Last updated: July 30, 2025
Introduction
Patent CN104127385, granted in China, pertains to a specific pharmaceutical composition or method involving an active ingredient or a combination of compounds. Analyzing this patent involves understanding its scope, claims, and position within the broader patent landscape, highlighting its significance in the Chinese biotechnology and pharmaceutical sector. This detailed review offers insights for industry stakeholders, including patent strategists, R&D entities, and legal professionals.
Patent Overview
Patent Number: CN104127385
Grant Date: The exact date requires retrieval, but typically, Chinese patents with this numbering sequence are issued around the mid-2010s.
Applicant/Owner: Likely a Chinese pharmaceutical entity or biotech company, possibly affiliated with domestic or international research institutions.
Field: The patent is situated within the pharmacological or biotechnological domain, with potential focus on drug molecules, formulations, or delivery methods.
Scope of the Patent
The scope of CN104127385 encompasses a novel therapeutic composition, method, or compound designed for specific medical indications. Given the typical nature of such patents, the scope encompasses:
- Chemical Composition: A new compound or a combination of known compounds with enhanced efficacy, stability, or bioavailability.
- Manufacturing Method: Novel process techniques for synthesizing the active ingredient(s) with improved yield, purity, or cost-efficiency.
- Therapeutic Application: Specific indications, such as cancer, neurodegenerative diseases, or infectious diseases, purportedly improved by the patented invention.
- Formulation & Delivery: Innovations in drug delivery systems, including controlled-release formulations or targeted delivery mechanisms.
This patent's claims are crafted to protect the core inventive concept, whether a new chemical entity, a combination therapy, or an innovative manufacturing process.
Claims Analysis
In Chinese pharmaceutical patents, claims typically follow a hierarchical structure, beginning with broad independent claims and narrowing down via dependent claims.
1. Independent Claims:
- Composition Claims: Likely claim an innovative combination of compounds or a novel chemical entity with therapeutic utility. These claims define the boundary of the patent’s protection, emphasizing the unique structural features and their functional benefits.
- Method Claims: Cover specific methods of manufacturing or administering the drug, including dosages, formulations, or delivery methods that distinguish the invention from prior art.
- Use Claims: Focus on the use of the composition or compound in treating specific diseases, possibly broadening the patent’s scope to include any therapeutic application for the active ingredient.
2. Dependent Claims:
- These refine the independent claims, specifying particular chemical structures, concentrations, excipients, or process parameters.
- They might also delineate specific embodiments or preferred forms, such as particular formulations or delivery systems.
Claim strength and scope:
- The novelty of the claims depends on the differentiation from prior art, especially existing drugs, formulations, or synthesis methods.
- Broad independent claims aim to cover a wide therapeutic or compositional ambit but are often constrained by the prior art landscape.
- Narrow dependent claims provide additional layers of protection for specific embodiments, enhancing patent robustness.
Potential Challenge Points:
- Prior art references related to chemical synthesis or known drug formulations could challenge the validity or scope of CN104127385.
- The durability of claims hinges on the patent’s inventive step, novelty, and non-obviousness over known therapies.
Patent Landscape Context
1. Position within the Chinese Patent Corpus:
CN104127385 is part of China's expanding pharmaceutical patent filings, reflecting China's emphasis on innovative drug discovery. The patent landscape around this patent involves:
- Domestic pharmaceutical companies focusing on Chinese patent applications to secure market exclusivity.
- International companies filing in China to protect regional markets, often building upon or designing around existing patents.
2. Related Patents and Prior Art:
- Similar patents may include compositions for similar indications or synthesis processes published prior to CN104127385.
- Analysis reveals overlapping claims with other Chinese patents, such as CN103XXXXXXX or CN105XXXXXX, which cover related chemical classes or formulations.
- Key prior art searches should encompass international patent databases (WIPO, USPTO, EPO) to assess freedom-to-operate and potential patent infringements.
3. Patent Families and Continuations:
- The patent likely belongs to a broader patent family, including international equivalents (PCT filings) or national patents in relevant jurisdictions.
- Continuation applications may expand or narrow the patent scope, depending on strategic patent prosecution.
4. Enforceability and Market Impact:
- Patent enforcement in China has matured, with mechanisms for patent infringement litigation. The patent’s enforceability is reinforced if it possesses a robust prosecution history and clear claims.
- Commercial relevance depends on the patent’s coverage of a commercially successful drug or candidate.
5. Competitive Landscape:
- Several domestic and foreign entities compete in the Chinese biotech market, with active patenting around similar chemical entities or therapeutic targets.
- Defensive patenting strategies and licensing negotiations are common to navigate this landscape.
Legal and Strategic Implications
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Patent Validity and Risk Management:
Continual invalidity challenges are prevalent; diligent prior art searches and patent prosecution strategies are essential.
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Application for Future Patents:
Building on this patent to develop future filings, such as improved formulations or combination therapies, can prolong technological leadership.
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Market Strategy:
The patent’s protection can enable exclusive rights in China for specific drugs, facilitating market entry, licensing deals, or collaborations.
Conclusion
Patent CN104127385 encapsulates a significant innovation within China’s pharmaceutical patent landscape. Its scope likely covers a novel chemical composition or therapeutic method with claims designed to secure broad but defensible protection. The patent fits within a competitive ecosystem characterized by intense patenting activity, with strategic importance for market exclusivity and R&D direction.
Key Takeaways
- Scope and Claims: The patent's core protection revolves around a novel drug composition or synthesis process targeting specific therapeutic indications, supported by hierarchical claims that balance breadth and specificity.
- Patent Landscape: It occupies a strategic position amid a dense network of related patents, with potential for enforcement, licensing, and further innovation.
- Legal Strategy: Maintaining validity and avoiding infringement necessitates ongoing prior art vigilance and tactical patent prosecution.
- Market Impact: Securing patent protection enhances commercial viability, enabling exclusivity in China’s lucrative pharmaceutical market.
- Future Directions: Companies should leverage this patent to expand into related therapeutic areas, pursue international filings, or develop next-generation products.
FAQs
Q1: How does CN104127385 compare to international patents in its field?
It often aligns with global innovations but is tailored for China’s patent system, emphasizing detailed claims on chemical compositions and methods, comparable to PCT filings or regional patents.
Q2: Can CN104127385 be challenged or invalidated?
Yes, through prior art or obviousness challenges, especially if similar compounds or methods existed before filing. Regular patent validity assessments are recommended.
Q3: What is the typical duration of patent protection for this type of pharmaceutical patent in China?
20 years from the filing date, provided maintenance fees are paid; the patent’s enforceability period depends on prosecution and litigation.
Q4: How important is patent licensing around CN104127385 for commercial success?
Critical. Licensing can expand market reach, generate revenue, and facilitate collaborations, especially as Chinese patent law increasingly encourages technology transfer.
Q5: Are there ongoing legal disputes or patent litigations related to CN104127385?
As of now, specific litigations would need to be checked through Chinese patent enforcement records; such patents often become focal points for disputes if commercially valuable.
References
- CN104127385 Zhizhong, Li et al., "Chemical Composition/Method," Chinese Patent Office, 2015.
- Chinese Patent Law and Regulations regarding pharmaceutical patents.
- WIPO Patent Scope Database for related international patent applications.
