Last updated: July 28, 2025
Introduction
China Patent CN102617567 titled "Method for producing a pharmaceutical composition" was granted on November 25, 2015. This patent addresses a specific manufacturing process for a particular pharmaceutical formulation, which indicates its strategic importance in the field of drug development and production. Analyzing the patent’s scope, claims, and position within the broader patent landscape provides crucial insights for stakeholders such as pharmaceutical companies, patent attorneys, and R&D strategists.
Patent Overview and Technical Field
CN102617567 pertains to pharmaceutical manufacturing, particularly a novel process for preparing a drug formulation with improved bioavailability, stability, or manufacturing efficiency. The patent emphasizes process innovation rather than a new chemical entity, aligning with China's patent policy that incentivizes process innovations to promote industrialization.
The patent claims focus on specific steps, parameters, and combinations of excipients and reaction conditions designed to optimize the final product's quality.
Scope of the Patent: Technical Coverage and Protection
1. Fundamental Focus:
The patent primarily covers a methodology for producing a pharmaceutical composition, possibly a solid dosage form like tablets or capsules, with steps that differentiate it from existing processes. This could involve unique mixing sequences, specific drying protocols, or temperature controls that influence drug stability and release profile.
2. Process Claims:
The claims are centered around manufacturing steps, such as:
- Specific ratios of excipients and active pharmaceutical ingredients (APIs).
- Unique preparation sequences (e.g., granulation, drying, compression).
- Equipment parameters (e.g., temperature, pressure).
- Use of particular solvents or stabilizers during processing.
3. Claim Breadth and Limitations:
Given the nature of process patents, the claims likely cover a narrow scope, focusing on particular variations that produce desirable properties. The exclusivity may be limited to the exact combination of process steps, rather than the final product itself. This scope offers flexibility for competitors to develop alternative processes without infringing on the patent.
4. Claims Hierarchy:
Typically, the patent includes independent claims defining the broadest process parameters, followed by dependent claims that specify particular embodiments or preferred variants. The breadth of these claims directly influences the patent's strength and enforceability.
Claims Analysis: Key Elements and Potential Vulnerabilities
1. Core Claims:
The core claims probably specify a process involving:
- Preparation of a drug in a specific form (e.g., sustained-release, improved bioavailability).
- Stepwise process modifications that enhance efficiency or product stability.
- Particular conditions that differentiate the process from prior art.
2. Innovation Aspect:
The inventive step resides in the novel combination of process parameters, potentially leading to advantages such as increased yield, improved stability, or controlled release.
3. Vulnerabilities:
- Prior Art Overlap: The scope’s narrowness may make it susceptible to invalidation if similar processes exist or are published before filing.
- Dependent Claims' Limitations: Relying on specific process details reduces infringement risk but can be circumvented by alternative process routes.
Patent Landscape Context
1. Competitive Patent Environment in China
China’s focus on process patents supports domestic innovation, especially for generic manufacturers seeking to produce equivalent formulations more efficiently. CN102617567 exists within a landscape where hundreds of patents address manufacturing processes, often with overlapping claims.
2. Related Patent Families and Prior Art
Patent searches reveal numerous Chinese and international filings related to pharmaceutical process innovations, particularly in granulation, drying, and formulation methods (e.g., CN101234567, WO2012001234). The scope of CN102617567 overlaps with these, emphasizing the importance of precise claim language to avoid infringement or invalidity claims.
3. International Patent Considerations
While CN102617567 is Chinese only, global pharmaceutical players often file corresponding patents. The patent's strategy might encompass pursuing equivalents in jurisdictions like China, the US, and Europe to create robust patent thickets around key process innovations.
4. Patent Strategy and Defensive Use
Patent holders may use this patent defensively to block competitors or offensively to establish licensing revenue or negotiate cross-licenses, especially if the process offers significant cost or efficacy advantages.
Legal and Commercial Implications
- Flexibility for Innovators: The narrow process claims allow development of alternative manufacturing methods, fostering innovation.
- Infringement Risks: Companies using similar process steps should conduct detailed freedom-to-operate analyses due to dense patent landscapes.
- Enforcement Challenges: Given the procedural focus, enforcement may require technical expert testimony to establish infringement on process specifics.
Conclusion
The patent CN102617567 delineates a specific, method-oriented innovation in pharmaceutical manufacturing within China's dynamic patent environment. Its scope emphasizes process modifications designed to optimize drug quality. While providing valuable protection for its inventor, the patent's narrow claims scope limits its standalone exclusivity, necessitating awareness of surrounding patents and alternative routes of manufacture. Stakeholders must interpret such patents carefully to navigate the complex patent landscape, avoiding infringement pitfalls while leveraging potential licensing opportunities.
Key Takeaways
- Scope Focus: CN102617567 claims a specific manufacturing process, emphasizing process steps and conditions rather than the drug product itself.
- Claim Strategy: Its narrow process claims allow for flexibility but require detailed analysis to assess infringement risks or invalidity.
- Landscape Position: The patent exists amid a crowded field of process innovations in China, underscoring the importance of comprehensive freedom-to-operate assessments.
- Competitive Edge: Innovators might leverage similar process modifications to achieve advantages in drug stability or manufacturing efficiency.
- Legal Considerations: Enforcement may demand detailed technical evaluations due to the process-centric claim structure.
FAQs
1. What types of claims are predominant in CN102617567?
Primarily, the patent features process claims focused on specific manufacturing steps, parameters, and sequences used to produce a pharmaceutical formulation.
2. How broad is the protection offered by CN102617567?
The protection is relatively narrow, covering particular process parameters. It doesn't extend to the final drug product unless explicitly claimed.
3. Can competitors develop alternative methods without infringing?
Yes, if they alter the process steps sufficiently or employ different parameters that fall outside the scope of the patent claims.
4. How does this patent compare with international patents?
While similar process patents exist globally, CN102617567’s scope and claims are tailored to Chinese manufacturing practices, with some variations in claim language and specific process steps.
5. What should patent holders consider to strengthen their protection?
They should consider broadening claims where possible, including product-by-process claims, and securing corresponding patents internationally to strengthen their portfolio.
Sources:
[1] CN102617567 Patent Document, China National Intellectual Property Administration (CNIPA).
[2] WIPO Patent Library: International Patent Classification Data.
[3] China Patent Law and Guidelines, CNIPA.
