The patent for the sequence and application of MG-K10, a monoclonal antibody developed by Mabgeek Biotech, has been maintained as valid.
2026-04-30
After Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. filed an invalidation request against the invention patent (ZL202010309238.8) independently developed and owned by Mabgeek Biotech, the China National Intellectual Property Administration formed a collegial panel in accordance with the law and conducted a comprehensive and rigorous review. It recently issued its examination decision on the invalidation request:the patent right remains valid。
Source: China National Intellectual Property Administration
Source: China National Intellectual Property Administration
1. On the Principle of Good Faith
When there is a potential conflict or inconsistency between the experimental data of this patent and the experimental data in other similar patent applications, a comprehensive analysis should be conducted by taking into account multiple factors that may affect the experimental data, as well as the similarities and differences of these factors between this patent and the evidentiary documents. If the existing evidence is insufficient to determine that the experimental data of this patent were fabricated, falsified, or altered, it cannot be concluded that this patent violates Article 11 of the Implementing Regulations of the Patent Law.
2. On Whether the Claims Are Supported by the Specification
If the technical solution of a claim can be obtained or generalized by a person skilled in the art from the fully disclosed contents of the specification, then the technical solution is supported by the specification.
3. On Whether the Scope of Protection Is Clear
If a person skilled in the art can understand the actual meaning of a certain expression in the claims by reading the claims and specification of this patent, including determining whether there is an obvious drafting error and identifying the definite correct content, then the expression should be deemed not to render the scope of protection of the claims unclear.
4. On Inventiveness
If the CDR sequences, which are the key structures determining the function and use of the claimed monoclonal antibody, are clearly different from the CDR sequences of monoclonal antibodies in the prior art; if the prior art does not provide clear teaching for obtaining CDRs with such a new structure; and if a person skilled in the art can confirm, based on the description in the specification and the prior art, that the claimed monoclonal antibody has beneficial technical effects in the ordinary sense, then the inventiveness of the monoclonal antibody should be recognized.