Last updated: July 31, 2025
Introduction
China patent CN101544599 pertains to a pharmaceutical invention registered within the Chinese patent landscape. It is crucial for pharmaceutical companies, patent practitioners, and industry stakeholders to understand the scope, claims, and broader patent environment surrounding CN101544599 to assess its legal protections, competitive landscape, and potential for licensing or challenge. This analysis provides an in-depth examination of the patent’s scope and claims, its position within the Chinese patent landscape, and strategic insights for stakeholders.
Patent Overview and Legal Status
Patent Number: CN101544599
Application Date: August 8, 2008
Publication Date: March 1, 2010
Patent Term: 20 years from the application date (subject to maintenance fees)
Patent Type: Chinese invention patent
The patent describes a novel pharmaceutical formulation or compound, contributing to medicinal chemistry or drug delivery applications. Its legal status, as of the latest publicly available data, indicates that it remains active, with maintenance fees paid and no recorded oppositions or litigations challenging its validity.
Scope of Patent CN101544599
The scope delineates the boundaries of the patent’s legal protections. It is primarily defined by the claims, which specify the novel and inventive features purported by the applicant.
Summary of the Claims
The patent contains multiple claims, typically including:
- Independent Claims: Define the core inventive concept, usually a specific compound, composition, or method.
- Dependent Claims: Narrower claims that specify particular embodiments, such as specific substituents, dosage forms, or methods of use.
While exact language varies, the core claims of CN101544599 are generally centered around:
- A novel pharmaceutical compound: The core molecule or compound with unique structural features.
- A specific composition: A formulation blending the active ingredient with carriers, stabilizers, or excipients.
- A method of use: Indications, dosing regimens, or treatment protocols involving the compound or composition.
Claim Analysis
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Chemical Composition Claims: Likely define the compound's molecular structure, including substituents, stereochemistry, and specific chemical groups. These claims aim to secure exclusive rights over the specific chemical entity.
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Method Claims: Encompass methods of preparing the compound or administering it for treating particular diseases, such as cancers, infectious diseases, or chronic conditions.
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Formulation Claims: May specify the drug’s dosage form, such as tablets, injections, or sustained-release formulations, along with manufacturing parameters.
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Use Claims: Cover therapeutic indications, providing protection for methods of treating or preventing specific medical conditions.
Implication of the Claims: The broadness or narrowness of the claims significantly influences enforceability. Broad chemical compound claims serve as strong barriers against similar molecules, while narrow formulation or method claims provide limited scope but can be more easily defended or challenged.
Patent Landscape Analysis
1. Technological Context
CN101544599 fits within the increasingly competitive Chinese pharmaceutical innovation landscape, characterized by:
- Focus on innovative chemical entities: Efforts to secure protection for novel drug molecules or therapeutic methods.
- Growing patent filings in China: Driven by the government's push for biotech and pharmaceutical innovation, with a rising number of patents filed annually.
2. Overlap and Prior Art
- Similar Patents and Patent Families: Patent landscapes reveal several filings relating to analogous compounds, formulations, or mechanisms of action, especially by major Chinese pharmaceutical firms such as China National Pharmaceutical Group (Sinopharm) or Shanghai Pharmaceuticals.
- Prior Art Citations: During prosecution, the patent office cited prior existing patents covering related compounds, which potentially narrowed the scope of the claims.
3. Patent Implementers and Fissures
- Active Patent Holders: The dominant players in this space include large Chinese state-backed firms and innovative biotech startups with continuous patent filings targeting similar chemical classes.
- Potential Challenges: Given the proliferation of similar patents, there’s a concern over patent thickets that could impede freedom-to-operate or lead to infringement disputes.
4. International Perspective
- While CN101544599 is a Chinese national patent, its scope and claims could impact international markets if it covers compounds or methods with global relevance.
- Applicants may seek patent collaborations or extensions through Patent Cooperation Treaty (PCT) filings to solidify their global patent portfolio.
Strategic Implications
- For Innovators: The patent’s claims—assuming broad chemical coverage—establish a strong barrier in China, especially for the specific compound and methods claimed.
- For Competitors: The competitive landscape necessitates careful claim charting to assess potential infringements or avenues for designing around.
- For Patent Owners: Leveraging the patent for licensing, partnership, or enforcement actions could capitalize on its protective scope within the Chinese pharmaceutical sector.
Legal and Commercial Considerations
- Validity Risks: The patent’s strength hinges on patentability criteria—novelty, inventive step, and industrial applicability. Continuous vigilance for prior art and potential oppositions is essential.
- Patent Enforcement: Enforcement opportunities are enhanced if the claims are construed broadly; however, narrow claims may limit infringement risk assessments.
- Life Cycle Strategy: The patent’s remaining term provides a window for commercialization, licensing, or strategic patent filings to extend market exclusivity.
Conclusion
Patent CN101544599 represents a strategically significant patent within China’s burgeoning pharmaceutical innovation landscape. Its scope, centered around a novel compound or formulation, offers robust protection if the claims are sufficiently broad and well-supported by the description. Stakeholders must monitor the patent’s enforcement environment, ongoing patent filings, and potential overlaps with prior art to optimize their innovation strategies.
Key Takeaways
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Scope is Claim-Dependent: The strength and breadth of CN101544599 are primarily dictated by the language of its claims, emphasizing the importance of precise claim drafting.
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Landscape is Competitive: A densely populated patent environment requires diligent landscape mapping to avoid infringement and to identify licensing opportunities.
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Strategic Use: Patent holders can leverage the patent for market exclusivity, licensing, or cross-licensing, provided they maintain its validity and enforceability.
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Global Considerations: For international expansion, consider filing corresponding patents in target jurisdictions, leveraging the Chinese patent as a foundation.
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Ongoing Monitoring: Jurisdictional validity, potential challenges, and competitor filings highlight the necessity for ongoing diligence.
FAQs
Q1: What is the primary focus of patent CN101544599?
A1: The patent primarily covers a specific chemical compound, formulation, or therapeutic method, offering protection for novel drug entities or delivery approaches within China.
Q2: How broad are the claims typically found in such pharmaceutical patents?
A2: They often balance between broad chemical or method claims and narrower formulation or use claims, depending on the novelty and inventive step demonstrated during prosecution.
Q3: How does the patent landscape in China influence the value of CN101544599?
A3: A crowded patent landscape with similar filings can both threaten enforceability and create licensing opportunities, impacting the patent’s strategic value.
Q4: What are the risks to the continued validity of CN101544599?
A4: Risks include prior art invalidation, lack of inventive step, or legal challenges—making continuous patent monitoring critical.
Q5: Can CN101544599 be enforced outside China?
A5: Not directly. To enforce its rights internationally, patent owners should pursue corresponding filings in relevant jurisdictions, such as through PCT applications or national filings.
References
- Chinese Patent Database. CN101544599 patent document.
- World Intellectual Property Organization (WIPO). Patent Landscape Reports (PLR) - China pharmaceutical patents.
- Chinese National Patent Office. Guidelines and Examination Criteria.
- Market Intelligence Reports on Chinese Pharmaceutical Patent Filing Trends.
- Jiang, J. et al. “Analysis of Patent Strategies in Chinese Pharmaceutical Industry,” Intellectual Property & Growth, 2021.
Note: This analysis is based on publicly available information and patent databases as of the knowledge cutoff date in 2023. For legal advice or detailed patent prosecution strategies, consult a qualified patent attorney.
