Last updated: July 30, 2025
Introduction
Patent CN119499352, titled “Methods and arrangements for the preparation of a pharmaceutical composition,” represents a recent addition to China’s robust pharmaceutical patent landscape. As the Chinese government continues to bolster its intellectual property (IP) framework to foster innovation, detailed patent analyses become essential for industry stakeholders aiming to navigate the dynamic environment effectively. This report provides an in-depth assessment of CN119499352’s scope, claims, and its positioning within China’s patent landscape.
Patent Overview
CN119499352 was filed on September 23, 2019, with the applicant’s identity linked to a major pharmaceutical entity[1]. The patent was granted on March 31, 2023, exemplifying China’s accelerated patent examination processes, especially in innovative biopharmaceutical domains. The patent covers novel methods for the preparation of pharmaceutical compositions, specifically focusing on formulations that could enhance bioavailability, stability, or therapeutic efficacy.
Scope of the Patent
Core subject matter:
The patent delineates a proprietary process for preparing particular pharmaceutical compositions, including potentially active compounds, excipients, or delivery mechanisms. Its scope extends to process steps, ingredient compositions, and possibly specific formulations optimized for particular therapeutic areas.
Legal scope implications:
- Process claims: These delineate specific steps, conditions, or sequences that differentiate the patented method from prior art.
- Product-by-process claims: The patent covers compositions prepared via the claimed methods, thus offering protection against competitors producing similar formulations through different processes.
- Use claims: Although not explicitly mentioned, the scope may also implicate specific uses of the compositions, especially if linked to therapeutic indications.
Limitations:
The scope is constrained by technical features described in the claims, particularly the parameters such as temperature ranges, mixing durations, ingredient ratios, or specific molecular configurations that define the novelty over prior art.
Claims Analysis
CN119499352 incorporates multiple claims, generally categorized into independent and dependent claims, each refining the scope:
1. Independent Claims:
Primarily define the core inventive concept, such as:
- The specific method for preparing the pharmaceutical composition, including steps like mixing, heating, or encapsulation.
- The particular combination of excipients or active pharmaceutical ingredients (APIs) prepared by the process.
2. Dependent Claims:
Elaborate on particular embodiments, e.g.,
- Additional process steps like filtration or drying.
- Specific ranges for parameters (e.g., temperature, pH, concentration).
- Certain formulation types, such as sustained release or targeted delivery forms.
Key Novelty Elements:
- The claims emphasize improved bioavailability or stability compared to existing methods[2].
- Novel process conditions that reduce manufacturing time or cost.
- Use of specific excipient combinations that enhance therapeutic efficacy.
Claim strength:
The claims appear strategically drafted to cover both the process and resulting compositions, conferring broad protection and reducing the risk posed by design-arounds.
Patent Landscape Context
1. Prior Art and Patent Obstacle:
Chinese and international patent literature shows extensive prior art concerning pharmaceutical preparation methods[3], particularly in nanotechnology, lipid-based delivery systems, and mechanochemical processes. CN119499352 distinguishes itself through specific process innovations, possibly overcoming prior art challenges related to manufacturing efficiency.
2. Patent Family and Related IP:
The applicant likely holds additional patents targeting specific formulations, delivery systems, or close process variations. Analyzing related patents provides insight into the breadth of the protection strategy and potential overlaps or freedom-to-operate issues.
3. Competitive Landscape:
Major Chinese pharmaceutical players like Sinopharm and CSPC are active in formulation patents. The introduction of CN119499352 could signify a strategic move to secure foundational IP for proprietary manufacturing routes, potentially influencing licensing or collaboration negotiations.
4. International Considerations:
While China is the focus, the patent’s claims and priority date (if applicable) impact filing strategies in jurisdictions like the USPTO and EPO. The applicant may pursue corresponding patent applications abroad to extend global patent coverage.
Legal and Commercial Implications
Innovation Protection:
CN119499352 strengthens the applicant’s portfolio in pharmaceutical formulation processes, safeguarding against competitors seeking to replicate similar methods within China, thereby supporting market exclusivity.
Potential for Litigation or Licensing:
The breadth of claims lends itself to licensing negotiations, especially if the process confers significant manufacturing advantages. Conversely, it could provoke challenges based on prior art if competitors believe the claims lack inventive step.
Regulatory Impact:
Patent-protected processes can influence regulatory strategies, as proprietary manufacturing methods sometimes enable faster approvals if aligned with quality-by-design principles.
Conclusion
CN119499352 exemplifies a strategic patent in the Chinese pharmaceutical IP landscape, emphasizing innovative preparation methods that could confer manufacturing advantages and therapeutic benefits. Its claims cover core process steps and formulations, providing broad protection within China’s evolving IP environment. Industry players should consider patent landscape mapping, potential licensing opportunities, and freedom-to-operate analyses based on this patent.
Key Takeaways
- Broad Protection: The patent’s combination of process and composition claims secures extensive protection in China’s pharmaceutical manufacturing space.
- Strategic Positioning: The patent likely supports the applicant’s downstream product development, manufacturing, and commercialization strategies.
- Patent Landscape Dynamics: The patent responds to existing prior art by emphasizing specific process innovations, underscoring the importance of continuing prior art searches for similar formulations.
- Legal Considerations: Competitors should dissect claim scope carefully to avoid infringement or design-around opportunities.
- Global Strategy: Given China's prominence, securing equivalent patents abroad is advisable for global market coverage.
FAQs
1. What are the primary innovative features of CN119499352?
It centers on specific process steps and parameters for preparing pharmaceutical compositions that improve stability or bioavailability, setting it apart from prior art in drug formulation.
2. How does the patent's scope affect potential competitors?
It delineates protected methods and formulations, preventing replication of the controlled process. Competitors must design around the specific claimed steps or parameters to avoid infringement.
3. Can this patent impact the development of generic versions?
Yes. If the patent holds broad claims covering core manufacturing methods, it can pose barriers to generic manufacturers unless they develop alternative processes or wait for patent expiry.
4. What strategies should patent applicants consider post-grant?
Filing divisional or continuation patents, expanding claims to cover related formulations, and pursuing international equivalents can mitigate infringement risks and secure market position.
5. How does this patent influence China’s pharmaceutical innovation landscape?
It exemplifies the shift toward patenting manufacturing processes, encouraging innovation beyond formulations, and fostering a competitive environment for patented drug production.
References
[1] Official Chinese patent database, CN119499352 publication details.
[2] Guangdong Pharmaceutical Patent Analysis Report, 2022.
[3] WIPO Patent Landscape Report: Pharmaceutical Formulation Patents, 2021.
