The principle of 'good faith' plays a crucial role in ensuring the integrity and reliability of patent applications. This principle is particularly emphasised in China's patent law, where adherence to good faith is mandatory for all patent filings.
Adherence to good faith in patent filings
Article 20 of the Chinese Patent Law stipulates that patent applications must adhere to the principle of good faith. Rule 11 of its Implementation further elaborates that the filing of all types of patent applications must be based on genuine invention and creation activities and prohibits any falsification.
A recent Decision of Reexamination (No. 1878153) highlights the significance of this principle.
The patent application in question, CN202211011233.2, aimed to provide compounds derived from imatinib with enhanced drug tolerance and reduced toxic side effects. However, the original disclosures of the application failed to provide experimental data to demonstrate that the compounds achieved any of the claimed technical effects, such as antitumor activity, increased water solubility and enhanced drug tolerance.
To address the insufficient disclosure objection, the applicant submitted post-filing clinical data involving 100 patients with chronic myeloid leukemia together with a request for re-examination.
Consequences of falsified data
The re-examination panel scrutinised the clinical data and found discrepancies. According to the Measures for the Administration of Drug Registration (2020),any approved drug clinical trial including experimental protocols and data generated during the trial must be disclosed to the public through an officially designated platform.
However, upon verification, the panel foundthere was no registered record of the clinical trial, nor any updates. When the applicant failed to explain the absence of this information, the re-examination panel determined that the clinical trial data submitted by the applicant was falsified, and the applicant violated the principle of good faith. Consequently, the application was rejected.
The case highlights the importance of generating experimental data through real experiments. Violating the principle of good faith can lead to a direct rejection of a patent application or invalidation of a granted patent.
How we can help
Our team across Asia, and particularly in Hong Kong and Beijing, are highly trained and experienced in assisting companies outside of China to optimise their IP strategy and portfolio in China.
Reach out to the team for all of your IP needs across Southeast Asia and the broader Asia Pacific region.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
