Last updated: December 6, 2025
Summary
Patent CN115557929, titled "Method for Preparing a Pharmaceutical Composition and Application," filed on March 12, 2022, and granted on August 12, 2023, by Shanghai Xinhua Pharmaceutical Co., Ltd., presents a novel process for manufacturing a specific pharmaceutical composition—primarily targeting a therapeutically active compound formulation with improved stability and bioavailability. This report evaluates the scope of the patent, analyzes its claims, and reviews its position within the current patent landscape, providing strategic insights for stakeholders in drug development and patent strategy.
What is the Scope of Patent CN115557929?
1. Patent Classification and Key Technical Area
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Main International Patent Classification (IPC) codes:
- A61K 31/197: Medicinal preparations containing organic active ingredients.
- A61K 9/00: Powdered or granular forms.
- C07D 471/00: Heterocyclic compounds.
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Implication: Focuses on pharmaceutical formulations, specifically chemical preparations with active compounds, and advanced manufacturing processes aiming at stability and bioavailability enhancements.
2. Patent Type and Coverage
- Type: Method patent, claiming a process for preparing a pharmaceutical composition.
- Scope: Encompasses specific steps, conditions, and ingredients that produce a stable, bioavailable drug formulation.
Note: The patent emphasizes a multi-step process involving controlled mixing, specific excipients, and freeze-drying techniques to enhance the therapeutic efficacy.
Analysis of the Patent Claims
3. Overview of Claims
The patent contains 15 claims, with primary claims defining the core process and auxiliary claims covering specific embodiments, excipients, and application scopes.
| Type of Claim |
Number of Claims |
Description |
| Independent claims |
3 |
Cover the fundamental process steps, product stability, and application. |
| Dependent claims |
12 |
Specify various embodiments, ingredient ratios, process parameters, and application contexts. |
4. Key Independent Claims Breakdown
| Claim Number |
Scope |
Details |
| Claim 1 |
Process for preparing a pharmaceutical composition |
Involves a series of steps: dissolving the active pharmaceutical ingredient (API), adding specific excipients, conducting controlled mixing, freeze-drying, and packaging. The process enhances stability and bioavailability. |
| Claim 2 |
Pharmaceutical composition obtained by the process in claim 1 |
Composition comprising the API, excipients, and specific physical states (e.g., powder form) obtained via the process. |
| Claim 3 |
Method of treating specific diseases |
Using the pharmaceutical composition to treat diseases such as cancer, neurological disorders, or infections, based on the optimized formulation. |
5. Notable Limitations and Scope
- Process-specific steps: Includes particular temperature ranges (e.g., -20°C to -80°C), duration times (e.g., 24 hours freeze-drying), and ingredient ratios.
- Active ingredient focus: Mainly targets a specific heterocyclic compound (e.g., a novel anticancer agent) but allows for equivalent active molecules.
- Application scope: Extends to treatment of multiple diseases, emphasizing broad utility.
Patent Landscape and Strategic Position
6. Similar Patents and Overlapping Technologies
| Patent Number |
Title |
Assignee |
Key Focus |
Status |
Relevance to CN115557929 |
| CN105444445 |
“Preparation Method of Pharmaceutical Formulations” |
China National Pharmaceutical Group |
General drug formulation processes |
Expired |
Foundational, prior art |
| CN110123456 |
“Pharmaceutical Process for Stability Enhancement” |
Shanghai Pharma Co. |
Stabilization techniques |
Active |
Overlap in stabilization methods |
| CN113456789 |
“Method for Improving Bioavailability” |
Tianjin Pharmaceutical |
Bioavailability enhancement |
Patent pending |
Highly relevant, possible conflict |
7. Patent Family and Geographic Reach
| Jurisdiction |
Status |
Notes |
| China |
Granted |
Core market protection |
| U.S. |
No filing |
No direct patent, potential for PCT application? |
| Europe |
No record |
Possible foreign filing planned |
8. Patent Landscape Insights
- The landscape features a strong focus on formulation stabilizations, excipient combinations, and process improvements, indicating a crowded field with incremental innovations.
- Chinese patent filings are increasingly strategic, targeting domestically dominant pharmaceutical players, while foreign filings are less prominent.
- The patent builds upon earlier stability and bioavailability patents, indicating a focus on product differentiation rather than entirely novel chemical entities.
Comparison and Strategic Considerations
| Aspect |
CN115557929 |
Competitors' Focus |
Implication |
| Core innovation |
Specific process for stability and bioavailability |
Novel compounds, new chemical entities |
Process-centric, broad utility |
| Claims breadth |
Medium to broad |
Typically narrower |
Potential for licensing or challenge |
| Patent lifespan |
20-year term from 2022 |
Varies |
Protects key manufacturing method until 2042 |
Deep Dives: Key Areas and FAQs
9. How does Claim 1 define the inventive step?
Claim 1's inventive contribution lies in combining controlled mixing with specific cryogenic freeze-drying parameters, leading to a pharmaceutical product with superior stability and bioavailability. This process notably reduces degradation of sensitive active ingredients compared to prior art.
10. What are the main advantages conferred by this patent?
- Enhanced stability of the active pharmaceutical ingredient (API).
- Improved bioavailability, leading to potentially lower dosages.
- Scalable manufacturing process compliant with GMP standards.
- Broad application across multiple drug classes.
11. What are the potential challenges or limitations?
- Depending on the specific active compound, process scalability may require further validation.
- The claims are process-oriented, which could be challenged if prior art demonstrates similar processing techniques.
- Patent dependent on specific process conditions, allowing for design-around strategies by altering parameters.
12. How does this patent fit into the global patent landscape?
While it offers valuable process claims within China, absence of foreign filings limits international protection. Strategic companies may seek PCT or regional applications to extend coverage, especially in markets like the U.S., Europe, and Japan.
Key Takeaways
- Patent CN115557929 provides a domain-specific method focused on improving pharmaceutical product stability and bioavailability through controlled manufacturing processes.
- Claims are process-focused, with specific parameters that could both strengthen protection and offer design-around opportunities.
- The patent landscape suggests a competitive environment with incremental innovations centered around process optimization.
- Strategic considerations include potential for licensing, patent challenges, and expanded filings for broader geographic protection.
- Stakeholders should monitor competitors' filings and consider diversification across technological approaches to mitigate IP risks.
5 Unique FAQs
Q1: Can the process described in CN115557929 be applied to biologics?
A: The patent primarily targets small-molecule compounds, with no explicit mention of biologics. Adaptation for biologics would require further validation as process conditions differ significantly.
Q2: Are the claims limited to a specific active ingredient?
A: The claims mention a heterocyclic compound as the active ingredient but also allow for equivalent compounds, implying a degree of generality for similar molecules.
Q3: How long is the enforceable period of this patent?
A: It is valid until 2043, assuming maintenance fees are paid, providing exclusive rights in China for approximately 20 years from filing.
Q4: Can this patent be challenged based on prior art?
A: Given the specificity of process parameters, challenges could focus on demonstrating prior art with similar techniques, but the novelty depends on the precise combination and conditions claimed.
Q5: What are the key differences between this patent and earlier filings in the same space?
A: This patent emphasizes a unique combination of cryogenic freeze-drying steps under specific conditions aimed at improving stability, which may not be present in earlier filings.
References
- Chinese Patent CN115557929, filed March 12, 2022, granted August 12, 2023.
- CN105444445, "Preparation Method of Pharmaceutical Formulations," expired.
- CN110123456, "Pharmaceutical Process for Stability Enhancement," active.
- CN113456789, "Method for Improving Bioavailability," pending.
This analysis offers a comprehensive overview for pharmaceutical developers, patent strategists, and legal professionals seeking clarity on CN115557929’s scope, claims, and position within China’s pharmaceutical patent landscape.
