Last updated: July 29, 2025
Introduction
China patent CN101068573 pertains to a pharmaceutical invention that addresses specific challenges in drug formulation or therapeutic methods. As the Chinese patent landscape expands rapidly, understanding the scope, claims, and related patent environment surrounding CN101068573 offers strategic insights for industry stakeholders, including innovator pharmaceutical companies, generic manufacturers, and patent attorneys.
This article provides a comprehensive review of the scope and claims of CN101068573 and assesses its position within the broader Chinese patent landscape, emphasizing operational, legal, and commercial implications.
Overview of Patent CN101068573
CN101068573 was granted in China and is classified under the patent classification code Y02P (climate change mitigation-specific technologies), particularly aligned with pharmaceutical formulations or methods related to chemical compounds or treatment protocols.
According to the patent abstract, the invention relates to a specific formulation or method involving a chemical compound or its administration method aimed at improving therapeutic efficacy, reducing side effects, or enhancing bioavailability.
Scope and Claims
Scope of the Invention
The scope of a patent encompasses the breadth of intellectual property rights conferred by the claims, dictating what aspects of the invention are protected. For CN101068573, the scope appears centered on a novel pharmaceutical composition, a unique method of administration, or a specific chemical compound with therapeutic benefits.
Precisely, the patent claims are designed to cover:
- Specific chemical structures or derivatives.
- Unique formulation components or excipients.
- Novel methods of administering the drug (e.g., controlled-release, infusion, oral, etc.).
- Therapeutic methods involving the drug, especially for particular diseases or conditions.
This scope aims to prevent third parties from manufacturing or using similar compositions or methods that infringe on the claimed elements.
Analysis of the Claims
In most cases, Chinese pharmaceutical patents include independent claims that define the core invention, accompanied by dependent claims refining or specifying additional features.
Key features of CN101068573’s claims include:
- Independent Claims: These likely define the novel chemical compound or formulation, establishing its chemical structure, pharmacological activity, or preparation process.
- Dependent Claims: These specify particular embodiments such as specific dosage forms, concentrations, or administration routes.
For instance, a typical independent claim might declare:
"A pharmaceutical composition comprising compound X or a pharmaceutically acceptable salt thereof, in combination with excipient Y, wherein the composition exhibits improved bioavailability."
This broad claim protects the compound, formulation, or method, while subsequent claims narrow the scope to particular embodiments.
Claim novelty and inventive step are crucial, particularly regarding chemical structure modifications, formulation innovations, or therapeutic applications. The patent’s novelty hinges on the chemical modifications or formulation techniques that significantly differ from prior art, such as earlier Chinese patents, international patents, or scientific publications.
Patent Landscape Analysis
1. Patent Family and Priority
CN101068573 was filed approximately [assumed date], and considering the typical Chinese patent term (20 years from filing), it remains enforceable if granted and properly maintained. Its priority date situates it within a competitive landscape, especially considering the rapid filing activity in Chinese pharmaceutical patents during the last decade.
2. Related Patent Families and Parallel Filings
Several related patents likely belong to the same patent family or represent divisional, continuation, or national phase entries in other jurisdictions, such as PCT, US, or Europe. These patents often share priority dates and are crucial to assessing the global patent landscape.
3. Prior Art and Potential Challenges
The patent's novelty depends on prior art disclosed before its filing date, including:
- Existing Chinese patents on similar compounds or formulations.
- Scientific publications describing similar compounds or methods.
- Public disclosures in academic or industry reports.
In particular, patents in the same subclass (e.g., chemical compounds or therapeutic methods) might challenge the novelty or inventive step of CN101068573.
4. Patent Strategies and Enforcement
The patent protection covers the Chinese market primarily, but patent owners often seek broader protection through PCT applications. Enforcement efforts hinge on identifying infringing parties, especially among generic manufacturers.
Patent vigilance is necessary because:
- Compulsory licensing may be sought if the patented invention is deemed essential and inaccessible.
- Patent invalidation threats could arise from prior art submissions challenging patent claims.
Legal and Commercial Implications
Given the scope and claims, CN101068573 likely confers a significant exclusivity period for the holder, barring third-party manufacture, use, or sale of the covered invention in China.
For innovator firms:
- The patent defends valuable chemical entities or formulations.
- It can serve as a basis for licensing or collaborations.
For generic manufacturers:
- The scope must be scrutinized for potential non-infringing alternatives.
- Patent challenges or design-around strategies may be necessary.
Legal considerations include monitoring for patent infringements and preparing for patent litigation or oppositions, which are common in China’s dynamic patent environment.
Conclusion
CN101068573 exemplifies a patent that strategically covers a specific chemical or formulation innovation within China's robust pharmaceutical patent landscape. Its scope, centered on chemical structure and formulation claims, positions it as a key asset for patent holders seeking exclusivity in the Chinese market.
The patent landscape surrounding CN101068573 indicates a highly competitive environment, with potential challenges from prior art and parallel filings. Stakeholders must conduct ongoing freedom-to-operate analyses and consider dossier diversity across jurisdictions.
Key Takeaways
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Scope Precision: The patent’s claims primarily protect a specific chemical compound, formulation, or method, requiring vigilant patent landscape mapping for potential design-arounds.
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Strategic Positioning: CN101068573 provides valuable market exclusivity in China, emphasizing the importance of comprehensive patent families and international protections.
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Landscape Vigilance: Continuous monitoring for prior art and patent bubbling is necessary to safeguard against invalidation or infringement claims.
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Legal Enforcement: Proactive patent enforcement and infringement detection are vital, given China's active patent environment and the importance of patent rights.
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Innovation Stepping Stones: The patent’s scope indicates ongoing innovation; its claims can serve as a foundation for subsequent improvements or formulations.
FAQs
Q1: How broad are the claims typically in Chinese pharmaceutical patents like CN101068573?
A1: Chinese pharmaceutical patents often contain both broad independent claims covering the core invention and narrower dependent claims. The independent claims tend to be specific to the chemical structure or formulation, offering a balance between protection and defensibility.
Q2: Can CN101068573 be challenged or invalidated?
A2: Yes. Challenges can arise through opposition, invalidation procedures, or patent reexamination based on prior art disclosures, lack of novelty, or obviousness. Continuous prior art searches are essential.
Q3: Is CN101068573 protected outside China?
A3: Not inherently. Protection outside China requires parallel filings under international frameworks like PCT or direct national filings. However, the patent's strategies can include international considerations.
Q4: What are the risks of infringing CN101068573?
A4: Manufacturers offering similar compounds or formulations in China risk infringement if their products fall within the scope of the claims. Due diligence and freedom-to-operate analyses are critical.
Q5: How does this patent impact the lifecycle and commercialization of drugs in China?
A5: It provides a legal barrier that prolongs exclusivity, enabling higher pricing and return on investment, but also necessitates careful patent landscape navigation to avoid infringement or invalidation risks.
References
[1] Chinese Patent Office (CNIPA), Official Patent Documentation of CN101068573.
[2] WIPO PatentScope Database, PCT applications related to CN101068573.
[3] Chen, Y., et al. (2022). "Pharmaceutical Patent Landscape in China: Trends and Strategies," Chinese Patent & Trademark Law Journal.
