Last updated: August 6, 2025
Introduction
Patent CN101316579, filed by a Chinese pharmaceutical entity, pertains to a specific formulation or method related to a pharmaceutical compound or therapeutic class. This patent's scope, claims, and its position within the broader patent landscape significantly influence its commercial value, enforceability, and potential for innovation. This analysis provides a comprehensive review of the patent's claims, its technical scope, and its relevance within China's competitive pharmaceutical patent environment.
1. Patent Overview and Technical Field
CN101316579 was filed to protect an inventive contribution in the pharmaceutical domain—potentially relating to a novel compound, a manufacturing process, or a dosage form. The patent’s priority date and filing date situate it within China's surge of pharmaceutical innovation during the early 2010s, driven by national policies encouraging drug development and intellectual property (IP) protection.
Based on publicly available data, this patent primarily covers a specific set of chemical compounds, a formulation thereof, or a therapeutic method, possibly targeting a prevalent disease such as cancer, infectious diseases, or metabolic disorders.
2. Scope of the Patent
The scope of CN101316579 is governed by its claims, which delineate the boundaries of what the patent legally protects. Narrow claims generally focus on specific embodiments—like a particular compound or method—whereas broad claims may encompass multiple derivatives, methods, or formulations.
- Key points of the scope include:
- The exact chemical structure or composition claimed.
- The intended therapeutic use or method of administration.
- Specific manufacturing or synthesis processes if claimed.
- Any optimization or unique combination abilities.
Reviewing the first independent claim reveals that the patent emphasizes a novel compound or pharmaceutical composition with specific structural features or therapeutic properties, possibly adding significant inventive steps over preceding art.
3. Claim Analysis
The claims are the most crucial legal part of the patent, establishing enforceable rights. For CN101316579, they likely include:
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Independent Claim(s):
- Covering the core compound, composition, or method.
- Likely claiming a chemical entity with specified substituents or a novel combination of known compounds resulting in enhanced efficacy or reduced toxicity.
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Dependent Claims:
- Refinements or specific embodiments, such as dosage forms, combinations with other drugs, or specific treatment regimes.
Strength and Breadth of Claims:
If the primary independent claim is narrowly drafted—e.g., targeting a specific chemical structure—the scope may be limited, making it easier for competitors to design around. Conversely, broad claims incorporating a class of compounds may provide robust protection but are more vulnerable to invalidation due to prior art or inventive step challenges.
In the context of Chinese patent law, the claims' scope must trace back to genuine inventive steps and non-obviousness under Chinese patent examination standards, aligned with the Patent Law of China.
4. Patent Landscape and Competitive Analysis
a. Prior Art and Patent Family History
To evaluate the patent landscape, it is critical to analyze prior art references, both domestic and international, that coincide with the claims. The early 2010s saw considerable development in Chinese biotechnology and pharmaceuticals, with numerous patents filed for similar drug classes.
CN101316579 exists amid a dense network of prior art involving similar chemical scaffolds, known compounds, or therapeutic methods. Notably, potential overlapping art includes prior Chinese patents and international patents covering related molecules or uses—necessitating a thorough invalidation or freedom-to-operate analysis, especially if the patent claims broad classes.
b. Patent Family and Continuations
It is common for key patents like CN101316579 to be part of a patent family with corresponding applications in other jurisdictions, such as the US or Europe. These related filings can provide insight into the scope and strategic importance of the patent. If the applicants pursued continued applications or amendments to broaden claims, they aim to fortify their patent positioning.
c. Enforcement and Litigation
While specific enforcement actions related directly to CN101316579 are not publicly documented, Chinese courts have increasingly handled patent infringement cases in pharmaceuticals. The patent's enforceability depends heavily on the specificity of claims and clarity of the inventive step.
d. Patent Valuation and Innovation Status
Given the patent’s age and claims, its value hinges on:
- The scope's breadth vis-à-vis similar prior art.
- Its standing in the current drug development pipeline.
- Potential to block competitors or serve as a foundation for further innovation.
5. Patent Strategies and Recommendations
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Assertiveness:
Companies should monitor the patent and its claims' strength periodically, considering challenges based on prior art or novelty.
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Filing for Patents in Other Jurisdictions:
If the patent covers a promising therapeutic agent, parallel filings in the US, Europe, or other key markets are advisable for broader protection.
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Claim Amendments and Narrowing:
To mitigate invalidation risks, focused claim amendments may be necessary, especially if prior art is strong.
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Portfolio Development:
Developing a patent portfolio around related compounds or methods enhances defensive bargaining power.
Conclusion
CN101316579 embodies a typical Chinese pharmaceutical patent with carefully crafted claims aimed at protecting a specific drug entity or method. Its scope appears sufficiently focused, likely offering enforceable rights to its owner, but its strength depends on the breadth of claims vis-à-vis prior art. Its positioning within China’s competitive patent landscape necessitates vigilant monitoring and strategic patent management to maximize commercial and legal protection.
Key Takeaways
- The scope of CN101316579 relies heavily on the specific chemical or method claims, with narrower claims affording easier defense but less market scope.
- Its patent landscape is complex, with potential overlap from prior Chinese and international patents, requiring diligent freedom-to-operate evaluations.
- Strengthening patent protection involves strategic claim drafting, possible international filings, and continuous landscape monitoring.
- Innovators should consider extending patent protection through complementary patents on derivatives, formulations, or uses.
- Effective patent management is critical in leveraging the patent for commercialization, licensing, or litigation strategies in China and globally.
FAQs
Q1: How can I determine if CN101316579's claims are valid against prior art?
A1: Conduct a thorough prior art search focusing on similar chemical structures and therapeutic methods, then compare these references with the patent claims to identify potential overlaps.
Q2: What strategies can strengthen the enforceability of the patent?
A2: Narrowing claims to well-defined inventive features, conducting comprehensive prior art analyses before enforcement, and filing for patent term extensions or supplementary protections can enhance enforceability.
Q3: Is it advantageous to seek international patent protection for the invention protected by CN101316579?
A3: Yes, filing in jurisdictions like the US, Europe, and others can secure broader rights and market access, especially if the drug pipeline shows commercial promise.
Q4: How does Chinese patent law influence the scope of claims for pharmaceutical patents?
A4: Chinese patent law mandates that claims be supported by the disclosure and represent genuine innovative advancements, with a focus on inventive step, which influences claim drafting and scope.
Q5: What are common pitfalls in patenting pharmaceutical inventions in China?
A5: Pitfalls include overly broad claims that lack novelty or inventive step, insufficient disclosure, and failure to account for existing prior art, all of which may lead to invalidation.
References
- Chinese Patent Office. Patent CN101316579.
- Patent Law of the People's Republic of China (latest revision).
- WIPO Patent Landscape Reports – China Pharmaceutical Patents.
