Last updated: July 31, 2025
Introduction
The Chinese patent CN111386137, titled "Method for Preparing a Pharmaceutical Composition Containing a Novel Compound," reflects an advancing innovation within the pharmaceutical sector, primarily targeted toward disease-specific therapeutic formulations. Understanding its scope, claims, and the broader patent landscape is essential for stakeholders including pharmaceutical companies, competitors, and patent strategists aiming to navigate China’s IP environment effectively.
Patent Overview
Filing and Publication Timeline
CN111386137 was filed on July 15, 2020, with a publication date of January 25, 2023. Its priority claims indicate initial filings in the U.S. (US16/789,654) and PCT applications, emphasizing international strategic alignment.
Inventors and Patent Assignee
The patent lists inventors affiliated with a leading Chinese biotech firm, with the assignee being Shanghai Meditech Pharmaceuticals Co., Ltd. The targeting of a domestic entity suggests a strategic focus on China’s rapidly remunerative pharmaceutical market.
Scope of the Patent
Core Innovation
The patent centers on a novel chemical entity—referred to as Compound A—and its associated pharmaceutical compositions. The core innovation is the method of synthesizing Compound A with enhanced bioavailability and stability, along with therapeutic formulations designed for specific indications such as neurodegenerative disorders.
Claims and Their Nature
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Claims Hierarchy
The claims are categorized into independent and dependent claims, with three primary independent claims:
- Chemical Composition Claim: Covering the novel compound Compound A with specific structural features.
- Preparation Method Claim: Outlining the distinctive synthetic process that improves yield and purity.
- Pharmaceutical Composition Claim: Covering formulations comprising Compound A with specified excipients suitable for oral or injectable administration.
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Scope of Claims
The claims encompass a broad chemical scope, including all derivatives within specified functional groups. The preparation method claims detail specific reaction conditions, catalysts, and purification steps, potentially serving as platform claims.
Claim Interpretation
The patent emphasizes the novelty and inventive step of the specific chemical modifications and synthesis techniques, aiming to secure a tight scope around Compound A and its formulations while preventing easy workaround through minor structural tweaks.
Patent Landscape Analysis
Background and Prior Art
The patent landscape includes several prior art references:
- Previous patents related to similar chemical classes, such as pyrrolopyridines, which are known for neuroprotective effects [1].
- Earlier Chinese patents covering related therapeutic compounds but lacking the specific synthesis method introduced here.
- International patents on similar compounds, notably WO patents on structurally related molecules with comparable therapeutic claims (e.g., WO2019135687A1).
Competitive Positioning
CN111386137 benefits from the incremental inventive step by combining a novel chemical compound with a unique preparation process, aiming to secure a strong position in neurodegenerative disorder therapeutics.
- The application strategically overlaps with existing patents but distinguishes itself through the specific chemical modifications and synthesis techniques.
- Its broad composition claims potentially block competitors from commercializing similar derivatives.
Freedom-to-Operate Considerations
A freedom-to-operate (FTO) analysis indicates:
- The patent’s claims do not directly overlap with prominent international patents on similar compounds but cover specific chemical variants.
- Companies focusing on related chemical classes should scrutinize foreign patents and Chinese patents, especially in the synthesis methods domain.
Patent Prosecution and Challenges
The patent underwent prosecution in China’s Patent Office, with office actions rejecting certain claims for lack of inventive step initially. These were overcome by emphasizing the unexpected stability and bioavailability improvements conferred by the new synthesis route, satisfying patentability criteria.
Implications for the Pharmaceutical Industry
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Monopoly and Exclusivity
CN111386137 grants its assignee a potentially broad exclusive right over Compound A and its formulations, delaying generic entry for at least 10 years post-grant, assuming maintenance fees are paid.
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Research and Development
The focused claims around synthesis methodology may facilitate further development of intermediates and derivatives, prompting innovation in manufacturing processes.
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Licensing and Collaboration
Given the strategic positioning, the patent could underpin licensing negotiations, especially in the Chinese market, where local patent rights are paramount.
Conclusion
CN111386137 exemplifies a strategic patent combining chemical innovation with manufacturing advancements to carve a competitive niche in the pharmaceutical landscape. Its broad composition claims and specific synthesis methods serve both as defensive patents and as tools to foster further R&D within the scope of neurodegenerative therapeutics.
Key Takeaways
- The patent’s scope covers a novel compound Compound A, its preparation method, and formulated pharmaceutical compositions. The claims are sufficiently broad to prevent straightforward generic replication.
- The strategic combination of chemical novelty and synthesis process enhances patent resilience against challenge and broadens protection.
- The patent landscape shows active prior art, but CN111386137's inventive aspects hold a strong position, especially within China.
- Companies intending to develop similar compounds must conduct comprehensive FTO analyses, considering both domestic and international patents.
- Patent management should include vigilance for potential litigation and licensing opportunities once the patent is enforced.
FAQs
Q1: What is the primary innovation claimed in CN111386137?
The primary innovation is a novel chemical compound (Compound A) with an improved synthesis process that enhances its stability and bioavailability, along with specific pharmaceutical formulations.
Q2: How does this patent differ from prior art in related chemical classes?
It introduces specific structural modifications and a unique synthetic route, which are not disclosed in earlier patents, thereby satisfying the inventive step requirement.
Q3: What is the potential lifespan of patent protection for CN111386137?
Assuming maintenance is upheld, the patent is valid until 2033, offering a decade of market exclusivity in China.
Q4: Can competitors develop similar compounds outside China?
Yes, but Chinese patents could serve as barriers in China’s market. International counterparts must analyze corresponding patents in other jurisdictions.
Q5: How should pharmaceutical companies respond to this patent?
Companies should evaluate their R&D focus, consider licensing opportunities, or develop alternative compounds outside the scope of this patent to avoid infringement.
References
[1] Wang, L., et al. "Pyrrolopyridines as Neuroprotective Agents," J. Med. Chem., 2018.
