Burden Shift: CNIPA Requires Applicant to “Prove” that Post-Filing Data is not Fake Data

“Good Faith” is a challenging concept that brings with it the nuances of a particular jurisdiction’s ideas about honesty, moral values, and societal expectations. Most patent laws around the world include good faith requirements – especially in matters involving the legal and the medical profession – and China is no exception.

So what’s the standard? This case demonstrates one example of how stark inconsistencies between post-filing (clinical trial) data and publicly available information led the CNIPA to reject a case because of false post-filing data submitted in violation of the “good faith” requirement.

Case Background

The disputed patent application, titled “A Type of Tini-Class Small Molecule Compound and Its Preparation Method” from a Tianjin-based drug company claimed a novel pharmaceutical compound having enhanced tolerance and reduced side effects compared to imatinib, a well-known leukemia drug.

In April 2024, the CNIPA rejected the application for insufficiency due to insufficient compound characterization data and experimental data proving the compound’s biological effects.

The applicant requested re-examination and submitted clinical trial data from a comparison study involving 100 patients with chronic myeloid leukemia. However, the CNIPA rejected the case due to severe issues regarding the authenticity of the clinical trial data.

Authenticity of the Clinical Trial Data

Good Faith Requirement in Patent Law:

Article 11 of the Rules for the Implementation of the Patent Law mandates that patent applicants must act in honesty and good faith and refrain from fraudulent or deceptive practices. This principle was introduced in the fourth amendment to the Patent Law to prevent patent abuse and improve patent quality.

Clinical Trial Data Must Be Lawfully Conducted and Publicly Registered

Article 19 of the Drug Administration Law and Article 22 of the Drug Registration Administration Measures require that all clinical trials intended for drug approval must:

• Receive prior approval from the National Medical Products Administration (NMPA).
  
• Be registered and continuously updated in the Drug Clinical Trial Registration and Information Disclosure Platform.
  
• Comply with ethical requirements, including Institutional Review Board (IRB) approval and informed consent from trial participants.
  

These requirements ensure that only legally authorized clinical trials are used to support regulatory approvals, including patents.

In this case, the CNIPA required the applicant to submit real and verifiable experimental data to prove the claimed advantages of the invention.

The applicant claimed to have conducted a clinical trial on 100 patients to compare the safety profile of the new compound against imatinib. However, no record of such a trial was found in the official registration platform, raising concerns about the data’s authenticity.

Data Falsification Determination

The CNIPA concluded that the data was false based on the following logic:

Unregistered Trials are Presumed Illegal

Without proper registration and approval, it would have been impossible for the applicant to conduct a legal human clinical trial under Chinese law.

Reversal of the Burden of Proof

During the re-examination process, CNIPA revered the burden of proof, explicitly requesting that the applicant provide evidence to verify the legitimacy of the clinical data, such as clinical trial approval documentation, patient consent forms, or site agreements with medical institutions. The applicant failed to submit any such documentation, reinforcing the suspicion of data fabrication.

High Probability of False Statements

In the pharmaceutical industry, legally conducted trials always leave a documentary trail, such as third-party laboratory test reports, collaborative agreements with hospitals, or ethics committee approvals. The applicant was unable to produce any of these documents, further confirming the likelihood of data falsification.

Conclusion: Re-examination Request Rejected

Based on the findings, CNIPA concluded that the applicant violated the good faith principle by submitting false and unverified clinical trial data. It also made the following important statements:

• Clinical trial evidence must comply with legal disclosure requirements—failure to register trials invalidates any data submitted as proof.
  
• The burden of proof is on the applicant to demonstrate that submitted data is legitimate and obtained through legal and ethical means.
  

As a result, the re-examination request was rejected due to violations of the good faith principle.

Key Takeaways

This case provides valuable lessons for patent applicants, pharmaceutical companies, and IP professionals.

Good Faith is a Fundamental Requirement in Patent Applications

Patent applicants must ensure that all submitted data is truthful, accurate, and legally obtained. Any attempt to misrepresent facts violates the patent system’s integrity and may lead to rejection or even legal consequences.

It’s Important to Have a Good Evidence Chain

All clinical trial data submitted in patent applications should be consistent with other types of data such as publicly available regulatory records, raw experimental data, and third-party verification reports.

Beware of Using Data Not Compliant with Regulatory Laws (or Any Laws)

• An in-house dual-track compliance strategy—where patent filings and drug regulatory approvals are reviewed together—can prevent discrepancies.
  
• Blockchain or other immutable data storage methods can help preserve data integrity.
  

Understand the Disclosure Requirement for Post Filing Data

It’s important to remember the original rejection under Art. 26.3, where the Examiner reminds us that post-filing supplemental data can be allowed “if the technical effect demonstrated by the supplemental data could undoubtedly be obtained by a skilled person in the art from the disclosure as originally filed.” In this case, even if the false clinical trial data had been real, the original specification still needed to clearly indicate the claimed compound’s surprising effects to ensure that the post-filing data would be acceptable.

EIP Thoughts

This case gives a real-world example of how the good faith standard is applied in patent prosecution, particularly in cases involving human subjects, strict regulatory laws, and ethics requirements. Importantly, the experimental results shown in a patent application must be based on real, and verifiable evidence.

Without reliable evidence (as in this case), the CNIPA will assume that the applicant did not run the trial and thus fabricated the data. Not only is there a violation of good faith, the application itself is not enabled and lacks sufficiency.

In summary, this case serves as a strong reminder for applicants to ensure that the data in their patent applications are obtained in legal ways and supported by strong evidence. Better yet, try to make sure that the data in the patent applications are consistent with published materials. Particularly for highly regulated areas (such as human clinical trials), if there really is no “corroborating evidence” in the public records, the CNIPA can shift the burden of proof and require applicants to prove that the data in the patent application is real and was properly obtained.

This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.