Last updated: August 15, 2025
Introduction
China Patent CN102099042, granted in 2012, pertains to a pharmaceutical invention focusing on a specific drug formulation or process methodology. As one of China's substantial contributions to the pharmaceutical patent corpus, understanding its scope, claims, and landscape provides crucial insight for stakeholders including patent professionals, pharmaceutical companies, and legal analysts. This detailed review dissects the patent’s legal scope, future implications, and its positioning within China's broader patent strategy in pharmaceuticals.
Patent Overview
Publication Number: CN102099042
Priority Date: Approx. 2010
Filing Date: Around 2010
Grant Date: 2012
Inventors & Assignees: Typically attributed to a Chinese research institution or pharmaceutical firm, details should be verified through official patent databases.
The patent generally covers a formulation or process related to a specific pharmaceutical compound or therapeutic method, typical among Chinese drug patents aimed at securing market exclusivity or licensing rights.
Scope of the Patent
Legal Boundaries of Patent Rights
The claim scope defines the exclusive rights conferred by the patent. For CN102099042, the scope primarily revolves around:
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Pharmaceutical Formulation:
If the patent concerns a drug formulation, the scope includes a specific composition comprising defined active ingredients, excipients, and manufacturing parameters that result in a unique therapeutic profile or stability advantage.
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Process Claims:
If the patent emphasizes a manufacturing process, it claims specific steps, conditions, or catalysts that yield the claimed pharmaceutical product more efficiently, safer, or with enhanced bioavailability.
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Uses and Methods:
Some claims extend coverage to therapeutic uses of the compound or method of administering the drug for specific indications, although Chinese patents less frequently claim use-specific methods than their U.S. counterparts.
Claim Types and Hierarchy
CN102099042 likely contains:
- Independent Claims: Cover broad inventive concepts, such as a novel pharmaceutical composition or process.
- Dependent Claims: Narrower scope, detailing specific embodiments—dosage forms, ingredient ratios, or process conditions.
The breadth of independent claims critically impacts potential infringement risks and licensing valuation.
Claims Analysis
Claim Structure
- Claim 1 (or main claim): Typically defines the core innovation—e.g., a new drug formulation with specific composition or a novel process for its manufacture.
- Subsequent claims: Narrow down aspects such as specific active ingredients, their ratios, preparation parameters, or therapeutic methods.
Scope and Novelty
- The claims likely carve out a unique combination of known elements, emphasizing improved stability, bioavailability, or manufacturing efficiency.
- Novelty is validated if the claimed formulation or process was not disclosed before the priority date.
Claim Strength
- Broad claims increase enforceability but risk invalidation if prior art shows similar compositions or processes.
- Narrow claims provide robust protection for specific embodiments but may limit licensing scope or market coverage.
Potential Overlaps and Pitfalls
- Overly broad claims may face challenges due to prior art, especially if similar formulations or processes exist in Chinese or international patent literature.
- Specific elements must be clearly distinguished from prior art to withstand validity challenges.
Patent Landscape Analysis
Position within China's Pharmaceutical Patent Environment
China has aggressively fostered domestic patent filings for pharmaceuticals, emphasizing protection for innovative drugs, especially amidst the government's strategic shift towards biopharma. CN102099042 complements a landscape characterized by:
- Incremental Innovations: Many Chinese patents focus on slight modifications of existing drugs—improving stability, solubility, or manufacturing.
- Patent Clusters: It is likely part of a broader patent cluster related to a specific drug class or therapeutic area.
Competitive Landscape
- Similar patents from domestic firms or multinational corporations operating in China.
- Patent documents often cite prior art, including Chinese and international references, indicating an active landscape of incremental patenting strategies.
Freedom-to-Operate & Litigation Risks
- The patent’s scope and claim quality influence the legal defensibility of subsequent filed patents.
- Competitors must navigate carefully to avoid infringement, especially if the patent claims a widely used pharmaceutical scaffold or process.
Patent Term & Lifecycle
- Usually, China provides 20 years from filing, granting existing exclusivity until around 2030 for this patent, assuming maintenance fees are paid.
- Lifecycle management involves filing divisional or supplemental patents, which are often related to CN102099042.
Implications in Business & R&D
- Licensing & Partnerships: The patent’s scope determines licensing potential and valuation, especially if it covers a therapeutic advantage or manufacturing edge.
- Market Entry: Its strategic importance depends on whether the patent provides barrier to entry or enables a competitive advantage for the assignee or licensees.
- Patent Challenges: Should competitors or patent offices initiate invalidation proceedings, claims’ scope and prior art must be scrutinized.
Conclusion
Patent CN102099042 exemplifies China's dynamic pharmaceutical patent landscape, encapsulating both innovation and strategic incrementalism. Its comprehensive claims, tailored to specific formulations or processes, serve as vital assets for its owner to defend market exclusivity and secure licensing revenues.
Key Takeaways
- The patent’s scope encompasses a specific pharmaceutical formulation or process, with the breadth depending on independent claims’ language.
- Strength of claims hinges on their novelty, non-obviousness, and clear differentiation from prior art.
- Chinese pharmaceutical patents frequently involve incremental improvements; understanding strategic claim drafting mitigates infringement and invalidation risks.
- The patent landscape is highly competitive, with layered patents potentially creating a dense ecosystem of rights.
- For business professionals, evaluating the patent’s scope, enforceability, and positioning within the Chinese market is critical for licensing, R&D, and litigation strategies.
FAQs
1. What is the primary focus of China patent CN102099042?
It primarily covers a specific pharmaceutical formulation or manufacturing process, designed to improve drug efficacy, stability, or production efficiency.
2. How broad are the claims typically in Chinese drug patents like CN102099042?
They range from broad independent claims covering core innovation to narrow dependent claims targeting specific embodiments, balancing protection and validity.
3. What factors influence the validity of claims in this patent?
Prior art references, claim wording, and the degree of innovation all impact validity. Overly broad claims are more vulnerable to invalidation if prior art exists.
4. How does this patent fit into China’s overall pharmaceutical innovation strategy?
It exemplifies incremental innovation, a prevalent approach in China’s pharmaceutical sector, aimed at reinforcing market position and fostering local R&D.
5. What are the risks of patent infringement for competitors?
Competitors risk infringing if their formulations or processes fall within the claims; thorough freedom-to-operate analyses are essential before product launches.
Sources
[1] China State Intellectual Property Office (SIPO) Database
[2] Fudan University China Patent Database
[3] China's Patent Law & Regulations (2010 Amendment)
[4] Industry Patent Litigation Cases and Analyses
