[Patent Perspective] Exploring the close relationship between patents and innovative medical devices

The author recently participated in an international medical innovation forum. It was originally a learning and understanding attitude, but the accident was that the leaders of the participating companies, the officials of the Food and Drug Administration, hospital professors and scholars were discussing, patents and innovative medical devices. relationship. This makes me very happy as a patent practitioner, but I also see the lack of patent expertise in some medical device practitioners. For example, in the innovative medical device approval process, why can it be only an invention patent? In addition to obtaining invention patents, is there any other way to obtain approval for innovative medical devices? What are the patent status of companies that are currently approved by innovative medical devices? Below I will review the hot topics and the relationship between patents and innovative medical devices.

1. Why is the approval of innovative medical devices limited to invention patents?

Since March 2014, the "Innovative Medical Device Special Approval Process (Trial)" was first released. It has been more than two years. This program has become a "green channel" for the declaration of innovative medical device products for medical device companies at home and abroad. The process of simplifying the implementation of industrialization in scientific research and innovation projects, shortening the approval period, and possibly having preferential fees. From the statistics of statistics, the “innovative products” that have been approved by the registration have an average approval period of more than 8 months, and the shortest is only two months. This is enough to reflect the country's emphasis on "innovative medical devices" and "privilege."

However, according to the Food and Drug Administration, 30% of the reasons for the failure to approve innovative medical devices are due to patent issues. In the "Special Examination and Approval Procedure for Innovative Medical Devices", the first paragraph of Article 2 stipulates: (1) The applicant has the patent right for product core technology invention in China through its leading technological innovation activities, or obtains the The Chinese invention patent right or its right to use; or the application for the core technology invention patent has been published by the patent administration department under the State Council.

Here, the Food and Drug Administration has stipulated patents for inventions, but did not include utility models and design patents, mainly because utility models and designs have only undergone preliminary examination, and patents can be granted after they are passed; As a result of substantive examination, the quality of these two types of patents has been criticized. From the perspective of improving the technical level of innovative medical devices, the SFDA stipulates that applicants need to have invention patents. But is this threshold a bit too high? After all, it takes two to three years for an invention patent to go from application to authorization. It may also fail to pass the substantive examination. Therefore, the SFDA has also pointed out two other major roads.

2. In addition to obtaining invention patents, is there any other way to obtain approval for innovative medical devices?

The other two methods are also mentioned in the regulations. One is that the applicant does not have to wait until the invention is authorized. As long as the invention patent application is made public, it can be registered by means of a public notice or a substantive examination notice. The other is that in the case that some companies do not have relevant patent reserves, they can also obtain the patent or patent right of others through purchase or license. This provision also highlights the government's good intentions, not only can promote exchanges and cooperation between enterprises, but also activate the enthusiasm of university applicants who have patent rights but are unable to transform, so that more medical equipment companies can The scientific research results of the university are used.

Taking "CT (Computed Tomography)" as an example, the search in the wisdom bud global patent database shows that there are the number of invention patents or patent application rights of "computed tomography technology" in domestic universities. Not only a few, more than 6,000 colleges and universities across the country have more than 3,000 related patents, such as Tsinghua University, Xi'an Electronic Science and Technology University, Beijing University of Aeronautics and Astronautics and other well-known institutions. If there are related companies that want to carry out research and development of innovative medical device production of CT technology, it is entirely possible to select suitable cooperative universities according to the specific conditions of these universities, and jointly promote the commercialization of innovation results.

Source: Smart Bud Global Patent Database

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