The medical device industry in China has entered a rapid development period. From 2017 to 2022, the market scale of the medical device industry in China has been continuously increased from 440.3 million yuan to 957.3 million yuan. In 2023, the market scale is expected to reach 1056.4 million yuan, and the industry development will take a new step. In spite of the fast development, the middle to low-end market still occupies a larger proportion, and the innovation level of the high-end market is somewhat low. In order to encourage the research and innovation of medical device, promote the popularization and application of new technologies of the medical device and promote the development of the medical device industry, National Medical Products Administration (former China Food and Drug Administration, (CFDA) ) formulates and issues a plurality of procedures to promote the healthy, rapid and high-quality development of the domestic medical device, wherein the Special Approval Procedure on China’s Innovative Medical Device issued in February 07, 2014 is an important measure proposed for promoting the innovative development of the medical device.
I. Brief introduction of accelerated approval procedure of medical device
An objective of the Special Approval Procedure on Innovative Medical Device is to accelerate the approval process of highly innovative medical device. Before a detailed introduction thereof, we will draw an overview of the current accelerated approval ways for the registration of a domestic medical device:
1. The Emergency Approval Procedure on medical device
The Emergency Approval Procedure was issued in August 2009. The core purpose of the procedure is to effectively prevent, control and eliminate the harm of public health emergency in time, and to ensure that the medical device required for the public health emergency are approved as soon as possible. It endows CFDA with the right to determine the time for starting and stopping the procedure according to the situations and the changes of the public health emergency. The procedure is suitable for approval of domestic third-class medical device, imported second-class and third-class medical device. It is required that no similar domestic products are on the market or the product supply cannot meet the emergency treatment requirement of public health emergency although the domestic products are on the market. The detection products of a plurality of companies in the novel coronavirus epidemic situation were registered within a few days through this procedure.
2. The Priority Approval Procedure on Medical Device
The Priority Approval Procedure on Medical Device was issued in January 2017 to accelerate the approval of the corresponding medical device meeting the conditions. A priority approval channel is separately arranged for the medical device.
The requirements for the Priority Approval Procedure on Medical Device are as follows:
(I) a medical device matching to one of the following conditions:
a) diagnosing or treating rare diseases and having obvious clinical advantages;
b) diagnosing or treating malignant tumor, and having obvious clinical advantages;
c) diagnosing or treating the unique and multiple diseases of the old, and no effective diagnosis or treatment means exists at present;
d) specially being used for children and having obvious clinical advantages;
e) the clinical application is urgently needed, and no medical device of the same variety has been approved and registered in China;
(II) listed in the Major National Science and Technology Projects or the National Key R&D Program of China;
(III) other medical devices which should be preferentially approved.
To apply the Priority Approval Procedure on Medical Device, the applicant should submit the medical device priority application form together with the registration application. In addition, the registered application items that have been approved according to the Emergency Approval Procedure on Medical Device are not subjected or applicable to the Priority Approval Procedure on Medical Device any more.
3. The Guidelines for Conditional Approval Marketing on Medical Device
The Guidelines for Conditional Approval Marketing on Medical Device was issued in December 2019, and initially constructed a framework for approving medical device for diseases which are seriously life-threatening and have no effective treatment means. For Conditional Marketing Approval, the medical device registrant should complete the requirements of the incidental conditions of marketing approval specified in the remark column of the medical device registration certificate within the specified time limit, and the validity period of the conditional approval medical device registration certificate coincides with the time limit of the incidental conditions specified by the registration certificate. In addition, Conditional Approval Marketing Procedure is not in conflict with other acceleration ways, e.g., the regulations in Guangdong province for the prevention and control of new coronaviruses make it clear that Emergency Approval Procedure can be used in tandem with Conditional Approval Marketing Procedure.
4. The Special Approval Procedure on Innovative Medical Device
The Special Approval Procedure on Innovative Medical Device was issued in February 2014, the core of this procedure is to encourage research and innovation of medical device, to promote the popularization and application of new medical device technologies, and to promote the development of the medical device industry. Thus, compared with the other three procedures, the Special Approval Procedure pays more attention to quantitative indexes of innovation, and only the medical device meeting the following requirements is applicable to the program: (I) patent support; (II), finalized product; and (III) product innovation.
Compared with the other three procedures, one great characteristic of the Special Approval Procedure is that the importance of intellectual property in the medical device registration application is firstly emphasized and is put into a very important position of the innovation index. The Special Approval Procedure aims at the medical device with the conditions of the core technical invention patents, international leadership, domestic initiatives, remarkable clinical application value and the like.
II. Introduction of the Special Approval Procedure on Innovative Medical Device
The Special Approval Procedure on Innovative Medical Device is the first approval way specially set for innovative medical device in China. It aims to accelerate the approval speed of the innovative medical device on the premise of ensuring the safety and effectiveness of medical device on the market.
The medical device technical evaluation center of CFDA has an innovative medical device approval office. Related experts may be organized to examine the application of the Special Approval Procedure.
The advantages of the Special Approval Procedure for the accelerated approval of medical device are as follows:
1. The medical device detection mechanism should preferentially perform medical device registration detection after receiving the sample and issue a detection report;
2. The medical device technical evaluation center of CFDA shall preferentially perform the technical evaluation for the medical device of which the application of the Special Approval Procedure has been accepted; after the technical evaluation is finished, CFDA should preferentially perform administrative approval after the technical evaluation;
3. The local food and drug administration department of the applicant shall designate a specially-assigned person and provide guidance in time. After receiving the application of checking (examining) the quality management system of the applicant, the quality management system should be handled preferentially.
The basic flow of the application of the Special Approval Procedure is shown as below:
As can be seen from the above flowchart, taking the application of domestic innovative device as an example, the provincial food and drug regulatory department completed the preliminary examination in 20 workdays; Subsequently, the CFDA must issue the review comments within 40 workdays. From the submission of the application to the approval of the CFDA, it only takes up to 60 workdays, and after that, the shortest publicity period of 10 workdays can be entered. Overall, it takes about 15 weeks from application to registration.
Of course, one premise of the great acceleration of approval time is that the procedure has very strict requirements on innovation. The Special Approval Procedure was issued in March 2014, the CFDA further revised the procedure in November 2018 introducing more strict requirements on intellectual property: the application date of the procedure should be no more than 5 years from the date of announcement of grant of the corresponding patent right; the patent shall accompany a search report made by the Search and Consultation Center of China National Intellectual Property Administration (CNIPA), which should state that the core technical solution of the product possesses novelty and inventiveness.
Statistically, the passing rate of such application is only about 23%. The reason of the low passing rate is that the patents themselves or submitted patent data do not meet corresponding regulations. This also could verify the extremely high requirements on patents and innovation in the Special Approval Procedure.
According to the provisions of the Special Approval Procedure, only the medical device conforming to the following conditions is applicable to the procedure:
(I) The applicant has the patent right of the core technology of the product through the leading technical innovation activity in China, or obtains the patent right of the invention or the use right thereof through assignment, and the application date of the procedure should be no more than 5 years from the date of announcement of grant of patent right; or the patent application of the core technology is disclosed by the Patent Administration Department of the State Council, and a search report should be issued by the Search and Consultation Center of China National Intellectual Property Administration (CNIPA) which should state that core technical solution of the product has novelty, inventiveness and the like.
(II) The applicant has already completed the preliminary research of the product and has basic fixed products, real and controlled research process and complete and traceable research data.
(III) The main working principle or action mechanism of the product is domestic initiative or pioneer, the product performance or safety is fundamentally improved compared with similar products, the technology is at the international leading level, and the product has obvious clinical application value.
The first of these requirements clearly stipulates the importance of intellectual property, and then CFDA issued “Guidelines for Preparation of Application Materials for the Special Approval Procedure on China’s Innovative Medical Devices” in August 2018, in which the requirements for intellectual property are further enforced and refined.
(III) Intellectual property condition and certificate of product
1. The description of the intellectual property of the core technology of the product should be provided. If there are several invention patents, it is recommended to display the title, patentee, patent status and so on of the invention patents in a list.
2. The supporting documents of relevant intellectual property should be provided
(1) Where the applicant has obtained the Chinese patent right for invention, he/she shall provide a copy of the patent authorization certificate signed and sealed by the applicant, the claims, the specifications, and the original copy of the patent register issued by the patent authority. The application date for the Special Approval Procedure of innovative medical devices shall not exceed 5 years from the date of announcement of grant of patent right.
(2) Where the applicant obtains the use right of an invention patent in China through assignment in accordance with the law, in addition to a copy of the patent authorization certificate, the claims, the specifications, and the original copy of the patent register held by the patentee, the applicant shall also provide the original Record of License Contract for Patent Exploitation issued by the patent authority. The application date for the Special Approval Procedure of innovative medical devices shall not exceed 5 years from the date of announcement of grant of patent right.
(3) Where the invention patent application has been published by the patent administration department under the State Council but has not been granted, a copy of the documents certifying that the invention patent has been published (such as Notification of Publication of the Application for Invention, Notification of Publication and Entering the Substantive Examination Procedure of the Application for Invention, Notification of Entering the Substantive Examination Procedure of the Application for Invention, etc.) signed and sealed by the applicant, and a copy of the published version of the claims and specifications shall be provided. A search report should be issued by the Patent Search and Consulting Center of the State Intellectual Property Office, which indicates that the product’s core technical solution is novel and inventive. In the process of examination, where the claims and the specifications are amended at the request of the patent examination department, the amended version shall be submitted; Where the patentee is changed, the supporting documents issued by the patent authority, such as a copy of the Notification of Passing the Examination on Formalities, shall be submitted.
The details of the intellectual property related matters in the above stipulations will be analyzed and discussed later herein.
III. IP issues in the Special Approval Procedure on Innovative Medical Device
1. Only the invention patent in China is applicable to the Special Approval Procedure.
In the Special Approval Procedure, the aim of the invention patent is not only to prove the innovativeness of the registered products, but also is a legal document for guaranteeing the independent intellectual property of the enterprise’s products, and is the basis for protecting the intellectual property of the innovative medical device. The patent protection itself is regional, and the patent protection granted in a country or a region is valid only in the scope of that country or region, and is invalid and not confirmed in other countries or regions. Thus, for example, U.S. patents or PCT patents that do not enter China are not applicable to the Special Approval Procedure because they can not provide legal support and protection for the innovative medical device in China. For Chinese patents, in addition to patents directly filed in China, patents entering China through PCT or Paris Convention are also included.
The Chinese patent includes three types: invention patent, utility model patent and design patent. Only the invention patent in the above three types meets the requirements of Special Approval Procedure. According to Chinese legal practice, the invention patent requires substantial examination, which requires prominent substantial features and notable progress with respect to the prior art, while the utility model patent only performs formal examination, and it only requires substantial features and progress with respect to the prior art, so that its innovativeness is lower than that of the invention patent and is not verified. The design patent is different from the invention patent and the utility model patent both, it only protects the shape, pattern, color or combination thereof of the product, belongs to the protection of the external visual effect of the product, and is not directed to the technical improvement of the product. Thus, the design patent can not be used for proving the novelty of the product.
2. The invention patent is not limited to a granted patent, a patent application can also be used for applying for Special Approval Procedure.
The patent application must be published, and a search report issued by the Search and Consultation Center of China National Intellectual Property Administration (CNIPA) which states that core technical solution of the product has novelty, inventiveness and the like should be provided.
Regarding the department which issues the search reports, the “Special Approval Procedure on Innovative Medical Device (revision manuscript)” published in November 2018 further strictly limits it to the Search and Consultation Center of China National Intellectual Property Administration (CNIPA) from the original information search institution in China or patent search institution, improves the authority of search reports, requires that the patent application should be high-quality patent application, and further improves the threshold of Special Approval Procedure.
Generally, the application of Special Approval Procedure based on the granted patent is a relatively conventional strategy, and the window period given to the applicant by this strategy is relatively long, no more than 5 years from the date of announcement of grant of patent right, and the applicant has enough time to evaluate the application and to prepare the corresponding file.
However, some companies may have other considerations (such as seizing the market) and need to make an application as soon as possible, while the time between publication and authorization of domestic patents may vary from 2 to 5 years. The patent examination period is too long for the companies that need to seize the market. Thus the companies need to choose to make an application for the Special Approval Procedure based on the published but yet unpatented patents, and at this time application time needs to be carefully considered. In this situation, the company may directly request a search report after the patent is published. The search report normally could be obtained within 1-2 months. The innovative medical device application can be directly filed after the search report with positive opinions is obtained. Generally, after the publication of the patent, the examination will enter into the substantial examination stage, and it will normally take several months (usually more than 2-3 months) from entering into the substantial examination stage to receiving the first Office Action. One reason for rapidly proposing the innovative medical device application immediately after receiving the search report is that according to the Chinese legal practice, the novelty/inventiveness of the invention patent will normally be challenged in the first Office Action, the possible negative opinions of the first Office Action may still have certain negative impact on the judgment of related experts of Special Approval Procedure. Even if the applicant makes a cogent argument, it will take further several months to reconsider the novelty/inventiveness.In case of amending the claims, the applicant will also need to submit the amended claims which increased the workload of the applicant. Since the approval cycle of Special Approval Procedure is usually 2 to 3 months, if an application is made immediately after a search report with positive opinions, it may avoid the issuance of the first Office Action, the passing probability may be increased.
3. The patentee(s) need to be fully in line with the applicant(s) for the Special Approval Procedure.
For example, in the case of an initial company or some person becomes the shareholder through the patent transfer, sometimes the patent right is not under the company’s name but under the name of a company originator, an enterprise legal person, or a technical developer. In this situation, the assignment of the patent right must be completed first as it is not acceptable to submit only a shareholding certification, an employee in-service certification, or the like. In addition to patents derived from independent development, patents derived from assignments are also in compliance with the provisions of Special Approval Procedure, the assignment includes transfer and license, which in turn includes exclusive license, sole license, simple license, sub-license, and cross-license. Currently the Special Approval Procedure do not limit the assignment way, but generally transfer and exclusive license are preferred.
4. The patent documents provided by the applicant to the corresponding department of food and drug administration should be a complete set of documents.
Specifically, 1. for the granted patent, copies of the patent certification, claims and specification, and an original copy of the patent register are required; 2. for the patents obtained by assignment, in addition to the above-mentioned documents, the original of Record of License Contract for Patent Exploitation is required; 3. for published and un-patented patents, patent publications, claims, descriptions, and search reports are required. Therefore, unlike communications with the patent office, which sometimes only provides the patent application number, the officials in the corresponding department of food and drug administration which are responsible for the examination may not be familiar with patent searching and the downloading of corresponding documents, a complete set of documents could reduce the workload of the officials
5. The quality of the patent and the association between the patent and the medical device are more important than the number of patents.
The Special Approval Procedure emphasizes the invention patents which could reflect the product's core technology. The most concerning matters are whether the product has the invention patent and whether the invention patent is the core technology of the product. Therefore, for the application of the Special Approval Procedure, there is no need to list all invention patents of the company, only the core invention patents fully related to the product are suggested. Otherwise, too many irrelevant patents may be distracting, and dilute the innovation point of the product. In addition, the quality requirement for the invention patent is very high. It required that the core technology described in the invention patent should be used for the first time in domestic products in China, and the performance of the products is remarkably improved due to the use of the core technology.
Compared with other industries, the medical device industry is characterized by complex technology, long research and development period, great importance to the protection of intellectual property, frequent lawsuits, and the like. The importance of intellectual property protection in the medical device industry is further emphasized by the Special Approval Procedure. The medical device industry in China is undergoing vigorous development at present, and the initiative of actively embracing intellectual property protection is obviously beneficial to companies under the condition that the current national policy increasingly supports intellectual property protection, in terms of not only accelerating approval, but also improving market share, protecting products, avoiding lawsuits and the like.