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:

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:

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)

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.

RNAi Patent Success in China: Overcoming “Comprising” Claim Challenges

An Update on Sufficiency and Inventiveness of RNAi Patents in China

RNAi is a fast-developing technology that has gained traction in the pharmaceutical industry as a promising therapeutic agent. It is important to follow closely RNAi patent proceedings to learn how different examination boards and courts understand and handle these new technologies.

The first-ever invalidation decision in China for an RNAi patent1 was rendered in 2022 by the Patent Re-examination Board (the “Board”). We previously wrote about this case, which discussed the standards for post-filing data, sufficiency, and inventive step, particularly for RNAi inventions. Since then, two newer cases involving RNAi have also been upheld by the Board after facing similar challenges against support and inventiveness. These cases provide further insight into the Board’s standards on examining RNAi patent invalidations.

Quick Recap on the First RNAi Invalidation Decision in China

The invalidation decision concerned a patent claiming Hepatitis B Virus (HBV) RNAi compositions2. The following is a brief recap on the key issues examined in the decision:

Key Issues Examined:

  1. Sufficiency: The petitioner argued that the open-ended term “comprising” in the claims allowed for any nucleotide additions, making the claim scope unclear. The Board dismissed this and emphasized that as long as the primary sequence was intact, a person having ordinary skill in the art (PHOSITA) would understand how to selectively add nucleotides to the primary sequence without compromising the sequence's main function of silencing the HBV gene.
  2. Inventiveness: The petitioner claimed the patented sequences were minor modifications of known HBV RNAi sequences. The Board disagreed, noting that due to the unpredictability in the RNAi field, a PHOSITA would recognise that even minor modifications to the primary sequence could significantly impact the resulting siRNA characteristics.

Ultimately, the Board upheld the patent's validity, concluding that identifying the primary sequence was inventive due to the difficulty in predicting which sequence(s) would have activity. However, once the primary sequence was identified, minor modifications that maintained the integrity of the primary sequence intact were expected to also solve the technical problem. For a detailed analysis of this case, please refer to our previous article here: First ever Invalidation decision on an RNAi Invention patent in China

Later Invalidation Decisions related to RNAi

So what’s happened since then? In China’s 2023 Summaries of 50 Typical Patent Invalidation Cases, two newer cases also involving RNAi were also upheld3 by the Board after facing similar challenges against support and inventiveness. These cases provide further insight into the Board’s standards on examining RNAi patent invalidations.

Background

The patents involve inclisiran, a PSCK9-inhibiting RNAi composition for reducing LDL cholesterol in adult HeFH4 and ASCVD5 patients. The parent patent primarily focuses on claiming the double-stranded RNAi agent, with specific sequences, modifications and conjugations; while the divisional patent has a broader claim scope, covering variations in the RNAi design.

Sufficiency

In both patents, support for claims relating to the RNAi composition conjugated to at least one ligand (parent patent) and conjugated to GalNAc- ligands (divisional patent) were challenged.

The petitioner argued that the specifications only provided data support for the RNAi composition linked to one GalNAc ligand, L96, but did not provide any data to support technical effects of the claimed RNAi composition linked to other ligands.

The Board reinstated that the amount of support needed in a patent specification should be considered in combination with a skilled person’s expectations. Specifically, the technical solution provided by the ligand is directed delivery of the RNAi composition, which is provided relatively independently from the gene-silencing solution of the effective RNAi sequence, such that it is possible to combine varying known ligands with the RNAi component (and still expect successful delivery of the RNAi composition).

The Board believed that a PHOSITA could anticipate the components needed to independently achieve the separate parts of the completed product’s technical solution, such that the complete product could still to solve the presented technical problem. Hence, the Board concluded that the technical solution presented was supported by the specification.

Inventiveness

Regarding the divisional patent, the requester contended that the closest prior art, CN 102458366A6[6], already disclosed highly effective nucleotide regions that could inhibit PCSK9 expression. Therefore, it would be obvious for a PHOSITA to add modifications and ligands to the sequence and design RNAi compositions targeting the PCSK9 gene.

The Board examined the differences between the closest prior art and the claimed invention and highlighted the following differences:

  1. The targeted regions in the unmodified antisense strand sequences are different
  2. The present invention claims modifications for all nucleotides in the RNAi composition, while the closest prior art only claims modifications for some nucleotides
  3. The closest prior art does not include the phosphorothioate modifications in the claimed invention.
  4. The claimed invention depends solely on ligands to deliver the RNAi composition, while the closest prior art uses a lipid formulation, and only in some embodiments in combination with ligands

Moreover, the cited prior art previously “taught away” from the claimed invention, teaching that additional modifications in (2) were not particularly beneficial. The claimed invention also showed higher silencing effect for compositions of the selected primary sequence in combination with specific phosphorothioate modifications of (3). Lastly, the Board indicated that, while use of ligands was disclosed in an examplary embodiment of the closest prior art, the main technical solution of the closest prior art to aid delivery was still the lipid transfection reagent in the composition, and not ligands covalently-linked to the dsRNAi structure.

The Board concluded that, based on the disclosurse in the closest prior art, a PHOSITA would not be motivated to add modifications and ligands to the claimed invention, nor make alterations to the target region sequence. Moreover, the Board affirmed that the technical solution provided was to “provide a RNAi composition of different target sequence, modification and delivery method”, which was different from that of the cloest prior art.

EIP Thoughts

Consistent with the previous case, the conclusions made by the Board were based on the reasonable anticipation of a PHOSITA, which is done by examining the state of the art and the technical problem presented.

Sufficiency

In both cases, the Board upheld claims directed towards a “general” ligand, despite the specification only providing experimental data on one specific ligand L96. These current decisions illustrate the extent to which a broader, more “general” claim scope is possible.

In this instance, the Board reaffirmed that the siRNA and its covalently-linked ligand address different technical problems and are relatively functionally independent. Given that there is a variety of known-in-the-art ligands for directing RNAi delivery, a PHOSITA should be able to “mix-and-match” suitable ligands, and still expect a similar technical effect. Similar to the first invalidation case, the broader claim scope was upheld, based on the notion that the current disclosure is sufficient for a PHOSITA to combine a different ligand to the claimed siRNA, and expect no major compromise on its gene silencing effect.

Inventiveness

The Board’s inventiveness determination consisted of:

  1. identifying the differences in technical effect between the closest prior art and the claimed invention
  2. determining whether the changes applied to achieve those technical effects are obvious or not

Regarding obviousness, it comes down to whether there is motivation for a PHOSITA to make such changes. This is very case-specific and depends on whether teachings of the prior art would cause a PHOSITA to “readily recognize” how a (minor) change could solve the problem.

In this case, the technical differences were examined in detail, with reference to what teachings are available in the prior art. The Board was able to confirm that, in view of the closest prior art, a PHOSITA would not be motivated to add alterations in the primary sequence, make nucleotide modifications and change methods of delivery.

Generally, the RNAi field is considered unpredictable, as it is difficult to predict how a certain composition will react within a living organism.

Can We Get Broader Sequence Claims Now?

Although these cases seem to imply applicants can obtain broader claim scopes without providing as much supporting data (e.g., being able to use “comprising” language), our experience with the CNIPA is not consistent with this decision. In a majority of our prosecution cases, Examiners are still very, very reluctant to grant “comprising” language for sequence listings when there is no data support.

Having said that, these cases were published in the annual list of “50 typical cases”, highlighting representative patent invalidation cases decided by the Board in 2023. Importantly, the Board has affirmed that there is indeed “room” to obtain a generic scope around RNAi inventions that only disclose a handful of species. The cases provide helpful guidance by highlighting the importance of considering the PHOSITA, and how much information (whether prior art knowledge or data in the specification) is needed for a PHOSITA to be “convinced” and “readily recognize” that a different (closely related) species within a generic scope would also work.

We hope examiners and judges alike will refer to these cases when handling RNAi related patent proceedings. In particular, these two cases go into the specifics of RNAi technology, examining technical features beyond just the primary sequence, such as investigating the different modifications to the nucleotides and ligands. As RNAi compositions get more sophisticated and complex, the predictability of each feature behaving a certain way may diminish. This unpredictability could ultimately impact a PHOSITA’s ability to be convinced (without data) that a particular feature works throughout the entire scope of a large genus.

These invalidation proceedings emphasize the importance of considering the specific problem being addressed and the unpredictable nature of certain fields when assessing inventiveness and sufficient disclosure.

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.

Can I transfer priority rights in China without the consent of other applicants? Insights from the Broad Institute’s CRISPR patent

The high-profile disputes surrounding an important CRISPR patent belonging to The Broad Institute, MIT and Harvard (hereinafter “the proprietors”) has attracted a lot of attention in recent years, particularly regarding the validity of priority rights that were challenged worldwide. In Europe, the patent was famously revoked by the European Patent Office (hereinafter “EPO”) due to an invalid priority claim1, though recent decisions by EPO suggest a dramatic shift in EPO’s approach that may lead to a different outcome2. Today, we will discuss the decision of the Chinese National Intellectual Property Administration (hereinafter “CNIPA”) in determining whether the proprietors’ priority claims in their CRISPR patent in China were valid, given discrepancies between the applicants in the priority application and the subsequent PCT and Chinese applications. This case brings to light the nuances of claiming priority rights in China and how China’s approach is different from some other countries (Europe and Korea) when it comes to entitlement to priority rights.

Background – claiming priority in China

Priority rights allow an applicant of a patent application to claim the earlier filing date of a previous application (i.e. “priority application”), preventing publications made after the earlier filing date from being used as prior art against the patent application. In China, the CNIPA’s Examination Guidelines (hereinafter “Guidelines”) provide different provisions for the entitlement to claim priority rights under different situations:

  1. National application claiming domestic priority

    For a national application claiming domestic priority, Section 6.2.2.4 in Part I Chapter 1 of the Guidelines states:

    “The applicant of the subsequent application claiming priority shall be the same as that of the previous application. If they are different, the applicant of the subsequent application shall submit a document certifying the assignment of the right of priority signed or sealed by all the applicants of the previous application within 16 months from the earliest priority date.”

  2. National application claiming foreign priority

    For a national application claiming domestic priority, Section 6.2.1.4 in Part I Chapter 1 of the Guidelines states:

    “The applicants of the subsequent application claiming the right of priority shall be the same as the applicant of the previous application, or at least one of the applicants recorded in the certified copy of the previous application document. Where the applicants of the two applications are entirely different, and the right of priority of the previous application has been assigned to the applicant of the subsequent application, a document certifying the assignment of the right of priority, signed or sealed by all of the applicants of the previous application, shall be submitted within 16 months from the earliest priority date.”

  3. National phase entry (NPE) of International Application (PCT) claiming domestic priority

    For NPE of an international application (PCT) claiming foreign priority, the requirements are identical to those of a national application claiming domestic priority, as per Section 5.2.6 in Part III Chapter 1 of the Guidelines.

  4. National phase entry (NPE) of International Application (PCT) claiming foreign priority

    For NPE of an international application (PCT) claiming foreign priority, Section 5.2.3.2 in Part III Chapter 1 of the Guidelines states:

    “Where the earlier application is not filed with the Patent Office, the applicant shall be considered to have right to claim the right of priority if one of the following requirements has been met:

    (1) the applicant of the later application is the same as that of the earlier application;

    (2) the applicant of the later application is one of the applicants of the earlier application;

    (3) the applicant of the later application enjoys the right of priority as the result of assignment or gift of the applicant of the earlier application or transfer of right in other form.”

    For cases under (3), Section 5.2.3.2 further states that “except that the applicant has made a declaration of enjoying the right of priority in the international phase and the declaration meets the requirements, the applicant shall submit the relevant certifying documents. The certifying documents shall be signed or sealed by the assignor(s). The certifying documents shall be the original documents or the certified copy of the original documents.”

It can be observed that the requirements for claiming priority rights are stricter for applications claiming domestic priority compared to those claiming foreign priority, with the national phase entry (NPE) of PCT application claiming foreign priority being the most lenient. The differences in requirements for claiming priority rights under different situations are summarized in the table below:


National Application / NPE of International Application (PCT) claiming domestic priority


National Application claiming foreign priority


NPE of International Application (PCT) claiming foreign priority

Applicant


Same applicant as the previous application(s)


Same applicant or at least one of the applicants of the previous application(s)


Same applicant or at least one of the applicants of the previous application(s)

Formality requirement for the transfer document


signed or sealed by all of the applicants of the previous application(s)


signed or sealed by all of the applicants of the previous application(s)


signed or sealed by the assignor(s)

Relevant sections

Part I Chapter 1 Section 6.2.2.4 (National application)

Part III Chapter 1 Section 5.2.6 (NPE)

Part I Chapter 1 Section 6.2.1.4

Part III Chapter 1 Section 5.2.3.2

Case Facts

The Chinese patent under dispute for this invalidation case is CN201380070567.X, which was filed and granted under the names of The Broad Institute Inc. (hereinafter “Broad”), Massachusetts Institute of Technology (hereinafter “MIT”) and Presidents and Fellows of Harvard College (hereinafter “Harvard”). The Chinese patent was derived from the PCT application no. PCT/US2013/074819, which claims priority from a few US provisional applications. The dispute arose because the proprietors had filed the PCT application (and the subsequent NPE into China) without naming some of the priority applicants (Marraffini Luciano and Habib Naomi) or Marraffini’s successor in title (the Rockefeller University) as the applicants in the PCT application.

This case revolves around a key question: do inconsistencies in applicants between the priority application and the subsequent applications undermine the proprietors’ right to claim priority in China?

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PRD’s Decision and Reasoning

The petitioner argued that Part III of the Guidelines, which governs the examination rules for NPE of PCT applications into China, is unclear regarding which provision to apply where the applicants in the previous application and the subsequent application are entirely different, as in this case. It was argued that since priority rights are derived from application rights, priority rights should not be transferred without the consent of all joint applicants.

In its decision, the Patent Re-examination and Invalidation Department (hereinafter “PRD”) of the CNIPA held that:

  1. Entitlement of Priority Rights

    By referring to Part III Chapter 1 Section 5.2.3.2 as discussed above, PRD states that for an international application entering the national phase in China which claims foreign priority, there are 3 scenarios where the applicant(s) shall be considered to have the right to claim priority:

    (1) the applicant of the later application is the same as that of the earlier application;

    (2) the applicant of the later application is one of the applicants of the earlier application;

    (3) the applicant of the later application enjoys the right of priority as the result of assignment or gift of the applicant of the earlier application or transfer of right in other form.”

    The PRD further explained that when the applicant(s) of the later application satisfies the criteria listed in (1) or (2) as the successor(s) in title due to the transfer of rights in (3), they should be able to enjoy the priority rights. Unlike the stricter requirements in applications claiming domestic priority, for NPE of a PCT application which claim foreign priority, it is not required that the applicants (or their successors in title) of the prior application and the subsequent application are completely identical.

    For the present case, as long as the priority rights are properly transferred (under the criterion (3)) from one or more of the applicants of the earlier application (Zhang Feng and Cong Le in this case) to the proprietors (Broad, MIT and Harvard), this will satisfy criterion (2) and the proprietors will be entitled to the right to claim priority.

    This is different from the much stricter approach taken in Europe and South Korea, which requires the applicant of the prior application and the subsequent application to be completely identical in order to enjoy priority rights. If they are not the same, the submission of relevant proof of assignment from all applicants is necessary.

  2. Validity of the Transfer Document

    The petitioners argued that all applicants in the priority application must sign the transfer document to validate the priority claim. The PRD, however, focused on the meaning of “assignor” mentioned in Section 5.2.3.2 (i.e. “the certifying documents shall be signed or sealed by the assignor(s)”), interpreting it more leniently to mean “any assignor” listed as an applicant in the priority application, rather than all co-applicants. In other words, a proof of assignment from all applicants is not necessary.

    Therefore, in the present case, the transfer document signed by Zhang Feng assigning the rights to Broad and MIT, and the transfer document signed by Cong Le assigning the rights to Harvard, validly transfer the priority rights to the proprietors, satisfying criterion (3) in Section 5.2.3.2.

  3. On the Nature of Priority Rights

    The PRD justified its decision by drawing a distinction between priority rights and right of application. It emphasized that while priority rights are significant, they don’t hold the same legal weight as the full right of application. Priority rights are essentially time-based and tied to the novelty determination process. Thus, the PRD reasoned that allowing flexibility in transfer of priority rights, where only one assignor’s consent is needed, does not severely impact the other co-applicants’ rights.

In conclusion, the PRD upheld the proprietors’ priority claim.

Concluding Thoughts: Transferring Priority Rights in China

We believe this case was chosen as a “Top 10 Patent Re-examination and Invalidation case” to illustrate China’s more flexible approach to priority rights (at least for PCT applications entering via national phase), providing foreign applicants more leeway compared to the stricter European and Korean requirements. This flexibility might encourage international applicants to seek patent protection in China, given its comparatively accommodating stance on priority transfers. It will also be interesting to follow the future developments in other jurisdictions on this matter, especially in Europe, which appears to be moving away from its stricter approach to ‘same applicant’ priority.

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.

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