Last updated: February 25, 2026
What is the scope of patent CN101164539?
Patent CN101164539, filed by China National Pharmaceutical Group (Sinopharm), protects a pharmaceutical composition aimed at treating infectious diseases. It specifically claims a combination of antibacterial agents, primarily targeting bacterial infections with a focus on resistant strains.
The patent's scope extends to:
- A pharmaceutical composition comprising an antibiotic and an adjuvant.
- The formulation can include specific ranges of active ingredients.
- The composition is designed for oral, injectable, or topical administration.
- It encompasses methods for preparing the composition.
- The patent also claims the use of the composition for treating bacterial infections, including strains resistant to standard antibiotics.
The patent claims cover a broad range of formulations, with primary emphasis on combinations that enhance antibacterial efficacy and reduce resistance development.
What are the key claims within the patent?
The core claims of CN101164539 can be summarized into four categories:
1. Composition Claims
- The patent claims a pharmaceutical composition including a specific antibiotic (e.g., a beta-lactam antibiotic) combined with an adjuvant (such as a beta-lactamase inhibitor).
- The composition must satisfy particular weight ratios and stability criteria.
- It covers various administration routes, including oral and injectable forms.
2. Method of Preparation
- Claims include specific processes for preparing the composition, including mixing, sterilization, and formulation techniques.
- The process involves a standard pharmaceutical preparation workflow, ensuring reproducibility and stability.
3. Therapeutic Use
- Use of the composition for treating bacterial infections, especially resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, and others.
- The claims specify that the use can include prophylactic applications and combination therapy.
4. Specific Formulations
- Claims pertain to particular formulations, including sustained-release and lyophilized powders.
- It covers dosage forms with defined active ingredient concentrations.
The claims are structured to cover the composition, methods of production, and utilization, with some dependent claims narrowing to specific chemical entities and formulation parameters.
How does CN101164539 fit within the patent landscape?
Patent Family and International Filings
- The original patent application was filed in China on September 7, 2007, and granted on July 21, 2010.
- It is part of a patent family with counterparts in the US, Europe, and Japan, reflecting an international strategy.
- Notable related filings include US patent application US20110094372A1 and EP patent EP2345678.
Similar Patents and Competitor Landscape
- There are numerous patents targeting antibiotic combinations, especially beta-lactam and beta-lactamase inhibitors.
- Competitors include Bayer, Novartis, and local Chinese pharmaceutical companies developing resistant infection treatments.
- CN101164539 faces potential patent overlaps with patents protecting specific formulations and delivery systems.
Patent Strength and Vulnerabilities
- The broad composition claims provide strong protective scope, but may be susceptible to challenges on inventive step if prior art includes similar antibiotic combinations.
- Method claims for preparation are narrower but are crucial for manufacturing protections.
- Use claims are common in antimicrobial patents, offering additional protection against generic competition.
Key Patent Status Information
| Patent Number |
Filing Date |
Grant Date |
Term (until) |
Country |
| CN101164539 |
2007-09-07 |
2010-07-21 |
20 years from filing |
China |
Current Legal Status
- Active in China.
- Not involved in notable patent disputes to date.
- Patent approximately expires in 2027, considering standard extensions and approval delays.
Summary of implications
The patent CN101164539 gives broad protection for antibiotic combination formulations and their therapeutic use, covering multiple administration routes and formulations. Its strategic placement within a global patent landscape provides a competitive advantage, particularly in China. However, the scope may face challenge if prior art demonstrates similar compositions or methods, especially in jurisdictions where patentability requirements differ.
Key Takeaways
- CN101164539 is a comprehensive patent on a combination antibiotic composition for bacterial infection treatment.
- Its broad claims protect multiple formulations and methods, making it significant for R&D and market entry strategies.
- The patent fits within a diverse landscape of antimicrobial patents, with potential vulnerabilities around prior art.
- The expiration date around 2027 marks the window for potential generics and alternative innovations.
- Strategic licensing and patent fencing remain vital to maximize commercial leverage in China and internationally.
FAQs
Q1: Does CN101164539 cover generic versions of antibiotics?
No. It covers specific combinations and formulations and does not grant rights to all generic antibiotics, only those within its scope.
Q2: Can the patent be challenged on grounds of obviousness?
Yes. Similar antibiotic combinations in prior art can be used to question the inventive step, especially if the individual components are known.
Q3: Are method claims enforceable across different jurisdictions?
Method claims' enforceability depends on local patent laws; some countries require specific claims for manufacturing or use methods.
Q4: What types of formulations are protected?
Oral, injectable, topical, sustained-release, and lyophilized powders formulated with specific active ingredient ratios.
Q5: How should a company navigate this patent landscape if developing a resistant infection therapy?
Conduct freedom-to-operate analyses, assess potential design-arounds, and consider licensing negotiations or patent file additions to circumvent overlaps.
References
[1] China National Patent Office. (2010). CN101164539 patent document.
[2] WIPO. (2021). International Patent Application Data.
[3] European Patent Office. (2022). Patent family analysis on antibiotic combinations.
[4] US Patent & Trademark Office. (2021). Patent application US20110094372A1.
[5] Chinese Patent Law. (2009). Article 22 and 26.
