes involved in the process of drug review, it is necessary for the State Food and drug administration to provide principled provisions in the measures for the administration of drug registration, and to specially introduce systems to manage patent disputes in the process of drug review and approval ◆ although the administrative measures for drug registration (2007 version - current version) does not explicitly stipulate the use of patent link system, a compromise clause has been adopted Article 18 the applicant shall provide a description of the patent of the applicant or other person in China and the ownership status of the drug or the prescription, process and use it applies for registration; if another person has a patent in China, the applicant shall submit a statement that the patent of another person does not constitute an infringement The drug regulatory department shall publicize the explanations or statements submitted by the applicant on the website of the administrative organ In case of patent disputes in the process of drug registration, they shall be settled in accordance with the relevant laws and regulations Article 19 for a drug for which another person has obtained a Chinese patent right, the applicant may file an application for registration within two years before the expiration of the patent term of the drug The State Food and drug administration shall, in accordance with these measures, examine and verify the compliance with the provisions, and issue the drug approval number, import drug registration certificate or medical product registration certificate after the expiration of the patent period ◆ the draft of administrative measures for drug registration (Draft for comments) 20191210 has been verified At present, the third draft of the draft does not involve any patent link system information, and there is no provision for intellectual property disputes at the drug review and registration stage ◆ the drug administration law of the people's Republic of China (revised version 20190826) has been verified, and there is no provision for drug patents involved It is preliminarily estimated that the above two laws and regulations need to be revised and similar relevant contents added ◆ only one notice of 20090819 was found on CDE official website: in order to facilitate the registration applicant to browse and query the patent information related to drug registration, our center specially added the link of SFDA website "public column of patent information related to drug registration" in the column of "service hall" on CDE website homepage, please pay attention From nmpa database, although there is a database named "publication of patent information related to drug registration", the database is not perfect and relevant For example, here is the U.S FDA's OB (Orange Book) search approach You can see the following patent related search entry However, there is no such a convenient patent link system in China 2、 China should establish a drug-related system consistent with the first paragraph above nationwide, including the right for patentees, licensees or marketing license holders to file a lawsuit before the alleged infringing products are licensed for marketing, and seek civil judicial procedures and rapid relief for the dispute resolution of the applicable patent validity or infringement China can also provide administrative procedures to resolve such disputes Analysis: according to the above analysis, it is estimated that the drug approval system and intellectual property law need to be properly adjusted At present, although the drug registration applicant is required to provide a declaration of non infringement in the administrative measures for drug registration (2007 version), the Bolar exception principle is generally adopted in the drug review and approval process Because for drugs, they have to go through a long process of project approval, technical research, animal test, clinical test and administrative approval before being put on the market Therefore, if it is allowed to register and apply for approval only after the expiration of the drug patent right, it means that during the several years of registration and approval, although the patent right has expired, other people still can not use the expired patent to obtain benefits, which is virtually equivalent to extending the protection period of the patent right, which is obviously unreasonable for the public Whether these behaviors supporting drug research and development but not supporting the commercialized sale of drugs infringe the rights will be more clearly defined after this Sino US trade negotiation 3、 The United States confirms that the measures in force in the United States give equal treatment to the provisions of this article Section 4 patents Section 1.12 extension of patent validity 1、 Both parties shall provide for the extension of patent validity to compensate for unreasonable delay in the process of patent authorization or drug listing approval How to say this paragraph? Although domestic CDE has been continuously investing resources to speed up the review and approval and strive to make the review and approval time meet the relevant provisions, unreasonable delay has always existed For unreasonable delay, it is estimated that domestic enterprises have more painful feelings and voice 2、 (1) at the request of the patentee, China shall extend the validity of the patent to compensate for unreasonable delay not caused by the applicant in the process of patent authorization For the purposes of this article, unreasonable delay shall include at least the fact that no patent right has been granted within 4 years from the date of filing the application in China or 3 years after the request for examination, whichever is later This one is very clear If the patent validity period is shortened due to the low administrative efficiency, appropriate compensation should be given Then, the generic companies will be more affected, and the pace of generic listing will slow down; and the original research companies or patent holders can use these terms to enjoy longer monopoly profits (2) At the request of the patentee, China shall adjust the validity period or patent validity period of the new drug product patent, its approved use method or manufacturing method patent approved for listing in China, so as to compensate the patentee for the patent validity period caused by the first listing approval process of the product in China Reasonable reduction Any such adjustment shall, subject to the same restrictions and exceptions, grant all the exclusive rights of the original patent to the patent claim of the product, its use method or manufacturing method applicable to the approved product and its use method China can limit this adjustment to no more than 5 years, and the total period of validity of the patent from the date of approval of listing in China is no more than 14 years Analysis: in any case, once the above provisions are implemented, they will have a strong protection effect on innovative drug companies or patent holders, and further promote the enthusiasm of drug research and development innovation However, in the short term, it will have a negative impact on some domestic enterprises that are trying to copy It is estimated that many R & D companies begin to evaluate the impact of their own projects to judge the later investment and the delay time of listing 3、 The United States confirms that the measures in force in the United States give equal treatment to the provisions of this article Section 7 production and export of pirated and counterfeit products Section 1.18 counterfeit drugs 1、 The parties shall take effective and prompt law enforcement action against counterfeit drugs and related products containing active pharmaceutical ingredients, bulk chemicals or biological products Analysis: China has taken more stringent measures to crack down on domestic counterfeit drugs With the construction of the drug electronic traceability system, the crackdown will be stronger and more accurate In the drug administration law, which came into effect on December 1, 2019, a more humanized clause has been added: import a small amount of drugs that have been legally listed overseas without approval, and if the circumstances are relatively minor, the punishment can be reduced or exempted according to law Now, according to the results of the Sino US trade negotiations, it is estimated that this operation space will be reduced in the future 2、 The measures China should take include: (1) taking effective and rapid law enforcement actions to combat counterfeiting of pharmaceutical and biopharmaceutical related products, including active pharmaceutical ingredients, bulk chemicals and biopharmaceutical products; (2) sharing with the United States the registration information of pharmaceutical raw material sites inspected by Chinese regulatory authorities and in compliance with the requirements of Chinese laws and regulations, as well as the necessity of relevant law enforcement inspection Information;
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