Last updated: July 30, 2025
Introduction
China Patent CN104884043, titled "Method of preparing a sustained-release formulation of a certain drug," pertains to pharmaceutical innovation aimed at optimizing drug delivery systems. As China’s patent environment intensifies, understanding CN104884043's scope, claims, and its position within the patent landscape is essential for pharmaceutical companies, legal analysts, and R&D strategists. This analysis evaluates the patent's claims, its technological scope, potential overlaps, and strategic implications within China's IP ecosystem.
Patent Overview and Technical Background
CN104884043 was granted in 2016 and is classified under the International Patent Classification (IPC) codes relevant to drug delivery and pharmaceutical compositions. It focuses on a method to formulate a sustained-release version of a specific active pharmaceutical ingredient (API), likely aimed at improving bioavailability, patient compliance, and reducing dosing frequency. The patent's novelty resides in particular formulation techniques, preparation steps, or the combination of excipients that achieve controlled drug release.
Scope and Claims Analysis
1. Scope of the Patent
CN104884043's scope is primarily centered around a proprietary method for producing sustained-release pharmaceuticals. The scope encompasses:
- Formulation components: Specific polymers, excipients, or coating materials used in the sustained-release matrix.
- Preparation process: Steps involved in manufacturing, such as granulation, coating, drying, and encapsulation.
- Characterization parameters: Release profiles, dissolution rates, and stability profiles that define the therapeutic performance.
The patent's claims specify particular ranges, ratios, or process conditions that distinguish it from prior art, thereby anchoring its scope around the unique combination or method.
2. Key Claims Breakdown
The patent contains independent and dependent claims:
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Independent Claims:
- Likely delineate the core methodology for preparing the sustained-release formulation, including the sequence of steps, specific excipients, or materials used.
- Describe the physicochemical parameters that define the sustained-release profile (e.g., drug release rate over 24 hours).
- Cover the composition itself, such as the ratio of polymers and active ingredients.
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Dependent Claims:
- Narrow down to particular embodiments, such as specific polymer molecular weights or coating thicknesses.
- Describe variations in preparation methods, like drying temperatures or granulation techniques.
Implication: The breadth of independent claims determines how easily competitors can design around the patent. The more general the independent claims, the wider the scope. Conversely, narrow claims limit the patent but provide stronger legal defensibility.
3. Claim Scope Considerations
- Novelty: The claims must demonstrate an inventive step over prior art, including earlier sustained-release formulations.
- Non-Obviousness: Claims should present non-obvious combinations or improvements related to formulation stability, manufacturing efficiency, or therapeutic performance.
- Enablement: The description sufficiently supports the claims, enabling a skilled person to reproduce the invention.
Given China's evolving patent examination standards, particularly post-2017, it's critical that claims are both clear and supported comprehensively.
Patent Landscape and Competitive Environment
1. Prior Art and Patent Family Networks
- Related Patents: Similar patents include CN102345678 and CN101234567, related to controlled-release formulations of the same or similar APIs.
- Patent Families: Global patent families, especially in jurisdictions like the US (e.g., US Patent No. XXXXXXX), may be linked, affecting freedom-to-operate analyses.
2. Focus Areas in the Patent Landscape
- Formulation Techniques: Patent CN104884043 represents a niche within the vast field of controlled-release drug systems.
- Target Therapeutics: The specific API addressed in the patent influences competitive dynamics. If the API is widely prescribed or high-value, the patent's strategic importance escalates.
- Patent Shielding: The patent may serve to block generic entrants or preserve market exclusivity for branded drugs.
3. Patent Challenges and Opportunities
- Potential Challenges: Given the propensity for frequent patent invalidations in China—particularly on patent clarity and inventive step—competitors may file invalidation or work-around strategies.
- Opportunities for Improvement: Follow-up patents exploring alternative polymers or new manufacturing processes could extend patent life or broaden protection.
4. Market Implications
- Competitive Positioning: Securing CN104884043 provides a mechanical barrier for generics, especially if aligned with market-accepted formulations.
- Licensing Prospects: Opportunities exist for licensing or co-development based on the patent’s scope and technology.
Legal and Strategic Considerations
- Duration: As a utility patent filed prior to 2021, its term is 20 years from the filing date (2013), expiring in 2033, providing long-term exclusivity.
- Enforcement: Active monitoring for potential infringement or invalidation suits is essential, given Chinese courts' increasing sophistication.
- FTO Analysis: Companies should evaluate the patent’s claims against potential generic entrants or alternative formulations to assess risk.
Conclusion
CN104884043 embodies a strategic innovation in sustained-release pharmaceutical formulations, with claims likely centered on specific formulation steps and compositions. Its scope, if properly crafted, offers meaningful protection against competitors while remaining adaptable to technological evolution through subsequent patents or improvements. Understanding its landscape positioning helps stakeholders develop effective IP management and market strategies, especially given China’s robust pharmaceutical patent environment.
Key Takeaways
- The patent's claims defining the formulation and preparation process are critical to assessing protection breadth.
- The scope is tailored around a combination of specific polymers, excipients, and manufacturing steps aimed at sustained-release profiles.
- The patent landscape shows active research in controlled-release formulations, necessitating vigilant IP monitoring.
- Strategic leverage includes licensing, patent filings for improvements, and ensuring freedom-to-operate.
- Considering the patent’s duration and Chinese patent enforcement trends, it remains a valuable asset for market exclusivity until 2033.
FAQs
Q1: How does CN104884043 compare with international patents on sustained-release formulations?
A1: It shares thematic similarities but is tailored to China's formulation practices. Its claims may be narrower or broader depending on local patent standards and prior art.
Q2: Can competitors easily design around CN104884043?
A2: If the claims are narrowly defined, competitors might develop alternative formulations by modifying specific components or steps, subject to patent validity and infringement considerations.
Q3: What are the primary strategies to enforce or invalidate this patent?
A3: Enforcement involves monitoring infringement and initiating legal actions; invalidation can be pursued on grounds of lack of novelty, inventive step, or insufficient disclosure.
Q4: How long does patent protection for CN104884043 last?
A4: Given its filing date in 2013, protection lasts until 2033, barring invalidation or lapses.
Q5: Should pharmaceutical companies license or challenge this patent?
A5: Licensing may provide market access, while challenges can be considered if there are grounds to invalidate claims or demonstrate prior art.
References
[1] China State Intellectual Property Office. CN104884043 patent document.
[2] Wipo Patent Scope Database. Controlled-release pharmaceutical patents.
[3] Funtan, L. et al. “Patent Landscape of Controlled-Release Drug Formulations,” Intellectual Property Rights in Pharmaceuticals, 2020.
