The meaning of "patent is invalid" in the case of the early settlement mechanism of drug patent disputes.

According to the State Intellectual Property Office statistics, as2023Year9Month30Day, total of administrative adjudication cases received149Piece, which has35PieceNon-acceptance, classified according to the reasons for non-acceptance, is divided into four main situations, as follows:(1)Generic drug applicants madeA Class of Declaration"There is no patent information related to generic drugs in the registration platform." (34%);(2)When requesting an administrative rulingThe claims of the patent registration involved were declared invalid (12%);(3)The subject matter of a registered patent claim is not of a type that allows registration, e.g.“crystal type patent”(31%);(4)Administrative decision request date earlier2021Year7Month5day,namely in 《Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes (for Trial Implementation) (hereinafter referred to 《Implementation method") Prior to the introduction, there was no patent declaration in such cases, also knownInRequest for administrative adjudication of "transition period"(20%).

For the above situation(2),According to the provisions of item (V) of article 10 of the administrative adjudication measures,If"If the claims involved in the patent are declared invalid by the State Intellectual Property Office", the administrative ruling request will not be accepted.Then, when the request for administrative ruling is filed, the State Intellectual Property Office has already made a decision to declare the patent right invalid, but the invalidation decision is still in the process of administrative litigation. Should the request for administrative ruling based on the patent right be accepted?

First of all,Effective upon the administrative decisionThis is the basic principle of administrative law and is determined by the theory of the public force of administrative act, which means that once an administrative decision is made, it has the legal effect of being presumed to be legal and effective and respected by anyone.^[1].Even if there is an objection to the legality of the administrative decision, the public determination requires that the counterpart of the administrative act should obey first.For example, Article 56 of the Administrative Procedure Law^[2]provisions,The act of the administrative counterpart who does not accept the administrative decision and provides legal relief does not affect the implementation of the administrative decision. As a national administrative agency, the State Intellectual Property Office makes an invalid decision in accordance with the law, and it should be presumed to have the legal effect of course before the decision is overturned by an administrative judgment.

Secondly, this understanding is logically consistent with Article 14 of the Administrative Adjudication Measures. Article 14 of the Administrative Adjudication Measures^[3]It is a provision for the interface between administrative adjudication and invalidation procedures, and according to this article,In the case of administrative adjudication, if part of the claims involved are declared invalid by the State Intellectual Property Office, the administrative ruling shall be made on the basis of maintaining the valid claims; if all the claims involved are declared invalid, the administrative ruling request shall be rejected.According to the same logic, if the State Intellectual Property Office has declared the rights involved invalid when the administrative ruling request is filed, the administrative ruling request should not be accepted.

In addition, this understanding is also consistent with the legal attributes of administrative rulings in the Implementation Measures.According to Article 9 of the "Implementation Measures", the State Food and Drug Administration can decide whether to transfer to the administrative approval link based on the conclusion of the administrative ruling, that is, in the context of the "Implementation Measures", the administrative ruling will take effect.Whether it is an administrative ruling or an invalid decision, it belongs to the specific administrative act made by the State Intellectual Property Office. In the case that the administrative ruling takes effect immediately after it is made, there seems to be no reason to require that the invalid decision must wait for the conclusion of the administrative lawsuit before it can take effect..

to sum up,If, at the time of filing the request for an administrative ruling, the State Intellectual Property Office has made a decision to declare invalid all the relevant patent claims on which the right holder claims rights, the request for an administrative ruling shall not be accepted.; of course,This also includes the case where the patentee modifies the claim in the invalidation procedure, resulting in the non-existence of the claim registered on the patent information platform and on which the claim is based..

【5]]https://zhuanlan.zhihu.com/p/663030918