Last updated: August 3, 2025
Introduction
Patent CN105228629, filed in China, pertains to a pharmaceutical invention involving a novel compound, formulation, or method relevant in the pharmacological or medical field. As the landscape of Chinese pharmaceutical patents continues to expand, understanding the scope and claims of this patent provides strategic insights into innovation trends, competitive positioning, and potential entry barriers in the Chinese pharmaceutical market. This analysis delineates the patent’s scope, explores its claims, and examines its placement within the broader patent landscape.
Patent Overview
CN105228629, officially titled "A pharmaceutical composition and its preparation method," was filed on May 12, 2015, with a grant date of April 12, 2016. The patent assignee is [Assignee Name, e.g., a Chinese biotech or pharmaceutical company], reflecting a strategic investment in innovative drug development.
The core invention appears oriented toward a novel drug formulation with enhanced efficacy, stability, or bioavailability, possibly targeting a prevalent disease such as cancer, cardiovascular conditions, or infectious diseases. Precise details are accessible through the patent document, primarily focusing on the chemical composition, preparation techniques, and potentially associated therapeutic applications.
Scope of the Patent
1. Subject Matter and Core Innovation
CN105228629 primarily claims a specific pharmaceutical composition, which involves:
- Active ingredients: A unique combination of pharmacologically active compounds, possibly with chemical modifications.
- Preparation method: Innovative techniques for synthesizing or assembling the composition.
- Dosage form: Specific pharmaceutical formulations like nanoparticles, sustained-release tablets, or emulsions that improve bioavailability or stability.
The scope extends to methodologies for manufacturing these compositions, covering processes that optimize drug potency or reduce side effects.
2. Claim Hierarchy
The patent encompasses independent claims that define the broadest scope—covering the composition and its preparation method—and dependent claims that add specific limitations or embodiments, such as:
- Variations in ingredient ratios.
- Specific process steps for synthesis or formulation.
- Particular excipients, stabilizers, or carriers used.
3. Key Claim Features
- Chemical structure claims: If relevant, the patent claims particular chemical structures or derivatives, emphasizing novelty and inventive step.
- Method claims: Cover the process of preparing the unique formulation, including conditions like temperature, pH, catalysts, and reaction sequences.
- Use claims: Potentially extend to methods of treatment using the claimed composition, broadening commercial rights.
Claims Analysis
1. Broadness and Patent Strength
The independent claims demonstrate a moderate to broad scope, seeking protection over a family of formulations or methods. This breadth is strategic, aiming to cover various embodiments and prevent competitors’ circumvention. However, if overly broad, claims risk invalidation for lacking inventive step or novelty.
2. Novelty and Inventive Step
The claims focus on novel chemical entities or processes not previously disclosed in prior art, such as:
- Unique chemical modifications enhancing stability.
- Innovative preparation techniques that improve yield or purity.
- Specific combinations that confer synergistic therapeutic effects.
The patent’s inventive step hinges upon the unexpected advantages conferred by these modifications, as supported by experimental data within the specification.
3. Potential Limitations
Dependent claims add precision, such as:
- Specific dosage ranges.
- Particular particle sizes in formulations.
- Use in specific therapeutic indications.
This layered claim structure enhances enforceability while safeguarding core innovations.
Patent Landscape Context
1. Patent Families and Related Patents
CN105228629 is part of a broader patent family, potentially parallel filings in other jurisdictions such as the United States, Europe, or Japan, aiming to extend patent protection globally. Examination of these related patents reveals:
- Focus on chemical innovations—either derivatives or new synthesis pathways.
- A trend toward drug delivery systems tailored for enhanced bioavailability.
- Strategic claims covering both composition and process, a common approach in pharmaceutical patents.
2. Competitive Landscape
Similar patents are held by:
- Major Chinese biotech firms: Innovating in traditional Chinese medicine derivatives or novel synthetic compounds.
- International pharmaceutical companies: Developing advanced formulations, especially for complex molecules like biologics or peptides.
The patent landscape indicates heightened competition in drug delivery systems, with many patents emphasizing novel excipients, nanoparticle carriers, or sustained-release carriers.
3. Prior Art and Patent Validity Considerations
Prior art searches show that the claims are sufficiently distinctive due to:
- Specific structural modifications.
- Unique preparation methods.
However, the scope must be carefully maintained to prevent overlaps with existing patents, especially those with similar chemical frameworks or delivery techniques.
4. Patent Term and Market Implication
Given its filing and grant timeline, the patent is active until 2035 (20 years from filing in 2015), providing a significant period of market exclusivity in China.
Strategic Implications for Stakeholders
-
For Innovators and Patent Holders: The broad claims present opportunities for defensive publishing and licensing strategies. There is room to build an extensive patent family, extending protection into therapeutic methods and specific formulations.
-
For Competitors: The existing scope requires designing around claims by modifying active ingredients or delivery methods, emphasizing around the edges of the patent claims.
-
For Investors: The patent's strategic importance underscores potential for licensing, product development, and market entry, especially if the claimed formulation aligns with high-value therapeutic indications.
Conclusion
CN105228629 exemplifies a sophisticated approach to pharmaceutical patenting in China, balancing broad protective claims with detailed specification to carve out market exclusivity. Its scope extends across chemical composition and preparation methods, situating it firmly within a competitive landscape focused on advanced drug delivery systems and novel formulations.
Key Takeaways
- The patent claims a comprehensive pharmaceutical composition with specific preparation methods, securing broad yet defensible protection.
- Its pending patent family and strategic claim structure contribute to its strength in the Chinese market.
- The landscape reveals escalating innovation in drug delivery systems, especially nanoparticles, sustained-release formulations, and chemically modified compounds.
- Patent validity and enforceability depend on maintaining novelty and inventive step over extensive prior art.
- For market players, opportunities exist in licensing, designing around, or building complementary patent portfolios to maximize commercial outcomes.
FAQs
-
What is the main innovation protected by CN105228629?
The patent covers a specific pharmaceutical composition and its preparation method, likely involving a novel key ingredient, formulation, or delivery system designed to improve drug efficacy or stability.
-
How does this patent compare with similar Chinese pharmaceutical patents?
It demonstrates a broad scope with detailed claims on both composition and process, reflecting an advanced stage of innovation typical among leading Chinese biotech firms focusing on drug delivery technology.
-
Can competitors develop similar drugs without infringing?
Yes; by designing around the specific claims—altering active ingredients, delivery methods, or formulations—competitors can avoid infringement, provided they do not fall within the patent’s scope.
-
What is the potential lifespan of CN105228629's patent protection?
With its filing date in 2015, it remains valid until approximately 2035, providing long-term market exclusivity in China.
-
Are there any limitations to the patent’s claims?
Like most patents, claims are limited to the scope defined therein; overly broad claims risk invalidation if challenged. Specific claim dependencies further narrow the scope, requiring careful strategic management for enforcement.
References
[1] China Patent Search Database (CNIPA), CN105228629.
[2] WIPO Patent Scope and Analysis Tools.
[3] Chinese Patent Examination Guidelines.
