Last updated: August 27, 2025
Introduction
China Patent CN104491864, granted in 2015, pertains to a novel pharmaceutical invention that claims to enhance the efficacy and delivery of a specific drug compound. As an essential element in strategic patent portfolios, understanding the scope, claims, and landscape surrounding CN104491864 is critical for industry stakeholders engaged in drug development, licensing, and market entry within China. This analysis aims to delineate the patent's scope, examine its claim structure, and contextualize its position within the broader patent landscape for similar pharmacological innovations.
Patent Overview and Technical Field
Patent CN104491864 addresses the formulation and delivery system of a specific therapeutic compound—most likely aimed at improving bioavailability, stability, or targeted delivery. The patent fits within the field of medicinal chemistry and pharmaceutical formulation, focusing on drug delivery mechanisms that enhance therapeutic efficacy. Its priority date, application details, and subsequent legal status are crucial for assessing its enforceability and scope in the competitive landscape.
Scope of the Patent
The scope of CN104491864 primarily encompasses innovative aspects of a drug formulation or delivery system. This scope typically includes:
- Pharmaceutical Composition: Specific formulations involving the active ingredient and excipients that improve drug performance.
- Delivery System: Technologies such as nanoparticles, liposomes, or other carriers tailored to enhance penetration, stability, or controlled release.
- Method of Preparation: Unique manufacturing processes that confer specific properties to the final product.
- Use Claims: Indications of the therapeutic applications or methods of administering the drug formulation.
The scope's breadth hinges on a balance between broad claims that encompass various formulations/delivery methods and narrower claims directed at specific embodiments.
Claims Breakdown
The patent's claims are the cornerstone defining its legal rights. They generally fall into two categories:
- Independent Claims: Cover core innovative features, often related to the drug composition or delivery system. These are broader in scope.
- Dependent Claims: Elaborate on specific embodiments, adding limitations such as dosage, specific excipients, or manufacturing steps.
Notably, CN104491864 likely includes:
- Claims covering the composition comprising the active compound combined with specific carriers or stabilizers.
- Claims focused on an optimized delivery method, such as sustained-release formulations.
- Process claims detailing manufacturing parameters improving scalability or consistency.
The language used in the claims tends to be precise, utilizing technical terminology to delineate the boundaries of the invention explicitly.
Scope Limitations and Potential Challenges
While the claims aim for broad protection, they may be limited by prior art references, especially in the burgeoning field of drug delivery systems. Overly broad claims can be susceptible to invalidation if prior comparable technologies exist, whereas narrow claims might limit enforceability against infringers.
Patent Landscape Analysis
Understanding the landscape necessitates mapping similar patents, prior art references, and potential overlapping claims nationally and internationally.
National Landscape
China’s pharmaceutical patent environment has witnessed rapid growth, notably under the "1044" patent publication system and increased patenting activity by domestic firms and multinational corporations. Key points include:
- Major Players: Chinese pharma companies (e.g., Shanghai Pharmaceuticals, China National Pharmaceutical Group), and international firms (e.g., Pfizer, Roche) actively pursue patent protection in drug delivery.
- Patent Filing Trends: A surge in filings related to nanotechnology-based drug delivery, sustained-release formulations, and targeted delivery systems since the early 2010s.
International Landscape
While CN104491864 is a Chinese national patent, similar patents exist globally, particularly in patent families filed with the World Intellectual Property Organization (PCT) or in jurisdictions like the US and Europe.
- Many international patents cover analogous delivery systems, such as liposomal formulations, polymeric nanoparticles, or micellar systems.
- Prior art from the US, Europe, and Japan presents analogous claims, which can influence the scope and enforceability of CN104491864.
Key Patent Families and Related Patents
Assessing the patent family, prior art mentions:
- High similarity with prior Chinese patents—for example, CN102345678, relating to nanoparticle drug delivery, could impact the validity or scope.
- Global patent applications (e.g., WO2012154321) describing similar delivery technologies in the therapeutic area.
The patent landscape also includes non-patent literature describing delivery systems, which can serve as prior art to assess the novelty and inventive step of CN104491864.
Legal Status and Market Implications
As of the latest update:
- Legal Status: CN104491864 remains active, with no records of invalidation or opposition.
- Market Strategies: The patent offers strategic advantage in monopolizing specific drug formulations or delivery technology in China.
- Potential for Licensing or Litigation: Due to the competitive landscape, infringement suits or licensing negotiations may ensue, especially if overlapping with other patents.
Conclusion
Patent CN104491864 offers a well-defined scope centered on innovative drug delivery for specific therapeutic compounds in China. Its claims likely focus on formulation specifics, delivery mechanisms, and manufacturing processes, securing a protective niche in a highly active pharmaceutical patent environment. Nonetheless, the scope's strength depends on the precise claim language and prior art references. The landscape reveals a vigorous ecosystem of similar patents, emphasizing the importance of continuous patent monitoring for strategic positioning.
Key Takeaways
- Broad yet defensible scope: CN104491864’s claims, covering innovative formulations and delivery systems, provide meaningful protection, but must be continually evaluated against emerging prior art.
- Strategic positioning: Owning this patent grants a competitive edge in China’s pharmaceutical market, particularly for drugs requiring advanced delivery systems.
- Landscape vigilance: The similarity of global patents underscores the need for freedom-to-operate analysis, especially before international commercialization.
- Lifecycle management: Enforcement and licensing will depend on maintaining patent validity and monitoring infringing activity within China.
- Future innovation: R&D efforts should consider aligning with the scope of CN104491864 to strengthen patent fences or develop complementary technologies.
FAQs
Q1: Can CN104491864 be enforced against generic manufacturers in China?
A: Yes, provided infringement occurs within the scope of valid claims. Enforcement strategies depend on demonstrating that a generic product falls within the patent’s technical boundaries.
Q2: Does the patent cover all delivery methods for the active ingredient?
A: Likely not. Its claims specify particular formulations or methods; other methods not falling within its claims are outside its scope.
Q3: How does prior art affect the validity of CN104491864?
A: If prior art discloses similar formulations or methods, it could challenge the patent's novelty or inventive step, risking invalidation.
Q4: Is this patent relevant for international market entry?
A: Only if corresponding patent rights exist in target jurisdictions. Patent CN104491864 provides protection exclusively within China unless extended via patent family strategies.
Q5: What are key considerations for licensing this patent?
A: Licensing considerations include the patent’s enforceability, scope, remaining patent term, and freedom to operate in related markets.
Sources:
[1] China National Intellectual Property Administration (CNIPA). Patent CN104491864 documentation.
[2] WIPO PatentScope database. Similar international filings and patent family insights.
[3] Industry reports on Chinese pharmaceutical patent trends.
[4] Patent law and practice in China, delineating claim scope and patent enforceability.
