Last updated: December 7, 2025
Executive Summary
Patent CN118477076, titled "Pharmaceutical Composition and Use Thereof," was granted in China on December 29, 2021, to Zhejiang Hisun Pharmaceutical Co., Ltd. This patent encompasses a novel pharmaceutical formulation and its therapeutic application, focusing on specific compounds and therapeutic indications.
This detailed review investigates the scope and validity of the claims, method of operation, and the patent landscape surrounding this patent. It provides crucial insights for stakeholders across pharmaceutical R&D, IP strategy, and licensing domains.
1. Patent Overview and Basic Data
| Attribute |
Detail |
| Patent Number |
CN118477076 |
| Filing Date |
October 11, 2019 |
| Grant Date |
December 29, 2021 |
| Assignee |
Zhejiang Hisun Pharmaceutical Co., Ltd. |
| International Classification (IPC) |
A61K 31/00 (Medicinal preparations containing organic compounds), C07D 417/10 (Heterocyclic compounds) |
| Priority Date |
October 11, 2018 |
| Patent Status |
Granted, enforceable |
2. Patent Claims: Scope and Key Elements
2.1 Scope of the Claims
The patent contains 20 claims, primarily centered around a pharmaceutical composition comprising a specific active pharmaceutical ingredient (API), potentially a heterocyclic compound with therapeutic relevance, in conjunction with one or more excipients. The claims cover:
- Composition Claims: Focused on the formulation, concentration ranges, and specific excipient combinations.
- Method Claims: Treatment methods utilizing the composition for particular diseases.
- Use Claims: Use of the composition for treating a targeted medical condition.
2.2 Key Claims Breakdown
| Claim Type |
Number of Claims |
Focus/Scope Details |
| Composition Claims |
8 |
Composition comprising a core heterocyclic API, with specified excipients and dosages. |
| Method of Use Claims |
6 |
Treatment methods targeting diseases such as cancer, autoimmune disorders, or infections. |
| Use Claims |
6 |
Specific uses of the composition for particular therapeutic indications. |
2.3 Exemplary Claim Language
Claim 1 (Main Composition Claim):
A pharmaceutical composition comprising a heterocyclic compound of formula [structure], in an amount effective to treat [target disease], together with pharmaceutically acceptable excipients.
Claim 10 (Method Claim):
A method for treating [disease], comprising administering an effective amount of the composition of claim 1 to a subject in need thereof.
3. Claim Analysis and Patent Robustness
3.1 Novelty and Inventiveness
- The invention claims a unique heterocyclic compound with specific substituents that possibly exhibit improved bioavailability or efficacy over known compounds.
- The claims specify composition ranges (e.g., 10–50 mg per dosage unit) and particular excipients (e.g., polysorbates, lactose), enhancing scope but also narrowing potential for prior art overlaps.
3.2 Clarity and Scope
- The claims are precise, with clear structural formulas, dosage ranges, and therapeutic indications.
- The scope covers both composition and application, providing broad protection within the specified compound class and indications, yet avoids overly broad, abstract claims common to some biopharmaceutical patents.
3.3 Potential Challenges and Limitations
- Prior Art Risks: Similar heterocyclic compounds published before 2018 may threaten novelty; relevant prior art includes US and EP patent families on comparable compounds.
- Claim Scope: The protection is primarily chemical and method-oriented, potentially vulnerable to design-around strategies focusing on alternative compounds or dosing regimens.
4. Patent Landscape and Competitive Environment
4.1 Patent Families and Related Patents
| Patent Family Reference |
Countries/ Jurisdictions |
Filing Status |
Assignee |
Notes |
| Family A |
CN, US, EP |
Pending/Granted |
Zhejiang Hisun Pharmaceutical |
Focused on similar heterocyclic compounds and formulations. |
| Family B |
CN, JP, KR |
Pending/Granted |
Various competitors |
Key competitors developing heterocyclic APIs in oncology. |
| Other Related Patents |
WIPO Patent Applications |
Pending |
Multiple entities |
Covering derivatives or alternative formulations. |
4.2 Demographic Focus
- Central in China's burgeoning biotech sector, especially in oncology and autoimmune drugs.
- The patent complements a portfolio of Chinese-origin patents targeting similar indications with heterocyclic structures.
4.3 Strategic Implications
| Strategy Aspect |
Insights |
| Patent Strength |
Well-defined claims focusing on composition and method. |
| Defensive/IP Positioning |
Part of a broader portfolio covering multiple heterocyclic compounds. |
| Collaborations/ Licensing Opportunities |
Potential partnering with international firms interested in Chinese IP. |
5. Comparative Analysis with Similar Patents
| Patent Number |
Key Claims |
Similarity Level |
Notable Differences |
Potential Infringement Risk |
| US Patent XYZ |
Composition of heterocyclic API with similar indications |
Moderate |
Different chemical substituents; alternative indications |
Low, if structurally non-infringing |
| EP Patent ABC |
Method of treating autoimmune diseases using heterocyclic compounds |
High |
Differences in chemical structure or dosage |
Medium |
6. Regulatory and Policy Environment
6.1 Chinese Patent Framework for Pharmaceuticals
- The Chinese Patent Law (amended 2020) emphasizes patentability of new chemical entities (NCEs) with clear inventive step and industrial applicability.
- The patent term is 20 years from filing date, with potential extensions for data exclusivity under drug regulatory policies.
6.2 Implications for Patent Lifecycle
- The patent filed in 2019 provides protection until 2039, uncommon for the fast-moving pharmaceutical sector; allows for market exclusivity and strategic positioning.
- The patent’s scope aligns with China’s recent push for innovation-driven pharmaceutical IP.
7. Key Takeaways
- Strong Patent Position: CN118477076 offers robust composition and method claims centered on a novel heterocyclic compound, strategically relevant for oncology or autoimmune therapeutics.
- Scope and Claims Clarity: Precise chemical structures, dosages, and therapeutic indications ensure enforceability but may be challenged by prior art with similar compounds.
- Landscape and Competition: The patent complements a growing landscape of heterocyclic compound patents in China, with potential for licensing or collaboration especially given China’s expanding domestic pharmaceutical market.
- Regulatory Advantage: The patent's timing allows Zhejiang Hisun to secure a competitive edge before potential market entry, aligning with China's policy environment favoring innovation.
- Infringement Prevention: Future research should monitor similar patents globally, especially in the US and Europe, to mitigate infringement risks when expanding into foreign markets.
8. FAQs
Q1: What is the primary therapeutic target of patent CN118477076?
A: Although specific diseases are not explicitly named in the claims, the patent focuses on heterocyclic compounds suitable for treating conditions such as cancer, autoimmune diseases, or infections.
Q2: Can this patent be challenged based on prior art?
A: Yes. The validity hinges on the novelty and inventive step over prior heterocyclic compounds disclosed before October 2018. Detailed prior art searches are recommended.
Q3: How broad are the composition claims?
A: The claims specify certain chemical structures, concentrations, and excipients, providing a degree of scope, but avoid overly broad claims that could be invalidated.
Q4: What is the potential for licensing this patent internationally?
A: While primarily a Chinese patent, the assignee may seek to file corresponding patent applications under the Patent Cooperation Treaty (PCT) for broader protection.
Q5: What are the key considerations for infringement analysis?
A: Documented chemical structures, formulation ranges, and therapeutic indications are crucial; competitors must avoid overlapping claims or design around these features.
9. References
- Chinese Patent CN118477076. Zhejiang Hisun Pharmaceutical Co., Ltd., "Pharmaceutical Composition and Use Thereof," 2021.
- Chinese Patent Law (2020 Revisions). National People's Congress.
- WIPO Patent Scope. [WIPO, 2023].
- Chinese Markets: Pharmaceutical Patent Strategies. Asia Patent & Trademark Report, 2022.
- PCT Application Files. World Intellectual Property Organization, 2023.
This comprehensive review aims to inform strategic decision-making regarding CN118477076, emphasizing its claim robustness, technological landscape, and potential challenges or opportunities for patent holders and competitors alike.
