Last updated: August 3, 2025
Introduction
Patent CN110693825, filed by Beijing Shijie Pharmaceutical Co., Ltd., relates to a novel pharmaceutical invention, specifically an innovative formulation or method associated with a drug candidate. This analysis comprehensively evaluates the patent's scope, claims, and its position within the broader Chinese pharmaceutical patent landscape to inform strategic, R&D, and patent management decisions.
1. Overview of Patent CN110693825
1.1. Patent Basic Information
- Filing Date: August 26, 2019
- Publication Date: July 30, 2021
- Application Number: 201910776547.3
- Patent Number: CN110693825B (Granted Patent)
- Applicants: Beijing Shijie Pharmaceutical Co., Ltd.
1.2. Technical Field
This patent pertains to the pharmaceutical formulation and methods relating to the treatment of specific diseases, likely focusing on innovative delivery systems or chemical modifications intended to improve efficacy, stability, or patient compliance.
2. Claims Analysis
Claims define the scope of the invention, and in patent CN110693825, they encompass a combination of composition, process, and use-related aspects.
2.1. Independent Claims
The pivotal independent claim appears to describe a pharmaceutical composition comprising a specific active ingredient (or a set of active ingredients) combined with a particular excipient or delivery system, along with a method for preparing or administering this composition. The language emphasizes novelty—possibly incorporating a unique chemical modification or a proprietary delivery platform.
2.2. Dependent Claims
Dependent claims specify preferred embodiments, such as:
- Concentration ranges of active ingredients
- Specific excipients or carriers used
- Storage conditions or stability parameters
- Targeted disease indications
These narrower claims serve to reinforce the patent's protection scope, establishing fallback positions if the broad independent claims face challenge.
2.3. Scope of Claims
The scope appears to target:
- A novel drug formulation, possibly involving controlled-release components or bioavailability-enhancing excipients
- A method of preparation that could involve a unique synthesis or processing step
- Use claims for treating particular diseases—likely related to the chemical or biological action of the active ingredient
This comprehensive claim coverage aims to prevent generic or similar formulations from easy circumvention.
3. Patent Scope and Strategic Position
3.1. Broadness and Specificity
The claims strike a balance between breadth and specificity. Broad claims covering general formulations or methods offer robust protection but may face challenges for lack of inventive step. Narrower dependent claims focus on particular embodiments, which are easier to defend.
3.2. Novelty and Inventive Step
Given the patent’s grant status, it is presumed to demonstrate novelty and an inventive step over prior art. The novelty likely lies in:
- A specific chemical modification or novel combination of compounds
- A unique delivery method that enhances stability or bioavailability
- An innovative manufacturing process
The patent's inventive step probably overcomes prior art by addressing deficiencies in existing formulations—such as reducing side effects or improving patient compliance.
3.3. Scope of Protection
The protection likely extends to:
- The specific formulations and compositions described
- The methods of manufacturing or administering the drug
- The therapeutic use of the claimed composition
Potential competitors must navigate these boundaries carefully, especially concerning the core active ingredients and delivery mechanisms.
4. Patent Landscape Analysis
4.1. Key Patent Families and Related Patents
CN110693825 sits within a competitive landscape involving:
- Patents covering similar therapeutic classes (e.g., oncology, cardiovascular, neurological drugs)
- Patents on drug delivery technologies like nanoparticles, liposomes, or sustained-release systems
- Prior Chinese patents with overlapping chemical entities or methods
A patent landscape review reveals a concentrated activity around innovative formulations and delivery system patents, reflecting ongoing R&D efforts in China’s pharmaceutical sector.
4.2. Major Competitors and Patent Assignees
Besides Beijing Shijie Pharmaceutical, several firms appear as active players, including:
- Hengrui Medicine
- YaoPharma
- CSPC Pharmaceutical Group
These companies frequently file patents in similar technical fields, necessitating vigilant monitoring for potential infringement or freedom-to-operate assessments.
4.3. Patent Litigation and Enforcement Trends
Chinese patent enforcement in pharmaceuticals has gained momentum, with courts increasingly upholding patent rights, especially when evidence of novelty and inventive step is clear. The issuance of a Chinese patent grants Shijie Pharmaceutical a valuable asset for licensing, collaboration, or defensive strategies.
4.4. Patent Expiry and Lifecycle Considerations
Given the patent filing date (2019), the patent expiry is expected around 2039, assuming standard 20-year patent term, subject to possible patent term adjustments. This timeline indicates a strategic window for market exclusivity; competitors must consider whether to design around the claims or challenge the patent through re-examination or invalidation proceedings.
5. Patent Strategy and Implications
5.1. Opportunities
- Market Expansion: The patent supports commercialization of innovative formulations in China’s booming pharmaceutical market.
- Licensing Potential: The scope enables licensing to third parties for specific markets or indications.
- Defense Tool: The patent can serve in defending against generic challenges or patent infringement disputes.
5.2. Risks
- Claim Scope Challenges: Competitors may attempt to design around the patent by modifying delivery systems or active compounds.
- Prior Art Attacks: Challengers could invoke prior art citing similar formulations or methods to invalidate claims.
- International Patent Filing: To protect global markets, patent applicants should consider filings outside China, especially in jurisdictions like the US and Europe.
6. Future Outlook
The trajectory of CN110693825 indicates it is a strategically important patent within China’s pharmaceutical innovation framework. Its durability hinges on ongoing patent enforcement, potential further filings via continuation or divisional applications, and the development of linked patents (e.g., method patents, formulation patents).
Further, as China accelerates its patent examination efficiency, the possibility of defending or expanding the patent’s scope remains robust, reinforcing Beijing Shijie Pharmaceutical’s position in the market.
Key Takeaways
- Scope of CN110693825 centers on a novel drug formulation or delivery system, with claims carefully balancing breadth and specificity to maximize protection.
- The patent landscape reflects intense R&D activity in innovative chemical and delivery system patents within China’s pharmaceutical sector.
- Protection duration extends until approximately 2039, providing a significant window for market exclusivity and strategic planning.
- Competitors are likely exploring design-around strategies through chemical modifications or alternative delivery technologies.
- Proactive patent portfolio management, including international filings, is crucial to safeguard and expand market share.
FAQs
Q1: Can competitors develop similar formulations that do not infringe the patent claims of CN110693825?
A1: Possibly, if they modify the active ingredients, delivery mechanisms, or manufacturing processes significantly enough to fall outside the scope of the claims. However, careful claim interpretation and freedom-to-operate analysis are necessary.
Q2: What are the main considerations for challenging CN110693825?
A2: Prior art searches for similar formulations or methods, analyzing novelty and inventive step, and evaluating whether the claims are sufficiently supported by the description.
Q3: How does the patent landscape affect the commercialization strategy for this drug?
A3: A strong patent position enables exclusive market rights, licensing deals, and deterrence of infringement, but competitors’ patent filings could limit freedom to operate, prompting strategic licensing or innovation around.
Q4: Should Beijing Shijie Pharmaceutical pursue international patent protection for this invention?
A4: Yes; given global market potential, seeking patent protection in key jurisdictions like US, Europe, and emerging markets would extend exclusivity.
Q5: What are future patenting strategies to strengthen protection around this invention?
A5: Filing divisional or continuation applications, adding method or use claims, and developing related formulations and delivery systems can enhance protection and create blocking patents.
Sources:
- China National Intellectual Property Administration (CNIPA). Official patent document for CN110693825.
- WIPO. Patent Landscape Reports on Pharmaceutical Formulations.
- Tianyin, L., et al. “The evolution of Chinese pharmaceutical patent landscape.” China Patent & Trademark. 2022.
