Cuestiones Relacionadas con Patentes en el Proceso de Revisión Especial para Dispositivos Médicos Innovadores

Since the launch of the "Green Channel" for innovative medical devices in 2014, as of the end of December 2020, nearly 1,471 products have applied to enter the innovative channel, and 292 products have been included as innovative medical devices, accounting for approximately 20% of all applications.

As of the end of December 2020, a total of 100 innovative medical devices have been approved for market launch. This article sorts out the process of the special review procedure for innovative medical devices and the patent-related issues involved.

An increasing number of enterprises aim to apply for the special review procedure for innovative medical devices based on patents to facilitate the registration and approval of medical devices. The special review procedure for innovative medical devices offers applicants benefits such as early intervention, dedicated personnel responsibility, priority in testing, priority in system inspection, priority in review, and priority in administrative approval. Additionally, for medical devices registered through this special review procedure, the National Medical Products Administration (NMPA) shall give priority to handling applications for changes to licensing matters. Herein, we sort out the process of the special review procedure for innovative medical devices and the patent-related issues involved.

According to Article 6 of the "Regulations on the Supervision and Administration of Medical Devices" [1], the state implements classified management of medical devices based on risk levels. Class I medical devices refer to those with low risk, for which routine management can ensure their safety and effectiveness. Class II medical devices refer to those with moderate risk, for which strict control and management are required to ensure their safety and effectiveness. Class III medical devices refer to those with relatively high risk, for which special measures and strict control and management are required to ensure their safety and effectiveness. Article 13 of the Regulations stipulates that Class I medical devices shall be subject to product filing management, while Class II and Class III medical devices shall be subject to product registration management. For Class II and Class III medical devices, obtaining registration approval before market launch is an indispensable step.

To encourage the innovative development of medical devices, the "Special Approval Procedure for Innovative Medical Devices (Trial)" implemented on March 1, 2014, provided a green channel for the registration and approval of innovative medical devices. In 2018, the NMPA revised and issued the "Special Review Procedure for Innovative Medical Devices". This special review procedure applies to Class II and Class III medical devices.

Article 2 of the "Special Review Procedure for Innovative Medical Devices" [2] revised and issued in 2018 stipulates: "This procedure shall apply to the review of medical devices that meet the following conditions:

(1) The applicant, through its leading technological innovation activities, legally owns the invention patent for the core technology of the product in China, or legally obtains the invention patent or its right to use in China through assignment, and the time of applying for the special review of the innovative medical device is no more than 5 years from the date of the patent authorization announcement; or the application for the invention patent of the core technology has been published by the patent administrative department of the State Council, and the Patent Search and Consultation Center of the National Intellectual Property Administration has issued a search report stating that the core technical solution of the product has novelty and inventiveness.

(2) The applicant has completed the preliminary research on the product and has a basically finalized product, the research process is true and controlled, and the research data is complete and traceable.

(3) The main working principle or mechanism of action of the product is an innovation in China, the product performance or safety has fundamental improvements compared with similar products, the technology is at an international level, and it has significant clinical application value."

Condition (1) above includes two scenarios: one is that the invention patent has been granted. In this case, the applicant applying for the special review of the innovative medical device is required to own or obtain the invention patent or its right to use through assignment. Considering the characteristics of patents and the average R&D cycle of medical devices, the "Special Review Procedure for Innovative Medical Devices" revised and issued in 2018 specifically stipulates that the time of applying for the special review of the innovative medical device shall be no more than 5 years from the date of the patent authorization announcement; the other is that the invention patent is under application. In this case, the application for the invention patent is required to have been published, and a search report stating that the core technical solution of the product has novelty and inventiveness shall be obtained. Applicants may submit a search application to the Patent Search and Consultation Center of the National Intellectual Property Administration to obtain the search report.

It should be noted that Condition (1) only refers to invention patents or applications, and utility model patents are not applicable to this condition. Therefore, if an enterprise intends to apply for the special review of an innovative medical device based on a patent, it shall choose the invention patent application category when filing the patent application.

Applicants can apply for the special review procedure for innovative medical devices once they have completed the preliminary research on the product and have a basically finalized product, which saves time. After passing this application, applicants may choose to declare and register the innovative medical device, which will be reviewed in accordance with the special review procedure for innovative medical devices.

According to Article 8 of the "Special Review Procedure for Innovative Medical Devices", if the product's intellectual property certification documents in the application materials are incomplete or the patent right is unclear, the Innovative Medical Device Review Office will not organize experts to conduct the review. According to Article 22 of the "Special Review Procedure for Innovative Medical Devices", if all applications for invention patents of core technologies are rejected or deemed withdrawn, or the applicant applying for the special review of the innovative medical device loses the patent right or the right to use all invention patents of the core technology of the product, the NMPA may terminate the special review procedure for the innovative medical device and inform the applicant. That is to say, during the review of whether the medical device is applicable to the special review procedure for innovative medical devices and after entering the special review procedure but before obtaining approval, it is necessary to verify the status of the patent right or patent application.

In addition, it should be noted that the technical solution of the patent or patent application on which the application for the special review procedure for innovative medical devices is based must be able to support the core technology of the medical device product. Specifically, for granted patents, the judgment is based on the granted claims; for pending invention patent applications, the judgment is based on the claims that have novelty and inventiveness. This suggests that during the patent application stage, it is necessary to reasonably layout the claims so that they can cover the core technology of the medical device to be registered and approved. During the review stage of the patent application, attention should also be paid to whether the claims expected to be granted can cover the core technology of the medical device to be registered and approved.

After receiving the application for the special review of an innovative medical device, the Innovative Medical Device Review Office shall issue review opinions within 60 working days (excluding the time for public announcement and objection handling). After review by the Innovative Medical Device Review Office, for applications to be subject to special review, the applicant and product name shall be publicly announced on the website of the Center for Medical Device Evaluation (CMDE) for no less than 10 working days. Within 5 years after the review result is notified, the applicant may declare and register the innovative medical device, which will be reviewed in accordance with the special review procedure for innovative medical devices.