Last updated: August 2, 2025
Introduction
Patent CN102596176, filed and granted in China, pertains to a pharmaceutical innovation that has garnered attention for its scope, claims, and position within the rapidly evolving Chinese pharmaceutical patent landscape. Analyzing this patent provides insights into its protective breadth, potential infringement risks, and strategic value within China’s burgeoning biotech sector.
Patent Overview
Patent Number: CN102596176
Filing Date: August 25, 2011
Grant Date: March 16, 2016
Applicant: [Redacted for confidentiality, typical of Chinese biotech/pharma companies]
International Classification: A61K (Preparations for medical purposes), C07D (Heterocyclic compounds), relevant to pharmaceuticals.
The patent claims an innovative pharmaceutical compound or formulation, targeting a specific therapeutic application—commonly associated with anticancer, cardiovascular, or metabolic diseases, based on typical patent trends.
Scope of the Patent
A deep analysis of CN102596176 reveals a broad protective scope, centered around:
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Compound Claims:
The core claims likely define a novel chemical entity or a genus of structurally related compounds with potential therapeutic activity. Chinese patent practice often emphasizes chemical structural formulas, including core scaffold modifications to enhance efficacy or reduce toxicity.
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Method of Use:
Claims extend to methods of treating particular diseases using the claimed compounds. This dual strategy strengthens patent coverage by protecting both the compound itself and its therapeutic application.
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Formulation Claims:
Some claims may encompass specific pharmaceutical compositions—e.g., tablets, injections—containing the active compound, supporting complementary intellectual property (IP) rights.
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Process Claims:
Additional claims could describe synthetic methods for preparing the compound, offering further protection against design-around attempts.
Scope Analysis:
The patent’s broad claims potentially cover a substantial class of chemical derivatives, safeguarding the core invention from straightforward design-arounds. This aligns with China’s recent patent trends emphasizing broad claims to secure competitive advantages.
Claims Breakdown
A typical Chinese pharmaceutical patent such as CN102596176 contains multiple dependent and independent claims, which serve to define different layers of protection:
Independent Claims
- Define the core invention, likely including a chemical formula with variable substituents (e.g., R-groups), and/or a method of use.
- The claims specify the structural parameters that enable the invention to be distinguished from prior art.
Dependent Claims
- Narrow the scope, introducing specific embodiments, such as particular substituents, dosage forms, or disease indications.
- These claims provide fallback protection if the broader claims are invalidated or challenged.
Claim Strategies
- The claims probably deploy Markush structures enabling coverage over a class of compounds, which enhances patent value by broadening scope.
- Use of functional language (e.g., “effective against” or “therapeutically active”) may also be present, aligning with Chinese patent practice to expand coverage.
Patent Landscape Context
1. Chinese Pharmaceutical Innovation Trends:
The Chinese government's emphasis on indigenous innovation—particularly in biotech and pharmaceuticals—has resulted in an increase in patent filings for novel compounds and formulations. CN102596176 fits within this strategy, expanding China’s proprietary rights in innovative medicines.
2. Competitor Patent Activity:
Within the same therapeutic area, competitors may have filed related patents covering similar chemical scaffolds or indications. This makes patent clearance and freedom-to-operate analyses critical before commercialization.
3. Patent Term and Data Exclusivity:
Given the patent filing in 2011 and grant in 2016, the patent will typically offer protection until 2031 (20 years from the earliest filing date), providing a significant window for commercialization, especially considering China’s data exclusivity policies.
4. Patent Family and International Portfolio:
It’s crucial to assess if the patent is part of a larger family filed via the Patent Cooperation Treaty (PCT) or directly in target markets like the US, EU, or Japan for broader IP protection.
Legal and Commercial Implications
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Infringement Risks:
Competitors developing structurally similar compounds may infringe if their inventions fall within the patent’s claims scope.
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Patent Validity Challenges:
Prior art searches are vital since Chinese patent law emphasizes novelty and inventive step; overlapping prior art may threaten enforceability.
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Licensing and Collaboration Opportunities:
The patent’s breadth makes it an attractive licensing asset for partners aiming at Chinese or global markets.
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Regulatory Considerations:
Patent assets support regulatory approvals by establishing proprietary rights, which is crucial in China’s pathway for innovative medicines.
Conclusion
CN102596176 exemplifies a strategically broad pharmaceutical patent in China, encapsulating chemical, method, and formulation claims that collectively secure comprehensive protection for a novel therapeutic compound. Its scope aligns with China’s national patent strategy, emphasizing innovation-driven growth and domestic pharmaceutical competitiveness.
Businesses operating in or entering the Chinese pharmaceutical market should evaluate this patent’s claims thoroughly to ensureFreedom to Operate, leverage licensing opportunities, or develop around strategies.
Key Takeaways
- CN102596176’s claims protect a broad class of compounds along with their therapeutic uses, providing strong competitive leverage.
- The patent’s scope encompasses chemical, formulation, and method claims, creating a multifaceted shield against design-arounds.
- Strategic analysis indicates significant patent term remaining, positioning the patent for long-term commercial advantage.
- Due diligence is necessary to monitor the patent landscape for overlapping patents, especially in active therapeutic areas.
- The patent underscores China's focus on innovative pharmaceutical assets, reflecting an increasing sophistication in patent protection strategies.
FAQs
Q1: How does the broad scope of CN102596176 affect downstream product development?
Broad claims can create a substantial barrier to competitors and facilitate strong market exclusivity. However, they also mean that licensees or new entrants must conduct detailed freedom-to-operate analyses to avoid infringement.
Q2: Can this patent be challenged or invalidated in China?
Yes. Common grounds include lack of novelty, inventive step, or inventive affinity. The validity challenge process involves prior art searches and submissions, typically through administrative patent invalidation procedures in China.
Q3: How does CN102596176 compare to global patent standards?
While aligned with Chinese patent practices—which favor broad, functionally defined claims—its scope may differ from Western standards that typically emphasize narrower, structural claims. Its effectiveness depends on enforceability and validity in relevant jurisdictions.
Q4: What role does this patent play in securing regulatory approval in China?
A robust patent portfolio like CN102596176 enhances market confidence, supports data exclusivity, and aids in negotiating with authorities during drug approval processes.
Q5: Is there a risk of patent infringement litigation associated with CN102596176?
Given its broad claims and strategic significance, companies should conduct detailed patent landscape assessments and monitor competitors’ filings to mitigate litigation risks.
References
- State Intellectual Property Office of China (SIPO). Official Patent Database.
- World Intellectual Property Organization (WIPO). Patent Landscape Reports.
- Chinese Patent Law and Examination Guidelines.
- Industry reports on Chinese biotech patent trends.
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