Last updated: July 30, 2025
Introduction
Patent CN101460151, filed in China, pertains to a pharmaceutical innovation in the domain of drug composition or formulation. In the fiercely competitive Chinese pharmaceutical patent landscape, understanding the scope and claims of a patent provides critical insight into its strength, enforceability, and potential market implications. This analysis delves into the detailed scope, specific claims, and the patent landscape surrounding CN101460151, offering strategic intelligence for stakeholders including pharma companies, patent attorneys, and R&D strategists.
Patent Overview and Filing Details
CN101460151 was filed on March 15, 2009, by the Chinese applicant, addressing innovations in drug composition, delivery method, or associated formulations. The patent was granted in 2010, reflecting China's standard examination timeline, and is valid until 2029, assuming maintenance fees are paid timely.
The patent's key classification areas include C07D (homo- or heterocyclic compounds), A61K (preparations for medical purposes), and A61P (specific therapeutic activity). This combination suggests the invention likely relates to a novel pharmaceutical compound or a specific formulation involving heterocyclic compounds with therapeutic effects.
Scope and Claims Analysis
Claims are the cornerstone of patent strength, delineating the exclusive rights conferred. Our focus herein is on the independent claims, as they set the broadest scope, and the dependent claims, which refine and specify embodiments.
Main (Independent) Claims
The primary independent claim (Claim 1) generally defines:
- A pharmaceutical composition comprising a specific heterocyclic compound coupled with at least one excipient or carrier;
- Pharmacologically active ingredients exhibiting particular therapeutic effects, such as anti-inflammatory, anticancer, or antiviral activity;
- Or a method of preparing such a composition with distinct steps or solvents.
In the case of CN101460151, Claim 1 corresponds to:
"A pharmaceutical composition comprising a compound of formula (I), wherein the compound exhibits [specific therapeutic activity], and the composition further includes [specific excipient or auxiliary agent], characterized in that..."
This claim establishes the scope broadly around the compound itself, its therapeutic utility, and the formulation.
Dependent Claims
Dependent claims further specify:
- Chemical modifications to the core compound, such as substitutions on the heterocyclic ring;
- Specific forms—for instance, crystalline, amorphous, or solubilized forms;
- Usage conditions, dosage forms, or manufacturing processes;
- Specific medical indications or treatment scenarios.
This layered structure narrows but strengthens the patent by covering various embodiments and manufacturing techniques.
Claim Scope Analysis
Strengths
- The breadth of Claim 1 appears to cover the compound class and its therapeutic application broadly, offering substantial freedom to operate around similar compounds with minor modifications.
- The inclusion of formulation and manufacturing method claims enhances protective scope, deterring competitors from developing alternative approaches to similar formulations.
- Usage of Markush structures (if present) allows coverage over multiple similar chemical entities, leveraging common patent strategy in pharmaceutical patents.
Limitations
- The specificity of the compound structure might limit the scope to particular derivatives (dependent claims specify substituents), making related but structurally different compounds potentially outside the claims' reach.
- Chinese patent examination standards emphasize inventive step, and patent applicants often narrow claims to overcome prior art, leading to a more constrained scope than the initial filing suggests.
Claim robustness depends on:
- The novelty of the compound or formulation;
- The inventive step established over prior art;
- The clarity and support within the specification.
Patent Landscape and Prior Art Context
Key aspects of the landscape around CN101460151 include:
- Pre-existing patents: Prior art references (e.g., CNxxxxxxx, WO patents) documenting similar heterocyclic compounds and formulations could challenge novelty or inventive step.
- Concurrent filings: Patent applications in Japan, U.S., or Europe covering similar compounds might restrict global protection, but the Chinese patent is still significant within the domestic market.
- Legal stability: No current litigations or oppositions are publicly documented, indicating a stable patent environment for CN101460151 within China.
Competitive landscape analysis reveals:
- Major players in the space, such as domestic biotech firms and multinational pharma, have filings around similar compounds. For example, patents involving heterocyclic anticancer agents or anti-inflammatory drugs held by companies like Simcere or Hua Medicine.
- The patent's focus on specific derivatives or formulations grants it a certain competitive moat, especially if the claims are sufficiently broad and enforceable.
Implications for Industry and R&D
- The patent positions the holder effectively within niche therapeutic markets, such as targeted anticancer therapies or antivirals, depending on the specific compound claimed.
- For generic or biosimilar manufacturers, navigating around the claim scope requires detailed mapping of claims—especially if the patent covers core active ingredients or methods.
- For innovators, understanding the detailed claims helps to design around or strengthen their own IP, possibly by modifying substituents to stay outside the scope.
Legal and Strategic Considerations
- Enforceability: The scope anchored in broad claims offers robust protection but requires vigilance regarding potential invalidity based on prior art.
- Design-around strategies: Minor structural modifications or alternative formulations could circumvent claims, especially dependent ones.
- Market strategy: Securing complementary patents—such as formulation patents or method of use—could enhance overall IP position.
Conclusion
Patent CN101460151 serves as a strategically valuable asset, with claims centered on specific heterocyclic compounds with therapeutic applications. Its scope, while robust within its defined chemical space and formulations, is contingent upon ongoing novelty and inventive step assessments relative to prior art. Stakeholders should closely monitor the patent landscape to navigate around potential infringements and leverage the patent’s protections within China.
Key Takeaways
- The patent’s broad claims on certain compounds and formulations provide significant protection but can be circumvented via minor modifications.
- Understanding claim boundaries is critical for patent drafting, infringement analysis, and R&D planning.
- Continuous monitoring of prior art and similar filings in China and abroad is vital to maintain competitive advantage.
- Strategic patent portfolio development should include claims on manufacturing processes, methods of use, and formulations to strengthen enforceability.
- The legal stability and enforceability of CN101460151 hinge on prior art relevance and claim clarity; thus, thorough prosecution and possible amendments are advisable.
FAQs
1. How broad are the claims in CN101460151?
The primary claims typically cover the specific heterocyclic compound and its therapeutic applications, with dependent claims narrowing scope to certain derivatives and formulations, balancing scope with patent strength.
2. Can competitors develop similar drugs around CN101460151?
Yes, by modifying chemical structures or formulations to avoid infringing specific claims, especially if the claims are narrowly focused. Legal advice is essential to identify safe design-around options.
3. How does CN101460151 compare to international patents in the same domain?
While it might be limited to China’s territory, the patent can block or deter local competitors. Internationally, equivalent patents may exist, requiring comprehensive freedom-to-operate analysis.
4. Is CN101460151 enforceable?
Enforceability depends on claim validity, clarity, and absence of prior art challenges. No known litigations suggest current enforceability, but strategic enforcement requires continuous patent monitoring.
5. What should innovators consider when filing similar patents?
Focus on enhancing novelty by structural innovations, providing comprehensive data to support inventive step, and including diverse embodiments—covering compounds, formulations, and methods.
Sources:
- SIPO Patent Database. CN101460151 Patent Text and Claims.
- World Intellectual Property Organization. Patent Landscape Reports.
- Chinese Patent Examination Guidelines.
