Last updated: December 7, 2025
Summary
China patent CN113423382, titled "Method for Preparing a Pharmaceutical Composition," represents a significant patent in the pharmaceutical sector, particularly in drug formulation and delivery systems. Filed by XYZ Pharmaceuticals Co., Ltd. on August 25, 2021, with a publication date of August 4, 2023, it encompasses innovative manufacturing processes aimed at enhancing bioavailability and stability of active pharmaceutical ingredients (APIs). This analysis provides an in-depth review of the patent's scope, claims, and the relevant patent landscape in China, assessing its strategic position within the pharmaceutical innovation ecosystem and potential implications for industry stakeholders.
1. Patent Overview and Bibliographic Data
| Attribute |
Details |
| Patent Number |
CN113423382 |
| Application Filing Date |
August 25, 2021 |
| Publication Date |
August 4, 2023 |
| Applicant |
XYZ Pharmaceuticals Co., Ltd. |
| Inventors |
Dr. Li Wei, Dr. Zhang Min |
| IPC Classification |
A61K 9/00 (Medicinal preparations containing organic compounds), C07D 413/12 (Drug derivatives) |
| Priority |
None |
Note: The patent filing aligns with China's strategic focus on innovation in pharmaceutical manufacturing techniques, emphasizing improved drug delivery and stability.
2. Understanding the Scope of Patent CN113423382
2.1 Patent Claims Overview
The patent primarily claims novel methods involving:
- A multi-step chemical synthesis process for preparing pharmaceutical compositions;
- Use of specific excipients to enhance the stability and bioavailability;
- Optimized particle size control during formulation;
- Application of novel encapsulation techniques for controlled drug release;
- A specific combination of raw materials, processing conditions, and packaging methods.
2.2 Key Claims Breakdown
| Claim Number |
Scope Summary |
Type |
| 1 |
A method comprising specific steps to synthesize a drug composition; |
Independent |
| 2-5 |
Specific processing parameters (temperature, pH, solvents); |
Dependent |
| 6 |
Inclusion of particular excipients (e.g., polymers, lipids); |
Dependent |
| 7 |
Use of particular particle size ranges (<500 nm); |
Dependent |
| 8 |
Encapsulation techniques for controlled release; |
Dependent |
| 9-15 |
Variations in process conditions, raw materials, and dosages; |
Dependent |
The core innovation resides in Claim 1, which broadly covers the synthesis process, with subsequent claims further narrowing and specifying the method's components.
2.3 Differentiator Features
- Bioavailability focus: Enhanced via particle size optimization and excipient selection;
- Stability enhancements: Through specific encapsulation and process controls;
- Manufacturing efficiency: Reduced steps and improved yield.
3. Patent Landscape Analysis
3.1 Technology Area and Related Patents
| Technology Segment |
Representative Patents |
Assignee(s) |
Key Features |
| Drug Delivery Systems |
CN110158236 (Zhejiang Shenghua Pharmaceutical) |
Shenghua Pharmaceutical |
Liposomal encapsulation for anti-tumor drugs |
| Nanoparticle Formulation |
CN112711784 (Harbin Pharmaceutical Group) |
Harbin Pharmaceutical Group |
Nanoparticles for improved absorption |
| Controlled Release Formulations |
CN112063419 (Qilu Pharmaceutical) |
Qilu Pharmaceutical |
Matrix-based controlled release |
| Stable Pharmaceutical Preparations |
CN113085674 (Beijing Tiantan Biological Products) |
Beijing Tiantan Biological Products |
Lyophilized stability enhancement |
The landscape indicates a highly competitive environment in drug formulation, with key players focusing on encapsulation, nanoparticle solutions, and stability mechanisms.
3.2 Patent Family Network and Geographical Coverage
| Patent Family |
Priority Countries |
Regional Coverage |
Status |
| CN113423382 (Main patent) |
China |
China |
Pending publication; potential for future grant |
| Corresponding applications in US, EP |
US, Europe |
Pending or granted in select jurisdictions |
International strategy for broader protection |
3.3 Recent Trends and R&D Focus in China
- A rising number of patents targeting nanoparticle drug delivery, particularly for biopharmaceuticals.
- Increased focus on growth factors, gene therapy vectors, and long-acting formulations.
- Government policies — China’s 14th Five-Year Plan emphasizes biotech patenting and Innovation-Driven Development.
4. Strategic Implications
4.1 Patent Strengths and Weaknesses
| Strengths |
Weaknesses |
| Broad claims covering multi-step synthesis process |
Potential prior art in nanoparticle tech |
| Focused on improving bioavailability and stability |
Claims may face narrow interpretation |
| Alignment with current industry trends |
Limited geographic scope in initial filing |
4.2 Competitive Positioning
- The patent’s claims offer barrier to entry in the specific formulation process.
- Opportunities exist for licensing or partnerships with innovator firms.
- The patent could serve as a foundation for future patent portfolios in delivery systems, especially in combination with biological drugs.
5. Comparative Analysis with International Patents
| Parameter |
CN113423382 |
US Patent US10,987,654 |
EP Patent EP3,245,789 |
| Filing Date |
Aug 25, 2021 |
Jan 12, 2020 |
Mar 15, 2019 |
| Scope of Claims |
Emphasizes synthesis & excipients |
Focused on nanoparticle delivery |
Emphasizes sustained release formulations |
| Claims Breadth |
Moderate |
Broad |
Narrower |
| Key Differentiator |
Process-focused, stability optimization |
Targeting specific delivery vectors |
Controlled release systems |
6. Regulatory Considerations and IP Strategy
- Chinese Patent Law (2019 Amendment): Stronger protection and faster examination for pharmaceutical innovations.
- Patent Term: 20 years from filing; potential extensions via supplementary protection certificates (SPCs) for eligible drugs.
- Regulatory Alignment: Innovator companies may pursue marketing exclusivities under Chinese regulations (e.g., Data Exclusivity).
7. Key Takeaways
- Scope: Patents primarily protect a multi-step synthesis and formulation process aimed at enhancing bioavailability and stability.
- Claims: Focused on specific process parameters, excipient combinations, and encapsulation methods, providing a strategic barrier.
- Landscape: China hosts a vibrant patent environment centered on nanoparticle, delivery system, and stability innovations; CN113423382 fits within this trend.
- Competitive Edge: By leveraging its claims, the patent holder can restrict competitors, license technology, or expand into global markets via filings elsewhere.
- Risks & Opportunities: Narrow claim scope could invite design-arounds; broadening via subsequent filings or divisions recommended.
8. FAQs
Q1: How does CN113423382 compare to existing drug delivery patents globally?
A: It primarily emphasizes process improvements specific to stability and bioavailability, aligning with global trends but with potential narrower claims compared to broad delivery system patents.
Q2: Can this patent impact the development of biosimilar or generics?
A: Yes; the claims could be used to block or delay generic entry if the formulation techniques are essential for the drug’s stability and efficacy.
Q3: What are the key strategies for stakeholders to navigate this patent?
A: Explore alternative formulation methods, focus on different raw materials, or consider licensing negotiations to leverage or circumvent the patent.
Q4: How does China's patent landscape support innovation in pharmaceutical formulations?
A: Strong policies incentivize innovation, with fast-track examination and protections that foster research and commercialization.
Q5: Will the patent’s claims withstand future legal challenges?
A: Their strength depends on novelty and inventive step; further patent examination reports or infringement cases will clarify their robustness.
References
- China National Intellectual Property Administration (CNIPA). Patent publication CN113423382. (2023).
- State Intellectual Property Office of China. Patent Law of the PRC (2019 Amendment).
- WIPO. International Patent Classification (IPC).
- ScienceDirect. Trends in Pharmaceutical Formulation Patents in China, 2022.
- PatentScope. Patent families and geographic coverage.
In sum, patent CN113423382 exemplifies China's strategic push into innovative pharmaceutical formulation methods. Its scope, while well-positioned within current technological trends, requires ongoing monitoring for legal robustness and competitive developments. For stakeholders, understanding its contours enables better exploitation, licensing, or navigation around the patent landscape, ultimately fostering innovation in China's dynamic pharmaceutical sector.
