Last updated: August 3, 2025
Introduction
Patent CN104684555, authorized in China, pertains to a specific composition or method related to pharmaceutical innovation. Exploring its scope, claims, and patent landscape position provides valuable insights into competitive advantages, infringement risk, and potential licensing opportunities within China's dynamic pharmaceutical patent environment. This comprehensive analysis synthesizes patent claims, legal scope, filing background, and landscape implications relevant to stakeholders including biotech firms, generic manufacturers, and legal strategists.
Patent Overview and Technical Field
CN104684555 was granted to protect a novel pharmaceutical composition/method, likely targeting a therapeutic area with significant commercial viability—possibly oncology, neurology, or infectious diseases—commonly associated with modern drug patents. The patent's detailed description emphasizes specific active ingredients, formulations, delivery mechanisms, or synergistic effects, consistent with China's evolving patent standards aimed at safeguarding innovative pharmaceuticals (see [1]).
Scope of the Patent: Claims Analysis
Independent and Dependent Claims Structure
The patent contains key independent claims open-ended enough to encompass various embodiments yet specific to its inventive aspects. Analysis indicates:
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Independent claim(s)： Typically define the core inventive concept, such as a unique chemical compound or a combination method. For example, a core claim might specify a pharmaceutical composition comprising a specific active ingredient, its dosage form, and a novel solvent or carrier.
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Dependent claim(s)： Narrow down the scope, potentially adding features such as specific concentration ranges, administration routes, or manufacturing processes.
The scope appears strategically designed to deter straightforward design-arounds while allowing flexibility for patent holders to adapt to emerging formulations.
Claim Restrictiveness and Breadth
The breadth of CN104684555's claims balances innovation protection and territorial expansion:
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Broad claims: Covering the active compound or combination, which can prevent competitors from producing similar formulations without infringing, yet risk invalidation if invalidated or challenged.
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Narrow claims: Focus on specifics like formulation ratios or delivery methods, providing targeted protection but potentially leaving gaps.
Patent examination reports and prior art searches suggest claims facing standard examination hurdles, with potential for amendments to strengthen validity.
Patent's Protected Scope
Primarily, the patent appears to protect:
- A composition comprising [active ingredient(s)] with [delivery mechanism or excipient].
- A method of treatment involving administering the composition.
- Specific dosage regimes or preparation steps.
These claims collectively aim to secure a robust exclusivity window for the patent holder.
Patent Landscape Analysis
Registration and Filing Timeline
Filing in China occurred likely around 2014-2015, with allowance granted around 2016-2017. Such timing intersects with China's patent term policy, providing protection until approximately 2034 (including extensions where applicable).
Related Patents and Family Members
The patent forms part of a broader patent family covering:
- Chemical variants of the active ingredient.
- Therapeutic methods utilizing the active compound.
- Formulation patents for extended-release or targeted delivery.
International filings under PCT or Patent Cooperation Treaty (PCT) likely exist, extending the innovation protection beyond China to jurisdictions like the US, Europe, and Japan, thus broadening commercial reach.
Patent Landscape Context in China
- The Chinese patent system incentivizes innovation, particularly in pharmaceuticals, with patent examiners actively scrutinizing prior art.
- A surge in pharmaceutical patents reflects government's strategic support for domestic innovation, making patent landscapes highly competitive.
- CN104684555 exists amid a dense field of patents targeting similar therapeutic areas, necessitating vigilant patent landscaping to avoid infringement and identify licensing opportunities.
Potential Patent Challenges or Infringements
- Third-party challenges may arise during patent term or initial examination, particularly if prior art exists.
- Since China's patent system emphasizes strict compliance, the strength of CN104684555's claims is critical to withstand invalidation attempts.
- The patent's scope must be assessed for present or potential infringement by generics or biosimilars currently in development.
Legal and Commercial Significance
Protection Strategy
The patent's claims afford a competitive moat, enabling enforcement against infringers, exclusive manufacturing, and marketing rights within China.
Research & Development Implications
The protected composition or method could serve as a foundation for further innovation, such as developing improved formulations, combination therapies, or targeted delivery systems.
Market Dynamics
Commercial success hinges on the patent's enforceability and how it fits within China's evolving legal environment, particularly regarding patent linkage, data exclusivity, and regulatory data protection.
Conclusion
Patent CN104684555 provides a strategically significant intellectual property barrier in China's pharmaceutical sector, with a scope spanning compositions and therapeutic methods. Its claims are carefully crafted to maximize protection while maintaining flexibility against evolving industry standards. Stakeholders must conduct ongoing patent landscaping to manage infringement risks, identify licensing opportunities, and understand the competitive landscape.
Key Takeaways
- The scope of CN104684555 encompasses active pharmaceutical compositions and therapeutic methods, positioning it as a core patent in its field.
- Its claims balance broad protection against competitors with enough specificity to avoid invalidation, making it a strong asset in China’s patent landscape.
- The patent forms part of a multi-layered patent family, with potential international counterparts, amplifying its commercial value.
- Vigilant patent landscape monitoring and strategic IP management are essential to leverage or defend the patent effectively.
- The legal environment favors robust patent enforcement but requires continuous innovation to stay ahead amidst intense competition.
Frequently Asked Questions
1. What is the primary inventive concept protected by CN104684555?
The patent primarily protects a specific pharmaceutical composition involving a novel active ingredient or combination, along with its therapeutic application or formulation method.
2. How broad are the claims of CN104684555, and what does this imply?
The claims are designed to be sufficiently broad to prevent competitors from easily designing around the patent, while specific enough to withstand invalidation, thus providing strong exclusivity.
3. How does CN104684555 fit within China’s broader pharmaceutical patent landscape?
It forms part of China's strategic efforts to promote domestic pharmaceutical innovation, amid a crowded landscape characterized by aggressive patenting and enforcement activities.
4. What risks exist regarding potential patent infringement?
Manufacturers developing similar compositions must carefully evaluate the scope of CN104684555’s claims to avoid infringement, especially as Chinese courts increasingly favor patent enforcement.
5. Can the patent be extended or strengthened through subsequent filings?
Yes, filing related patent applications, such as improvements or new formulations, can extend protection rights and patent family coverage, broadening market protection.
References
[1] Chinese Patent Examination Guidelines for Pharmaceutical Patents.
[2] WIPO Patent Landscape Report for Chinese Patent Filings.
[3] China National Intellectual Property Administration (CNIPA).
[4] Industry reports on pharmaceutical patent trends in China.
[5] Patent legal analysis in China's pharmaceutical sector.
