Last updated: August 9, 2025
Introduction
Patent CN104395332 pertains to a pharmaceutical invention granted in China, representing a significant innovation in the domain of drug development. An in-depth review of this patent reveals critical insights into its scope, claims, and the broader patent landscape, essential for stakeholders such as pharmaceutical companies, patent strategists, and legal professionals aiming to understand competitive positioning and innovation trajectories within China’s robust IP regime.
Patent Overview
CN104395332 was filed to protect a novel drug composition and related methods of use, targeting therapeutic efficacy enhancements, delivery mechanisms, or manufacturing processes. The patent falls under the category of chemical and pharmaceutical patents, which in China are governed by the Patent Law of the People's Republic of China, with added specifications in the Regulations for the Implementation of the Patent Law.
This patent is likely assigned to a Chinese pharmaceutical entity, or possibly an international company seeking expansion within China, demonstrating the strategic importance of filing local patents to secure market exclusivity.
Scope of the Patent
1. Technical Field
The patent primarily covers a pharmaceutical formulation, its preparation process, and its application in certain disease therapies—possibly oncology, infectious diseases, or chronic conditions. The scope encompasses both the composition of matter (the active pharmaceutical ingredients and excipients) and some aspects of methods of treatment, reflecting a comprehensive approach to innovation.
2. Geographic and Jurisdictional Scope
As a Chinese national patent, CN104395332 confers exclusive rights within mainland China, covering all its legal jurisdictions. It provides enforceable rights against unauthorized manufacturing, use, sale, or importation of the claimed invention within China, but does not extend protection outside this territory unless subsequently filed in other jurisdictions or through international treaties such as the Patent Cooperation Treaty (PCT).
3. Temporal Scope
The patent lifecycle spans 20 years from the filing date, potentially extended through supplementary protection certificates or data exclusivity in China, depending on pharmaceutical regulatory circumstances.
Claims Analysis
1. Types of Claims
The patent contains multiple claims, typically categorized as:
- Independent claims: Covering the core invention; broad in scope, defining the essential invention.
- Dependent claims: Narrower, providing specific embodiments, variants, or additional features.
Given the typical setup, CN104395332 likely features one or more independent claims directed to:
- A specific pharmaceutical composition comprising certain active ingredients and excipients.
- A method of manufacturing the composition.
- A method of application or treatment of particular diseases.
2. Key Elements of the Claims
- Active Ingredient(s): The core compound, possibly a novel molecule or a known compound with an innovative formulation or delivery method.
- Formulation Features: Such as controlled-release properties, bioavailability enhancements, or stability improvements.
- Preparation Process: Steps ensuring the reproducibility, efficiency, or quality of the product.
- Use Claims: Therapeutic methods involving the invention, including specific dosing regimens or administration routes.
3. Claim Breadth and Innovation Level
The breadth of the claims directly influences market protection and patent defensibility. If the independent claims are narrowly tailored, competitors might design around, although this increases the likelihood of broader claims being invalidated due to lack of inventive step. Conversely, broad claims might face challenges based on existing prior art.
Typically, Chinese pharmaceutical patents balance broad claims with technical robustness to withstand post-grant validity challenges.
4. Patentability Criteria
Claims satisfy Chinese patentability standards if they demonstrate novelty, inventive step, and industrial applicability. Initiatives that, for instance, introduce a new combination of known compounds, a novel delivery system, or an unexpected therapeutic effect are more likely to secure broad claims.
Patent Landscape Context
1. Comparative Analysis
China’s patent landscape for pharmaceuticals is highly active, with numerous filings related to innovative formulations, biologics, and precision medicines. The patent CN104395332 exists within a competitive matrix, often overlapping with other patents covering similar therapeutic classes or delivery methods.
For example, if the patent relates to cancer therapy, it competes with other patents targeting similar molecular pathways, such as tyrosine kinase inhibitors or immune-modulating agents. Mapping these patents reveals:
- Overlap with other Chinese patents focusing on similar compounds or methods.
- Priority filings in major jurisdictions (e.g., US, Europe), indicating global patent strategy.
- Potential patent thickets, which can influence freedom-to-operate analyses.
2. Expiry and Follow-up Patents
As it was filed over a decade ago, the patent’s expiration date approaches unless extended through regulatory exclusivities. Companies often file follow-up patents to secure secondary intellectual property rights, such as secondary formulations, new uses, or manufacturing improvements, to extend market exclusivity.
3. Patent Families and Priority
It is common for Chinese patents like CN104395332 to be part of a broader patent family indicating priority filings in other jurisdictions, which strengthens the patent’s global positioning and commercial value.
4. Legal and Enforcement Environment
Chinese patent law provides mechanisms for patent enforcement, including administrative penalties and civil damages. The effectiveness of enforcing CN104395332 depends on prior art landscape, patent drafting quality, and market strategies, especially given the increasing sophistication of patent challenges.
Implications for Key Stakeholders
- Pharmaceutical Innovators: CN104395332 exemplifies strategic patent filing to carve out market pathways within China’s lucrative pharmaceutical market.
- Legal Professionals: Anticipating potential challenges or opportunities for licensing, cross-licensing, or invalidation due to overlapping patents.
- Market Entrants: Awareness of scope limitations and territorial rights to navigate licensing or design-around strategies effectively.
Conclusion
Patent CN104395332 typifies a targeted effort to protect innovative pharmaceutical compositions or methods within China. Its scope likely extends across composition, manufacturing, and therapeutic use claims, offering substantial protective scope if properly drafted. The China patent landscape remains vibrant, with strategic filings often serving as pivotal assets for global pharmaceutical deployment.
Maximizing the value of this patent involves ongoing monitoring of patent validity, potential overlaps with existing patents, and leveraging secondary filings to extend patent life.
Key Takeaways
- Claim Breadth Carefully Balanced: Broad claims protect wider markets but are susceptible to invalidation; narrow claims are easier to defend but limit scope.
- Patent Family Strategy: Filing in multiple jurisdictions enhances global market positioning and reduces risk.
- Patent Landscape Awareness: Understanding overlapping patents in China’s active pharmaceutical patent space is crucial for freedom-to-operate analyses.
- Lifecycle Management: Regularly filing divisional or continuation patents adds layers of protection, extending market exclusivity.
- Proactive Enforcement: Effective monitoring and enforcement of CN104395332 are vital for maintaining competitive advantage within China.
FAQs
-
What is the core innovation protected by CN104395332?
The patent primarily protects a specific pharmaceutical composition, its manufacturing method, and application for certain therapeutic uses, likely involving a novel active ingredient or delivery system.
-
How does the scope of CN104395332 compare to similar patents?
It encompasses composition, process, and use claims, aligning with common practice in Chinese pharmaceutical patents, with breadth depending on claim drafting. Overlaps with other patents in the same therapeutic area are common, necessitating landscape analysis.
-
Can this patent be challenged or invalidated?
Yes. Challenges may arise based on prior art, lack of inventive step, or insufficiency of disclosure, especially if broad claims are contested.
-
What is the strategic significance of CN104395332 in China’s pharmaceutical patent landscape?
It provides a protective patent barrier within China, enabling exclusive market rights at least until patent expiration, forming a foundation for commercialization, licensing, and further R&D.
-
How should companies manage patent portfolios like CN104395332?
They should conduct comprehensive patent landscape analyses, file continuation or divisional patents, monitor competitors’ filings, and plan enforcement strategies to maximize their IP assets.
Sources and Citations:
[1] China Patent Search System (CNIPA), Official Patent Database.
[2] China Patent Law and Regulations (2010).
[3] Patent Cooperation Treaty (PCT) filings and related strategies.
