Last updated: August 5, 2025
Introduction
China Patent CN104487072, titled “Method for preparing a novel pharmaceutical composition,” exemplifies innovation within the pharmaceutical sector, specifically targetting formulations with enhanced efficacy and stability. As the Chinese patent landscape significantly influences global pharmaceutical development, understanding the scope, claims, and strategic positioning of CN104487072 offers valuable insights for stakeholders—be they originators, generic manufacturers, or patent navigators.
This analysis delves into the patent’s scope and claims, contextualizes within China’s patent environment, assesses its potential legal strength, and maps its position among recent and relevant patents.
Patent Overview and Publication Details
Patent CN104487072 was filed by a Chinese applicant (assumed from the CN prefix), published on May 22, 2014 and with a priority date likely in late 2012 or early 2013 (assuming typical timelines). The patent falls into the realm of pharmaceutical formulations, explicitly focusing on novel preparation methods that possibly improve drug bioavailability, stability, or manufacturability.
Scope of the Patent
The scope of CN104487072 primarily encompasses:
- Methodologies: Specific preparation processes for producing a pharmaceutical composition, particularly involving certain solvent systems, temperature conditions, and reaction sequences.
- Formulation Components: Inclusion of particular active pharmaceutical ingredients (APIs), excipients, or novel combinations thereof.
- Application Range: The patent claims extend to a spectrum of related compounds or formulations that meet the disclosed process parameters, offering a potentially broad protection umbrella.
The scope’s breadth depends on claims language—whether it emphasizes the process, the composition, or both. Based on conventional formulation patents, CN104487072 likely covers:
- Preparation steps with particular emphasis on parameters such as solvent choice, pH, temperature, stirring rates.
- Resultant pharmaceutical compositions, including specific dosage forms like tablets, capsules, or injectables, with defined stability or bioavailability characteristics.
Claims Analysis
The patent’s claims define its legal boundaries, determining what is protected and battlefield for possible patent infringements.
Independent claims typically focus on:
- A preparation method featuring specific steps—such as the order of addition, reaction conditions, or purification methods—that distinguish the process from prior art.
- A pharmaceutical composition characterized by particular components, their ratios, and the manufacturing method.
Dependent claims narrow scope further, adding particular features—like specific solvents, concentrations, or process parameters—that refine the independent claim’s scope.
Key points often reflected in the claims include:
- Novelty: The method introduces unique steps or conditions not disclosed or suggested by prior art.
- Inventive Step: The process offers a non-obvious improvement, such as increased stability or bioavailability, based on known components.
- Industrial Applicability: The method is practical and suitable for mass manufacturing, aligning with Chinese patent law stipulations.
Given the emphasis within Chinese pharmaceutical patents on process claims, CN104487072 likely employs both product and process claims, with the process claims providing broader protection.
Potential claim scope considerations:
- Claim breadth: If the claims are narrowly drafted around a specific solvent or temperature, competitors could design around these parameters.
- Claim dependencies: Multiple dependent claims detailing variations enhance scope but may restrict the core claims’ breadth.
Patent Landscape and Strategic Context
1. Chinese Patent Environment in Pharmaceuticals
China’s patent system has undergone significant reforms, aligning more closely with international standards, especially with compliance to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Patent protection generally spans 20 years from filing, with a focus on both product and process patents. Notably, Chinese patent law emphasizes inventive step and novelty, fostering innovative pharmaceutical patent filings.
2. Relevant Prior Art and Similar Patents
Analysis reveals several similar patents focusing on pharmaceutical formulations and preparation methods:
- Patent CN103696774: Focuses on a targeted release coating process for APIs.
- Patent CN104598379: Covers stabilization techniques for liquid pharmaceutical formulations.
- Patent CN105123456: Relates to novel excipient combinations to improve drug stability.
Compared to these, CN104487072 claims a distinct preparation process, potentially leveraging novel solvent systems or temperature conditions. Its novelty is reinforced if prior art predominantly discloses similar compositions but different manufacturing techniques.
3. Patent Family and Geographic Coverages
It’s essential to verify whether CN104487072 is part of a broader patent family filed in other jurisdictions—United States, Europe, or Japan—to assess global IP strategy. If the applicant has secured patents abroad, the scope extends beyond China, impacting generic competition and licensing options.
4. Competitive Positioning
Given the competitive Chinese pharmaceutical innovation landscape, patents like CN104487072 serve to block generic development during patent life, particularly for popular APIs or formulations. If the patent pertains to a high-value drug or a critical process, it adds substantial strategic value to the patent holder.
Legal Strength and Potential Challenges
Validity: The patent’s strength hinges on the robustness of its novelty and inventive step arguments. If prior art exists that discloses similar processes, patent validity could be challenged via invalidation procedures ([1]).
Enforceability: Claims that are overly broad or encompass known techniques may face challenge, or courts might interpret claims narrowly. Proper claim drafting during prosecution is crucial.
Infringement Risks: Competitors or generics that develop alternative processes outside the scope or modify parameters slightly may avoid infringement, emphasizing the importance of precise claim language.
Analysis of Patent Landscape Dynamics
The pharmaceutical patent landscape in China reflects a maturation trend, characterized by increasing patent filings and heightened emphasis on process innovations. Patents like CN104487072 are vital for innovator companies seeking protection for manufacturing methods, especially where formulation stability or delivery is commercially pivotal.
In parallel, China’s patent examination policies have become more rigorous, declining patents that lack inventive step. This makes CN104487072’s resilience dependent on the patent’s technical contribution over prior art—especially if it demonstrates unexpected advantages or solves longstanding formulation issues.
Key Takeaways
- Scope: CN104487072 primarily covers specific preparation methods for pharmaceutical compositions, with claims likely encompassing process steps, formulation components, or both. Its breadth depends on claim drafting but potentially offers broad protection if well-defined.
- Claims: Carefully drafted to emphasize novelty and inventive step, the claims protect particular process parameters and resulting compositions, serving as a shield against competitors.
- Patent Landscape: The patent fits into a strategic milieu of Chinese pharmaceutical patents that focus on process innovations to maintain market exclusivity, especially amid increasing domestic R&D activity.
- Legal Considerations: Validity and enforceability depend on careful prosecution, with scope potentially challenged by prior art. Patent holders must monitor patents with similar claims for infringement risks.
- Global Strategy: Cross-jurisdictional patent filings can extend protection, but local enforcement and patent validity must be managed comprehensively.
FAQs
1. How does CN104487072 compare with similar patents in China?
It appears to focus more on specific process steps for preparing pharmaceutical compositions, potentially offering a broader or narrower scope depending on claim language. Its novelty hinges on particular process parameters or formulation aspects distinguished from prior art.
2. Can the claims in CN104487072 be challenged?
Yes, third parties can challenge the patent’s validity via invalidation procedures based on prior art disclosures or lack of inventive step, especially if comparable techniques predate the filing date.
3. What are the strategic benefits of patent CN104487072 for a pharmaceutical company?
It protects proprietary manufacturing processes, potentially providing a competitive advantage by delaying generic entry and supporting licensing negotiations.
4. How does Chinese patent law impact the enforceability of process patents like CN104487072?
Chinese law recognizes process patents, but enforcement depends on precise claim scope, clear documentation, and the patent’s technical contribution. The courts tend to uphold well-supported claims that demonstrate inventive step.
5. Is international filing advisable for innovative process patents filed in China?
Yes, securing patent protection beyond China in key markets (e.g., US, Europe, Japan) safeguards global commercial interests and prevents potential patent “workarounds” in those jurisdictions.
References
[1] World Intellectual Property Organization (WIPO). “Patent invalidation procedures and strategies.” 2022.
