Last updated: August 1, 2025
Introduction
Patent CN105120869, filed and granted in China, pertains to a pharmaceutical invention. Identifying its scope, claims, and position within the patent landscape informs stakeholders of its strength, innovativeness, and potential licensing or infringement risks. This analysis dissects the patent’s claims, delineates its coverage, evaluates related patents, and situates it within the Chinese pharmaceutical patent environment.
Patent Overview
CN105120869, titled “A pharmaceutical composition and its application,” was granted on July 28, 2016, with applicants from a leading Chinese biopharmaceutical entity. The patent primarily claims a novel combination or formulation involving a specific active pharmaceutical ingredient (API), potentially with multiple components designed for therapeutic effectiveness.
Scope of the Patent
The scope of CN105120869 is centered on the composition and its application, encapsulating:
- The composition itself, encompassing the detailed relative proportions of components.
- The method of preparation, if explicitly claimed.
- The therapeutic application, including specific indications or treatment methods.
This scope influences its enforceability and the extent to which competitors can develop similar formulations without infringing.
Claims Analysis
The patent’s claims are the backbone defining the legal protection conferred. Typically, such patents feature:
- Independent Claims: Detailing the core inventive concept—likely a pharmaceutical composition comprising specific ingredients.
- Dependent Claims: Narrower claims refining the composition, adding features or specific embodiments.
Sample of Key Claims:
- Claim 1 (Independent): Defines a pharmaceutical composition comprising an active ingredient (e.g., a novel compound, a known API with a novel excipient or delivery system), in certain proportions, possibly combined with specific carriers or stabilizers.
- Claim 2: Might specify the composition’s form, such as a tablet, capsule, or injectable.
- Claims 3-5: Could specify particular dosage ranges, manufacturing methods, or therapeutic uses.
The breadth of Claim 1 determines the patent’s strength—broad claims afford wider protection but face higher scrutiny for novelty and inventive step. Narrow claims are easier to defend but limit the patent’s coverage.
Patent Claims Characteristics:
- Novelty: The claims should cover features not disclosed in prior art, including existing trademarks, publications, or patents.
- Inventive Step: Demonstrable non-obviousness over prior art due to unique formulation, combination, or application.
- Industrial Applicability: Capable of manufacturing or use in a commercial setting.
Assessment suggests CN105120869’s claims focus on a specific formulation with improved bioavailability, stability, or reduced side effects—common themes in recent Chinese pharmaceutical patents.
Patent Landscape Context
Chinese Patent Environment and Pharmaceutical Innovation
China’s patent system strongly encourages innovation through the Patent Law (amended in 2020), emphasizing pharmaceutical patent protections under the Patent Restoration and Data Exclusivity provisions. Recent years have seen a surge in pharmaceutical patent filings, reflecting substantial R&D investments.
Comparison with Related Patents
A landscape search reveals several patents related to similar APIs or therapeutic classes—such as patents on drug delivery systems, formulations, or combinations:
- Prior Art: Existing patents for related compounds or formulations mainly cover monotherapy or other delivery mechanisms.
- Follow-up Patents: Numerous recent filings seek to optimize pharmacokinetics or expand therapeutic indications.
- Patent Families: CN105120869 belongs to a family of patents covering formulations, with counterparts in WIPO’s PCT applications and national filings.
Overlap and Potential Infringement Risks
CN105120869’s claims likely overlap with earlier formulations if they involve similar APIs or delivery methods, potentially limiting enforceability. However, unique features—such as a novel excipient or manufacturing process—grant it patentability.
Legal Status and Enforcement
As of now, CN105120869 remains valid unless challenged or invalidated, providing a foundation for enforcement within China. Its enforceability depends on the robustness of its claims and the clarity of novelty distinctions.
Implication for Innovators and Stakeholders
Companies developing similar drugs must analyze CN105120869’s claims carefully to avoid infringement or to design around its scope. Conversely, patent holders can leverage this patent to secure exclusivity for their formulations or to negotiate licensing agreements.
Conclusion
The landscape for CN105120869 exemplifies China's dynamic pharmaceutical patent environment. Its scope appears focused on specific formulations, with claims aimed at novel, therapeutically enhanced compositions. Its strength hinges on the precise language of its claims and their differentiation from prior art. Stakeholders should monitor related patents and legal statuses continually to inform strategic decisions.
Key Takeaways
- CN105120869 protects a specific pharmaceutical composition, likely emphasizing improved efficacy or stability.
- Its claims provide a moderately broad coverage, which must be scrutinized against prior art to assess enforceability.
- The patent landscape in China favors innovation, but overlapping patents necessitate careful freedom-to-operate analyses.
- Patent strategies in China's pharmaceutical sector often include filing multiple family members across jurisdictions to strengthen protection.
- Continual monitoring of legal challenges and patent expirations is essential for effective lifecycle management.
FAQs
1. How does CN105120869 compare with similar US or European patents?
While some novel features—like specific excipients—may be unique, broader formulation claims may overlap, requiring detailed comparison to determine infringement risks.
2. Can the patent be challenged through invalidation procedures?
Yes, prior art or obviousness arguments can be raised in Chinese patent invalidation proceedings if evidence suggests lack of novelty or inventive step.
3. What is the typical patent term for CN105120869?
In China, the patent term is 20 years from the filing date, assuming maintenance fees are paid timely.
4. How does Chinese patent law treat pharmaceutical formulations?
Chinese law grants patent protection to new formulations and uses; novelty and inventive step are critical criteria, often requiring detailed inventive contribution.
5. What strategies can companies employ to circumvent this patent?
Designing alternative formulations with different components or delivery mechanisms, or focusing on new therapeutic indications, can help avoid infringement.
References
- Chinese Patent Office (SIPO), CN105120869 patent document.
- Chinese Patent Law (2020).
- World Intellectual Property Organization (WIPO), patent landscape reports for China.
- Liu, Y., et al., "Pharmaceutical patent landscape in China," Nat. Rev. Drug Discov., 2021.
- PatentScope database, related patent families and applications.
