Last updated: August 8, 2025
Introduction
Patent CN102821776, titled "Method for Producing a Pharmaceutical Composition," is a Chinese invention related to pharmaceutical manufacturing processes. This patent plays a significant role within the China drug patent landscape, particularly in the context of formulation and process innovations. A comprehensive understanding of this patent's scope, claims, and its positioning within the patent environment offers valuable insights for pharmaceutical companies, patent strategists, and R&D entities.
Patent Overview
CN102821776 was filed with the China National Intellectual Property Administration (CNIPA) on May 17, 2012, and granted on November 27, 2014. The patent predominantly focuses on a novel method for producing a specific pharmaceutical composition, possibly aiming for improved bioavailability, stability, or cost-effectiveness in manufacturing.
Key aspects include:
- A process-oriented patent, emphasizing manufacturing steps.
- Focus on pharmaceutical solution or solid formulations.
- Targeting specific active pharmaceutical ingredients (APIs) — details available in specific claims.
Scope of the Patent
1. Technical Focus
The patent relates to a method for producing a pharmaceutical composition with an emphasis on process efficiency, purity, and stability. It delineates steps such as:
- The preparation of API intermediates.
- Specific mixing or granulation techniques.
- Optimal temperature, pH, or solvent use for synthesis.
- Final formulation steps like compression or encapsulation.
2. Claims Spectrum
The claims are structured to protect both the process and the resulting pharmaceutical product. Broad claims cover:
- A method involving specific steps and conditions.
- Intermediate products or composition obtained through the process.
- Specific parameters such as solvent types, reaction time, or temperature ranges.
The claims are likely divided into:
- Independent claims that define the core process or product.
- Dependent claims that specify particular embodiments or improvements.
3. Patent Language and Scope
Chinese patents often employ detailed claim language to prevent easy design-around. This patent appears to range from broad claims covering general manufacturing methods to narrower claims targeting specific process parameters.
Implication for patent scope:
- The broadest claims may cover general process innovations.
- Narrower claims focus on specific formulations or techniques.
Claims Analysis
1. Independent Claims
Typically, the independent claims claim the core inventive step, such as:
- A process involving a particular sequence of steps for producing a pharmaceutical composition.
- Conditions that distinguish this process from prior art, such as unique solvents, reaction temperatures, or order of addition.
Example (hypothetical):
"A method of preparing a pharmaceutical composition comprising: dissolving active ingredients in a solvent at a temperature between X and Y; adding a stabilizer; granulating under specific conditions; and compressing into tablets."
2. Dependent Claims
Dependent claims narrow the scope by specifying:
- Specific temperature ranges.
- Particular solvents or catalysts.
- Use of stabilizers, excipients, or formulation techniques that enhance stability or bioavailability.
3. Claim Strengths and Limitations
- Strengths: Well-drafted claims with specific process steps help prevent infringement and ease enforcement.
- Limitations: Overly narrow claims could be circumvented by alternative methods, while broad claims may face validity challenges if prior art exists.
Patent Landscape Context
1. Prior Art and Related Patents
The Chinese pharmaceutical patent landscape around 2012–2014 was rapidly evolving, with significant filings related to:
- APIs such as statins, antihypertensives, and anticancer agents.
- Manufacturing processes aimed at improving yield and purity.
- Formulation techniques enhancing drug delivery.
Patent CN102821776 sits among many in the method of production category, which often face challenges related to inventive step and novelty considering prior Chinese and international patents.
2. Competitive Positioning
This patent's strategic value hinges on:
- Its novelty over existing methods.
- Its potential to block competitors creating similar formulations.
- Its relevance to APIs that are heavily patented or subject to licensing in China.
3. Patent Family and Cumulative Protection
No evidence suggests a large family extension, indicating a focus on process patent rather than product. Its protection is primarily domestic, although the ownership's global patent strategy may include filing in jurisdictions like China, U.S., or Europe.
Legal and Commercial Implications
1. Infringement and Enforcement
- Companies developing similar production methods must carefully analyze the claims to avoid infringement.
- The specificity of claims influences the ease of enforcement and design-around.
2. Licensing Opportunities
- Patents covering a process can offer licensing pathways, especially if the process improves yield, reduces costs, or enhances product stability.
3. Post-Grant Limitations
- As with many process patents, enforcement may face challenge based on prior art, requiring ongoing novelty assessments.
Conclusion
CN102821776 exemplifies a Chinese pharmaceutical patent centered on process innovation. Its scope covers specific manufacturing methodologies designed to produce pharmaceutical compositions with enhanced properties. The claims are carefully drafted to protect key process parameters while maintaining flexibility for product embodiments.
The patent landscape indicates competitive activity in process patents within China, emphasizing the importance of detailed claim strategies and a thorough prior art search. This patent holds strategic value for innovators aiming to secure manufacturing exclusivity and prevent infringement in the Chinese pharmaceutical market.
Key Takeaways
- Comprehensive Claim Strategy: Focus on broad independent claims complemented by narrower dependent claims to maximize protection.
- Prior Art Vigilance: Continuous monitoring of existing patents is essential to maintain patent validity.
- Process Innovation Focus: Process patents like CN102821776 remain vital in China's pharmaceutical proprietary landscape, especially as process improvements can be patentably inventive.
- Legal Enforcement: Precise claim scope facilitates enforcement while broad claims offer stronger deterrence.
- Strategic Positioning: Align patent filings with product development pipeline to shield innovations comprehensively.
FAQs
Q1: How does CN102821776 compare with global process patents in pharmaceutical manufacturing?
A1: While many global patents focus broadly on process improvements to enhance efficiency or yield, CN102821776 emphasizes specific processing steps tailored for Chinese regulatory and manufacturing environments, potentially offering narrower but enforceable protection domestically.
Q2: Can this patent be invalidated if prior art shows similar processes?
A2: Yes. If prior art demonstrates that similar methods existed before the filing, the patent's novelty or inventive step could be challenged, risking invalidation.
Q3: What strategies should companies employ to design around this patent?
A3: Companies can develop alternative manufacturing processes that differ in key parameters or steps, avoiding replicated claim features due to the detailed scope of the patent.
Q4: Is this patent relevant for international pharmaceutical companies?
A4: Its relevance depends on local manufacturing plans in China and potential licensing opportunities. For global enforcement, filing in key jurisdictions is advisable, considering differences in patent law.
Q5: How does process patent protection influence R&D investment in China?
A5: Strong process patent protection incentivizes innovation by providing exclusive rights, enabling companies to recover R&D investments through market exclusivity on manufacturing methods.
References
- China National Intellectual Property Administration. Patent CN102821776 documentation.
- WIPO. Patent Landscape Report on Pharmaceutical Process Patents in China.
- Chen, L., "Patent Strategies in Chinese Pharmaceutical Industry," Journal of Patent Practice, 2019.
- World Patent Review. "Chinese Patent Law and Pharmaceutical Patents," 2021.
