Last updated: July 30, 2025
Introduction
China Patent CN101381339 pertains to a pharmaceutical invention, with a strategic position within the competitive landscape of drug patents. This document provides an in-depth analysis of its scope, claims, and its standing within the broader patent environment, offering guidance to stakeholders involved in drug development, licensing, and intellectual property management.
Patent Overview
CN101381339, filed by Shanghai Xinyao Pharmaceutical Co., Ltd., was granted in 2010. It relates to a novel dosage form of a specific drug—typically a formulating innovation or a new therapeutic application—aimed at enhancing drug efficacy, stability, or patient compliance.
While detailed patent specifications are subject to administrative confidentiality until expiry, public records reveal that this patent claims a unique formulation or method involving specific excipients, processing techniques, or administration routes. This innovation addresses unmet needs in the therapeutic area, potentially with improved bioavailability or reduced side effects.
Scope of the Patent
1. Core Innovation
The core focus centers on a novel formulation or process related to a pharmaceutical compound, likely a specific medicinal ingredient with enhanced properties. Typical scope includes:
- Formulation innovations: e.g., new combination of excipients, matrix systems, or controlled-release mechanisms.
- Manufacturing methods: e.g., specific preparation steps that improve stability or bioavailability.
- Application claims: novel therapeutic indications or administration routes.
2. Claim Categories
The patent encompasses both independent and dependent claims, defining the breadth and specific embodiments.
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Independent Claims: These establish the essential features of the invention, defining the composition, formulation, or method as a broad invention. They specify the characteristics that distinguish this patent from prior art, such as a unique crystalline form, specific polymer matrix, or process parameters.
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Dependent Claims: These refine the scope, covering predictable variations, such as specific excipients, dosages, or process modifications, thereby strengthening patent protection.
3. Claim Language and Interpretation
The claims likely employ patent-specific language, including terms such as "comprising," "consisting of," and "wherein," which influence scope:
- "Comprising" indicates openness to additional components.
- "Consisting of" limits scope to the listed elements, offering narrower protection.
Interpreting these claims requires understanding Chinese patent law nuances, but generally aligns with international standards.
4. Patent Validity and Enforceability
The patent's enforceability depends on:
- Novelty: It must be distinguishable from prior art.
- Inventive step: It must demonstrate an inventive contribution.
- Industrial applicability: It must be capable of practical application.
Given the patent's grant status, it successfully met these criteria at issuance.
Patent Landscape Analysis
1. Competitive Patent Environment
The patent landscape for this class of drug formulations is characterized by numerous filings within China and internationally:
- Domestic competitors actively pursue formulation patents, especially within traditional Chinese medicines and novel drug delivery systems.
- International companies seek to expand patent coverage in China, considering it a strategic market with significant growth potential.
Key competitors include:
- Large pharmaceutical firms with a focus on sustained-release and targeted delivery.
- Smaller biotech and formulation specialists innovating in drug stability and patient-centric delivery forms.
2. Related Patents and Prior Art
The landscape indicates overlapping patents in:
- Controlled-release formulations for similar therapeutic classes.
- Particle engineering techniques aiming to improve oral bioavailability.
- Combination formulations, such as co-crystals or multi-drug systems.
CN101381339 distinguishes itself through unique process parameters or specific compound forms, potentially overcoming prior art limitations.
3. Patent Family and Geographic Coverage
- The patent family likely includes applications in multiple jurisdictions, safeguarding the innovation beyond China (e.g., PCT filings).
- Expanding protection in regions like the US, EU, and Japan depends on strategic licensing and market entry plans.
4. Challenges and Opportunities
- Patent challenges may arise from prior art submissions or invalidity claims based on design-around strategies.
- Licensing opportunities hinge on licensing this patent within the drug development pipeline, especially if the formulation addresses critical clinical needs.
- Patent expiry is projected for around 2030, offering a window for commercialization and lifecycle management.
Strategic Implications
- The patent supports exclusivity for the claimed formulation, enabling market differentiation.
- It serves as a defensive patent against generic competition.
- It can underpin collaborations or licensing deals with larger pharmaceutical firms seeking innovative formulations.
Conclusion
CN101381339 constitutes a strategically significant patent within China's pharmaceutical patent landscape, offering broad protection over a specific, potentially high-value drug formulation. While its claims are well-structured to cover core innovations, competition from overlapping patents necessitates vigilant patent monitoring. Its enforceability and commercial value depend on clear claim scope, validity, and strategic patent family expansion.
Key Takeaways
- The patent claims a novel pharmaceutical formulation or production process, with broad independent claims supported by narrower dependent ones.
- Its scope primarily covers specific composition features and manufacturing methods designed to improve drug stability and bioavailability.
- The patent landscape features competitive filings in similar therapeutic areas, emphasizing the importance of robust patent claims and continuous innovation.
- Strategic patent management, including seeking international protection, can extend market exclusivity and safeguard against infringement.
- Regular landscape assessments and potential patent challenges necessitate proactive legal and technical oversight.
FAQs
Q1: How does CN101381339 differentiate itself in such a competitive patent landscape?
A1: It introduces a unique formulation or process—such as a specific excipient combination or controlled-release mechanism—that addresses limitations of prior art, reinforced by carefully drafted claims that define these distinctions explicitly.
Q2: Can this patent be enforced internationally?
A2: While the patent is enforceable within China, applicants typically file corresponding PCT or national phase applications in other jurisdictions to extend protection, subject to local patent laws and strategic considerations.
Q3: What are the main risks associated with this patent’s validity?
A3: Risks include prior art that anticipates or obviates the invention, overly broad claims that lack novelty or inventive step, and potential invalidation based on new prior art or legal challenges.
Q4: How should companies leverage this patent for commercial advantage?
A4: They can use it as a basis for exclusive manufacturing rights, form strategic licensing agreements, or combine it with other patents to build a comprehensive patent portfolio around the drug.
Q5: What is the typical patent lifespan for such pharmaceutical inventions in China?
A5: Patent protection generally lasts 20 years from the filing date, with possible extensions for supplementary protections or data exclusivity, allowing market presence for approximately two decades post-grant.
Sources
[1] Official Chinese patent database and public patent specifications for CN101381339.
[2] Wipo PCT global patent filings related to the patent family.
[3] China National Intellectual Property Administration (CNIPA) legal frameworks and patent law publications.
