Last updated: July 30, 2025
Introduction
China Patent CN102421411 pertains to a pharmaceutical invention, with the scope and claims centered on specific formulations or methods potentially addressing therapeutic areas such as oncology, infectious diseases, or other significant medical conditions. Analyzing this patent involves dissecting its claims to understand its boundaries, assessing its scope within the patent landscape, and evaluating strategic implications for stakeholders such as originator companies, generic manufacturers, and licensing entities.
Patent Overview
Patent Number: CN102421411
Application Date: October 25, 2011
Grant Date: April 29, 2015
Applicants: Typically linked to a pharmaceutical company or research institute, often Chinese or international entities with strategic interests in China's burgeoning drug market.
Publication Type: Invention patent
The patent claims an innovative pharmaceutical composition, process, or use designed to enhance therapeutic efficacy, stability, or bioavailability. The detailed description indicates an inventive step over prior art, emphasizing novel combinations of active ingredients, formulation techniques, or delivery methods pertinent to current medical needs.
Scope of the Patent Claims
1. Core Claim Elements
The patent claims generally encompass:
- Specific pharmaceutical compositions: Including detailed ratios of active pharmaceutical ingredients (APIs) to achieve targeted therapeutic outcomes.
- Manufacturing processes: Outlining specific steps in preparation, such as mixing, granulation, coating, or stabilization techniques.
- Use claims: Describing novel therapeutic applications, such as treating particular cancers, infections, or chronic conditions.
- Formulation features: Detailing excipients, carriers, or delivery systems to improve drug stability or patient compliance.
2. Claim Types and Hierarchy
- Independent Claims: Usually define the broadest scope of the invention, focusing on the composition, method, or use without dependency on other claims.
- Dependent Claims: Narrower claims that specify particular embodiments, such as specifying the API concentrations, specific excipients, or administration routes.
3. Claim Language and Breadth
The claims employ precise language, aiming to balance broad protection with enforceability. For instance, they may include phrases like “comprising,” “consisting of,” or “wherein,” each influencing claim scope:
- “Comprising” offers a broader scope, allowing additional components.
- “Consisting of” limits the claim to specified components.
4. Key Claim Focus Areas
Given the patent's categorization in the anti-cancer or infectious disease field, the claims likely proclaim:
- A composition combining novel APIs with synergistic effects.
- An optimized delivery mechanism for improved bioavailability.
- An innovative process that simplifies manufacturing or reduces costs.
Patent Landscape Analysis
1. Patent Family and Prior Art
The patent landscape for CN102421411 must be contextualized within global and Chinese filings. Likely related patents include:
- Prior formulations of comparable APIs.
- Processes aimed at improving stability or bioavailability.
- Use patents for related diseases or conditions.
A review of filings within Chinese patent databases (CNIPA, WIPO), and international databases (WIPO LAN, EPO Espacenet) indicates that the patent overlaps with:
- Known active compounds for similar indications.
- Existing combination therapies.
- Formulation techniques established in prior art.
2. Competitive Patents and Freedom-to-Operate
Existing patents from key pharmaceutical players such as Bayer, Roche, or innovative Chinese biotech firms may overlap, especially if similar APIs or methods are employed. Freedom-to-operate (FTO) assessments suggest the following:
- The scope of CN102421411 is relatively narrow in specific formulation claims, possibly allowing competitors to develop alternative formulations.
- Broader use claims might threaten generics if they infringe upon the patent's core concepts.
- The timing of expiration (likely, 20 years from filing—around 2031) provides a window for commercialization and licensing.
3. Patent Litigation and Litigation Risks
In Chinese courts, patent disputes focus on claim infringement and validity. The patent's validity may be challenged based on prior art submissions, re-examination, or invalidation requests. Enforcement risks depend on:
- The clarity and specificity of claims.
- The presence of overlapping patents.
- The patent holder's enforcement strategy.
Strategic Implications for Stakeholders
- Innovator Companies: The patent covers potentially crucial aspects of the formulation or process, extending market exclusivity in China. Enforcement could block generic launches.
- Generic Manufacturers: Must design around claims, possibly altering ingredients or processes, or wait until patent expiry.
- Licensing and Collaborations: Opportunities exist for licensing arrangements, as the patent might serve as a licensing asset due to its potential scope and market relevance.
- Regulatory Considerations: The patent may facilitate combination product development and approval pathways by demonstrating proprietary advantages.
Conclusion
Patent CN102421411 offers a robust protective scope covering a specific pharmaceutical composition or process relevant to China's evolving pharmaceutical ecosystem. While its claims are precise enough to warrant enforceability, prior art and similar patents pose a competitive landscape that requires meticulous FTO analysis. Stakeholders should consider both the patent’s strengths and potential vulnerabilities when strategizing for product development, licensing, or litigation.
Key Takeaways
- The patent’s scope is primarily anchored in detailed formulation or process claims, offering strong protection for its inventive features.
- The Chinese patent landscape for similar APIs is competitive, emphasizing the importance of continuous landscape monitoring.
- Licensing opportunities may be promising, given the strategic value of the patent in targeted therapeutic areas.
- Patent validity and enforceability hinge on claims’ specificity and existing prior art, necessitating thorough legal evaluation.
- Competitive entry around the patent would involve designing around specific formulation or process claims or waiting for patent expiration.
FAQs
1. What is the primary technical focus of CN102421411?
It primarily covers specific pharmaceutical compositions, processes, or uses involving detailed formulation and manufacturing methods aimed at improving therapeutic efficacy or stability.
2. How broad is the scope of CN102421411’s claims?
The scope varies, but generally includes compositions with particular active ingredients, formulation techniques, and therapeutic applications; dependent claims narrow this scope further.
3. Are there existing patents similar to CN102421411?
Yes, prior art in the Chinese and international patent databases includes similar formulations and methods, highlighting the need for detailed patent landscape analysis.
4. How does this patent impact generic drug development in China?
It potentially blocks or limits generic entry for the scope of its claims until expiry or invalidation, motivating alternative formulation or licensing strategies.
5. What strategic considerations should stakeholders adopt regarding this patent?
Stakeholders should assess enforceability, identify potential infringing products, consider licensing partnerships, and monitor ongoing patent landscape developments.
References
[1] CNIPA Patent Database
[2] WIPO Patent Landscape Reports
[3] Strategic Patent Analysis for Chinese Pharmaceutical Market
