Case Update: Decision to Uphold Rejection Due to Violation of the Principle of Good Faith (Reexamination Decision No. 1878153)

On February 25, 2025, the China National Intellectual Property Administration (CNIPA) issued a decision on a reexamination request for the invention patent application titled "A Tinib Small Molecule Compound and Its Preparation Method" (Application No. 202211011233.2). The decision concluded that the reexamination petitioner had submitted fraudulent clinical trial data in support of the application, thereby violating the principle of good faith. Consequently, the reexamination request was rejected, and the original decision to dismiss the patent application was upheld.

Key Legal Basis

Article 11 of the Implementing Regulations of the Patent Law (R. 11) stipulates that patent applications must adhere to the principle of good faith. All patent applications must be based on genuine inventive activities, and any form of falsification is prohibited.

Case Background
The application claims a tinib-class small molecule compound that purportedly improves human tolerance to tinib drugs and reduces toxic side effects. To demonstrate this technical effect, the petitioner submitted clinical trial data involving 100 patients with chronic myeloid leukemia.

Legal Violations Identified

Pharmaceutical Regulations:
- Under Article 19 of the Pharmaceutical Administration Law, clinical trials must report detailed data (e.g., research methods, quality metrics, pharmacological/toxicological results) to the State Council’s drug regulatory department for approval.
- Article 33 of the *Drug Registration Measures (2020)* mandates that trial sponsors register trial protocols and results on the Drug Clinical Trial Registration and Information Disclosure Platform and ensure data authenticity.
Fraudulent Evidence:
- The collegial panel verified that no records of the claimed clinical trial existed on the official platform, indicating the trial lacked legal authorization and was likely fabricated.
- The petitioner cited an article from Drug Evaluation arguing that "patient consent alone suffices for drug research." However, the panel noted that the article referred to approved drugs, whereas the application involved unapproved compounds, rendering the argument invalid.

Decision Rationale
The panel determined that the petitioner's submission of falsified clinical trial data violated the principle of good faith under R. 11. This case exemplifies the application of the principle, introduced in the 2020 Patent Law amendment, to combat fraudulent patent filings and uphold the integrity of the patent system.

Significance
This decision marks a landmark case under the revised Implementing Regulations, reinforcing the critical role of good faith in patent applications and setting a precedent for future enforcement.

Author: Feng Shangjie (Gasoll Feng)
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