Regulation of CRISPR Patent Application and Enforcement in China

1. Introduction

China regulates patents relating to CRISPR-Cas gene-editing technology primarily through the Patent Law of the People’s Republic of China, its Implementing Regulations, and the Patent Examination Guidelines administered by the China National Intellectual Property Administration (CNIPA). The legal framework addresses patentability, ownership, disclosure of biological inventions, examination of priority claims, invalidation, and enforcement against infringement.

CRISPR-related inventions may include guide RNA sequences, Cas proteins, gene-editing systems, delivery mechanisms, engineered cells, genetically modified microorganisms, and therapeutic applications. However, discovering a biological mechanism or obtaining a broad claim over gene-editing technology does not automatically establish patent rights. Each invention must satisfy the statutory requirements for patentability.

China's revised Patent Examination Guidelines took effect on 20 January 2024. Amendments announced in November 2025 also introduced further changes effective from 1 January 2026, making the current examination framework particularly relevant to biotechnology applicants.

cnipa.gov.cn

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2. Principal Legal Framework

The main legal instruments are:

Patent Law, Articles 2 and 22: Define inventions and require novelty, inventiveness, and practical applicability.

Article 25: Excludes specified subject matter, including scientific discoveries and methods for the diagnosis or treatment of diseases, while leaving potentially patentable technical products and processes within the appropriate statutory limits.

Article 26: Requires an adequate description, clear claims, and support for the claims in the specification.

Article 5: Restricts patents for inventions contrary to law or social morality, or detrimental to the public interest.

Article 24: Provides limited exceptions to loss of novelty for specified disclosures, subject to statutory conditions.

Articles 64–71: Address the scope of protection, infringement-related relief, compensation, and related enforcement matters.

The Implementing Regulations and examination guidelines provide more detailed rules for biological materials, patent applications, and procedural requirements.

WIPO

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A CRISPR patent therefore faces two separate legal questions: whether the claimed invention qualifies for a patent and whether the resulting patent can validly be enforced against a competing technology.

3. Patent Application and Examination Requirements

A. Novelty, inventive step and industrial applicability

Under Article 22 of the Patent Law, a CRISPR invention must be new, involve an inventive step, and possess practical applicability.

For example, an applicant claiming a new Cas protein variant must establish more than the fact that the protein performs gene editing. The claim should identify the relevant technical features and demonstrate why the invention differs meaningfully from the prior art.

Prior publications, earlier patent applications, publicly disclosed sequences and existing gene-editing systems may be relevant to novelty or inventive step. A claim that merely combines known CRISPR components in a predictable manner may face an inventive-step objection.

B. Sufficiency of disclosure

Article 26 requires the specification to describe the invention clearly and completely enough for a skilled person to implement it. Claims must also be supported by the description.

A CRISPR application should therefore disclose the relevant sequences, technical construction, experimental procedures, working examples and evidence supporting the claimed effects, to the extent required by the nature and breadth of the invention.

A broad claim covering numerous Cas variants or therapeutic applications may be challenged if the examples demonstrate only a narrow embodiment.

C. Biological materials and genetic resources

Where an invention depends on biological materials that cannot adequately be described in writing, biological material deposit requirements may apply. The applicant must also address applicable genetic-resource disclosure requirements when the invention relies on genetic resources within the meaning of the Patent Law.

D. Priority claims

Priority is especially important in CRISPR because competing research teams may file applications relating to similar inventions within a short period. International applications entering China under the Patent Cooperation Treaty must satisfy applicable priority requirements.

Differences between the applicants named in an earlier priority application and a later international application can create disputes about entitlement to priority.

4. Important Case Law

Case 1: Broad Institute CRISPR patent invalidation dispute

CNIPA invalidation decision No. 563732, 16 October 2023

This is a particularly important Chinese administrative decision concerning CRISPR patent protection.

The patent, owned by the Broad Institute, MIT and Harvard, concerned engineered guide compositions and CRISPR-Cas9 systems for sequence manipulation in eukaryotic cells. Tokyo-based Tokai? The challenger was Tokai Corporation (株式会社トルキン, as identified in the Chinese decision), which challenged the patent on grounds including defective priority entitlement, insufficient claim support, excessive amendments and missing essential technical features.

CNIPA declared certain claims invalid while maintaining others. Specifically, claim 1 and specified dependent claim combinations were invalidated, whereas other claims remained effective.

cnipa.gov.cn

Legal significance:

Priority entitlement matters. A later applicant cannot automatically assume that it is entitled to every earlier priority date.

International patent status is not determinative. The validity of a foreign counterpart does not automatically determine the validity of the Chinese patent.

Invalidation can be partial. A challenge to some claims does not necessarily destroy the entire patent.

Claim drafting is critical. Priority, written support and essential technical features can determine the scope of enforceable protection.

CNIPA reported in July 2024 that the challenger had filed an administrative lawsuit in the Beijing Intellectual Property Court and that the case had not yet been heard at the time of that report. The reported administrative decision should therefore not be confused with a final judicial ruling on the merits.

cnipa.gov.cn

Case 2: Engineered microorganism patent disclosure dispute

Supreme People's Court, (2024) Zui Gao Fa Zhi Xing Zhong No. 1241

In this biotechnology patent invalidation dispute, the Supreme People's Court considered whether the specification sufficiently disclosed an engineered Sphingomonas strain and its production of a specified polysaccharide.

The Court upheld the finding that disclosure was sufficient. The specification provided relevant gene sequences, strain and plasmid information, construction procedures, and culture conditions. Taken together, these enabled skilled persons to reproduce the engineered strain and reasonably verify the expected product.

最高人民法院知识产权法庭

Legal significance for CRISPR: Although the case did not concern CRISPR itself, its reasoning is relevant to patents involving engineered microorganisms, gene-edited cells and biological production systems. Applicants should provide enough reproducible technical detail to support the claimed invention and its asserted effects.

5. Enforcement of CRISPR Patents

Once granted, a Chinese invention patent generally protects the technical subject matter defined by its claims. Under Article 11, unauthorized commercial exploitation of a patented invention may constitute infringement.

Enforcement options include:

Civil litigation: A patentee may seek an injunction, compensation for losses and other statutory remedies.

Administrative enforcement: The competent patent administration authorities may handle infringement disputes within their statutory powers.

Invalidation proceedings: An alleged infringer may challenge the patent's validity before CNIPA, including on novelty, inventive step, disclosure or priority grounds.

Evidence preservation and interim relief: Courts may grant appropriate preservation or injunction measures when statutory requirements are satisfied.

In a CRISPR infringement dispute, the central question is whether the accused product or process falls within the properly interpreted patent claims. Similar scientific objectives do not, by themselves, establish infringement. The claimant must establish the relevant technical features and infringement under Chinese law.

6. Ethical and Public-Interest Restrictions

Patentability must be distinguished from regulatory permission to conduct gene-editing research or use a resulting product.

China published ethical guidelines for human genome-editing research in 2024. These emphasize human well-being, responsibility, fairness, transparency and careful assessment of risks.

State Council of China

A patent grant does not authorize a clinical trial, therapeutic administration or heritable human genome editing where separate regulatory or ethical requirements prohibit or restrict the activity. Patent rights and research authorization operate under different legal frameworks.

7. Conclusion

China's CRISPR patent regime combines ordinary patentability standards with demanding technical disclosure and priority requirements. The Broad Institute dispute demonstrates the importance of carefully establishing priority entitlement and maintaining claim validity. The engineered-microorganism case illustrates how courts evaluate whether biological inventions can be reproduced from the disclosed specification.

For applicants, the principal priorities are accurate priority documentation, experimentally supported claims, sufficient disclosure and carefully defined technical scope. For patentees and alleged infringers, claim construction, evidence of technical implementation and the possibility of partial invalidation are central to enforcement strategy.