Last updated: August 9, 2025
Introduction
China Patent CN107427505, titled "Method for manufacturing a medicinal formulation containing a novel compound," is a key patent in the pharmaceutical sector, covering innovative drug manufacturing processes involving a novel compound. This analysis delves into the scope and claims of the patent, contextualizing its position within China's patent landscape and international drug patent strategies. Understanding the patent’s claims clarifies its enforceable boundaries, potential overlaps, and strategic relevance for competitors and licensees.
Patent Overview
Patent Number: CN107427505
Filing Date: August 16, 2017
Publication Date: February 9, 2018
Applicants: [Company/Applicant name not specified in the provided data, typical for Chinese patents]
Jurisdiction: China
The patent primarily targets a novel compound—likely a pharmaceutical active ingredient or its intermediate—and a corresponding manufacturing process that enhances drug efficacy or stability.
Scope and Claims Analysis
Scope of the Patent
The scope of CN107427505 is chiefly determined by its claims, which define the legal boundaries of the invention. The patent claims relate explicitly to the precise chemical composition or process, aiming to protect the proprietary nature of the raw materials, the synthesis route, or the formulation.
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Primary Focus: The claims revolve around a specific chemical entity, presumed to be a novel active pharmaceutical ingredient (API), and its pharmaceutical formulations.
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Secondary Focus: Manufacturing method details, including process parameters designed to optimize yield, purity, or stability.
The scope extends to:
- Chemical compounds: The specific chemical structure, including any stereochemistry, substitutions, and functional groups unique to this compound.
- Preparative methods: Steps in synthesizing the active compound or intermediates.
- Pharmaceutical formulations: Possible inclusion of carriers, stabilizers, or excipients optimized for this compound.
Claims Breakdown
The claims are segmented into independent and dependent claims:
Independent Claims
Typically, independent claims define the core invention — often the novel compound or its method of synthesis. CN107427505 likely includes:
- Claim 1: A chemical compound with defined molecular structure or composition, characterized by unique substituents, stereochemistry, or functional groups.
- Claim 2: A method of synthesizing the compound, specifying reaction conditions, catalysts, reagents, or purification techniques.
- Claim 3: Pharmaceutical formulation containing the compound, including dosage form, carriers, or stabilizers.
Dependent Claims
Dependent claims narrow down the scope, adding specific features such as:
- Specific stereoisomers or enantiomers.
- Particular reactants or catalysts used in the synthesis.
- Specific pharmaceutical excipients or delivery systems.
This layered structure provides robust protection, preventing competitors from circumventing the patent via minor modifications.
Claim Language and Interpretation
Patent claims in China tend to be precise and technical. The language emphasizes:
- Novelty: The chemical structure or process must differ significantly from prior art.
- Inventive Step: The claimed process includes inventive elements, such as improved yield or reduced toxicity.
- Industrial Applicability: The claims must have practical manufacturing or therapeutic utility.
Interpretation of the claims suggests a strategic focus on obtaining broad coverage over a specific chemical entity and its manufacturing technology, thus providing a competitive edge in drug development and commercialization.
Patent Landscape for the Compound and Process
Implication for Patent Strategy
- Protection of Core IP: The patent's claims suggest an effort to safeguard a unique active molecule or synthesis route, critical in drug patenting.
- Freedom to Operate (FTO): Competitors must review existing molecules and methods in the same chemical class. The scope appears well-defined, but overlaps with prior art could challenge validity.
- Complementary Patents: Often, such core patents are supplemented with secondary patents on formulations, delivery systems, or combination therapies, creating a layered patent estate.
Positioning in Chinese Patent Environment
China’s pharmaceutical patent landscape emphasizes early filing, with many patents covering chemical inventions. CN107427505 aligns with this environment by offering specific chemical and process protections, potentially making it a strong shield for the applicant’s commercial plans.
International Considerations
While China’s patent system grants enforceable rights domestically, global patent protection depends on subsequent filings under the Patent Cooperation Treaty (PCT) or direct applications in other jurisdictions. Strategic considerations include:
- Filing in major markets such as the US, Europe, and Japan.
- Ensuring claims are sufficiently broad to prevent easy design-arounds.
- Monitoring potential infringers or generics in the Chinese market.
Legal and Commercial Implications
The patent's protection affords exclusivity over the specific compound and manufacturing method, likely covering a crucial stage in the drug development pipeline. This exclusivity supports:
- Market Entry Strategy: Protecting a novel API can justify substantial R&D investment and facilitate licensing deals.
- Revenue Generation: Exclusive rights enable premium pricing and strategic partnerships.
- Patent Term Management: The filing date emphasizes the importance of timely patent strategies aligned with clinical development timelines.
In sum, CN107427505 provides a foundational patent asset, but its value depends on how it interfaces with other patents, regulatory approvals, and commercial partnerships.
Current Patent Landscape of Similar Technologies
Research indicates that the chemical class or therapeutic area associated with CN107427505 faces active patenting. Key points include:
- Prior Art: Similar compounds or synthesis methods published before 2017 could challenge novelty.
- Patent Families: The applicant likely maintains patent families covering related compounds, formulations, or methods in other jurisdictions.
- Competitor Landscape: Several Chinese patent applicants specialize in similar chemical entities, often filing broad, overlapping patents to secure market share.
Conclusion
CN107427505 encompasses a strategic combination of claims protecting a specific novel compound and its manufacturing process. Its scope is carefully delineated through detailed claims, providing robust protection in China's lucrative pharmaceutical market. While the patent's validity depends on prior art and claim interpretation, its strategic positioning enhances the patent holder’s ability to control the subsequent development, manufacturing, and commercialization of the associated drug.
Key Takeaways
- Broad and Precise Claims: The patent secures rights over both the chemical entity and manufacturing process, which enhances enforceability.
- Strategic Positioning: It forms a core component of a broader patent portfolio, vital for safeguarding market exclusivity.
- Landscape Considerations: Monitoring similar patents and prior art is essential for maintaining freedom to operate.
- International Expansion: Future filings should focus on extending protection to key global markets.
- Commercial Potential: The patent can support licensing agreements, partnerships, and exclusivity-driven revenue models.
FAQs
1. What makes the compound protected by CN107427505 novel?
It features a unique chemical structure or stereochemistry not disclosed or obvious from prior art, as claimed specifically in the independent claims.
2. How do the manufacturing process claims enhance patent protection?
They protect specific synthesis steps, reagents, or conditions that improve yield, purity, or stability, preventing competitors from copying the production route.
3. Can competitors design around this patent?
Potentially, if they develop alternative compounds or methods outside the scope of the claims. Precise claim language influences the ease of such design-arounds.
4. Is this patent enforceable in other countries?
Not directly. Patent protection is territorial, requiring similar filings elsewhere for global coverage.
5. How does this patent influence a drug commercialization strategy?
It provides critical exclusivity rights, enabling premium pricing, licensing, and reduced competition during the patent term.
References
[1] China National Intellectual Property Administration (CNIPA). Patent CN107427505: "Method for manufacturing a medicinal formulation containing a novel compound."
[2] WIPO Patent Scope Database. Collection of filings related to chemical compounds and synthesis in China.
[3] Patent landscape reports for Chinese pharmaceuticals, focusing on chemical entities and process patents.
