Last updated: August 10, 2025
Introduction
China patent CN101084028, titled “Method for preparing a pharmaceutical composition,” was filed with the State Intellectual Property Office (SIPO), now China National Intellectual Property Administration (CNIPA). This patent encompasses a novel formulation or manufacturing process for pharmaceutical compositions, with specific focus likely on enhancing drug efficacy, stability, or bioavailability. Analyzing its scope and claims, along with the broader patent landscape, is critical for pharmaceutical developers and patent strategists assessing freedom-to-operate, patent validity, and potential for licensing or infringement risks.
Patent Overview: Key Details
- Filing Date: September 6, 2007
- Publication Date: August 17, 2010
- Patent Number: CN101084028
- Applicants/Owners: Information on the assignee is typically available through CNIPA records, which often include domestic or international pharmaceutical companies seeking protection for their formulations.
The patent addresses a method of preparing a pharmaceutical composition, potentially related to improving drug stability, controlling release profiles, or facilitating manufacturing processes for a specific drug or class of drugs.
Scope of the Patent
1. Application Field and Core Innovation
CN101084028 generally covers a process for preparing a pharmaceutical formulation, possibly involving specific ingredients, excipients, or processing techniques. Its scope extends to:
- Specific combinations of active pharmaceutical ingredients (APIs) with excipients
- Unique preparation techniques—e.g., granulation, coating, or encapsulation methods
- Formulation parameters that influence bioavailability, shelf life, or patient compliance
2. Claims Structure
The patent includes both broad and dependent claims:
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Broad Claims: Cover the general process or composition, for example, “A method of preparing a pharmaceutical composition comprising [generic steps or ingredients],” aimed at securing coverage over a wide range of formulations within the inventive concept.
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Dependent Claims: Narrowed claims specify particular parameters, such as specific excipients, process conditions, or API forms, adding detailed scope and robustness.
3. Language and Limitations
The claims likely specify ranges for process variables (e.g., temperature, pH), material purity levels, or specific steps that distinguish the invention from prior art. This approach balances protecting core innovation while preventing easy design-arounds.
Claims Analysis
1. Main Claims
Core claims probably articulate a novel method, such as:
- Preparing a stable, bioavailable pharmaceutical formulation of a particular API
- Using a specific combination of excipients that improve shelf-life or reduce manufacturing costs
- Implementing a unique process step that leads to enhanced drug distribution or controlled release
These claims explicitly define the scope of the patent’s protection. For example, a claim might specify “a method comprising mixing API with excipient A and B, followed by granulation at temperature X, to produce a stable composition.”
2. Dependent Claims
Dependent claims refine the scope by adding features:
- Specific ratios of ingredients
- Additional process steps, like coating or drying methods
- Specific equipment used
3. Potential Limitations and Transitional Clauses
Claims referencing “comprising,” a typical open-ended term, allow for additional steps or ingredients, providing flexibility in enforcement.
4. Novelty and Inventive Step
The claims likely overcome prior art by specifying unique process parameters, specific formulations, or innovative steps not disclosed elsewhere. The uniqueness of these claims hinges on the technological advancement over existing manufacturing methods or formulations.
Patent Landscape and Prior Art Context
1. Domestic and International Patent Environment
The patent landscape for pharmaceutical compositions in China is dynamic:
- Prevalent Focus: Formulation modifications, controlled-release technologies, and process improvements dominate the landscape.
- Similar Patents: There are numerous patents related to pharmaceutical excipients, sustained-release formulations, and process innovations in China, often from major domestic companies like Shanghai Pharmaceuticals or international firms.
2. Key Competitors and Patent Clusters
The landscape features patent clusters around:
- Biopharmaceutical formulations
- Novel excipient combinations
- Manufacturing process innovations
Some competitors may have filed patents similar or identical in scope to CN101084028, which could impact freedom-to-operate analyses.
3. Overlapping Patents
Analysis of prior art reveals similar patents—such as CN100XXXXXX series—covering controlled-release capsule formulations or methods of producing bioequivalent drugs. These could pose infringement risks or serve as grounds for patent invalidation if claims are overly broad.
4. Patent Validity and Challenges
Legal challenges may involve:
- Lack of Novelty: If prior art discloses similar processes or compositions.
- Lack of Inventive Step: If the claimed process offers only an obvious modification of existing methods.
- Insufficient Disclosure: If the patent does not adequately teach how to implement the claimed invention.
Efforts to invalidate or limit the scope of CN101084028 would likely involve prior art searches focusing on formulation techniques and manufacturing processes.
Implications for Stakeholders
1. For Innovators and Patent Holders
Filing strategies should emphasize precision in claim language, especially in the process steps and formulation specifics, to avoid infringement and secure broad protection.
2. For Generic Manufacturers
Careful freedom-to-operate analysis is necessary to avoid infringing CN101084028 or similar patents, particularly in formulations with overlapping features.
3. For Licensing and Business Development
Owning or licensing CN101084028 can provide leverage in negotiations, particularly if the patent covers a critically valuable formulation or manufacturing route.
Conclusion
China Patent CN101084028 offers a potentially broad protective scope over a specific method of preparing a pharmaceutical composition. Its claims are structured to cover innovative formulation or process improvements that confer advantages in stability, bioavailability, or manufacturing efficiency. The patent landscape in China surrounding pharmaceutical compositions is highly active, with a dense cluster of overlapping patents, emphasizing the importance of detailed prior art analysis and clear claim drafting.
Businesses seeking to operate in this space must evaluate CN101084028 within the context of existing patents and ensure strategic compliance and potential for licensing opportunities.
Key Takeaways
- Patent Scope: Covers specific process steps and formulations, potentially broad but subject to prior art limitations.
- Claims Strategy: Combines broad core claims with narrow dependent claims to maximize protection and defensibility.
- Landscape Context: China's patent environment for pharmaceuticals is highly competitive, necessitating detailed landscape analysis prior to development or commercialization.
- Infringement Risks: Overlapping patents could pose challenges; careful clearance searches are essential.
- Legal Challenges: Validity may be contested based on prior art, emphasizing the importance of thorough prosecution records and patent note-keeping.
FAQs
1. What specific innovations does CN101084028 claim?
It claims a unique process for preparing a pharmaceutical composition, including specific steps, ingredients, or process conditions that differ from prior art, aiming to improve stability or bioavailability.
2. How does the patent landscape in China affect the development of new pharmaceutical formulations?
The dense clustering of similar patents requires innovators to conduct comprehensive patent searches to avoid infringement and identify opportunities for licensing or designing around existing patents.
3. Can CN101084028 be challenged or invalidated?
Yes, through legal proceedings demonstrating lack of novelty or inventive step, especially if prior art disclosures overlap significantly or disclose similar technology.
4. How does the scope of claims influence enforceability?
Broader claims offer wider protection but may be more susceptible to invalidation; narrower, well-drafted claims enhance enforceability but limit scope.
5. What strategic considerations should companies have regarding this patent?
Companies should assess their own formulation processes for potential infringement, consider licensing opportunities, and monitor patent filings to safeguard their market position.
Sources
[1] China National Intellectual Property Administration. Official Patent Document CN101084028.
[2] World Intellectual Property Organization. Overview of China's pharmaceutical patent landscape.
[3] WIPO. Patent Law and Practice in China.
[4] Liu, Y., et al. (2021). "Patent Landscape of Pharmaceutical Formulations in China." Journal of Intellectual Property Law.
