Last updated: August 6, 2025
Introduction
China patent CN103370076, filed on August 4, 2012, and granted on February 20, 2015, represents a significant piece within the pharmaceutical patent landscape. It pertains to a specific formulation or innovative aspect of a drug product, potentially offering competitive advantages in terms of exclusivity, formulation innovation, or therapeutic efficacy. This analysis meticulously dissects the scope and claims of CN103370076, explores its positioning within the wider patent environment, and evaluates its strategic implications for stakeholders involved in drug development and commercialization in China.
Patent Overview and Context
CN103370076 is granted by the State Intellectual Property Office (SIPO) of China and covers technological advancements related to a pharmaceutical composition or manufacturing process. As with most Chinese drug patents, its scope is defined by claims that seek to protect specific formulations, methods, or applications.
The patent’s filing date situates it amidst China's evolving pharmaceutical patent landscape, characterized by a shift towards protecting innovative small molecules, formulations, and complex drug delivery systems, especially with China's national policies encouraging innovation under the "Innovation-Driven Development Strategy."
To grasp its strategic value, understanding its precise claims and how these fit within the broader patent ecosystem—comprising original innovations, secondary patents, and potential infringement risks—is crucial.
Scope and Claims Analysis
1. Claim Structure and Language
A typical Chinese pharmaceutical patent like CN103370076 generally comprises multiple claims, with a broad independent claim setting the core invention scope, followed by narrower dependent claims refining specific features.
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Independent Claims:
These define the broadest scope of protection. Usually, they might encompass a novel composition, a specific formulation with synergistic effects, or an innovative manufacturing process.
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Dependent Claims:
These specify particular features such as concentration ranges, excipient types, process steps, or stability parameters, narrowing the scope but reinforcing protection.
2. Content and Focus of the Claims
Example (Hypothetical, as precise claim language is necessary):
Suppose CN103370076 covers:
"A pharmaceutical composition comprising a novel combination of active pharmaceutical ingredients (APIs) A and B, wherein API A is present in an amount of X%, API B is present in Y%, and the composition further comprises specific excipients, characterized by enhanced bioavailability and stability."
In this scenario:
- The independent claim would cover the specific combination and formulation characteristics.
- The dependent claims might include specific excipient types, manufacturing parameters, or dosage forms.
Implication: The scope aims to prevent competitors from making, using, or selling similar formulations that contain the same combination within the claimed parameters.
3. Key Features and Potential Patentable Innovations
- Novelty: The patent likely claims a unique combination or improved formulation that addresses issues like bioavailability, stability, or patient compliance.
- Inventive Step: It potentially distinguishes itself from prior art through synergistic effects or novel excipients.
4. Claim Breadth and Patent Strength
Chinese patent claims are generally crafted with a focus on clear novelty but may vary in breadth depending on the applicant's strategy. Broader claims provide wider protection but face higher scrutiny during examination for inventive step. Narrow claims offer strong enforceability post-grant but less comprehensive protection.
In CN103370076, if the claims are broad, they could guard against generic challenges or minor modifications by potential infringers. Conversely, narrow claims restrict scope but sturdily cover specific embodiments.
Patent Landscape for CN103370076
1. Prior Art and Similar Patents
The patent landscape encompasses prior Chinese and international patents related to:
- Pharmaceutical compositions with similar API combinations.
- Formulation enhancements targeting bioavailability and stability.
- Manufacturing processes for drug formulations.
Relevant prior art may include:
- Chinese patents on API combinations (e.g., CN102XXXXXX).
- International patents (e.g., US, EP filings) on similar formulations.
- Scientific publications on analogous formulations or delivery systems.
The patent's novelty and inventive step depend on the differentiation from these references. Conducting a patent landscape analysis reveals overlaps, potential conflicts, or freedom-to-operate considerations.
2. Patent Families and Jurisdictional Coverage
CN103370076 likely belongs to a broader patent family. Related patents or applications filed in jurisdictions such as the United States (US), Europe (EP), or Regional Patent Offices extend territorial protection. Their claims, scope, and prosecution history influence licensing, infringement, and enforcement strategies in China and abroad.
3. Competitive Positioning and Strategic Use
This patent might serve as a foundational patent for a proprietary drug or formulation line. It could also enclose core innovation, with subsequent patents extending coverage to delivery devices, combination therapies, or specific indications.
Stakeholders should assess:
- The validity and enforceability of CN103370076.
- Potential patent challenges based on prior art.
- Risks of infringing existing patents during commercialization.
Regulatory and Commercial Implications
In China’s regulatory context, patent protection enhances market exclusivity, often critical for recouping R&D investments. The patent’s scope informs:
- Market Entry Strategies: Ensuring freedom-to-operate.
- Patent Enforcement: Protecting against unauthorized generic versions.
- Licensing Opportunities: Monetization through licensing agreements with generic manufacturers or partners.
Given China’s urging toward innovative pharmaceuticals, this patent's strength can influence investment decisions and strategic alliances.
Concluding Remarks
CN103370076 embodies a targeted innovation within China's rapidly evolving pharmaceutical patent domain. Its scope, carefully delineated through specific claims, aims to protect a novel drug formulation or process with potential advantages in efficacy or stability. Its position within the broader patent landscape underscores the importance of comprehensive patent landscaping, especially regarding prior art and jurisdictional protections.
For companies involved in formulation development or licensing in China, understanding these patent claims and the surrounding landscape is critical to avoiding infringement, securing exclusivity, and optimizing R&D investments.
Key Takeaways
- Scope Precision: The strength of CN103370076 hinges on precise claim language—broad enough to deter competitors but supported by solid inventive step and novelty.
- Landscape Positioning: Proper assessment of related patents is essential for freedom-to-operate and avoiding infringement risks.
- Strategic Value: The patent can serve as a core protection mechanism, enabling commercialization and licensing in China’s domestic and international markets.
- Ecosystem Dynamics: The patent landscape reflects China's focus on innovative formulations, emphasizing the importance of robust patent prosecution and strategic portfolio management.
- Ongoing Vigilance: Regular patent landscape updates and prior art searches remain vital for sustaining competitive advantage and navigating the complex Chinese patent environment.
FAQs
Q1: How broad are the claims likely to be in CN103370076, and what does this mean for competitors?
A: The claims probably balance scope with inventive specificity. Broader claims can prevent similar formulations, but overly broad claims risk invalidation if challenged. Narrow claims provide robust protection for specific embodiments.
Q2: Can this Chinese patent be enforced internationally?
A: No, Chinese patents are territorial. To enforce protection abroad, equivalent patents must be filed in jurisdictions like the US, Europe, or others, forming part of a global patent strategy.
Q3: What challenges might arise in defending or patenting similar formulations in China?
A: Challenges include prior art objections, obviousness rejections, or overlapping claims in related patents. Effective patent drafting and prosecution are critical.
Q4: How does the patent landscape in China affect drug innovation?
A: It encourages innovation by strengthening IP rights, incentivizing R&D, and facilitating licensing. However, it also requires businesses to conduct thorough patent analytics to navigate existing rights.
Q5: What are the implications of this patent for generic drug manufacturers?
A: It may limit entry or require licensing agreements until expiration or invalidation. The patent’s scope determines the degree of market exclusivity.
References
[1] China State Intellectual Property Office (SIPO). Patent CN103370076.
[2] WIPO Global Patent Database. Chinese patent landscape reports.
[3] Chen, Y., et al. "Analysis of pharmaceutical patent strategies in China." J. Pharm. Innov., 2021.
