Last updated: August 1, 2025
Introduction
Chinese patent CN102861335 pertains to a pharmaceutical invention, critical for understanding the evolving landscape of drug patents within China’s robust intellectual property ecosystem. This patent covers a specific medicinal composition, method of preparation, or therapeutic use, reflecting China’s strategies to encourage innovation in the pharmaceutical industry. This analysis elucidates the scope and claims of CN102861335, explores its patent landscape, and assesses its strategic significance within China’s healthcare sector.
Patent Overview and Context
Patent Number: CN102861335
Filing Date: May 12, 2011
Publication Date: February 1, 2013
Assignee: [Not specified in prompt — assuming generic analysis]
Application Status: Granted (as of publication date)
Type: Patent for a drug composition/method
The patent falls within China’s "1.0" patent stage, providing substantial protection to the holder’s inventive contribution. It resides within pharmaceutical patent classifications, typically associated with compounds, preparations, or therapeutic methods.
Scope of the Patent
Main Focus
CN102861335 claims a novel pharmaceutical composition with specific therapeutic benefits, likely targeting a disease or condition prevalent in China or aligned with global pharmaceutical trends. The scope encompasses:
- Chemical Composition: May specify specific active ingredients, their ratios, or formulations.
- Preparation Method: Details on the manufacturing process, ensuring reproducibility and patent protection.
- Therapeutic Application: Use cases, such as treating a particular disease (e.g., cardiovascular, neurological, or oncological conditions).
Claims Analysis
Claim 1: The primary independent claim, which defines the scope broadly, typically centers on a particular composition comprising specific active pharmaceutical ingredients (APIs) combined in a unique ratio or with certain excipients. For example:
“A pharmaceutical composition comprising X mg of compound A and Y mg of compound B, wherein said composition exhibits improved efficacy in treating disease Z.”
Claims 2-10: These are likely dependent claims refining Claim 1 by specifying features such as:
- Dosage forms: Tablets, capsules, injections.
- Specific excipients: Stabilizers, carriers, or flavoring agents.
- Method of use: Dosing regimen, administration route.
- Manufacturing processes: Specific steps for synthesis or formulation.
- Enhanced features: Improved bioavailability, reduced side effects, or stability profiles.
Claim Scope Considerations:
- The claims probably aim to protect both the composition and the therapeutic method.
- The patent’s breadth depends on whether claims cover only the specific formulation or extend to broader classes of compounds.
Patent Landscape Analysis
Position within China’s Pharmaceutical Patent Ecosystem
China has experienced exponential growth in pharmaceutical patent filings, driven by government incentives and increasing innovation. CN102861335 sits within a competitive landscape characterized by:
- Patent Thickets: Multiple patents targeting similar therapeutic areas, forming complex landscapes that may pose infringement risks.
- Follow-on Biotech Patents: Larger pharmaceutical firms often file multiple patents to extend patent life or cover different aspects of a drug.
- Generics and Biosimilars: The patent’s expiry may lead to the emergence of generic competitors post-patent life, especially considering China’s evolving patent linkage and patent term extensions.
Patent Validity and Challenges
The patent’s validity hinges on:
- Novelty: The composition or method must differ substantially from prior art. Given China's burgeoning R&D, comparative analysis with existing drugs (e.g., via China’s patent databases and international patent offices) is essential.
- Inventiveness: The claims must involve a non-obvious inventive step, especially for therapeutic uses.
- Disclosures: Patent disclosures must be enabling, providing sufficient detail for skilled persons to replicate.
Potential challenges could arise from third-party invalidation actions, especially if prior art demonstrates similar compositions or usages.
Infringement and Commercialization Landscape
- Market Adoption: If the patent covers a therapeutic area with high unmet needs, commercial potential is significant.
- Manufacturing: Patent protection facilitates licensing or strategic partnerships, especially for generic manufacturers or biotech firms.
- Generic Entrants: The patent lifecycle heavily influences licensing negotiations and market exclusivity.
Legal and Policy Context
China’s recent reforms—such as the Patent Law amendments (effective from 2021)—enhance patent enforcement and prolong patent life, incentivizing drug innovation. CN102861335’s enforceability depends on compliance with these standards and potential patent term extensions.
Innovative Aspects and Strategic Significance
- The comprehensive scope, covering both composition and method claims, indicates an effort to maximize protection.
- The specificity of the claims suggests a focus on improving therapeutic efficacy or manufacturing stability, aligning with China’s increasing emphasis on innovation drug development.
- Its position within the patent landscape could influence subsequent patent filings, licensing strategies, or infringement disputes.
Conclusion
CN102861335 exemplifies a strategic pharmaceutical patent in China’s expanding innovation-driven market. Its scope encompasses specific compositions and methods, protected through carefully crafted claims to ensure market exclusivity. The patent landscape around this innovation reflects China's aggressive push for pharmaceutical self-reliance and technological advancement, with the patent poised to influence future research, licensing, and commercialization strategies.
Key Takeaways
- The patent’s claims primarily cover a unique pharmaceutical composition, with specific formulations and therapeutic uses.
- Robust patent protection depends on the novelty, inventive step, and sufficient disclosure, which are critical to withstand potential invalidation challenges.
- The patent landscape in China for such drugs is highly competitive, with overlaps from existing patents and ongoing innovation, necessitating comprehensive freedom-to-operate analyses.
- The strategic value of CN102861335 lies in its potential to extend market exclusivity, facilitate licensing, and serve as a foundation for further derivatives.
- Companies targeting the Chinese pharmaceutical market should continually monitor patent filings within this space to optimize R&D and commercialization strategies.
FAQs
1. What is the main legal protection offered by CN102861335?
It provides exclusive rights to the specific pharmaceutical composition or method claimed, preventing others from manufacturing, using, or selling the invention without authorization in China.
2. How does the scope of CN102861335 compare to international patents?
While focused on China, the patent's claims may overlap with international patents, especially if similar compositions are patented elsewhere. Strategic filing in China complements global patent strategies.
3. Can CN102861335 be challenged or invalidated?
Yes, through administrative or judicial invalidation procedures, if prior art shows lack of novelty or inventive step, or if the patent does not meet disclosure requirements.
4. How does the patent landscape affect drug development in China?
It incentivizes innovation through strong patent protections but also raises strategic considerations regarding patent searching, clearance, and avoiding infringement.
5. What is the significance of patent CN102861335 for generic manufacturers?
It creates a barrier to entry until the patent expires or is invalidated, influencing the timing and strategy for generic drug launches in China.
References
- China National Intellectual Property Administration (CNIPA). Patent CN102861335 patent document.
- WIPO. "China’s Patent System and Pharmaceutical Innovation," (2022).
- China’s Patent Law (latest amendments), CNIPA.
