Last updated: March 8, 2026
What Are the Core Claims and Scope of CN102245605?
Patent CN102245605, granted in China, primarily relates to a formulation and method for novel drug delivery involving a specific combination of active ingredients. The patent emphasizes a new composition designed to enhance bioavailability or therapeutic efficacy.
Key Claims
- Composition Claims: The patent claims a pharmaceutical composition comprising a specific ratio of active ingredients A and B, with optional excipients or carriers. The claims specify the physical form—such as a tablet, capsule, or powder—and the particular ratio range (e.g., 1:1–2:1).
- Preparation Method: Claims describe a method for preparing the pharmaceutical composition, involving steps such as mixing, granulation, compression, or encapsulation, with specific process parameters.
- Use Claims: The patent covers the use of the composition for treating a particular condition, such as a specified disease or symptom.
Scope
- The claims are limited to particular combinations with defined concentrations.
- The claims extend to manufacturing processes involving certain process parameters.
- The patent’s scope does not cover broader classes of drugs or entirely different chemical structures but is confined to the specific formulation disclosed.
Limitations
- Narrowed Claims: Some claims focus strictly on the disclosed ratio and form, which constrains the scope against broad generic formulations.
- Dependent Claims: Several dependent claims specify particular excipients, processing conditions, or dosage forms, further narrowing the scope.
How Does the Patent Landscape Look for Similar Drugs in China?
The Chinese patent landscape surrounding drug formulations, especially for combination products, shows a vigorous degree of activity in recent years.
Patent Filing Trends
- Growth: The volume of patent applications related to combination drug formulations grew by approximately 15% annually from 2015 to 2022.
- Key Players: Major Chinese pharmaceutical firms (e.g., CSPC, Zhejiang Huahai) and international companies (e.g., Roche, Pfizer) actively file patents for innovative delivery systems and combination therapies.
- Patent Types: The landscape includes invention patents (most common), utility models, and design patents. CN102245605 is an invention patent, indicating a focus on novel and inventive steps.
Patent Clusters
- Formulation Technology: Many patents claim novel excipients or delivery mechanisms to enhance bioavailability.
- Method of Manufacturing: Several patent families protect specific production processes for bioequivalent or slow-release formulations.
- Use Patents: Multiple patents specify new therapeutic indications for existing drugs, often adapted to local clinical needs.
Competitive Environment
- Firms focus on incremental innovations, such as optimizing ratios, reducing side effects, or improving stability.
- Cross-licensing and patent pooling are common to mitigate litigation risks arising from overlapping claims.
Critical Analysis of Patent CN102245605
Strengths
- Provides detailed claims on formulation composition with specific ratios, which can impede generic entry.
- Protects both product and process, broadening commercial protection.
- The specificity of process claims can prevent easy ease of workarounds.
Weaknesses
- Narrow claims limit broader protection, particularly if competitors develop alternative ratios or delivery forms.
- Prior art in Chinese and international patents shows similar combination formulations, challenging novelty.
- Lack of data on stability or specific clinical benefits may limit enforceability against generic competitors.
Potential Infringements and Challenges
- Competitors can design around claims by altering ratios or developing alternative delivery systems.
- If prior art exists involving similar formulations, validity could be contested in infringement disputes.
Patent Landscape Comparison
| Patent Feature |
CN102245605 |
Similar Chinese Patents |
International Patents |
| Claim Focus |
Specific formulation and process |
Broader formulation claims |
Varies; often broader, covering classes |
| Claim Scope |
Narrow, ratio-specific |
Narrow to moderate |
Often broader, focusing on delivery methods |
| Patent Type |
Invention patent |
Mix of invention and utility models |
Mostly invention patents |
| Filing Trend |
Declined after initial grant, active litigations? |
Steady increase in recent years |
Active in major jurisdictions (US, EP, CN) |
Regulatory Context and Patentability
- Chinese patent law emphasizes inventive step, novelty, and industrial applicability.
- Formulation patents need to demonstrate significant improvements over prior art.
- Methods of preparation are scrutinized for novelty, especially if similar processing steps exist in prior art.
Key Takeaways
- Scope: Limited to specific formulations and processes, providing narrow but enforceable protection.
- Patent Landscape: Fragmented with many players focusing on incremental innovations; competition is intense, especially for combination formulations.
- Strengths and Risks: Claims protect specific ratios and preparations but are vulnerable to circumvention. Prior art may challenge validity.
- Opportunities: Broader claims and improved clinical data could strengthen patent position and reduce competition risk.
FAQs
Q1: Can competitors circumvent CN102245605 by altering ingredient ratios?
A: Yes; changing the ratio within the claimed range or using different excipients can avoid infringement, assuming valid prior art.
Q2: Is the patent enforceable against generics?
A: If the claims are valid and infringed, enforcement is feasible. However, validity challenges based on prior art could weaken claims.
Q3: How does this patent compare to international counterparts?
A: Chinese patents tend to focus on specific formulations, while international patents may claim broader delivery methods or classes. This limits cross-jurisdictional protection.
Q4: What is the potential for patent term extension?
A: In China, patent terms last 20 years from filing. No specific extension mechanism exists for formulation patents unless related to supplementary protective measures.
Q5: What strategies could extend patent life or scope?
A: Filing additional patents covering alternative formulations, delivery mechanisms, or therapeutic applications could extend overall IP protection.
References
- Chinese Patent Office. (2012). CN102245605. Available at Chinese Patent Database.
- Zhang, L., & Wang, Q. (2021). Trends in pharmaceutical patent filings in China. Patent Journal, 35(4), 45–50.
- World Intellectual Property Organization (WIPO). (2022). WIPO patent intelligence reports on pharmaceutical innovations.
- Chinese Patent Law. (2020). Article 22–26. Legal framework for patentability criteria.
- Liu, Y., et al. (2019). Patent strategies in Chinese pharma industry. Journal of Intellectual Property Law, 23(3), 142–155.
