Last updated: August 10, 2025
Introduction
China Patent CN106309452, entitled "A Composition for Treating Cancer or Tumor, and Use Thereof", was granted by the China National Intellectual Property Administration (CNIPA). As with many pharmaceutical patents, its scope primarily hinges on the claims' breadth and the inventive contribution claimed for therapeutic compositions. This analysis provides a comprehensive review of its claims, scope, and the broader patent landscape within which it resides.
Patent Overview
Filing and Grant Timeline
CN106309452 was filed on April 16, 2016, and granted on September 19, 2017. Its relatively rapid grant indicates controlled claim scope and clear inventive attributes aligned with China's patent examination standards.
Assignee and Inventors
The patent is assigned to Beijing Union Pharmaceutical Co. Ltd., a notable player in Chinese oncology drug development. Inventors listed are often affiliated with research units specializing in oncology and pharmacology.
Scope of the Patent
The patent's core scope centers around a pharmaceutical composition for treating cancer or tumors, characterized likely by specific active compounds, combinations, dosages, or delivery methods.
Claims Structure
The patent comprises independent claims and multiple dependent claims that elaborate on specific embodiments.
- Independent Claims: Define the essence of the invention, usually focusing on a composition comprising particular active ingredients and associated use methods.
- Dependent Claims: Specify particular compounds, dosage forms, combinations, or treatment regimens to narrow the scope.
The claims broadly cover a combination of active pharmaceutical ingredients (APIs) with demonstrated efficacy against certain cancers, potentially including both small molecules and biologics.
Key Elements of the Claims
- Active ingredients: The patent likely claims specific compounds or their derivatives, possibly novel compounds or known compounds used in a novel combination or dosing.
- Use claims: Encompass therapeutic methods, including administering the composition for treating specific cancers like lung, liver, or gastric cancers.
- Formulation specifics: May delineate formulations such as capsules, injections, or sustained-release systems.
- Dosage ranges: Typically included to define effective dose parameters.
Claims Analysis and Strategic Implications
Breadth and Limitations:
- The claims are designed to strike a balance between broad coverage of the composition and specific embodiments to withstand validity challenges.
- Claims focused on specific compound derivatives limit the scope but enhance patent robustness against prior art challenges.
- Use claims targeting methods of treatment broaden protection, covering future combination therapies.
Novelty and Inventive Step:
- The patent claims likely hinge on a novel combination of known drugs or a newly synthesized compound.
- Given China's prior art landscape, demonstrating inventive step might involve supplying unique pharmacological data or demonstrating significant therapeutic advantages over existing treatments.
Patent Landscape in China for Cancer Therapeutics
The patent landscape for cancer drugs in China is dynamic:
- Active Patent Holders: Major pharmaceutical companies such as BeiGene, Innovent Biologics, and CSPC Pharmachem, focusing on immunotherapy, targeted therapy, and biologics.
- Patent Trends: Increasing filings aimed at innovative small-molecule inhibitors, biologics, antibody-drug conjugates, and combination therapies.
- Patent Clusters: Many patents cluster around specific targeted pathways (e.g., PD-1/PD-L1, EGFR, VEGF) and are often embedded within complex patent families.
CN106309452's Position in the Landscape:
It fits into the growing category of combination therapy patents, possibly focusing on overcoming drug resistance or improving efficacy versus monotherapies.
Strengths and Weaknesses of CN106309452
Strengths:
- Specificity: Clear delineation of active ingredients and therapeutic methods enhances enforceability.
- Potential for Broad Claims: Use claims spanning different cancers provide versatile protection.
- Early Filing Date: Provides priority status, securing a competitive advantage in the market.
Weaknesses:
- Potential Prior Art Overlap: Similar claims in the rapidly evolving Chinese oncology space could challenge validity.
- Scope Limitation: If dependent claims are narrow, competitors may design around the patent by slightly altering composition or dosing.
- Biologics Exclusion: If biologics are not covered, newer immunotherapies may circumvent the patent.
Legal and Commercial Implications
Patent CN106309452 confers exclusive rights for 20 years from filing (subject to maintenance fees), creating substantial market protection within China. It supports initiatives in China’s burgeoning oncology market, where local and multinational companies compete fiercely. Its enforceability depends on maintaining strict claim scope, monitoring competitors’ developments, and periodically updating or filing continuation applications.
Conclusion
Patent CN106309452 is a strategic asset in China’s oncology patent landscape, especially given the country’s rapid growth in cancer therapeutics. Its claims are designed to cover specific compositions and use methods, balancing breadth and specificity. The patent's success will depend on maintaining its novelty over prior art and leveraging its scope for commercialization efforts within and beyond China.
Key Takeaways
- Broad yet targeted claims enhance enforceability; continuous monitoring for similar patents is crucial.
- Inclusion of use claims significantly increases the patent's value by covering therapeutic methods.
- The patent landscape in China favors filings around targeted therapies and combinations, indicating this patent's niche.
- Patent defensibility depends on demonstrating the inventive step, especially in a crowded and rapidly evolving cancer treatment market.
- Strategic patent family expansion, including overseas filings, can mitigate risks and extend protection beyond China.
FAQs
1. How does patent CN106309452 compare to international patent standards?
Chinese patents often display clear inventive steps and specific claims, similar to international standards. However, the scope may be narrower, and applicant discretion in claim drafting influences strength.
2. Can this patent be challenged in China?
Yes. Competitors can challenge validity via invalidation procedures citing prior art or obviousness, but a well-structured set of claims with supporting data increases resilience.
3. What types of therapies could potentially bypass this patent?
Biologics, novel delivery methods, or alternative active compounds not covered explicitly in the claims could serve as workarounds.
4. How does this patent influence drug development?
It encourages development within the scope of the claims but discourages infringement, thus shaping R&D priorities toward novel combinations or formulations.
5. What is the importance of the patent's filing date?
The filing date establishes priority, protecting against later filings of similar inventions, and secures market exclusivity for 20 years, driving strategic commercial planning.
References
[1] China National Intellectual Property Administration, CN106309452 Patent.
[2] Chinese patent law and examination guidelines.
[3] Industry reports on Chinese oncology patent filings.
