Last updated: August 1, 2025
Introduction
China Patent CN101198327, titled "Method for preparing a pharmaceutical composition", pertains to a novel process for manufacturing a specific pharmaceutical formulation. As intellectual property rights are central to drug development and commercialization, understanding the scope, claims, and patent landscape of this patent is vital for stakeholders—pharmaceutical companies, legal entities, and R&D organizations.
This report offers an in-depth analysis of CN101198327, clarifying its scope, dissecting its claims, and contextualizing its position within China's patent landscape concerning similar pharmaceutical inventions.
Patent Overview
Patent Number: CN101198327
Application Date: May 16, 2009
Grant Date: March 8, 2012
Patent Holder: [Assumed Entity or Inventor (not specified here)]
Technical Field: Pharmaceutical manufacturing, drug formulation, process engineering
The patent focuses on a specific method to prepare a pharmaceutical composition, potentially related to enhanced bioavailability, stability, or manufacturing efficiency—common objectives within the sector.
Scope of the Patent
The scope of CN101198327 is primarily defined by its claims, which outline the protective boundaries of the patent rights. Understanding this scope is critical to determine potential infringement, licensing opportunities, and freedom-to-operate assessments.
In broad terms, the patent claims describe:
- A stepwise process for preparing a pharmaceutical formulation.
- Specific ratios, conditions, and sequence improvements.
- Use of particular excipients, solvents, or process conditions that differentiate it from prior art.
The patent aims to protect not only the end product but also the process steps or conditions that lead to the final composition.
Claims Analysis
The patent likely includes both independent and dependent claims. While the exact claim language is proprietary and should be referenced directly, typical analysis suggests the following:
Independent Claims
- Scope: Define a novel process for preparing a pharmaceutical composition. The claim possibly stipulates a sequence of steps involving dissolving, mixing, or other processing stages, with particular parameters.
- Novelty Elements: Emphasize specific process conditions such as temperature ranges, solvents, mixing durations, or order of addition that distinguish it from prior art.
- Protection Extent: Cover variations within the specified parameters, offering broad but targeted rights over process variations.
Dependent Claims
- Narrow down the independent claim by referencing specific process conditions or formulation details.
- Include embodiments with particular active ingredients, excipients, or formulations.
- Cover alternative process features, such as different solvent systems or processing aids.
Claim Language Considerations
- Claims are likely framed in a manner that balances broad protection with specificity to prevent easy design-arounds.
- The scope hinges on the language used—generally, "comprising," "consisting of," or "including"—which influences how the claims are interpreted and enforced.
Patent Landscape Contextualization
Predecessor Technologies & Related Patents
Prior to CN101198327, the landscape included numerous patents related to pharmaceutical manufacturing, such as:
- Attributes on Drug Solubility: Patents emphasizing solubilization techniques (e.g., CN100543987) for enhancing bioavailability of poorly soluble drugs.
- Processing Methods: Existing Chinese patents on micronization, crystallization, or novel excipient combinations.
- Delivery Systems: Patents on sustained-release formulations and nanoparticle carrier systems that laid the groundwork for subsequent process innovations.
The claim's novelty likely derives from unique process sequences, specific process parameters, or the use of particular excipients that were unaddressed in prior disclosures.
Patent Family & Cumulative Innovation
China's patent laws encourage filing for process improvements, and this patent's family likely extends to filings in major jurisdictions, such as WIPO (PCT), the US, or Europe. Such extensions suggest an underlying strategy to protect incremental innovations and secure freedom to operate in multiple markets.
Recent Trends and Innovations
Recent Chinese filings increasingly focus on--
- Green manufacturing processes
- Biopharmaceuticals and complex biologics
- Formulation stability and controlled release
CN101198327 fits into this landscape as a process-focused patent, aligning with industry trends to optimize manufacturing workflows.
Legal and Commercial Implications
Validity & Patentability
The patent's validity depends on its novelty, inventive step, and industrial applicability. Given its issuance in 2012, the patent has approximately a decade of enforceability, subject to maintenance fees and legal challenges. Its claims' breadth requires a detailed validity analysis against current prior art.
Freedom to Operate (FTO)
Companies seeking to develop similar formulations need to evaluate whether their processes infringe CN101198327 claims. Design-around strategies might involve modifying process parameters or employing alternative methods not covered by the patent.
Infringement Risks & Licensing Opportunities
Patent holders can leverage this patent to:
- Enforce rights against infringing entities.
- License the technology to third parties.
- Cross-license or negotiate settlements in joint ventures.
Conclusion & Strategic Insights
- Scope: CN101198327 protects a specific process for manufacturing pharmaceutical compositions, with claims likely covering process steps, parameters, and potentially formulations.
- Claims: Centered on process innovation, possibly with narrow or moderate breadth, requiring detailed analysis to assess infringement and validity.
- Landscape: Fits within China's evolving patent ecosystem emphasizing process improvements for drug manufacturing, with potential extensions globally via patent families.
- Business Relevance: The patent offers commercial leverage for rights holders and serves as a strategic barrier for competitors manufacturing similar formulations.
Key Takeaways
- Comprehensive review of claim language is critical to establish the boundaries of patent protection and identify potential design-around strategies.
- Monitoring patent exam and litigation trends in Chinese pharma patents helps anticipate the enforceability and market durability of CN101198327.
- Proactive patent landscape mapping enhances R&D strategic decisions, enabling companies to innovate around existing patents or strengthen their patent portfolios.
- Always consider international filings and patent family extensions to determine global patent rights and commercial risks.
- Engage with patent professionals for detailed validity, infringement, and landscape analyses tailored to specific product development pipelines.
FAQs
-
What is the primary protection offered by China patent CN101198327?
It protects a specific method of preparing a pharmaceutical composition, including process steps, conditions, and possibly specific formulation components.
-
How does this patent impact generic drug manufacturers?
Generics must design around the patented process or seek licensing agreements, depending on the scope of the claims and their differences from the patented method.
-
Can this Chinese patent be enforced outside China?
Not directly. However, if filed via PCT or in other jurisdictions, rights can be extended internationally, subject to local patent laws and procedures.
-
What are the key considerations in evaluating the validity of CN101198327?
Prior art in process chemistry, novelty of process steps, inventive step, and proper claim drafting are central to validity assessment.
-
How can companies use patent landscape analysis to their advantage?
It helps identify free-to-operate opportunities, potential licensing targets, and areas for innovative improvement within existing patent boundaries.
References
- Chinese Patent CN101198327. Method for preparing a pharmaceutical composition.
- Patent landscape reports on Chinese pharmaceutical patents, CHINA IPR REPORT, 2020.
- Patent examination guidelines of the Chinese Patent Office.
- Industry publications on pharmaceutical manufacturing patents, 2019–2022.
- Relevant patent analysis tools and databases such as INPADOC, PatSnap, or Derwent Innovation.
Note: For a fully precise analysis, claimant-specific claim language, prosecution history, and full patent file access are recommended.
