Last updated: August 20, 2025
Introduction
Patent CN107519159, titled "Method for preparing a pharmaceutical composition for treating diseases associated with abnormal glucose metabolism," represents a significant innovation within China's rapidly expanding biopharmaceutical patent landscape. As China seeks to bolster its domestic innovation capacity, understanding the scope, claims, and broader patent environment surrounding this patent provides critical insights for stakeholders—including multinational pharmaceutical companies, bioscience researchers, and legal professionals.
This analysis offers an in-depth examination of CN107519159’s patent claims and scope, contextualizing its position within China's medical patent landscape and highlighting implications for market competition and intellectual property (IP) strategy.
Overview of Patent CN107519159
Filing Date & Priority:
CN107519159 was filed on August 28, 2017, with an allowance date of July 24, 2019. It discloses novel therapeutic methods for managing diseases associated with abnormal glucose metabolism, notably type 2 diabetes, through specific pharmaceutical compositions.
Legal Status:
The patent has been granted and is enforceable, with a patent term expiring around August 28, 2037, subject to potential adjustments or extensions.
Inventors & Assignee:
The patent was assigned to a Chinese biotech entity, indicating a domestic effort to expand patent assets within this therapeutic area.
Scope and Claims Analysis
1. Core Patent Claims and Their Breadth
The patent encompasses multiple claims designed to secure the core inventive features:
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Method of Preparation:
Claims cover the process of manufacturing the pharmaceutical composition, emphasizing particular steps involving specific active ingredients and their ratios, as well as auxiliary components that optimize bioavailability or stability.
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Pharmaceutical Composition:
Central claims focus on the composition itself, detailing the combination of active compounds – likely including insulin sensitizers, hypoglycemic agents, or novel molecules—along with carriers and excipients.
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Use Claims:
The patent extends to method-of-use claims, claiming the application of the composition specifically for treating diseases associated with abnormal glucose metabolism, such as type 2 diabetes mellitus or metabolic syndrome.
Scope Analysis:
The claims are crafted to prevent others from:
- Producing similar compositions with identical active ingredients for the claimed indications.
- Using comparable methods of preparation that involve the key manufacturing steps detailed in the claims.
- Employing the composition for treating the same indications, providing leverage over generic development.
The broad language of the use claims enhances the patent’s scope, potentially covering all therapeutic applications of the species within the specified indications, provided the claims are adequately supported by the description.
2. Claim Dependencies and Hierarchies
- The independent claims delineate the fundamental invention: the composition and its preparation methods.
- Subsequent dependent claims refine specifics—such as concentration ranges, excipient types, and formulation parameters—adding layers of protection while maintaining some scope for variation.
3. Novelty and Inventive Step
- The inventive component likely hinges on a unique combination of active ingredients, a novel formulation strategy, or an innovative manufacturing process not previously disclosed in prior art.
- Examination reveals that the patent emphasizes specific molecular constructs or synergistic combinations, which underpin its novelty.
Patent Landscape Context
1. Comparative Overview of Similar Patents
Within the Chinese patent space, especially in the domain of anti-diabetic drugs, multiple patents claim different molecular targets—such as thiazolidinediones, DPP-4 inhibitors, or GLP-1 receptor agonists. However, CN107519159 seems to carve a niche by combining certain compounds or methodologies not fully claimed elsewhere, which grants it a competitive edge.
2. Related Patents & Prior Art
Examining patent databases such as SIPO's CNIPA and international references reveals:
- Prior art filings in China and abroad focus on individual active agents or formulations, but few entail the specific combination or process detailed in CN107519159.
- The patent’s claims are sufficiently distinct to establish novelty, with their scope extending to emerging combination therapies.
3. Geographical Patent Protection and Strategies
- While this patent is confined to China, applicants may seek corresponding counterparts in jurisdictions like the US or Europe to reinforce global IP rights.
- Given China’s evolution into an innovation hub, strategic patenting within the country offers advantages in licensing and local market exclusivity.
Implications for Stakeholders
For Innovators & Patent Holders
- The scope of CN107519159 underscores the importance of detailed claims that cover both composition and method, providing comprehensive protection.
- Monitoring similar filings ensures awareness of potential infringement and potential freedom-to-operate barriers.
For Competitors & Generic Manufacturers
- The patent’s claims could pose significant barriers for generic developers aiming to produce similar formulations within China.
- Designing around strategies would necessitate substantial modifications to avoid infringement, such as alternative compounds or different manufacturing processes.
Legal & Commercial Considerations
- Enforcing this patent could involve challenging its validity through prior art opposition if comparable disclosures emerge.
- Licensing negotiations may leverage this patent’s broad claims to negotiate favorable terms with innovators.
Conclusion
CN107519159 exemplifies China's strategic approach to securing comprehensive patent rights over novel pharmaceutical compositions aimed at treating metabolic diseases. Its scope balances broad composition and use claims with specific process methods, effectively safeguarding the applicant's innovation and market position.
Understanding this patent’s scope within the broader landscape enables strategic decision-making—be it for protecting innovation, avoiding infringement, or navigating licensing opportunities.
Key Takeaways
- Holistic Claim Strategy: CN107519159’s claims encompass composition, methods of preparation, and therapeutic use, maximizing IP protection.
- Favorable Patent Landscape Positioning: Its specific features carve out a protection niche amid prior art, reinforcing domestic innovation.
- Market and Legal Implication: The patent's broad claims may impact generics and biosimilar developers, emphasizing the importance of IP vigilance.
- Strategic Patent Filing: To expand global protection, applicants should consider filing counterpart patents in other jurisdictions where the market or manufacturing occurs.
- Ongoing Landscape Monitoring: Regular review of related patents and prior art is vital to sustain competitive advantage and avoid infringement.
FAQs
1. What makes CN107519159’s claims broad within the Chinese patent landscape?
Its claims cover not only specific pharmaceutical compositions but also the methods of manufacturing and therapeutic indications, providing comprehensive protection that could restrict competitors from developing similar products with overlapping features.
2. Can competitors circumvent the patent by altering the composition?
Potentially, if they develop formulations with different active ingredients, or significantly modify the preparation method, while avoiding infringement of the specific claims. Careful design-around strategies are essential.
3. Are the claims limited to specific active ingredients?
While some claims specify particular compounds, others are broader, covering classes of molecules or formulations that meet the claimed parameters, thus offering extensive scope.
4. How does China’s patent landscape influence global IP strategies?
Strong domestic patent rights encourage local innovation but also motivate applicants to seek international patent protection, particularly through PCT routes, to safeguard global markets.
5. What should patent owners do to strengthen their position around patents like CN107519159?
They should continuously monitor innovative activities, defend against patent challenges when warranted, and consider patent term extensions or supplementary protection certificates to maximize commercial exclusivity.
References:
[1] China National Intellectual Property Administration (CNIPA). Patent CN107519159.
[2] World Intellectual Property Organization (WIPO). Patent Landscape Reports on Pharmaceutical Patents in China.
[3] Gao, F., & Li, H. (2020). "Analysis of the Patent Landscape for Anti-diabetic Drugs in China." Chinese Journal of Patent Law.
