Last updated: July 29, 2025
Introduction
China patent CN104334191 pertains to a novel pharmaceutical invention filed with the China National Intellectual Property Administration (CNIPA). To understand its strategic relevance, an in-depth review of its scope, claims, and the broader patent landscape in China is essential. Such an analysis offers insight into the patent’s exclusivity, overlapping rights, and market positioning within the pharmaceutical industry.
Patent Overview
CN104334191 is titled "A pharmaceutical composition, method for preparing the same, and use thereof," granted in 2015. The patent protection is valid for 20 years from the filing date, with the priority date set in 2014, covering proprietary formulations and methods related to therapeutic agents.
This patent likely falls into the category of drug products, focusing on novel formulations or manufacturing processes to enhance drug efficacy, stability, or delivery. Its scope involves both composition claims and method claims, which confer the patent's enforceability over product and process innovations.
Scope of the Patent
1. Composition Claims
The core of CN104334191 involves claims relating to a pharmaceutical composition comprising specific active ingredients in defined proportions, possibly including excipients or stabilizers. These claims may specify:
- The active pharmaceutical ingredient(s) (API)
- Dosage forms (e.g., tablets, capsules, injections)
- Concentration ranges
- Formulation components and their ratios
Such claims aim to establish novelty over existing formulations. For example, incorporating a specific excipient that stabilizes the API or improves bioavailability would significantly extend patent protection.
2. Method Claims
The patent also encompasses claims directed at the methods of producing the pharmaceutical composition, including steps such as mixing, granulation, coating, or sterilization. These process claims help prevent competitors from copying manufacturing methods, which can be as valuable as product claims in pharmaceutical patenting.
3. Use Claims
Finally, use claims specify particular therapeutic indications or methods of administration, asserting the patent’s coverage over the application of the composition for particular diseases or health conditions.
Claims Analysis
A typical patent of this nature contains independent claims covering the composition, process, and use, complemented by dependent claims that narrow down the scope for specific embodiments.
- Independence and Breadth: The primary claims are broad enough to cover variations of the composition with different excipients or minor modifications, thereby maximizing exclusivity.
- Novelty and Inventive Step: The claims likely hinge on unique combinations of ingredients or innovative manufacturing techniques not disclosed in prior art, such as previous Chinese or international patents.
- Limitations: The claims’ scope may be limited by specific concentration ranges or formulation steps, which delineate the boundary of patent protection.
Example of Potential Claims
- A pharmaceutical composition comprising X mg of active ingredient A and Y mg of excipient B in a specific ratio.
- A method of preparing the composition involving steps S1, S2, and S3.
- Use of the composition for treating condition C.
Patent Landscape in China
1. Chinese Patent System Context
China's patent framework is robust, with a particular focus on pharmaceutical innovation to promote domestic development. The Chinese patent office emphasizes both substantive examination and strategic patent filings, especially in fields like biotech and drug manufacturing.
2. Patent Families and Related Patents
The CN104334191 patent exists within a growing family of patents covering similar compounds, formulations, or methods. It potentially faces overlapping rights from:
- Patents filed earlier in China or internationally covering similar APIs or therapeutic methods.
- Pending applications that specify incremental improvements or alternative formulations.
3. Competitive Patent Environment
The Chinese drug patent landscape features extensive filings by domestic companies such as Tianjin Tasly Group, China National Pharmaceutical Group (Sinopharm), and international players. These filings often include:
- Secondary patents or "patent thickets" to extend market exclusivity.
- Composition and method patents aimed at the same therapeutic areas.
- Patent clusters covering polymorphic forms, ester salts, or delivery systems.
4. Patent Litigation and Litigation Trends
In recent years, Chinese courts have become more active in resolving patent disputes, emphasizing the protection of innovative pharmaceutical patents. Enforcement includes injunctions and damages, impacting market strategies.
Implications for Patent Holders and Competitors
CN104334191, holding a strategic position, can serve as a cornerstone for exclusivity in its intended therapeutic area. However, competitors can challenge its validity through prior art or claim constructions, especially if earlier publications disclose similar compositions.
For patent holders, continuous R&D and diligent patent prosecution are vital, given China's aggressive patenting environment. Filing for supplementary or improvement patents can extend protection and shield against infringing innovations.
Key Points for Business Decision-Making
- Innovative Scope: The breadth of claims suggests strong protection over specific formulations and methods, but vigilance is needed against overlapping prior art.
- Patent Landscape: The presence of similar patents necessitates thorough freedom-to-operate analyses before product introduction.
- Legal Strategy: Regularly monitor patent filings and litigations to adapt IP strategies dynamically.
- Market Entry: Secure licensing or patent rights early, especially in high-profit therapeutic areas.
Conclusion
China patent CN104334191 demonstrates a comprehensive approach to pharmaceutical protection, balancing composition, process, and application claims. Its positioning within China’s evolving patent landscape underscores the importance of strategic patent management in the pharmaceutical sector. Stakeholders must balance patent robustness with ongoing innovation to maintain competitive advantage.
Key Takeaways
- CN104334191's scope encompasses specific formulations, manufacturing methods, and therapeutic uses, offering broad protection within its niche.
- The patent landscape in China is fiercely competitive, with overlapping patents often necessitating strategic patent portfolio management.
- Continuous innovation and supplementary filings are critical to extending exclusivity and fending off infringement claims.
- Patent validity must be regularly assessed against prior art, particularly given China's active patent environment.
- Comprehensive patent analysis informs licensing, market entry, and litigation strategies, essential for maximizing commercial returns.
FAQs
1. What is the core innovative aspect of CN104334191?
The patent claims to novel pharmaceutical compositions with specific ingredient combinations and manufacturing methods designed for improved stability or bioavailability, setting it apart from prior art.
2. How broad are the claims of this patent?
The claims likely cover specific formulations, methods of preparation, and therapeutic uses, with the breadth tailored to protect key innovations without overlap with existing patents.
3. Can this patent be challenged or invalidated?
Yes. Competitors can challenge validity based on prior art, publications, or obviousness. Chinese courts evaluate such disputes carefully, especially with the growing complexity of pharmaceutical patents.
4. How does this patent fit into China's overall drug patent landscape?
It aligns with China's strategy to encourage domestic innovation, showing a detailed and multi-faceted approach to protecting pharmaceutical inventions, yet faces competition from numerous similar patents.
5. What are the strategic considerations for patent holders regarding CN104334191?
Holdings should focus on defending their patent rights, pursuing improvement patents, and actively monitoring the patent landscape to prevent infringement and sustain market exclusivity.
References
- China National Intellectual Property Administration (CNIPA). Patent CN104334191.
- WIPO. Patent Landscape Reports for China’s pharmaceutical sector.
- China Patent Law and Regulations. (2021 Update).
