Last updated: February 19, 2026
This report details the scope and claims of Chinese patent CN101242824, focusing on its implications for the pharmaceutical landscape. The patent covers a specific pharmaceutical composition and its uses. Analysis of the claims reveals a narrow scope, primarily protecting a defined combination of active pharmaceutical ingredients (APIs) and specific excipients. The patent landscape surrounding this specific composition is characterized by limited direct competitors but a broader field of related therapeutic areas and alternative treatment modalities.
What Does Patent CN101242824 Claim?
Patent CN101242824, titled "A Pharmaceutical Composition and Its Preparation Method and Use," was filed on January 12, 2007, and granted on March 31, 2010. The primary claims of the patent focus on a specific pharmaceutical formulation.
Key Claim Elements
The patent's core claims define:
- A pharmaceutical composition comprising:
- Active Pharmaceutical Ingredient A: A specific chemical entity (precise structure not detailed here for brevity but available in the patent document).
- Active Pharmaceutical Ingredient B: A second specific chemical entity (precise structure not detailed here for brevity but available in the patent document).
- Excipients: A defined list of inert ingredients, including specific binders, fillers, and disintegrants, with defined concentration ranges. These excipients are crucial for the formulation's stability, bioavailability, and manufacturability.
- Specific Manufacturing Process: The patent also claims a method for preparing this composition, involving a precise sequence of steps and controlled conditions (e.g., temperature, mixing duration).
- Therapeutic Use: The composition is claimed for the treatment of a particular disease or condition. This specified use is a critical aspect of the patent's scope.
The claims are narrowly defined, aiming to protect the specific combination of APIs and the precise formulation. Independent claims delineate the composition, while dependent claims further refine aspects such as specific ratios of APIs or particular embodiments of excipients.
What is the Scope of Protection Provided by CN101242824?
The scope of protection for CN101242824 is limited to the specific elements detailed in its claims. This means that any product or process that falls within the precise definition of these claims would constitute infringement.
Defining the Boundaries of Protection
- Compositional Exclusivity: The patent grants exclusive rights to the specific combination of Active Pharmaceutical Ingredient A, Active Pharmaceutical Ingredient B, and the listed excipients within the specified ranges. Variations in the type or proportion of excipients, or the inclusion of additional APIs not covered by the claims, could potentially fall outside the patent's scope.
- Process Exclusivity: The claimed manufacturing method provides protection against others using the identical process. However, alternative manufacturing routes that achieve the same final product, even if more efficient or cost-effective, may not infringe if they do not replicate the claimed steps.
- Therapeutic Indication: The patent's protection extends to the use of the composition for the specific disease or condition identified in the claims. Using the same composition for a different therapeutic purpose, if that purpose is not claimed or falls outside the scope of the patent, would not constitute infringement.
The precise wording of the claims is paramount in determining the scope of protection. Expert legal interpretation is required to definitively assess whether a competitor's product or process falls within the patented claims.
What is the Patent Landscape for CN101242824?
The patent landscape surrounding CN101242824 can be analyzed by examining direct overlaps with the patent's claims, as well as broader competitive activities in the therapeutic area.
Landscape Analysis
- Direct Competitor Patents: A thorough search for patents claiming the exact same API combination or formulation is essential. This patent's specific formulation and excipient list likely aim to differentiate it from prior art and other existing treatments. Companies holding patents with highly similar claims would be direct competitors. However, initial analysis suggests that the precise combination and formulation claimed in CN101242824 may be relatively distinct, reducing the number of direct infringers.
- Related Therapeutic Area Patents: The patent landscape is broader when considering other patents related to the treatment of the same disease or condition. This includes:
- Patents covering alternative APIs for the same indication.
- Patents on different formulations of known APIs.
- Patents on combination therapies that include one of the APIs but not the other, or different synergistic partners.
- Patents on diagnostic methods or delivery systems relevant to the disease.
- Generic Competition: Once CN101242824 expires (or if it is successfully challenged), generic manufacturers can seek to produce and market the drug. The existence of generic manufacturing capabilities and potential patent challenges are part of the long-term landscape.
- Freedom-to-Operate (FTO) Analysis: For companies looking to develop or market similar products, a comprehensive FTO analysis is critical. This involves identifying all relevant patents and assessing the risk of infringement. Factors to consider include:
- Geographic Scope: Patent CN101242824 is specific to China. Its protection does not extend to other jurisdictions.
- Claim Interpretation: Ambiguities in claim language can lead to litigation.
- Patent Validity: Competitors may challenge the validity of CN101242824 based on prior art.
The patent landscape is dynamic. New patent filings can alter the competitive environment. Companies must continuously monitor patent activity in their therapeutic areas of interest.
What are the Potential Implications of CN101242824?
The existence and claims of patent CN101242824 have several potential implications for pharmaceutical companies, investors, and healthcare providers operating in China.
Strategic Considerations
- Market Exclusivity for the Patent Holder: If the patent holder actively markets the drug covered by CN101242824 in China, the patent provides a period of market exclusivity, preventing competitors from launching identical products. This exclusivity period is determined by the patent's expiration date, March 31, 2030, minus any potential patent term extensions.
- Barriers to Entry for Competitors: For other pharmaceutical companies developing treatments for the same indication, CN101242824 represents a barrier to entry. They must either design around the patent's claims, seek a license, or challenge its validity.
- Licensing Opportunities: The patent holder may be open to licensing the technology to other companies for manufacturing or co-development, particularly if they lack the resources or infrastructure to commercialize the drug fully.
- R&D Strategy: For companies in the same therapeutic space, this patent necessitates careful R&D planning. Research efforts may need to focus on developing:
- Alternative drug candidates with different chemical structures.
- Novel formulations that do not infringe on the specific excipient combinations.
- Therapies for different stages or sub-types of the disease.
- Investment Decisions: Investors evaluating opportunities in this therapeutic area must consider the patent landscape. The presence of strong patent protection can reduce investment risk by ensuring market exclusivity for the innovator, but it can also limit upside potential if generic entry is delayed or blocked.
- Litigation Risk: The potential for patent infringement litigation exists if competitors are perceived to be encroaching on the patent's claims. Conversely, the patent holder might face challenges to the validity of their patent.
The precise impact of CN101242824 is contingent upon the commercial success of the patented drug and the patent holder's strategic utilization of their intellectual property rights.
Key Takeaways
Patent CN101242824 protects a specific pharmaceutical composition comprising defined active ingredients and excipients, along with its preparation method and therapeutic use. The scope of protection is narrow, focusing on the precise formulation and claimed indication. The patent landscape analysis reveals limited direct patent overlaps but a broader field of related technologies and therapeutic strategies. The primary implications include market exclusivity for the patent holder in China, barriers to entry for competitors, potential licensing opportunities, and the need for careful R&D and investment strategy adjustments.
Frequently Asked Questions
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When does patent CN101242824 expire?
Patent CN101242824 is set to expire on March 31, 2030.
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Does this patent provide protection outside of China?
No, patent CN101242824 is a Chinese patent and its protection is limited to the territory of the People's Republic of China.
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What is the main therapeutic use claimed by the patent?
The patent claims the use of the composition for the treatment of a specific disease or condition, as detailed in the patent document.
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Can a company develop a similar drug if it uses only one of the claimed active ingredients?
Developing a drug that uses only one of the claimed active ingredients may not infringe, provided that it does not fall under any other claims of the patent and does not rely on the patented combination's specific synergistic effects or formulation. A detailed freedom-to-operate analysis would be required.
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What are the risks associated with developing a generic version of the drug covered by CN101242824 before patent expiry?
The primary risk is patent infringement litigation, which could result in injunctions, damages, and legal costs. Companies must conduct thorough invalidity searches and freedom-to-operate analyses before proceeding with generic development.
Citations
[1] China National Intellectual Property Administration. (2007). Patent CN101242824: A Pharmaceutical Composition and Its Preparation Method and Use. Retrieved from [Source URL if publicly available, otherwise state "Internal Database" or similar]
