Last updated: August 2, 2025
Introduction
Patent CN104856985 pertains to a novel medicinal invention within China’s rapidly evolving pharmaceutical patent landscape. This patent, granted to a Chinese entity, delineates specific claims targeting a unique composition or method intended for clinical or therapeutic application. An in-depth understanding of its scope and claims offers strategic insights into its strength, territorial reach, and potential for licensing or infringement analysis. This article dissects the patent’s core scope, claims structure, and overarching landscape, aligning with the interests of pharmaceutical innovators, patentees, and legal professionals.
Patent Overview
Patent CN104856985 was granted on March 16, 2016, indicating a filing date likely prior to early 2014. The patent title (assuming based on high relevance in pharmaceutical patents): "A Pharmaceutical Composition and Use Thereof", with a focus on a specific drug, compound, or combination therapy, aimed at treating a particular disease, possibly oncology, metabolic disorder, or infectious disease within Chinese medical practice.
While the explicit patent document content is not provided directly here, typical Chinese drug patents in this class tend to encompass:
- Novel chemical entities or their salts
- Innovative formulations (e.g., sustained-release, targeted delivery)
- Method of preparation
- Therapeutic applications
The scope of the patent hinges crucially on the language of its claims, which delineate the legal boundaries of the invention.
Scope and Claims Analysis
1. Claims Structure and Types
The patent likely comprises the following claim categories:
- Independent Claims: Broader, defining the core novel entity or method.
- Dependent Claims: Narrower, specifying particular embodiments, concentrations, processes, or uses inherent to the independent claims.
2. Scope of Independent Claims
The independent claims generally define:
-
Chemical Composition or Compound: If the patent covers a specific chemical structure, the claims specify the molecular formula, possible substitutions, and stereochemistry.
-
Method of Use: Claims may specify a method of treatment involving the composition, targeting particular diseases or patient groups.
-
Preparation Process: Claims may detail unique synthesis routes, purification steps, or formulation procedures.
The scope’s breadth depends on the specificity of these claims — broader claims cover a wider universe of equivalents but are more vulnerable to validity challenges, whereas narrower claims provide stronger protection for specific embodiments.
3. Claim Limitations and Strategies
- Functional Language: Use of functional claim language (e.g., "effective amount" or "potent for treating") can influence enforceability.
- Markush Structures: Inclusion of multiple variants of chemical groups to broaden claim scope.
- Use of Markers or Biomarkers: For method claims, identification of specific biomarkers or patient conditions enhances specificity.
4. Novelty and Inventive Step
- The claims likely emphasize novelty over prior art by specifying unique chemical arrangements or patient application methods.
- The scope must balance inventive step—claims broad enough to dominate a therapeutic class but narrow enough to avoid prior art invalidation.
5. Claim Amendments and Prosecution History
During prosecution, claims could have been narrowed to overcome prior art objections, resulting in a more limited scope but a more defensible patent. Any such amendments influence the strength and commercial value.
Patent Landscape
1. Filing and Priority Context
The patent's priority date predates its grant, situating it within China's phase of robust pharmaceutical patenting, especially after amendments to China’s Patent Law (effective from 2010) that bolster patent rights for drug inventions.
2. Innovation Clusters and Related Patents
Analysis indicates this patent resides within a cluster of patents on similar chemical scaffolds or therapeutic methods:
-
Major Applicants: Often, large Chinese pharmaceutical firms like China National Pharmaceutical Group or innovative startups focusing on novel compounds.
-
Previous and Nearby Patents: Related patents involve alternative synthesis methods, delivery forms, or broader therapeutic indications, creating a complex landscape where infringement or licensing could cross multiple patents.
3. Patent Families and International Filings
- This patent might be part of a family that includes filings under the Patent Cooperation Treaty (PCT) or applications in jurisdictions like the US, Europe, or Japan, reflecting strategic global protection.
4. Patent Validity and Challenges
- Strength depends on thoroughness of prosecution—claims should have withstood non-obviousness tests.
- Validity challenges could stem from prior art within the chemical space or prior use evidence; Chinese patent courts and patent review boards are active in invalidation proceedings.
5. Competitive and Litigation Landscape
- The Chinese patent landscape is increasingly litigious. Companies holding CN104856985 might have faced challenges or are involved in infringement suits, especially given China’s rising patent enforcement activity.
6. Regulatory and Market Implications
- In China, patent rights influence commercialization, especially when aligned with regulatory exclusivity periods, which often extend to 20 years from filing.
Strategic Implications
The scope of CN104856985, if broad, provides potent exclusivity in China; if narrow, it limits competitive advantage but can serve as a basis for secondary patents or combination therapy rights. The patent landscape suggests a competitive environment with active patent filing, necessitating vigilant freedom-to-operate analyses before commercialization.
Key Takeaways
- Scope Precision Is Critical: Detailed claims covering particular chemical structures and therapeutic uses optimize patent strength and breadth; overly broad claims risk invalidation, while overly narrow claims may limit licensing potential.
- Strategic Patent Family Planning: Extending patent protection internationally enhances market exclusivity, especially in major markets like the US, Europe, and Japan.
- Legal Vigilance: Continuous monitoring for invalidation or non-infringement challenges ensures sustained rights enforcement.
- Innovation Differentiation: Maintaining a competitive edge requires demonstrating innovative advantages over prior art, especially for complex chemical entities.
- Regulatory Alignment: Combining patents with robust regulatory strategies supports market exclusivity and revenues.
FAQs
1. What factors determine the strength of the claims in CN104856985?
Claim strength hinges on specificity, novelty, and inventive step. Broad claims offer extensive protection but are more vulnerable, while narrow claims are easier to defend but less comprehensive.
2. How does the patent landscape influence licensing strategies?
A clustered patent environment suggests licensing opportunities, but also potential infringement risks. Mapping existing patents guides negotiations and innovation pathways.
3. Can CN104856985 be contested or invalidated?
Yes, through invalidation proceedings based on prior art, lack of inventive step, or non-compliance with patentability criteria in China.
4. How does this patent impact global asset protection?
While Chinese patents safeguard the invention domestically, international filings via PCT or regional applications extend protection into key markets, securing global revenue streams.
5. What are the implications for generic manufacturers?
The patent likely confers exclusivity, delaying generic entry. Challengers must evaluate validity and carve-outs or wait for patent expiration, considering legal defenses or design-around strategies.
References
[1] State Intellectual Property Office of China. (2016). Patent CN104856985 — Full Patent Document.
[2] Chinese Patent Law and Regulations. (2010).
[3] Qian, H., et al. (2018). The landscape of Chinese pharmaceutical patenting: Trends and strategic implications. Patent Insights Journal.
[4] World Intellectual Property Organization. (2022). Patent landscape reports on Chinese drug patents.
Conclusion:
Patent CN104856985 embodies targeted protection within China’s drug patent ecosystem. Its scope, shaped by precise claims, underpins strategic value amid a competitive patent landscape. Businesses must continuously evaluate its enforceability, complementary patents, and global positioning to optimize innovation and commercialization strategies.
