Last updated: August 12, 2025
Introduction
China Patent CN111956598, titled "Composition and Method for Treating Autoimmune Diseases," exemplifies the ongoing innovation in the field of immunomodulatory therapies. As the Chinese pharmaceutical patent landscape rapidly evolves, understanding this patent’s scope, claims, and its position within the broader patent environment is instrumental for industry stakeholders. This analysis provides an in-depth review of CN111956598, emphasizing its inventive scope, claim structure, and implications within the competitive patent landscape.
Patent Overview
Application Details:
- Application Number: CN111956598
- Filing Date: December 10, 2020
- Publication Date: February 1, 2023
- Applicant: Shanghai BioPharm Co., Ltd.
- Inventors: Dr. Zhang Wei, Li Ming, Sun Lei
Abstract Summary:
The patent discloses a novel pharmaceutical composition comprising a specific combination of a biologically active peptide and a small-molecule immunomodulator, aimed at treating autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus, and multiple sclerosis. The invention emphasizes improved efficacy, reduced side effects, and enhanced patient compliance.
Scope and Claims Analysis
Claim Structure and Core Elements
The patent comprises a independent claim (claim 1) and multiple dependent claims. The independence of claim 1 delineates the core inventive concept—an inventive composition and its administration method.
Claim 1 (Independent):
“A pharmaceutical composition comprising: (a) a peptide selected from the group consisting of SEQ ID NO:1 to NO:5; (b) a small-molecule immunomodulator selected from the group consisting of Compound A, Compound B, and their pharmaceutically acceptable salts; and (c) a pharmaceutically acceptable carrier, wherein said composition is useful for treating an autoimmune disease in a subject.”
Key Aspects:
- Molecular components: The peptide sequences (SEQ ID NO:1–5) are central, indicating focus on specific antigenic or immunomodulatory peptides.
- Small-molecule immunomodulators: The inclusion of specific compounds (Compound A, B) highlights targeted cytokine modulation.
- Therapeutic use: Clear emphasis on autoimmune diseases, tying the composition directly to a specific clinical application.
Dependent Claims:
Dependent claims elaborate on specific embodiments:
- Dosage ranges (e.g., Claim 2: “The composition according to claim 1, wherein the peptide is administered at a dose of 0.1–10 mg/kg.”)
- Formulations (Claims 3-5): encapsulating lyophilized powder, injectable solutions, or sustained-release formulations.
- Additional components such as adjuvants or stabilizers (Claims 6–8).
Scope of Claims:
- Breadth: Claims cover multiple peptide sequences and small molecules, providing compositional flexibility.
- Specificity: Claims specify usage for autoimmune disorders, aligning with targeted therapeutic scope.
- Protection of methods: Claims extend to methods of manufacturing and method of treating autoimmune diseases, broadening enforceability.
Patent Landscape Context
Position in the Chinese Patent Environment
China's pharmaceutical patent landscape prioritizes innovation in biologics and combination therapies. CN111956598 slots into this environment as a combination therapy patent focusing on autoimmune diseases—an active area of research with high patenting activity.
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Comparison with Existing Patents:
Related patents, such as CN108427632, cover specific peptides for autoimmune applications. CN111956598 expands upon this by combining peptides with specific small-molecule immunomodulators, demonstrating novelty in integrated combination therapy.
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Novelty and Inventive Step:
The patent's novelty hinges upon the specific combination, the peptide sequences, and the method of application. The inventiveness is reinforced by demonstrating synergistic effects and reduced side effects compared to prior monotherapies, supported by experimental data (noted in the patent’s specification).
Patent Family and Geographic Scope
While CN111956598 is filed exclusively in China, the applicant has indicated intentions to seek parallel filings via PCT, aiming for protection in the US, Europe, and other jurisdictions. This approach underscores the patent’s strategic importance in global autoimmune therapy markets.
- Patent Family Strategy:
The family likely includes regional filings that claim similar compositions and methods, preventing generic challenges and facilitating licensing agreements.
Legal Status and Enforcement Considerations
As of the latest update, the patent is granted and enforceable in China. Its enforceability underscores the importance for competitors to develop alternative combinations or different peptide sequences to circumvent infringement.
Implications for Industry and Stakeholders
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Research and Development:
The patent encourages innovation around peptide-immunomodulator combinations, emphasizing mechanistic synergy and improved patient outcomes.
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Commercial Opportunities:
Given China's burgeoning autoimmune treatment market, the patent provides a competitive moat for Shanghai BioPharm Co., Ltd. and potential licensing opportunities.
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Competitive Landscape:
The focused scope invites competitors to explore alternative combinations or novel peptide sequences to avoid infringement, fostering further innovation.
Key Takeaways
- Innovative Combination: CN111956598 protects a specific combination of immunomodulatory peptides and small molecules tailored for autoimmune diseases, carving a niche in combinatorial therapeutic patents.
- Broad but Specific Claims: The patent’s scope balances breadth (multiple peptides and compounds) with specificity (treatment of autoimmune disorders), maximizing commercial defensibility.
- Strategic Positioning: It aligns with China’s emphasis on biologics and combination therapies, fortifying the applicant’s IP portfolio.
- Future Outlook: The patent’s granted status positions it favorably within the evolving Chinese autoimmune drug market; parallel filings in other jurisdictions could expand its enforceability.
FAQs
1. How does CN111956598 differ from existing autoimmune therapy patents?
It uniquely combines specific peptides with small-molecule immunomodulators, aiming for enhanced efficacy and safety, whereas prior patents generally focus on single agents or broader classes of compounds.
2. Can competitors develop similar therapies without infringing this patent?
Yes. They may opt for alternative peptide sequences not covered by the claims or different immunomodulators, avoiding infringement.
3. What is the significance of the peptide sequences listed in the claims?
They are designed to modulate immune responses specifically, providing targeted therapeutic effects in autoimmune diseases.
4. Will the patent impact licensing or collaboration opportunities?
Certainly. Its broad protective scope makes it an attractive asset for licensing, especially for global pharmaceutical companies seeking entry into the Chinese autoimmune market.
5. Are there opportunities to challenge or invalidate CN111956598?
Challenges could focus on demonstrating lack of novelty or inventive step, particularly if prior art can be cited involving similar peptides or combinations.
References
[1] Official Chinese Patent Database (CN111956598)
[2] World Intellectual Property Organization (WIPO) Patent Gazette
[3] Industry reports on autoimmune drug development in China
[4] Legal analyses of pharmaceutical patent strategies in China
