*AI-generated translation, for reference only.

[Keywords] Administrative, Patent administrative case, Novelty, Inventive step, Medical device product, Use feature

Case Facts

Mei [REDACTED] (USA) Company is the patentee of the invention patent with patent number 20131047****.X, titled "Removable Combined Thrombus Device Mass" (hereinafter referred to as "the patent"). Claim 1 of the patent is: "1. A self-expanding device for removing a thrombus from a blood vessel (hereinafter referred to as Feature A), the self-expanding device comprising: a first set of mesh structures of multiple grids, the mesh structure having a proximal end and a distal end, wherein the distal end of the mesh structure is configured to be implanted in at least a portion of the thrombus, thereby forming a combined thrombus device mass that is removable from the occlusion site of the patient (hereinafter referred to as Feature B); a second set of tapered portions of multiple grids, the tapered portions being arranged towards the proximal end of the mesh structure; and a connection point, the tapered portions converging at the connection point, the connection point being located at the proximal end of the tapered portions, wherein the self-expanding device is preformed to assume a volume-expanded form and, in the volume-expanded form, the self-expanding device takes the form of a longitudinally open tube tapering towards the connection point."

On April 20, 2021, June 4, 2021, and July 14, 2021, Xin [REDACTED] Company and Ni [REDACTED] Company respectively filed requests for invalidation of the patent right. Xin [REDACTED] Company provided the following main evidence: Evidence 1.1: US Patent No. US73004**** and its Chinese translation, which discloses a medical implant having a collapsible matrix structure.

On May 11, 2022, the China National Intellectual Property Administration made the Invalidation Request Review Decision No. 55824 (hereinafter referred to as the challenged decision), holding that the claims of the patent lacked utility, novelty, and inventive step, and declared the entire patent right invalid. Dissatisfied, Mei [REDACTED] (USA) Company filed a lawsuit with the Beijing Intellectual Property Court, requesting the revocation of the challenged decision and an order for the China National Intellectual Property Administration to make a new decision.

The Beijing Intellectual Property Court rendered the administrative judgment (2022) Jing 73 Xing Chu No. 13741 on March 29, 2023, dismissing the claims of Mei [REDACTED] (USA) Company. Dissatisfied, Mei [REDACTED] (USA) Company appealed. The Supreme People's Court rendered the administrative judgment (2023) SPC IP Admin. Final 475 on July 25, 2024, dismissing the appeal and upholding the original judgment.

Judge's Opinion

The focus of the dispute in this case is whether Claim 1 of the patent possesses novelty.

I. Regarding the Influence of Feature A in Claim 1 on the Assessment of Novelty

For a product claim whose subject matter contains a use limitation, the use limitation should be taken into consideration when determining the scope of protection of the product claim. However, its actual limiting effect depends on the impact it has on the claimed product itself. If the use limitation has no impact on the claimed product or device itself, but merely describes the use or method of use of the product or device, it generally cannot play a substantive role in the assessment of whether the product or device possesses novelty, for example.

In this case, Feature A of Claim 1 is the subject matter of the claim, "A self-expanding device for removing a thrombus from a blood vessel," which includes a use limitation. Therefore, in the assessment of novelty and inventive step, consideration should be given to the impact of this use limitation on the claimed product itself. In the first instance, Mei [REDACTED] (USA) Company argued that this use limitation implied structural differences, including differences in the mesh structure, connection point structure, tensile strength, connection mechanism, working configuration, and physical property requirements. In the second instance, it mainly emphasized that Evidence 1.1, as a medical implant, should have a detachable connection point where the tapered portions converge, whereas the patent, as a device for removing a thrombus, has a non-detachable connection point. However, none of the above structures are necessary structural differences between a device for removing a thrombus and a medical implant. For example, whether the connection point of the patent is detachable does not necessarily correspond to its function of removing a thrombus, and constructing the connection point as a detachable structure does not necessarily affect its effective performance in removing a thrombus. The specification of the patent also explicitly states that Evidence 1.1 can be "incorporated herein by reference in its entirety," indicating that the structure of Evidence 1.1 can be fully used in the patent. Therefore, the arguments of Mei [REDACTED] (USA) Company regarding Feature A implying structural differences and thus constituting a distinction from Evidence 1.1 lack a sufficient basis.

Where a person skilled in the art can determine that substantially identical technical solutions can be applied to the same technical field, solve the same technical problem, and achieve the same expected effect, it cannot be concluded that they do not constitute the same invention or utility model merely because they are drafted for different uses. In this case, first, the use limitation in Feature A is a limitation on therapeutic use. Pursuant to Article 25, Paragraph 1, Item 3 of the Patent Law of the People's Republic of China, methods for the diagnosis or treatment of diseases are not patentable. When the only distinction of a medical device product claim over the prior art lies in the therapeutic use, granting a patent based solely on this distinction would similarly raise ethical issues such as restricting the freedom of doctors. Therefore, a limitation on therapeutic use should not be considered a feature that has a substantive impact on the assessment of novelty or inventive step of a product claim. Mei [REDACTED] (USA) Company argued that the use of medical devices should be protected by reference to the principle of pharmaceutical use claims. However, medical devices are different from pharmaceuticals, and a simple analogy cannot be drawn between the two. The mechanism of discovering new uses of a pharmaceutical product for different diseases in the human body, and thus discovering new uses for the drug, cannot be equated with medical devices acting on the human body through different physical methods to be suitable for different indications. Therefore, the use of medical devices generally cannot be protected by reference to the principles of pharmaceutical use claims. Second, Evidence 1.1 has already disclosed all the structural features of Claim 1 of the patent. A person skilled in the art, based on their general knowledge, can determine that the technical solutions of Evidence 1.1 and the patent are applicable to the same technical field, solve the same technical problem, and achieve the same expected effect. This is also corroborated by other cited references in the inventive step analysis section of the challenged decision. Therefore, the relevant grounds of appeal by Mei [REDACTED] (USA) Company are untenable and are not supported.

II. Regarding the Influence of Feature B in Claim 1 on the Assessment of Novelty

For a product claim containing a use feature, it should be considered whether the use feature implies that the claimed product has a specific structure and/or composition. If the use is inherent to the product itself, and the use feature does not imply a change in the structure and/or composition of the product, the product claim defined by such a use feature generally lacks novelty over the product of the cited reference. The above standard is equally applicable to the comparison of whether such technical features are identical in the assessment of inventive step.

In this case, Feature B of Claim 1, "the distal end of the mesh structure is configured to be implanted in at least a portion of the thrombus, thereby forming a combined thrombus device mass that is removable from the occlusion site of the patient," does not imply a change in the product structure. Based on reasons similar to those for Feature A, Feature B cannot have an impact on the assessment of novelty of the patent in question.

In conclusion, since neither Feature A nor Feature B can have an impact on the assessment of novelty of the patent, and Evidence 1.1 has already disclosed all the structural features explicitly defined in Claim 1, the technical solution of Claim 1 constitutes a substantially identical technical solution to that of Evidence 1.1. A person skilled in the art can determine that these two substantially identical technical solutions are applicable to the same technical field, solve the same technical problem, and achieve the same expected effect. Therefore, Claim 1 lacks novelty over Evidence 1.1.

Judgment Digest

Unlike pharmaceutical use patent claims, for medical device product patent claims containing therapeutic use features, if the distinguishing technical features over the prior art lie solely in the therapeutic use, and such distinguishing technical features have no impact on the medical device product itself, it generally cannot be determined that the medical device product claim possesses novelty or inventive step merely because of the existence of such distinguishing technical features.

Related Index

Article 22, Paragraph 2, Paragraph 4 of the Patent Law of the People's Republic of China (The provisions applicable in this case are Article 22, Paragraph 2, Paragraph 4 of the Patent Law of the People's Republic of China as amended in 2000)

First Instance: Beijing Intellectual Property Court, (2022) Jing 73 Xing Chu No. 13741 Administrative Judgment (March 29, 2023)

Second Instance: Supreme People's Court, (2023) SPC IP Admin. Final 475 Administrative Judgment (July 25, 2024)