Supreme Law Intellectual Property Dispute Determination Rules | Drug Patent Linking System to Make Patent Law Warm and Grounded

Medicine is a special commodity. It not only has the attributes of general commodities, but also has some special attributes because of its close relationship with human life and health. Compared with other technical fields, drug research and development is often more difficult because of the remarkable characteristics of "long cycle, high risk and high cost. As a result, pharmaceuticals rely on patent protection more than any other field of technology. A survey shows that without patent protection, 65% of drugs will not be developed and 60% of drugs will not be marketed. The development of medicines is also linked to public health issues, directly affecting the public's access to essential treatment and health services in many developing countries. Therefore, there is a need to establish a "balance" between the interests of pharmaceutical companies and public health ". In the field of medicine, drugs can usually be divided into original research drugs and generic drugs. Because it can directly promote the reduction of drug prices, generic drugs are an important basis for ensuring drug accessibility and benefiting public health. Original research drugs and generic drugs are both competitive and indispensable. Balancing the development of the two has become an important part of the design of the government management system, and the drug patent link system is produced in this context.

The drug patent linkage system originated from the U.S. Drug Price Competition and Patent Period Compensation Act of 1984, the Hartke-Waxman (Hatch-Waxman) Act ". In the 1930 s, the "sulfonamide elixir incident" and "thalidomide incident" aroused the attention of the United States to drug safety issues, and carried out a series of reforms to the drug management system. The United States subsequently introduced a series of bills requiring pharmaceutical companies to prove the safety and effectiveness of their drugs in strict accordance with the requirements before they can be marketed. However, strict examination has also brought about a greater negative impact. On the one hand, the market monopoly period of original research drugs under patent protection has been greatly reduced; on the other hand, the cost of generic drugs has increased significantly. As a result, the pharmaceutical industry in the United States has fallen into a passive position, and drug prices have remained high for a long time. The original research drug companies and generic drug companies realize that they must cooperate to strive for policies and system design that are more conducive to industrial development. Subsequently, Hartke (Orrin Hatch), chairman of the U.S. Senate Labor Committee, who represents the interests of the original drug companies, and Representative Henry A.Waxman (Henry A.Waxman), a liberal Democrat who represents the interests of generic drug companies, jointly proposed the Drug Price Competition and Patent Period Compensation Act, which was signed and passed in 1984. For the first time, the bill sets up the system of extending the protection period of drug patent, the exemption system of infringement test and the data protection system of drug test, and the drug patent link system is also one of the important contents of the bill.

Drug accessibility is the basic evaluation index of public health and well-being, and drug availability (mainly contribution of original research drugs) and affordability (mainly contribution of generic drugs) are the two ends of drug accessibility. The dynamic balance of interests at both ends of drug accessibility is regarded as the standard of the patent link system. The so-called drug patent link system has two meanings. One is the link between the approval of generic drug listing applications and the corresponding drug patent effectiveness review procedures; the other is the functional link between the drug supervision and administration department and the patent administration and judicial agencies. The effective coordination between the drug supervision and management department, the patent administrative department and the people's court is of key significance to the smooth operation of the system. The basic structure of the operation of the drug patent linkage system is to clearly stipulate the obligations of the original drug research enterprise in publishing patent information and the generic drug enterprise in making patent declarations, and to determine whether there is an objection to the patent issue based on the information provided by the two. If there is no objection between the two parties, the drug will be approved for listing according to the procedure; if there is an objection, the dispute will be resolved before the drug is listed by determining whether the patent is valid and whether the generic drug falls within the scope of patent protection. Therefore, the drug patent linkage system is often referred to as the "early resolution mechanism of drug patent disputes".

Drug registration and approval is an important link to ensure drug quality and ensure the safety of human drug use. The drug registration approval system is also called the drug marketing administrative licensing system. The drug supervision and administration department examines the applications submitted by the drug marketing license applicants in accordance with the statutory marketing standards, and makes administrative licensing decisions in accordance with the law. Drug registration approval is an act of administrative empowerment, which is a legal act in which the administrative subject directly gives a specific administrative counterpart the legal qualification to engage in drug production and sales. The patent system is a legal monopoly granted by the state to the patentee for a limited period of time through the administrative power of the government for the purpose of encouraging innovation and promoting scientific and technological and social progress. Patent right is created by the legal system and granted by the administrative organ, but it still belongs to the category of private right in essence, and it is a property right with the nature of private right. From the aspects of system form, system purpose, system category and system operation mechanism, there is no inevitable connection between drug patent protection and drug marketing administrative license. However, based on the identity of protection and management objects, there is a certain connection between drug patent protection and drug registration approval. The reason why the drug marketing administrative license and drug patent protection should be linked is determined by the particularity of the drug itself. Based on the particularity of drugs, they are subject to administrative supervision and patent protection. The protection of drug patent rights and the administrative license for drug marketing belong to different fields and are under the management of different administrative departments, and the nature and responsibilities of the two departments are also different. From the perspective of external manifestations, there is no inevitable connection and cross-relationship between the two, and they operate under the framework of their respective institutional systems. However, the independent operation of the two systems will inevitably lead to conflicts between legal norms and interests. In order to overcome the shortcomings of the system caused by the independent operation of the two systems, make up for the defects of the system and reconcile the relevant conflicts of interest, it is necessary to consider the connection between the administrative licensing system of drug listing and the patent protection system through the corresponding system design. The design of drug patent link system skillfully combines the two, links the function between drug patent protection and administrative examination and approval, and can solve the system defects caused by the independent operation of the two systems. The independent operation of drug patent protection and drug marketing administrative licensing system, the separation of the functions of patent examination and authorization agencies and drug registration review and approval agencies, resulting in the lack of effective cooperation and communication between various departments, drug registration information and drug patent information asymmetry situation. In this case, patent applications for drugs are often earlier than drug registration, so patent infringement often occurs in the process of drug registration. According to the operating mechanism of the system, in principle, the legal status of drug patents does not affect the drug marketing license. The drug supervision and administration department has no right and obligation to examine the patent ownership status of the drug to be applied for marketing, nor is it obliged to notify the patentee of the patent ownership status of others in the drug registration application for drug invention and the statement that the patent of others does not constitute infringement. For the suspected infringement of drug marketing registration application, if the drug supervision and administration department can not determine whether the approval of the case, it may infringe on the registration rights and interests of the drug marketing registration applicant. According to the originality and novelty of drug material basis, drug registration application can be divided into new drug (also known as original research drug or patent drug) registration application and generic drug registration application. New drug registration applications have not been proven to be safe and effective, so detailed preclinical research data and clinical trial data are required to prove that the new drug meets the safety and effectiveness requirements. The application for generic drug registration is the imitation and imitation of new drugs. The safety and effectiveness of new drugs have been proved, so only bioequivalence test data need to be submitted. Under normal circumstances, only after the expiration of the effective patent protection period of the original research drug can the generic drug enterprise implement the new drug patent of the original research drug enterprise. Unlike the production and marketing of general products, the production and marketing of drugs need to go through a strict review process. Drug registration review and approval mainly carries out drug technical review to evaluate the safety and effectiveness of drugs, but not legal review. The legal status of the patent of the drug to be applied for listing does not affect the approval and marketing of the drug, and generic pharmaceutical enterprises take advantage of the shortcomings of this system to manufacture, sell and promise to sell patented drugs during the patent protection period of the original research drug, infringing the patent rights of the original research drug enterprises. In order to promote the timely listing of generic drugs, all countries have provided exceptions for patent infringement in their patent laws, providing a "safe harbor" for generic drug companies to exempt from infringement ". According to this, the original research drug company cannot initiate litigation procedures on the grounds that the registration of generic drugs infringes its patent rights, and can only seek judicial relief after the generic drugs are listed. At this time, it has caused irreparable losses to the original research drug's exclusive market interests. The act of drug listing registration declaration does not belong to the act of infringement of patent right, and the people's court usually does not make a determination on whether the declared generic drug falls into the scope of drug patent protection. However, drug marketing approval does not need to examine whether there is infringement of drugs, resulting in a large number of patent infringement of drugs on the market, a serious infringement of the legitimate interests of the original research drug pharmaceutical enterprises. At the same time, in the case of patent infringement, approved drugs will face the risk of stopping the production, manufacture and sale of infringing drugs, destroying the inventory of infringing drugs and huge compensation, which wastes social resources and increases social costs. Therefore, a system design is needed to protect the legitimate interests of the original drug research enterprises, provide pre-market rights relief channels for the original drug research enterprises, and prevent and stop the occurrence of patent infringement in the drug registration approval process. The main function of the drug patent linkage system is to provide a way to resolve patent disputes before the approval of generic drugs, and to improve the predictability and certainty of the listing of generic drugs.

From the perspective of the Constitution, private property rights, as the basic rights of citizens, are protected by the Constitution, and any administrative organ should respect citizens' legitimate private property rights in accordance with the Constitution, and the exercise of public power shall not infringe upon citizens' legitimate private property rights. The drug patent link system meets the requirements of the constitution to protect private property rights, provides effective remedies when property rights are violated, and provides institutional guarantees for the realization of property value. Administrative license is a kind of beneficial administrative act, which is a kind of right or qualification granted by the licensing authority to the applicant. Whether or not to grant administrative license is related to the interests of the applicant, interested parties, the public and other subjects. The value orientation of administrative licensing is to protect the basic rights of citizens as the core, while taking into account the convenience of administrative management and improving administrative efficiency. One of the basic functions of administrative licensing is to protect citizens' personal and property safety and public interests. The administrative counterpart (the applicant) obtains the license, exercises the licensed rights, and obtains the relevant benefits. Such interests are likely to infringe upon the legitimate rights and interests of others, so it is necessary to go through strict procedural examination and grant relief procedures to interested parties before approval, such as setting up a hearing system in administrative licensing procedures. In the administrative license review procedure, in addition to examining the applicant's subject qualification (right ability and behavior ability), whether the application conforms to the legal procedure and form, and whether it conforms to the relevant conditions stipulated by laws and regulations, the licensing authority shall also examine whether it infringes upon the public interest or the interests of interested parties. When examining an application for administrative license, the licensing authority shall inform the interested parties if it finds that the administrative license matters are directly related to the vital interests of others. The applicant and the interested parties shall have the right to state and defend themselves, and the licensing authority shall guarantee the right of the interested parties to express their opinions. As the statutory administrative licensing authority for drug marketing, the pharmaceutical supervisory and administrative department shall follow the basic principles and systems of the general procedures for administrative licensing. In the application procedure of drug marketing license, if the generic drug applied by the generic drug applicant involves a valid patent, the issuance of the marketing license by the drug regulatory department will have an adverse impact on the patentee of the new drug. The act of issuing a license to infringe on the patent right of others by the pharmaceutical supervision and administration department violates the basic spirit of the Constitution's provisions on property rights. Therefore, the drug supervision and administration department has the obligation and responsibility to ensure that the drugs issued with the marketing license do not infringe the patent rights of others, and provide sufficient time and relief opportunities for the patentee or interested parties to safeguard their rights. From the perspective of the division of functions of state agencies, the drug supervision and administration department does not have the functions, technology, personnel, professional knowledge and experience to review the validity of patent rights and judge whether it is infringing or not. It is not reasonable for it to preside over the hearing procedure to judge whether the generic drug to be applied for listing infringes the patent rights of others. From the point of view of economic benefit and efficiency, the examination and judgment of patent infringement is time-consuming and laborious, and it is not enough to be examined and judged by the drug supervision and administration department. From the point of view of right relief, patent right is the right granted by the patent administrative department, but it still belongs to the category of private right in essence, whether the infringement should be solved by the right holder through administrative or judicial channels. The drug patent linkage system can be regarded as an alternative procedure to the hearing procedure, and the patent right holder or interested party of the drug to be listed shall resolve the patent right dispute through administrative or judicial channels in the drug approval process. The advantages of this approach are: first, it is conducive to ensuring the registration rights and interests of drug registration applicants; second, it is conducive to ensuring that the drug marketing license issued does not infringe upon the legitimate rights and interests of new drug patentees; third, it is conducive to improving the efficiency of drug examination and approval by drug supervision and administration departments; fourth, it is helpful to prevent the risk of patent infringement in the listing of generic drugs.

Development Status of Chinese Pharmaceutical Industry in (I)

In January 2020, China and the United States signed an intergovernmental economic and trade agreement, in which Articles 1.11 and 1.12 of Section III, "Drug-related intellectual property rights", became the direct impetus for the early resolution mechanism of drug patent disputes in China. From a deeper level analysis, the fundamental reason for promoting the establishment of this mechanism is that the stable and rapid development of my country's pharmaceutical industry, the health needs of the people, and the adjustment of industry policies have put forward higher requirements and new challenges to the drug patent protection policy.

From 2016 to 2020, the number of applications for registration of domestic chemical innovative drugs in China has increased from 77 varieties to 258, and the number of varieties approved for clinical trials has increased from 91 to 298, showing a trend of rapid growth (see Figure 4 and Figure 5); since 2018, the number of class 1 chemical innovative drugs approved by China has also begun to grow explosively (see Figure 6). It is foreseeable that a considerable number of domestic innovative drugs will be approved for marketing in the next few years, and the need to strengthen domestic drug patent protection is becoming more and more urgent.

Although the innovation ability of China's pharmaceutical industry has made great progress in recent years, there is still a significant gap compared with the world's advanced level. According to statistics, among the 840 small molecule chemical drugs approved in the world from 2005 to 2020, only 6% of the new drugs were approved for the first time in China, and only about 40% of the original drugs were registered and imported in China. At this stage, the innovative drugs approved for listing in China every year are still mainly imported drugs, and there are only a handful of domestic innovative drugs. The number of generic drug applications (ANDAs) accepted by the National Drug Administration's Drug Review Center each year is much larger than the number of new drug applications (NDAs) (see Figure 7).

Therefore, although the overall innovation level of my country's medicine is steadily improving, it still belongs to and will belong to a large generic drug production country for a long time. How to encourage innovation while promoting the development of generic drugs is a huge challenge facing my country's pharmaceutical patent protection; in addition, my country's pharmaceutical market The development space is vast and the potential is huge, and it is urgent to build a pharmaceutical patent protection system that matches the future large-scale and complete drug R & D and production level; the accelerated adjustment of pharmaceutical industry policies has accelerated the survival of the fittest and transformation and upgrading of the whole industry. There is an urgent need for matching high-value intellectual property protection policies. At the same time, with the increasingly close relationship between patent protection and the development of the pharmaceutical industry, the objective demand for rapid and efficient settlement of drug patent disputes is becoming stronger and stronger. It can be seen that it is the development status and practical needs of the pharmaceutical industry that determine the early resolution mechanism of drug patent disputes with national characteristics suitable for our country.

(II) the development of drug patent linkage system in China

In October 2017, the General Office of the Central Committee of the Communist Party of China 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 Drugs and Medical Devices", requesting to explore the establishment of a drug patent link system. In November 2019, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the Opinions on Strengthening the Protection of Intellectual Property Rights, which once again proposed to explore the establishment of a drug patent link system. In March 2020, the linked judicial interpretation of drug patents was included in the Supreme People's Court's 2020 Judicial Interpretation Project.

In October 2020, the Patent Law was amended for the fourth time, adding Article 76 and setting up an early resolution mechanism for drug patent disputes, which is commonly referred to as the drug patent linkage system. This clause innovatively writes the link between the three departments of the Food and Drug Administration, the Intellectual Property Office and the People's Court on drug administrative approval and patent protection into the law, and establishes the key to China's drug patent link system-the early stage of drug patent disputes Resolution mechanism. This clause makes it clear that in the process of drug marketing review and approval, the parties can put forward the appeal of early settlement of drug-related patent disputes. As far as the original research pharmaceutical companies are concerned, they can "justifiable" to the people's court as soon as possible, or request the State Intellectual Property Office to make an administrative ruling, instead of the status quo mentioned above, they must wait until generic drugs have been manufactured, marketed, etc. After the substantive behavior can be sued for infringement. As one of the parties, generic drug companies can also file a "confirmation of non-infringement" litigation request or administrative ruling request to the people's court and the State Intellectual Property Office, so as to clarify the infringement risk of generic drugs as soon as possible. In addition, the provision also stipulates that the FDA "may" rather than "must" make a decision on whether to suspend the approval of the listing of relevant drugs in accordance with the effective judgment of the people's court. In other words, it is clear to judge whether the drug applied for approval falls into the scope of patent protection, which is not directly related to the administrative examination and approval of the drug. Combined with supporting policies, this clause makes it clear that the administrative examination and approval of drugs mainly considers the safety and effectiveness of drugs technically, and the judgment of patent infringement is two parallel but independent procedures.

In order to cooperate with the implementation of Article 76 of the Patent Law, the Civil Division of the Supreme People's Court drafted the Provisions on Several Issues Concerning the Application of Law in Civil Cases of Patent Disputes Related to Drugs Applied for Registration (hereinafter referred to as the "Provisions"). From October 29 to December 14, 2020, it publicly solicited opinions from the public, and successively solicited opinions from relevant central departments, the national court system, relevant industry associations, and social organizations. At the same time, in order to match the specific convergence measures of the relevant administrative departments of the State Council on the settlement of patent disputes in the stage of drug marketing license examination and approval and drug marketing license application, as mentioned in the third paragraph of Article 76 of the Patent Law, the formulation of judicial interpretation of drug patent links and the drafting of the above-mentioned specific convergence measures are promoted as a whole. On May 24, 2021, the 1839th meeting of the Judicial Committee of the Supreme People's Court deliberated and adopted the Provisions. On July 4, 2021, the State Food and Drug Administration and the State Intellectual Property Office issued the Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes (Trial) (hereinafter referred to as the "Implementation Measures"), which is Article 76, paragraph 3, of the Patent Law The specific convergence measures mentioned above will take effect on the same day. On July 5, 2021, the Supreme People's Court issued the Regulations, and the State Intellectual Property Office issued the Administrative Adjudication Measures for the Early Resolution Mechanism of Drug Patent Disputes (hereinafter referred to as the "Adjudication Measures"), that is, Article 76 of the Patent Law The administrative links referred to in paragraph 2 will take effect on the same day. Since then, my country has initially established a drug patent linking system under the guidance of Article 76 of the Patent Law and the "Regulations", "Implementation Measures" and "Adjudication Measures" as supporting facilities.

China's drug patent linkage system draws lessons from the mature practice of the U.S. drug patent linkage system. The main contents include: platform construction and information disclosure system, generic drug patent declaration system, judicial linkage and administrative linkage system, approval waiting period system, drug review and approval classification processing system, first generic drug market exclusive period system (patent challenge), etc.

(I) platform construction and information disclosure system

China's listed drug patent information registration platform corresponds to the drug orange book (Orange Book) of the U.S. drug patent link system, which is the key connection point to realize the drug listing approval process and the drug patent dispute resolution process. The applicant for drug listing needs to register the core patent information of the declared drug on the platform when applying, which is used as the basis for the generic drug applicant to provide the patent ownership status declaration. If the patentee is lazy in exercising his rights and does not register the patent information on the platform, the drug patent link system (early resolution mechanism for drug patent disputes) cannot be applied.

Article 4 of the implementation measures stipulates that the drug marketing license holder shall, within 30 days after obtaining the drug registration certificate, register the drug name, dosage form, specification, marketing license holder, relevant patent number, patent name, patentee, patent licensee, patent authorization date and expiration date of protection period, patent status, patent type, corresponding relationship between drug and relevant patent claims, correspondence address, contact person, contact information, etc. If the relevant information changes, the drug marketing authorization holder shall complete the update within 30 days after the information change takes effect. The drug marketing authorization holder shall be responsible for the authenticity, accuracy and completeness of the relevant information registered by it, and shall promptly verify and handle the relevant objections received and record them. The registration information shall be consistent with the relevant information in the patent register, patent bulletin and drug registration certificate, the patent right for medical use shall be consistent with the indications or functional indications of the approved drug instructions, and the scope of relevant patent protection shall cover the corresponding technical scheme of the approved drug. The relevant information modification shall be explained and made public.

The specific drug patents that can be registered in the patent information registration platform for listed drugs in China include: patents for active ingredient compounds of chemicals (excluding bulk drugs), patents for pharmaceutical compositions containing active ingredients, and patents for medical use; patents for traditional Chinese medicine compositions, patents for traditional Chinese medicine extracts, and patents for medical use; patents for the sequence structure of active ingredients of biological products, and patents for medical use. Related patents do not include intermediates, metabolites, crystal forms, preparation methods, detection methods and other patents.

If, in the process of drug marketing review and approval, the patentee or interested party files a lawsuit with the people's court on the basis of the claim, which does not belong to the above-mentioned type of patent that can be registered on the platform, the people's court shall not accept it; if it has already accepted it, it shall rule to reject the lawsuit.

(II) patent declaration system for generic drugs

When submitting an application for drug marketing license, an applicant for a chemical generic drug, an applicant for a drug with the same name and the same prescription of a traditional Chinese medicine, and an applicant for a biosimilar drug shall make a statement on each relevant drug patent of the generic drug against the patent information published on the drug patent information registration platform in China. The statements fall into four categories:

Class I statement: there is no patent information related to generic drugs in the patent information registration platform of listed drugs in China;

Class II statement: the patent rights related to generic drugs included in the Chinese listed drug patent information registration platform have been terminated or declared invalid, or the generic drug applicant has obtained the patent owner's relevant patent implementation license;

Three types of statements: China's listed drug patent information registration platform contains the generic drug-related patents, generic drug applicants promise that the generic drug applied for will not be listed before the expiration of the corresponding patent right;

Four types of statements: The patent rights related to generic drugs included in the patent information registration platform for listed drugs in China shall be declared invalid, or the generic drugs shall not fall within the scope of protection of the relevant patent rights.

Within 10 working days after the generic drug application is accepted, the generic drug applicant shall notify the listing license holder of the corresponding statement and the basis for the statement. Among them, if the declaration does not fall within the scope of protection of the relevant patent right, the basis of the declaration shall include the comparison table of the relevant claims of the generic drug technical scheme and the relevant patent and the relevant technical data. In addition to paper materials, generic drug applicants should also send the statement and the basis for the statement to the electronic E-mail registered by the listed license holder on the patent information registration platform for listed drugs in China, and keep relevant records.

(IV) judicial and administrative linkage system

If the patentee or interested party disagrees with the four types of patent declarations, he may file a lawsuit with the people's court on whether the relevant technical scheme of the drug applied for listing falls within the scope of protection of the relevant patent right or request an administrative ruling from the patent administration department of the State Council, that is, judicial channels and administrative channels. Within the prescribed time limit, the patentee may choose the route on its own. If a party chooses to request an administrative ruling from the administrative department for patent under the State Council and refuses to accept the administrative ruling and files an administrative lawsuit with the people's court, the waiting period shall not be extended. If the patentee or interested party fails to file a lawsuit or request an administrative ruling within the prescribed time limit, the generic drug applicant may file a lawsuit or request an administrative ruling in accordance with the relevant provisions to confirm that its relevant drug technical solution does not fall within the scope of relevant patent protection.

(V) waiting period system

If the patentee or interested party has any objection to the four types of patent declaration of the chemical generic drug registration application, it may, within 45 days from the date when the national drug review agency discloses the drug marketing license application, whether the relevant technical scheme of the drug applied for listing falls within the scope of patent protection to the people's court or request an administrative ruling from the patent administrative department of the State Council. If the patentee or interested party files a lawsuit or requests an administrative ruling within the prescribed time limit, it shall submit a copy of the notice of filing or acceptance to the national drug review agency within 15 working days from the date of filing the case by the people's court or acceptance by the patent administrative department of the State Council, and notify the generic drug applicant. After receiving the case filed by the people's court or the copy of the notice of acceptance of the patent administrative department of the State Council, the drug regulatory department of the State Council shall set a waiting period of 9 months for the application for registration of chemical generic drugs.

If the applicant of a chemical generic drug declares that the patent right related to the generic drug included in the patent information registration platform of China's listed drug shall be declared invalid (this is a patent challenge), if the patentee or interested party fails to file a lawsuit with the people's court or request an administrative ruling from the patent administration department of the State Council on whether the relevant technical scheme of the listed drug falls within the scope of patent protection, the waiting period shall not be initiated.

(VI) drug review and approval classification processing system

For the application for registration of a chemical generic drug that triggers the waiting period, the patentee or interested party, and the chemical generic drug applicant shall submit the relevant documents to the national drug review agency within 10 working days after receiving the judgment or decision. For applications for the registration of chemical generic drugs that have been approved through technical review, the national drug review agency shall handle them accordingly in conjunction with the effective judgment of the people's court or the administrative ruling of the patent administration department of the State Council:

If the (I) confirms that it falls within the scope of protection of the relevant patent right, the application for registration of the relevant chemical generic drug shall be transferred to the administrative examination and approval process before the expiration of the patent right;

If the (II) confirms that it does not fall within the scope of relevant patent protection or the two parties make a settlement, the relevant chemical generic drug registration application shall be transferred to the administrative examination and approval process in accordance with the procedures;

If the relevant patent right of the (III) is invalidated according to law, the application for registration of the relevant chemical generic drug shall be transferred to the administrative examination and approval process according to the procedures;

(IV) the waiting period is exceeded, the drug regulatory department under the State Council has not received the effective judgment or mediation document of the people's court, or the administrative ruling of the patent administrative department under the State Council, and the relevant chemical generic drug registration application is transferred to the administrative examination and approval process in accordance with the procedures;

(V) the pharmaceutical supervisory and administrative department of the State Council receives the effective judgment of the people's court or the administrative ruling of the patent administrative department of the State Council during the administrative examination and approval period, and confirms that it falls within the scope of protection of the relevant patent right, the relevant chemical generic drug registration application shall be submitted to the national drug review agency in accordance with the provisions of Item 1 of Paragraph 2 of this Article.

After the drug regulatory department of the State Council makes a decision to suspend the approval, if the people's court overturns the original administrative ruling, the two parties reconcile, the relevant patent right is declared invalid, and the patentee or interested party withdraws the lawsuit or administrative ruling request, the generic drug applicant You can apply to the drug regulatory department under the State Council for approval of the listing of generic drugs, and the drug regulatory department under the State Council can make a decision on whether to approve or not. (Article 9 of the Measures)

For the application for the registration of chemical generic drugs with Class I and Class II declarations, the drug regulatory department of the State Council shall make a decision on whether to approve the listing according to the conclusion of the technical review; for the application for the registration of chemical generic drugs with Class III declarations, if the technical review is passed, the decision to approve the listing shall be made, and the relevant drugs shall not be listed until the expiration of the validity period of the corresponding patent right and the market monopoly period. (Article 10 of the Implementation Measures)

(VII) first generic drug market exclusivity system (patent challenge)

According to Article 6 of the "Implementation Measures": When submitting an application for drug marketing license, a chemical generic drug applicant shall make a statement for each relevant drug patent of the generic drug against the patent information that has been disclosed on the drug patent information registration platform in China. If a chemical generic drug applicant submits a drug marketing license application, it makes four types of declarations for each relevant drug patent of the generic drug, and declares that the patent rights of the generic drug included in the Chinese listed drug patent information registration platform should be declared invalid, it constitutes a patent challenge.

In order to promote generic drugs to challenge the patents of original research drugs, the U.S. Hatch-Waxman Act stipulates that the first ANDA applicant who has passed the patent challenge and obtained the listing approval will be granted a 180-day market monopoly period. During these 180 days, FDA will not approve the listing of other generic drugs. At the same time, the bill also provides for the loss of market exclusivity by ANDA applicants, such as those who have not been listed within 75 days after passing the FDA's review, and those who have not obtained FDA's marketing authorization within 30 months from the date of application for ANDA. The drug patent link system ensures the innovation power of the original drug manufacturers in the United States, and also greatly promotes the development of generic drugs. Since the implementation of the US Hatch-Waxman Act, the drug innovation market has shifted from Europe to the United States, and has promoted the sales of original research drugs and generic drugs. As one of the earliest countries to implement the drug patent link system, the United States has formed a complete system through more than 30 years of development, and domestic pharmaceutical companies in the United States have also established corresponding countermeasures. In the process of establishing the patent linking system in China, the experience of the United States is referred to to a certain extent, but considering the many differences in patent law between China and the United States, China's patent linking system has its own uniqueness. China gives a market exclusivity period to the first chemical generic drug that successfully challenges the patent and is the first to be approved for listing, and the FDA will no longer approve the listing of generic drugs of the same variety within 12 months from the date of approval of the drug; however, the market exclusivity period shall not exceed the patent term of the challenged drug.

For biosimilar drugs and Chinese medicine with the same name drug registration application, there is no waiting period and the first imitation drug market exclusive period. If the patentee or interested party files a lawsuit or applies for an administrative ruling within the specified time, the Food and Drug Administration will not stop the technical review; if the technical review is passed, the Food and Drug Administration will directly make a decision to approve the listing. If the people's court or the intellectual property office confirms that the relevant technical scheme falls within the scope of patent protection before the completion of the drug administrative examination and approval procedure, the FDA shall indicate that the patent can only be marketed after the expiration of the patent right when making the decision to approve the listing. The decision on drug marketing license that has been approved according to law shall not be affected by patent disputes, and the patentee or interested parties may seek relief through the relevant provisions of the Patent Law. Compared with the application procedure for the registration of chemical generic drugs, the application procedure for the registration of biosimilar drugs and Chinese medicine drugs with the same name is relatively simple. We will also pay close attention to whether the "patent dance" system for biosimilar drugs in the United States will be introduced in the future.

With the revision of the Patent Law and the introduction of the subsequent supporting system, China has established a set of drug patent linkage system with Chinese characteristics. The establishment of this system will become an important institutional innovation in the field of intellectual property protection in my country, reflecting my country's emphasis on drug patentees, drug marketing license applicants and the balance of public interests, and will also have a positive impact on the development of my country's pharmaceutical industry. The drug patent link system has set up a "bridge of hope" for the original research drug companies, generic drug companies and the public ".

Analysis on Coping Strategies of (I) Original Pharmaceutical Research Enterprises

The original research and development enterprises should first pay attention to China's listed drug patent information registration platform, the current drug patent link system has not yet clarified the "China listed drug catalog", China listed drug patent information registration platform two systems of convergence, need to pay attention to relevant supporting measures, timely registration of drugs and patent information. For the original drug research enterprises, it is necessary to do a good job in the layout of high-value patents, build a strict and efficient patent protection network, and finally form a patent portfolio that is beneficial to the enterprise. The lawsuit of the early resolution mechanism of drug patent puts forward higher requirements on the quality of the claim, and the reasonable and stable high-quality patent of the original research enterprise is the cornerstone to curb the listing of generic drugs. Establish an early warning and prevention and control mechanism, and regularly pay attention to the patent information registration platform for listed drugs in China. According to the provisions of the Implementation Measures, the national drug review agency shall disclose the application information and corresponding statement to the public on the information platform; the generic drug applicant shall notify the listing license holder of the corresponding statement and the basis of the statement, and the listing license holder is not If the patentee, the listing license holder shall notify the patentee. Where the statement does not fall within the scope of protection of the relevant patent right, the basis of the statement shall include the comparison table of the relevant claims of the generic drug technical scheme and the relevant patent and the relevant technical data. In addition to paper materials, generic drug applicants should also send the statement and the basis for the statement to the electronic E-mail registered by the listed license holder on the patent information registration platform for listed drugs in China, and keep relevant records. Therefore, the relevant patentee or drug licensee needs to continue to pay attention to the registration platform, relevant statements and notices, and make a preliminary judgment on the infringement of the registration information on the platform. When determining the infringement of generic drugs, it is necessary to file a lawsuit and apply for administrative ruling in accordance with the early dispute resolution mechanism of drug patent disputes in a timely manner to hinder the listing of generic drugs. If the early resolution mechanism of drug patent disputes is not used in time to hinder the approval of generic drugs, the original research drug company should still actively protect its rights and carry out infringement investigation in a timely manner. If it is determined that the generic drug company has sold or promised to sell, the original research drug company should timely preserve the evidence and file a patent infringement lawsuit in the place of infringement or the place where the defendant is located.

2. Coping strategy analysis of generic drug enterprises

For generic drug companies, pre-project research is essential. Before the research and development project, make full preparation for information research and discuss whether to carry out project research work. The preliminary research should not only pay attention to the risk of patent infringement, but also carry out drug registration information, clinical information, experimental technical analysis and market analysis. Of course, the risk assessment of patent infringement is one of the most important links. Generic drug enterprises should check the current valid patents, and at the same time, they should also consider and analyze other unauthorized patents to determine whether the authorization of these patents will constitute an obstacle to the product market. Construction of patent dispute response strategies in the process of listing approval. In the process of listing and approval, if you encounter a patent lawsuit or ruling application initiated by the original research and development pharmaceutical company, you should actively respond to it. You can take the defense of existing technology, have the defense of legal circumstances that are not regarded as patent infringement, or directly invalidate the patent involved. Actively launch patent challenges, strive for the first generic drug opportunity, seize the market exclusive period. Because after the success of the generic drug patent challenge, no other chemical generic drugs of the same variety will be approved for listing within 12 months, so generic drug companies can win exclusive market for enterprises by patent challenge and obtaining the first generic drug qualification for listing.

In short, with the landing and implementation of the drug patent link system, we expect the rapid growth of drug patent disputes, but also put forward higher requirements for the patent work of enterprises. Both original drug research companies and generic drug companies need to strengthen the creation, application, management and protection of patents to better release the vitality of innovation.

my country has initially established a drug patent link system, which takes into account the different demands of original research drug companies and generic drug companies, and is committed to making people "have medicine to eat" and "can afford medicine"! Let the patent law have warmth and grounding.