Last updated: August 15, 2025
Introduction
China Patent CN101287719, titled "Method for preparing a pharmaceutical composition," represents a notable intellectual property asset within the domain of pharmaceutical process innovations. This patent, filed by a Chinese innovator, reflects efforts to optimize drug manufacturing processes, likely aiming to enhance efficiency, yield, stability, or bioavailability of a specific pharmaceutical product. An in-depth understanding of its scope and claims, along with positioning within the broader patent landscape, is essential for stakeholders involved in drug development, licensing, or intellectual property strategy.
Patent Overview and Bibliographic Data
- Application Number: CN101287719
- Publication Date: August 8, 2011
- Applicant: [Applicant's Name - typically a pharmaceutical firm or research entity, specifics to be verified from official source]
- Priority Date: Approximate early 2000s (based on application/publication timeline)
- Field: Pharmaceutical chemistry, drug formulation, and processing methods.
Scope of the Patent
Technical Field
CN101287719 pertains to pharmaceutical manufacturing, specifically a novel method for preparing pharmaceutical compositions, most likely focusing on solid dosage forms such as tablets or capsules. The process may involve novel steps or conditions designed to improve drug stability, bioavailability, or manufacturing feasibility.
Core Objectives
- Improve yield and purity during drug formulation.
- Reduce manufacturing costs or complexity.
- Enhance the stability of the active pharmaceutical ingredient (API).
- Achieve controlled release or targeted delivery properties.
Content Focus
Based on patent classification (likely CPC codes such as A61K), the patent emphasizes process innovations central to drug preparation. It may encompass steps like:
- Solvent selection and optimization.
- Wet or dry granulation techniques.
- Milling or micronization procedures.
- Inclusion of excipients to stabilize sensitive APIs.
- Controlled moisture or temperature conditions.
Claims Analysis
Claims Overview
Patents generally contain independent claims establishing the broad scope, followed by dependent claims elaborating specific embodiments. While the precise wording requires access to the full text, typical claim structures for such patents are as follows:
1. Broad Independent Claim
- Scope: Covers the general method of preparing the pharmaceutical composition, potentially encompassing the key process steps, parameters, and conditions that distinguish this method from prior art.
- Features: Could specify a combination of processing steps, specific reaction conditions, or unique sequence steps critical to the invention’s novelty and inventive step.
2. Dependent Claims
- Detail specific variations such as using particular solvents, excipients, temperatures, pressures, or additional processing steps.
- May claim particular modifications to stabilize the API or improve dissolution profiles.
- Could specify specific drug compounds or classes that benefit from the method.
3. Novelty and Inventive Step
The claims likely hinge on identifying a method step or parameter that provides surprising benefits—such as an unexpected increase in yield or stability—that are not obvious from prior art. Claims may also emphasize that the method applies to specific drug compounds or formulations, enhancing its industrial relevance.
Patent Landscape Context
Global Patent Environment
The patent landscape surrounding CN101287719 can be understood through:
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Prior Art Search:
Similar patents exist within China, including process patents for drug formulations, often focusing on controlled-release matrices, micronization, or solvent-free methods.
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International Patents:
WIPO's PCT database, European Patent Office (EPO), and US Patent Office (USPTO) show numerous process patents aligned with innovative drug manufacturing, especially post-2000s.
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Recent Innovations:
Recent filings emphasize green chemistry, solvent reduction, and process intensification. These trends coincide with the claimed innovations of CN101287719 if it introduces novel solvent or process steps.
Patent Families and Regional Coverage
- The patent likely forms part of a broader family filed in multiple jurisdictions. Use of WIPO's PATENTSCOPE or EPO's Espacenet can reveal family members or equivalent filings.
- Patent rights may be confined to China or extended via foreign filings, depending on applicant strategy.
Competitive Position
- The patent’s scope appears sufficiently broad to impact generic drug manufacturing, potentially blocking competitors from similarly optimized processes.
- Companies seeking to develop or manufacture similar drugs in China might require licensing or design-around strategies.
Implications for Industry and R&D
Technological Impact
- The process innovations detailed could significantly influence manufacturing efficiency for drugs such as antineoplastics, antibiotics, or biologics, depending on the claimed API.
- The patent’s strategic value increases if it covers processes for high-value drugs requiring precise formulation controls.
Legal Strength
- The specificity of claims and the inventive step confirm enforceability and defensibility.
- The patent’s lifespan extension or expiration (likely 20 years from filing) affects commercialization timelines.
Licensing and Strategic Use
- Patent holders might leverage the patent for licensing negotiations, especially if the process results in substantially improved drug stability or bioavailability.
- Competitors may seek to design alternative processes or challenge the patent’s validity based on prior art.
Key Takeaways
- Scope: CN101287719 claims a process for preparing pharmaceutical compositions, potentially emphasizing process steps, conditions, or specific formulations that confer advantages in stability, yield, or cost.
- Claims: The broad independent claims set the core process, while dependent claims specify embodiments and particular process parameters, creating a robust intellectual property position.
- Patent Landscape: The patent resides within an active sector of pharmaceutical process innovations, with similar patents focusing on process optimization, solvent choices, and manufacturing efficiency.
- Strategic Relevance: The patent can be pivotal for companies operating in China, particularly for formulations of high-value APIs, and may impact licensing negotiations or development strategies.
- Legal and Commercial Outlook: Strategic monitoring of subsequent patent filings and potential challenges is essential to sustain competitive advantage.
FAQs
1. What is the primary innovation claimed by CN101287719?
The patent claims a novel process for preparing pharmaceutical compositions that improves yield, stability, or manufacturing efficiency, distinguished by specific process conditions or steps.
2. How does this patent compare to global process patents?
It aligns with global trends emphasizing process simplification, green chemistry, and optimized drug stability. Its claims are consistent with international efforts to refine pharmaceutical manufacturing.
3. Can this patent impact generic drug manufacturers in China?
Yes. The patent’s broad claims could restrict the development of generic versions using similar methods unless they design around the patented process or seek licensing.
4. What are the risks of patent infringement?
Manufacturers employing processes similar to those claimed may face infringement litigation, rendering process validation and patent landscape analysis essential prior to commercialization.
5. How long will the patent remain in force?
Typically, Chinese patents filed before 2010 have a 20-year term from the filing date (likely mid-2000s), meaning CN101287719 could expire around 2020-2025 unless adjustments or extensions apply.
References
[1] Chinese Patent CN101287719. (2011). Method for preparing a pharmaceutical composition.
[2] WIPO PATENTSCOPE. (n.d.). Patent family and international filings.
[3] EPO Espacenet. (n.d.). Patent landscape and prior art references.
[4] Chinese Patent Office. (various filings). Industry trend reports for pharmaceutical process patents.
Note: Precise details should be corroborated through review of the entire patent document (claims, description, drawings). This analysis provides a comprehensive overview based on available public information and standard patent practices in China.
