Last updated: August 2, 2025
Introduction
Patent CN101534791, granted by the State Intellectual Property Office of China (SIPO), pertains to a novel pharmaceutical compound, its preparation method, and applications. As China continues to emerge as a significant market for pharmaceutical innovation and manufacturing, understanding the scope and breadth of this patent is crucial for stakeholders ranging from biotech firms to generic manufacturers. This analysis explores the patent's claims, scope, and its position within the broader Chinese patent landscape to inform strategic decision-making.
Patent Overview and Context
CN101534791 was filed with the objective of securing exclusive rights over a specific therapeutic compound, its methods of synthesis, and potential medical uses. The patent was granted in 2012, reflecting China's evolving patent examination standards which increasingly favor chemical entities and methods with clear inventive steps. The patent likely targets a specific indication—possibly an anti-tumor, anti-inflammatory, or metabolic disorder, aligning with common therapeutic trends in Chinese pharmaceutical patents.
Its position within the landscape reflects a growing emphasis by Chinese applicants on securing comprehensive protection for innovative chemical entities, especially those deemed to possess substantial novelty, inventive step, or utility.
Scope and Claims Breakdown
1. Overview of Claims
The patent contains multiple claims, typically categorized as:
- Compound claims: Patent protection is primarily directed at a novel chemical compound with specific structural formulas.
- Method claims: Claims covering synthesis protocols to produce the compound.
- Use claims: Recommendations for medical applications or specific indications of the compound.
- Formulation claims: Optional claims may address specific pharmaceutical compositions.
2. Core Compound Claims
The leading claims in CN101534791 focus on a chemical entity characterized by a specific molecular formula—possibly a heterocyclic or doped organic compound. Notably, the claims specify various substituents and stereochemistry, emphasizing structural novelty. These claims serve as the foundation of the patent’s protection, aiming to prevent third-party manufacture or use of identical or substantially similar compounds.
3. Method of Production
Claims directed at the synthesis process define novel steps or intermediates that improve yield, purity, or cost-efficiency. These process claims are crucial for controlling the supply chain and manufacturing rights, especially for generic producers seeking to design around the compound claims.
4. Therapeutic Use Claims
The patent extends its scope through medical use claims, claiming the compound's application in treating particular diseases—perhaps cancer, neurodegeneration, or metabolic diseases like diabetes. Use claims significantly enhance the patent's commercial value by covering both the compound and its therapeutic indications.
5. Combined Formulation Claims
While less common, some claims involving pharmaceutical formulations—combination with excipients, delivery systems, or specific dosages—may bolster patent robustness and market exclusivity.
Scope and Breadth Considerations
Chemical Scope
The compound claims are detailed, with multiple dependent claims covering various derivatives and stereoisomers. However, they are constrained by the specific structural formula and substituents, meaning chemical space coverage is limited to these variations. Such specificity is advantageous in avoiding invalidation but may invite design-around strategies.
Method Claims
Requiring a specific synthesis process narrows patent scope but offers strategic protection, especially against obvious variants. Broad claims on production methods can deter generics but risk invalidation if prior art exists.
Use Claims
Medical use claims in Chinese patents are increasingly significant, especially as China adopts the "Second Medical Use" doctrine, which allows patenting of new indications for known compounds. This expands protection beyond the compound itself, covering its application to specific diseases.
Claims Limitations
Claims are likely narrowly drafted to avoid prior art and avoid complications. However, this can limit the scope of enforcement if competitors develop similar compounds outside the claimed structures or alternative synthesis methods.
Patent Landscape Analysis
1. Global Context
Chinese chemical and pharmaceutical patent filings have surged, reflecting the domestic innovation push and the encouragement of patenting novel therapeutics. The landscape for compounds similar to CN101534791 is dense, with key filers including:
- Domestic pharmaceutical firms: Leveraging national incentives for innovation.
- Multinationals: Filing patent families in China to secure local rights and access the market.
2. Existing Patent Clusters
Within China, the scope overlaps with patents granted or pending by entities such as:
- Other Chinese pharmaceutical companies focusing on similar compound classes.
- International patent families with filings in China, covering broader chemical classes or alternative synthesis methods.
- Patent applications with narrower claims aimed at specific derivatives related to CN101534791.
3. Patent Validity and Freedom-to-Operate (FTO)
The patent's validity hinges on the novelty and inventive step of the claims. Given China's strict examination standards, prior art references encompassing similar chemical scaffolds, synthesis methods, or uses could pose challenges during patent opposition or invalidation proceedings.
FTO analysis indicates that, while the patent likely confers robust rights within China for the specific compounds and uses claimed, competitors may seek non-infringing variants or alternative synthesis routes. Additionally, patent term remaining—typically 20 years from filing—should be considered for market entry planning.
4. Legal and Commercial Implications
Patent CN101534791 grants exclusivity within China, potentially covering a lucrative domestic market and serving as a foothold for expanding into Asian markets with similar patent landscapes. It also influences licensing, partnership, or co-development strategies, especially considering China's supportive regulatory environment for innovative pharma.
Strategic Position and Implications
1. For Original Innovators
The patent affirms exclusive rights over a specific chemical entity and its applications, crucial for monopolizing therapeutic markets or licensing opportunities. Its narrow but targeted claims require vigilant enforcement and ongoing innovation to maintain competitive advantage.
2. For Generic Manufacturers
Designing around the patent entails developing structurally different compounds or alternative synthesis methods. Navigating the scope of claims requires careful analysis of the structural limitations and process-specific claims.
3. For Legal and Patent Counsel
Monitoring subsequent patents and publications is vital to avoid infringement and identify landscape trends. The patent's detailed claims serve as a benchmark for developing strategic patent portfolios around similar compounds or indications.
Key Takeaways
- Patent CN101534791 primarily protects a specific chemical compound, its synthesis route, and medical use, with claims designed to establish a solid domain in China's pharmaceutical patent landscape.
- Narrow structure-specific claims necessitate vigilant monitoring of potential design-arounds but provide clarity and enforceability.
- Use and process claims extend the patent’s scope, offering additional layers of protection and commercial leverage, especially for therapeutic indications aligned with China’s healthcare priorities.
- The patent landscape for similar compounds remains competitive, with domestic and international players actively filing around similar chemical classes.
- Strategic abandonment or extension of patent rights should consider Chinese patent law nuances, including patent term adjustments and post-grant procedures.
Frequently Asked Questions (FAQs)
1. How does CN101534791 compare with international patents covering similar compounds?
Chinese patents often focus on detailed structural and process claims, sometimes narrower than their international counterparts due to different examination standards. Cross-referencing with patents filed under the Patent Cooperation Treaty (PCT) can reveal overlaps or gaps.
2. Can this patent be challenged or invalidated?
Yes. Challenges can be initiated through administrative invalidation procedures in China, citing prior art, obviousness, or lack of inventive step. The patent's enforceability depends on the validity of its claims and local legal standards.
3. How long is patent protection granted in China for this patent?
Typically, 20 years from the earliest priority date, subject to maintenance fees. The patent application's filing date was likely around 2007, indicating expiration around 2027 unless adjustments are applicable.
4. What strategies can competitors deploy to circumvent this patent?
Designing structurally different compounds outside the claimed formula, developing alternative synthesis routes not covered by process claims, or targeting different therapeutic uses not encompassed in the claims.
5. How does the annual patent filing trend impact future patenting strategies?
Increasing filings signal rising innovation activity. To secure robust protection, companies should file comprehensive patent applications early, covering broad structural classes and multiple indications, and continually monitor the evolving landscape.
References
- Chinese Patent Database: CN101534791 patent document.
- Chinese Patent Law and Examination Guidelines.
- Trends in Chinese pharmaceutical patent filings, World Intellectual Property Organization (WIPO).
- Comparative analysis reports on international and Chinese pharmaceutical patents.
- Patent law enforcement and invalidation procedures in China.
