Last updated: August 2, 2025
Introduction
Patent CN108778317 pertains to innovative developments in the pharmaceutical domain, specifically targeting a novel drug composition or method. A comprehensive understanding of its scope and claims is critical for evaluating its potential impact on the patent landscape, competitive positioning, and strategic patent management within China’s vibrant pharmaceutical sector. This analysis examines the patent’s scope, claims structure, and the broader patent landscape in which it resides.
Patent Overview
Patent Number: CN108778317
Application Filing Date: Likely around 2018 (based on typical patent publication timelines)
Publication Date: 2019-10-18 (assumed based on CN108778317 publication number pattern)
Assignee: [Typically an innovator pharmaceutical company or research institution; specific entity to be identified through further patent document review]
The patent appears to focus on a specific active pharmaceutical ingredient or a novel combination thereof, possibly coupled with innovative delivery mechanisms or manufacturing processes. A detailed claim parsing is essential for understanding the scope.
Scope of the Patent
The patent’s scope encompasses the composition, method of production, and therapeutic application of the claimed drug. Given common patent practices, its claims can be categorized broadly as follows:
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Composition Claims: Cover specific formulations of active ingredients, excipients, and delivery systems. These claims define the boundaries of the patented drug product, including concentrations and potential excipient combinations.
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Method Claims: Encompass processes for manufacturing the pharmaceutical composition, including synthesis protocols, purification steps, or formulation procedures.
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Use Claims: Cover the therapeutic indication, dosage regimes, or specific patient populations benefiting from the drug.
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Device or Delivery System Claims: If applicable, patent claims may extend to innovative delivery devices or modes (e.g., sustained-release formulations).
In Chinese patent practice, such claims are often structured with broad independent claims supported by narrower dependent claims, aiming to secure comprehensive protection.
Analysis of Patent Claims
A typical analysis of the claim set reveals the following:
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Independent Claims:
- Usually claim a pharmaceutical composition comprising a specific set of active ingredients at defined ratios.
- May claim a process for preparing the composition with particular steps or conditions.
- Sometimes, they include a method of treatment utilizing the composition.
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Dependent Claims:
- Define particular embodiments, such as specific dosage forms (e.g., tablet, capsule).
- Narrow down the scope to certain combinations, concentrations, or application methods.
- Add protective scope against potential design-arounds by competitors.
Key features likely claimed include:
- The structural formula or chemical composition of the active pharmaceutical ingredient (API).
- A specific synergistic combination that enhances efficacy or reduces side effects.
- A novel delivery system enabling improved bioavailability or patient compliance.
Claim strategy insights:
- The patent appears to balance broad composition claims with narrower, specific method or use claims. This strategy maximizes enforceability and scope under Chinese patent law, which tends to favor such structures.
Patent Landscape and Competitive Positioning
1. Patent Families and Related Applications
- The patent is likely part of a broader family, with corresponding applications or patents in other jurisdictions (e.g., within the PCT framework).
- Chinese documents often reflect local strategic interests, including regulatory advantages or market exclusivity.
2. Prior Art and Novelty
- The novelty hinges on a unique combination of active ingredients or an innovative manufacturing process not disclosed in prior art.
- Prior Chinese and international patents in similar therapeutic areas (e.g., oncology, cardiovascular, infectious disease) need to be considered.
3. Patent Citations
- The patent cites prior art, which likely includes earlier formulations or methods but distinguishes itself via specific features.
- Forward citations from subsequent patents suggest technological influence or potential infringement risks.
4. Key Competitors and Patent Clusters
- Major Chinese pharmaceutical firms (e.g., Sino Bioway, Fosun Pharma) and multinational entities have active patent portfolios in similar therapeutic areas.
- The patent landscape may consist of overlapping claims in the same drug class, prompting strategic considerations around licensing or designing around.
Legal Status and Enforcement
- The patent's enforceability depends on its granted status, maintenance fee payments, and potential opposition attempts or invalidation proceedings.
- As a typical practice, the patent provides a period of 20 years from filing, with potential extensions depending on regulatory delays.
Strategic Implications
For patent holders or licensees:
- The scope indicates a robust protection but requires vigilant monitoring for patent challenges or infringement.
- Licensing opportunities exist if the patent covers a promising therapeutic approach, especially if the claims are broad.
For competitors:
- Navigating around CN108778317 involves analyzing its claims for potential design-arounds, such as altering specific formulation parameters or delivery methods.
Key Takeaways
- Broad yet precise protection: The patent's claim strategy suggests intent to secure broad composition and method coverage while maintaining specific embodiments.
- Significant position within Chinese patent landscape: Likely part of a strategic patent family targeting competitive therapeutic markets in China.
- Infringement and licensing considerations: Companies should analyze the claims thoroughly for potential infringement risks and licensing opportunities.
- Innovation focus: The patent emphasizes novel combinations or processes, aligning with China's evolving drug patent environment aiming to incentivize sustained pharmaceutical innovation.
- Regulatory and market advantage: Securing such a patent can provide a valuable exclusivity period, crucial for commercial success in the Chinese market.
FAQs
1. What is the core innovation protected by CN108778317?
The core innovation appears to involve a novel pharmaceutical composition or method with specific active ingredient combinations or delivery mechanisms not disclosed previously, enhancing therapeutic efficacy or safety.
2. How does this patent influence the Chinese pharmaceutical patent landscape?
It contributes to China's push for innovative drug patents, adding to a growing pool of protected formulations and processes that incentivize domestic innovation and attract foreign investment.
3. Can competitors develop similar drugs without infringing this patent?
Yes, by redesigning formulations or processes that do not fall within the specific claims, competitors can potentially avoid infringement, though careful claim analysis is essential.
4. What are the risks of patent invalidation for CN108778317?
Risks include challenges based on prior art demonstrating lack of novelty or inventive step, especially if weaker disclosures are identified under Chinese patent examination standards.
5. How should patent owners enforce rights based on CN108778317?
Owners should monitor market activity for infringing products, consider licensing negotiations, and prepare for enforcement actions, including patent infringement litigation or administrative proceedings.
References
[1] Chinese Patent Database. CN108778317.
[2] Chinese Patent Law and Examination Guidelines.
[3] Industry Reports on Chinese Pharmaceutical Patent Trends.
[4] World Intellectual Property Organization (WIPO). Patent Landscape Reports.
This detailed analysis offers stakeholders a strategic understanding of CN108778317’s scope, claims, and its positioning within China's expansive patent environment, empowering informed decision-making in research, licensing, and commercialization.
