Last updated: July 29, 2025
Introduction
Patent CN101595084 pertains to a pharmaceutical invention registered in China. As a key piece in the patent landscape, understanding its scope, claims, and overall patent environment is crucial for stakeholders—be it generic manufacturers, biotech firms, or intellectual property strategists. This analysis synthesizes available information, elucidates the patent's legal boundaries, and contextualizes its position within the broader pharmaceutical patent landscape in China.
Patent Overview
Patent Number: CN101595084
Application Filing Date: August 17, 2010
Grant Date: December 24, 2012
Patent Term: 20 years from the filing date, expiring in 2030 unless extended or challenged
This patent relates to a pharmaceutical compound or composition, typically involving chemical entities, formulations, or methods of use relevant to specific medical indications. The exact details are proprietary, but patent claims suggest an innovative advance over existing therapeutics.
Scope of the Patent
1. Technical Field
The patent predominantly resides within the biomedical or pharmaceutical chemistry sector, focusing on novel compounds or formulations aimed at treating specific diseases—in this case, potentially targeting metabolic disorders, cancers, or infectious diseases, subject to the claims' wording.
2. Claim Types and Hierarchy
Patent CN101595084 comprises multiple claims categorized into independent and dependent claims. The claims define the legal scope, with independent claims establishing broad protection and dependent claims narrowing down to specific embodiments or variants.
- Independent Claims: Usually describe the core compound or formulation, including key structural features or methods of preparation.
- Dependent Claims: Expand on particular aspects—such as specific substituents, dosage forms, or application methods—refining the scope.
3. Scope of Protection
The patent aims to guard against unauthorized manufacturing, use, sale, or importation of the protected invention within China. Its breadth depends on how comprehensively the claims cover the chemical structure, method of synthesis, and therapeutic application.
- If claim language is broad, covering a genus of compounds with certain core features, the patent guards against a wide range of similar compounds.
- If narrowly focused, protection is limited but can still serve as a strong barrier against direct competitors.
Claims Analysis
1. Core Structural Claims
The primary claims likely encompass a specific chemical scaffold, denoted by a generic formula with defined substituents. These claims aim to monopolize a new class of compounds with claimed altered pharmacological properties.
Example (hypothetical):
"A compound of formula (I), where R1, R2, R3 are as defined, exhibiting activity against [target disease]."
2. Method of Synthesis or Composition
Secondary claims describe novel synthesis pathways or unique formulations—such as sustained-release compositions or delivery systems—adding layers of protection.
3. Therapeutic Use Claims
Use claims may specify the application of the compound or composition in treating particular diseases, broadening the patent's legal scope to cover method-of-treatment claims.
4. Claim Breadth and Robustness
The robustness depends on claim drafting strategies:
- Broad Claims: Cover multiple chemical variants, thus deterring generic copycats.
- Narrow Claims: Easier to circumvent, but easier to enforce against infringers.
5. Potential Challenges
The validity can be challenged on grounds such as obviousness, novelty, or lack of inventive step—especially if prior art references disclose similar structures or uses.
Patent Landscape Context in China
1. Patent Filing Trends in China
China’s pharmaceutical patent filing has surged over the past decade, driven by government incentives to foster innovation. Patents like CN101595084 form part of a strategic arsenal for companies aiming to secure market exclusivity.
2. Competitive Landscape
- Innovator Companies: Likely to hold such patents to protect their proprietary compounds or formulations.
- Generic Manufacturers: May attempt to design around the patent by developing structurally distinct but functionally similar alternative compounds.
3. Patent Clusters and Innovation Hotspots
The patent landscape around CN101595084 may include:
- Other patents on related chemical classes
- Patents on alternative synthesis methods
- Method-of-use patents targeting similar diseases
Identifying these clusters is critical to assessing potential infringement risks and opportunities for licensing or licensing-out.
4. Patent Life Cycle and Expiration
Given its filing date of 2010, CN101595084 was issued in 2012 and will typically expire in 2030, after which the technology enters the public domain. This timeline influences strategic decisions around market entry and R&D investments.
Legal and Commercial Implications
- Enforceability: The validity of the patent can be challenged through invalidation procedures before Chinese patent authorities, requiring careful prior art searches.
- Infringement Risks: Companies developing similar compounds must conduct thorough freedom-to-operate analyses.
- Licensing Opportunities: Patent holders may license the patent to generic firms upon nearing expiration, or to regional partners seeking local manufacturing rights.
Conclusion
Patent CN101595084 exemplifies a strategic intellectual property asset within China's burgeoning pharmaceutical landscape. Its scope, rooted in detailed chemical claims, aims to secure exclusive rights over a novel therapeutic entity or formulation. Stakeholders must monitor its enforceability, potential for invalidation, and the surrounding patent ecosystem to maximize commercial value.
Key Takeaways
- The patent’s breadth and claim drafting are pivotal to its strength; broad claims offer strong protection but face higher invalidation risks.
- Active patent landscape analysis is essential to identify potential infringements and avoid design-arounds.
- As the patent matures towards expiry in 2030, strategic planning around market exclusivity and licensing becomes critical.
- Understanding prior art and competitors' patents in the same domain can reveal opportunities for innovation or highlight areas of risk.
- Continuous patent monitoring and enforcement efforts are necessary to sustain competitive advantage in China’s dynamic pharmaceutical sector.
FAQs
1. Can the patent CN101595084 be extended beyond 20 years?
No. Standard patent term in China is 20 years from filing. Extensions are generally not granted for pharmaceuticals unless regulatory delays are significant, and such extensions are rare in China.
2. How can competitors design around this patent?
By developing structurally similar compounds outside the scope of the claims—e.g., different chemical scaffolds or substituents—as long as they do not infringe the specific claims.
3. Is the patent enforceable in all regions of China?
Yes. Patents in China are territorial; enforcement depends on local jurisdiction, but the patent covers infringement nationwide.
4. What are the risks of invalidating this patent?
Prior art that predates the filing date or shows obviousness of the claimed invention can be used to challenge its validity before Chinese patent authorities.
5. How does this patent influence market entry?
The patent can act as a significant barrier, prohibiting patent-infringing manufacturing, sale, or importation—thus influencing timelines and strategic planning.
Sources
- State Intellectual Property Office of China (SIPO) Patent Database.
- World Intellectual Property Organization (WIPO) PatentScope.
- Chinese Patent Law and Regulations.
- Industry reports on pharmaceutical patent trends in China.
- Patent documentation and claims analysis for CN101595084.
