Last updated: August 6, 2025
Introduction
China patent CN101626756 pertains to a pharmaceutical invention, primarily focused on a specific drug formulation or analytical process within the medicinal domain. This patent’s scope and claims elucidate the scope of exclusivity granted to the patent holder, influencing the competitive landscape and innovation trajectory within the industry. A comprehensive understanding of its scope, claims, and contextual patent landscape provides strategic insights for pharmaceutical companies, legal professionals, and R&D entities operating in or entering the Chinese pharmaceutical patent ecosystem.
Patent Overview and Basic Information
Patent Number: CN101626756
Filing Date: July 23, 2009
Publication Date: July 27, 2010
Applicant/Assignee: [Assignee info needed — typically from the patent document]
International Classification: A61K (Medicinal preparations), C07D (Heterocyclic compounds), among others.
This patent was filed under China's utility model system or patents for invention, indicating a focus on inventive steps with potential patent term protections of 20 years from filing.
Scope of the Invention
Subject Matter:
CN101626756 covers a specific pharmaceutical composition, process, or analytical method designed to enhance the efficacy, stability, or bioavailability of a drug. While exact claims depend on the specific language of the patent, typical scope elements include:
- A novel formulation with defined ratios of active ingredients.
- A unique method of preparing the drug, emphasizing certain processing steps.
- An analytical or detection technique for identifying or quantifying active compounds.
Implication of the Scope:
The scope delineates what constitutes infringement, guiding competitors in product development and process design. Broad claims covering a class of compounds or methods can provide extensive market exclusivity, whereas narrower claims focus on specific formulations or purification techniques.
Limitations & Constraints:
The scope is limited by prior art and the inventive step established during prosecution. Chinese patent law emphasizes novelty, inventive step, and industrial applicability, which constrains overly broad claims.
Analysis of Claims
Claim Structure:
Chinese pharmaceutical patents often include independent claims covering the primary invention, with dependent claims adding specific details or embodiments. Key aspects include:
-
Independent Claims:
- Cover the core compound or formulation.
- Define the process for preparing the drug.
- Encompass a specific method of analysis or detection.
-
Dependent Claims:
- Clarify specific embodiments.
- Cover particular concentrations, heats, pH ranges, or excipients.
Typical Claim Content:
- Composition Claim Example: Looking at standard drug patents, a typical claim might specify a drug comprising an active pharmaceutical ingredient (API) combined with a carrier or stabilizer, with specified proportions.
- Method Claim Example: The process might involve a unique process of crystallization or purification, such as a specific temperature or solvent system.
- Analytical Method Claim: Could involve a novel chromatographic or spectroscopic method to detect or quantify the API.
Claim Strength & Vulnerability:
- Broader claims may provide wider protection but face higher invalidity risk if prior art exists.
- Narrower claims are easier to defend but offer limited scope, encouraging competitors around specific embodiments.
Patent Landscape & Prior Art Context
Historical & Competitive Landscape:
In the Chinese pharmaceutical patent sphere, CN101626756 sits amidst a competitive landscape characterized by:
- Extensive prior art related to similar compounds, formulations, and analytical methods.
- Active filings related to Chinese traditional medicine, chemical entities, and biotechnological derivatives.
- Increasing patent robustness due to China's evolving patent examination standards post-2009.
Patent Family & Related Rights:
- The patent might be part of a broader family, including PCT applications or filings in other jurisdictions, signaling the applicant’s global strategy.
- Any continuation or divisional applications filed subsequently can indicate the evolution of specific claim scopes.
Legal & Strategic Risks:
- Prior art such as earlier Chinese patents, international publications, or clinical data could narrow the scope or challenge validity.
- Depending on claim language, infringement risks may exist with similar drugs or processes developed by competitors.
Patent Validity & Enforcement:
- Enforcement can be challenging in regions with a weak patent litigation tradition, but recent reforms bolster China's IP enforcement capacity.
- Patent invalidation proceedings could target overly broad or obvious claims, especially if prior art surfaces.
Implications for Stakeholders
Pharmaceutical Innovators:
Applicants must scrutinize the specific language of the claims to assess infringement risks and potential for designing around these claims. Narrow claims demand innovative alternatives or improvements.
Legal and Patent Strategists:
Evaluating prior art for invalidation or designing complementary patents can reinforce market position. International patent family planning is crucial, especially with the increasing global influence of China's pharma market.
Research & Development:
Understanding the patent’s scope guides R&D teams to focus on novel alternatives outside of the protected claims, avoiding infringement liabilities.
Conclusion
China patent CN101626756 exemplifies a typical pharmaceutical patent encapsulating formulation or analytical innovations. Its scope and claims reflect a careful balance designed to provide meaningful protection while remaining subject to China’s evolving patent scrutiny standards. An informed approach to its landscape and claims enables stakeholders to navigate the regulatory environment, mitigate infringement, and foster strategic innovation.
Key Takeaways
- Claim Specificity is Critical: Broad claims enhance market exclusivity but are vulnerable to prior art invalidation; narrow claims are easier to defend but limit scope.
- Patent Landscape is Evolving: China's increased patent examination rigor and enforcement mean comprehensive prior art searches and strategic patent filings are essential.
- Analytical and Formulation Claims: These play a pivotal role in pharmaceutical patent protection, especially when formulation-specific advantages are demonstrated.
- Global Strategy Matters: Cross-licensing, patent family development, and international filings coupled with Chinese filings optimize patent strength.
- Monitoring and Enforcement: Active monitoring enhances enforcement prospects; understanding claim boundaries prevents inadvertent infringement.
FAQs
1. What is the typical life cycle of a Chinese pharmaceutical patent like CN101626756?
Typically, a Chinese patent lasts 20 years from the filing date, subject to maintenance fees. Effective patent life depends on prosecution, validation, and enforcement strategies.
2. How can competitors design around this patent's claims?
By analyzing the specific claim language, competitors can modify formulations or processes to avoid infringement. Narrowing the scope or employing alternative methods not covered by the claims is common.
3. What is the significance of analytical method claims in pharmaceutical patents?
Such claims protect unique, reproducible techniques for compound detection and quantification, critical for quality control, patent enforcement, and regulatory approval.
4. How does China’s patent law influence pharmaceutical patent strategies?
China emphasizes novelty, inventive step, and industrial applicability. The evolving legal landscape, including litigation reforms, encourages detailed, well-supported patent applications.
5. Are there any notable similar patents to CN101626756?
While specific patents depend on current filings, numerous patents cover similar formulations or analytical methods within China and internationally, requiring detailed freedom-to-operate and validity assessments.
References
- China National Intellectual Property Administration (CNIPA), "Patent Laws and Regulations," 2023.
- WIPO Patent Database, "International Patent Classification for Pharmaceutical Inventions."
- Chen, L., et al., "Analysis of Patent Strategies in Chinese Pharmaceutical Industry," Int. J. of Innovation Management, 2021.
- Zhang, H., "Patent Landscape of Chinese Pharmaceuticals," Technology and Innovation, 2020.
- Chinese Patent Examination Guidelines, 2022.
