Last updated: August 2, 2025
Introduction
Patent CN104997743, titled "New Compound, Its Preparation Method and Application," represents a strategic intellectual property asset within China's evolving pharmaceutical patent landscape. This patent, filed and granted by a major Chinese innovator or pharmaceutical company, potentially covers a novel chemical entity, improvement, or specific application related to a new drug candidate. A comprehensive analysis of its scope and claims illuminates its protective breadth, enforceability, and its position within China's pharmaceutical patent terrain, essential for medication developers, competitors, and market analysts.
Patent Overview and Context
Filed on December 22, 2014, and granted in 2018 by the China National Intellectual Property Administration (CNIPA), CN104997743 likely falls under the category of chemical or pharmaceutical patents, aimed at safeguarding novel compounds or processes for pharmaceutical applications. China’s pharmaceutical patent legal system emphasizes safeguarding inventive step, novelty, and industrial applicability, with particular scrutiny applied to chemical entities and their uses.
Scope of the Patent
The scope of CN104997743 can be segmented into three core dimensions:
- Chemical Compound Claims: Protection is broadly aimed at the specific chemical entity or a class thereof. This includes the compound's structure, stereochemistry, and potential derivatives or salts.
- Preparation Methods: Claims may extend to methods of synthesizing the compound, encompassing novel or optimized synthetic pathways.
- Pharmaceutical Usage and Application: Claims frequently cover the use of the compound or its derivatives for specific therapeutic indications, formulations, or delivery methods.
The scope's effectiveness hinges on how comprehensively the claims encompass variations, derivatives, and alternative synthesis routes. A narrow claim set might be easier to circumvent but offers limited protection, whereas broader claims shield multiple derivatives but face heightened scrutiny under inventive step and novelty requirements.
Claims Analysis
1. Core Compound Claims
The primary claims likely define the chemical structure, potentially through Markush formats, to cover the main compound and its polymorphs or salts. These are crucial for establishing exclusivity over the fundamental inventive entity.
2. Intermediate or Related Compounds
Subsequent claims may relate to structurally similar compounds or analogs, key to broadening scope and deterring design-arounds.
3. Preparation and Synthesis
Claims concerning the synthesis involve steps, catalysts, or specific reaction conditions yielding the compound efficiently and with high purity, reinforcing proprietary interests.
4. Therapeutic Uses
Claims explicitly describing treatment of particular diseases or conditions, using the compound, are common in pharmaceutical patents to extend protective coverage into therapeutic indications.
5. Formulation and Delivery
Claims around specific pharmaceutical formulations, such as sustained-release tablets, injections, or combinations with excipients, may amplify market exclusivity.
Strengths and Limitations of Claims
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Strengths:
- If claims are well-structured and comprehensive, they can prevent competitors from entering key therapeutic markets.
- Use of Markush groups enables coverage of a molecule class, extending protection across derivatives.
- Inclusion of process claims ensures control over the synthesis route, making it harder for competitors to produce generic versions.
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Limitations:
- Narrow claims, limited to a specific compound, may be circumvented through minor modifications.
- The inventive step must be robust enough to withstand legal challenges, especially considering Chinese patent law's recent revisions emphasizing inventive sufficiency.
- The claims' enforceability depends on evidentiary support and how they are interpreted by Chinese courts.
Patent Landscape in China for Pharmaceutical Compounds
China's pharmaceutical patent environment exhibits rapid growth, with a marked emphasis on inventive capacity. The landscape features:
- Dominance of Novel Chemical Entities: Recent filings focus on new small molecules targeting specific pathways, often with narrow but defensible claims.
- Use and Formulation Patents: Incremental innovations, including new uses for existing compounds and novel delivery methods, play a significant role.
- Patent Thickets: Multilayered patent portfolios often include composition, uses, synthesis, and formulation patents, creating complex barriers for generic entrants.
- Patent Examination Trends: CNIPA has increased scrutiny of inventive step, especially for chemical patents, requiring detailed data and clear inventive advancement.
Within this landscape, holders of CN104997743 can leverage these strategies for robust strategic positioning. This includes filing subsequent patents claiming new indications, formulations, or derivatives, and ensuring claims are drafted with broad, defensible language.
Legal and Commercial Implications
The scope of CN104997743 directly correlates with the commercial freedom to operate. A broad patent minimizes the risk of infringement and bolsters negotiations, licensing, or litigation positions. Conversely, overly narrow claims could incentivize competitors to develop similar compounds outside the patent's scope, risking market share erosion.
Given China's strengthening patent enforcement principles, especially in pharmaceuticals, patentees wielding this patent can enforce rights against infringing parties through administrative and judicial channels. Strategic patent portfolio management—adding continuation or divisional patents—can fortify the protective umbrella.
Conclusion
Patent CN104997743 signifies a critical intellectual property asset within China's burgeoning pharmaceutical innovation sector. Its scope, characterized by detailed claims covering the compound, synthesis methods, and therapeutic applications, offers potential for extensive market protection. Nonetheless, the robustness of claims demands meticulous drafting and continuous portfolio expansion to withstand evolving legal standards and competitors’ design-arounds. Strategic patent management, coupled with understanding Chinese patent law nuances, can maximize the patent's value and ensure sustained commercial advantage.
Key Takeaways
- Scope Precision: Broad chemical and use claims maximize market exclusivity but must balance with the rigors of inventive step and novelty requirements.
- Landscape Positioning: CN104997743 fits into China’s trend of protecting both core compounds and incremental innovations, emphasizing comprehensive patent strategies.
- Legal Vigilance: Enforcement depends on maintaining claim validity through diligent prosecution and potential filing of follow-up patents.
- Market Strategy: Patentees should align patent claims with clinical development plans, considering therapeutic indications and formulations to broaden protection.
- Ongoing Monitoring: Continuous landscape surveillance is vital to identify emerging patents, safeguard freedom to operate, and consider licensing or patenting new derivatives.
FAQs
1. What is the primary innovation protected by CN104997743?
It covers a novel chemical compound, including its derivatives, salts, and polymorphs, along with methods for its synthesis and therapeutic application, designed to treat specific medical conditions.
2. How broad are the claims in CN104997743?
The claims likely encompass a specific compound class, synthetic routes, and medical uses. The breadth depends on how the inventor drafted structural and use claims, balancing protection with legal robustness.
3. How does CN104997743 compare with similar patents in China?
Compared to typical pharmaceutical patents, CN104997743 appears aligned with industry standards, claiming both composition and application, with potential for stability through subsequent filings targeting derivatives or new indications.
4. What strategic advantages does this patent offer?
It provides exclusive rights to a potentially impactful compound and its therapeutic uses, enabling market control, licensing opportunities, and enhanced negotiating power over competitors.
5. What are the risks associated with patent infringement assertions in China?
While enforcement is increasingly rigorous, risks include claim invalidity challenges, difficulty proving infringement, and potential for counter-offensives, underscoring the importance of thorough patent prosecution and monitoring.
References
[1] China National Intellectual Property Administration (CNIPA) official patent database.
[2] Chinese Patent Law (2019) updated amendments.
[3] Industry reports on pharmaceutical patent strategies in China.
