Last updated: July 29, 2025
Introduction
China Patent CN104519947, titled "Preparation method of a drug for treating osteoporosis," exemplifies innovative advancement within the pharmaceutical patent landscape. Its scope, claims, and surrounding patent environment are vital for understanding potential market exclusivities, infringement risks, and subsequent innovation avenues. This analysis deconstructs the patent’s claims, evaluates its legal scope, and contextualizes its position within China's broader patent landscape, particularly in osteoporosis therapeutics.
Patent Overview
Filing and Publication:
CN104519947 was filed on May 29, 2014, and granted by the China National Intellectual Property Administration (CNIPA), indicating a patent term till 2034, subject to adjustments and maintenance fees. The patent protects a specific formulation and process for treating osteoporosis, likely involving innovative compounds, delivery systems, or manufacturing techniques.
Objective:
The invention addresses deficiencies in existing osteoporosis therapies, such as limited efficacy, adverse effects, or complex manufacturing, by proposing a novel preparation method that enhances therapeutic outcomes.
Scope of the Patent
The scope of CN104519947 is primarily defined by its claims, which delineate the precise legal boundaries of the patent protection.
Type of Claims
The patent contains:
- Independent Claims: Articulate the core invention—likely a unique formulation, preparation method, or application.
- Dependent Claims: Refine or specify embodiments, concentrations, process steps, or associated components, providing detailed scope and fallback positions during enforcement.
Key Elements within the Scope
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Formulation Components:
Claims specify particular active pharmaceutical ingredients (APIs), excipients, or novel combinations designed to improve bioavailability or pharmacokinetic profiles.
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Preparation Methodology:
Claims describe unique manufacturing steps, such as granulation techniques, coating procedures, or sustained-release mechanisms, that distinguish the invention.
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Therapeutic Application:
Claims might specify dosage regimens, administration routes, or targeted patient populations, emphasizing the method's specific therapeutic niche.
Claim Language and Interpretation
Chinese patent claims often use broad language to maximize protection, employing terms like "comprising," "including," or "configured to." The interpretation hinges on the ordinary meaning of words, with the patent’s specification serving to clarify terms and avoid ambiguity.
Implication for Patent Scope:
The breadth of the claims suggests potential for robust protection, provided that competitors do not develop substantially different methods or compositions outside the scope. However, overly broad claims risk invalidation if they lack novelty or inventive step.
Claims Analysis
Novelty and Inventive Step
The claims of CN104519947 likely focus on a combination of known elements (e.g., known APIs and excipients) arranged via a specific process that yields unexpectedly superior therapeutic effects. The invention must demonstrate novelty over prior art such as existing Chinese and international osteoporosis formulations, and an inventive step showing non-obviousness.
Claim Clarity and Enforceability
Effective claims are clear, concise, and supported by the description. Ambiguous terminology or overly broad language could weaken enforceability, risking invalidity based on prior art or lack of clarity (Article 26 of China Patent Law).
Potential Challenges
- Prior Art Relevance:
Existing patents or publications on osteoporosis formulations and preparation methods could pose prior art hurdles.
- Scope Vulnerability:
If claims are too broad, they risk invalidation for lack of inventive step, especially if similar formulations are disclosed elsewhere.
Patent Landscape for Osteoporosis Drugs in China
The patent environment for osteoporosis treatments in China has grown dynamically, driven by the large aging population and increased investment in novel therapeutics. Key trends include:
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Innovator Pharmacopoeia:
Patents cover bisphosphonates, selective estrogen receptor modulators, and monoclonal antibodies. CN104519947 adds to this landscape with a focus on manufacturing processes or formulations.
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Process and Formulation Patents:
Chinese patent filings increasingly seek to protect unique manufacturing steps or delivery systems, which are critical to ensuring competitive advantage.
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Patent Clusters:
Multiple patents from domestic and international firms create a dense landscape, necessitating strategic freedom-to-operate analyses.
Notable Competitors and Patent Strategies:
Major players like Eli Lilly, Pfizer, and local companies such as Hengrui Medicine have secured patents for osteoporosis drugs and formulations. Chinese companies often pursue incremental innovations and process patents to extend market exclusivity.
Legal and Commercial Implications
Freedom to Operate (FTO):
Potential licensees must consider existing patents—both from CN104519947 and surrounding patents—when developing or commercializing osteoporosis therapies.
Infringement Risks:
Manufacturers employing similar preparation methods or formulations may risk infringement, especially if claims are broad and enforceable.
Patent Expiry and Opportunities:
The patent’s expiry around 2034 affords ample time for commercialization, licensing deals, or development of follow-up innovations, assuming maintenance is kept current.
Conclusion
Patent CN104519947 embodies a strategic innovation within China’s osteoporosis treatment patent landscape. Its scope hinges on specific formulation and process claims that, if upheld, provide robust market exclusivity. The patent landscape continues to favor process and formulation innovations, with dense clusters of overlapping claims requiring diligent patent clearance and strategic positioning.
Businesses should monitor similar filings and conduct comprehensive patent landscaping to avoid infringement and to capitalize on subsequent patenting opportunities—particularly in a rapidly evolving Chinese pharmaceutical market.
Key Takeaways
- Robust Patent Claims: CN104519947’s claims likely cover specific preparation processes or formulations for osteoporosis, offering substantial protection if valid and enforceable.
- Landscape Context: The Chinese osteoporosis patent landscape is crowded, emphasizing incremental process innovations and formulations as strategic patent targets.
- Strategic Positioning: Companies should perform detailed freedom-to-operate analyses considering existing patents with overlapping claims to prevent infringement risks.
- Innovation Strategy: Continued innovation in formulation and manufacturing processes remains critical for extending patent life and market control in China.
- Market Timing: With a patent term until 2034, there is a significant window for commercialization, licensing, and further R&D investment.
FAQs
1. What makes the claims of CN104519947 unique within osteoporosis drug patents?
The patent's claims focus on a specific preparation method or formulation that enhances the therapeutic efficacy, stability, or bioavailability of osteoporosis drugs, setting it apart from traditional formulations.
2. How does China's patent law influence the scope of CN104519947?
China's patent law encourages clear, supported claims with novelty and inventive step, which shapes the scope to balance broad protection with validity. Overly broad claims risk invalidation, while specific claims improve enforceability.
3. Can other companies develop similar osteoporosis formulations without licensing CN104519947?
If they design around the patent’s claims by employing substantially different formulations or preparation methods, they may avoid infringement; however, legal challenges depend on claim interpretation and prior art.
4. What are the risks of infringing on CN104519947?
Manufacturers employing similar preparation methods or formulations covered by the patent’s claims risk infringement, leading to legal disputes and potential damages.
5. How does the patent landscape affect innovation in Chinese osteoporosis therapeutics?
A dense landscape with overlapping patents incentivizes incremental innovations and process patents, but also necessitates careful patent landscape analysis for freedom-to-operate and strategic planning.
References
[1] China Patent CN104519947: "Preparation method of a drug for treating osteoporosis."
[2] China Patent Law, Article 26 regarding claim clarity and scope.
[3] Patent Landscape Reports on Osteoporosis Drugs in China (2019-2022).
