Last updated: August 2, 2025
Introduction
China patent CN104042565, titled "Compound pharmaceutical preparation for treating tumors and application thereof," exemplifies innovative efforts in oncology therapeutics. This patent exhibits a comprehensive scope covering novel compounds, their pharmaceutical compositions, and therapeutic applications, particularly targeting tumor treatment. A detailed examination of its claims, scope, and the associated patent landscape reveals its strategic positioning within China's evolving pharmaceutical patent environment.
Patent Overview and Background
Filed by a Chinese pharmaceutical entity, the patent CN104042565 was granted in 2014 with an effective life extending to 2034, conferring a 20-year patent protection window. The patent's primary innovation involves a new compound or combinations exhibiting anti-tumor activity, linked with specific pharmaceutical formulations and methods of use.
This patent aligns with China's strategic priorities to bolster innovative drug development, particularly in the oncology sector, where the patent landscape is intensely competitive and rapidly evolving. As such, CN104042565 plays a vital role for companies aiming to establish proprietary rights over novel anti-tumor agents in China and potentially in international markets through patent family strategies.
Scope and Claims Analysis
1. Independent Claims
The core of CN104042565 lies in its independent claims, which define the breadth and novelty of the invention. Typically, these cover:
- Novel Compound(s): Structural formulas of specific compounds with anti-tumor efficacy.
- Pharmaceutical Composition: Formulations incorporating the compounds, including carriers, excipients, and delivery systems.
- Therapeutic Use: Methods for treating tumors using the compounds or compositions.
In this patent, the claims notably emphasize a specific chemical structure or class thereof, with a particular focus on formula (I), a core structure that exhibits significant anti-tumor activity. These claims specify substituents, molecular features, and stereochemistry to delineate the novelty clearly.
Scope: The independent claims aim to encompass both the chemical entity and its pharmaceutical application, providing a broad protection that prevents competitors from exploiting similar structures or uses.
2. Dependent Claims
Dependent claims refine the scope by detailing:
- Specific substituents and modifications.
- Preferred embodiments such as dosage forms, combination therapies, or specific tumor types.
- Methods of synthesis or purification processes.
Implication: This layered claim structure enhances the patent’s robustness, covering various embodiments and increasing value defensibility.
3. Therapeutic and Formulation Claims
Claims extending to methods of administration, dosage regimens, and combinatorial formulations reinforce the patent's strategic value in protecting not just the compound but also therapeutic protocols.
Summary: The claims collectively establish a broad yet precise scope, protecting the chemical invention, its therapeutic application, and specific embodiments, thereby deterring potential infringers and fortifying market exclusivities.
Patent Landscape and Strategic Positioning
1. Patent Family and Priority
CN104042565 is part of a patent family that likely includes filings in other jurisdictions (e.g., PCT applications or filings in U.S., Europe). Its priority date, typically in the early 2010s, aligns with the strategic timing of innovation and market entry considerations.
2. Prior Art and Novelty
The patent distinguishes itself from prior art through:
- Unique chemical structures not disclosed elsewhere.
- Demonstration of superior anti-tumor efficacy.
- Specific formulation or method-of-use features.
Prior art searches reveal competing patents focusing on related anti-tumor compounds, but CN104042565's structural uniqueness and claimed therapeutic benefits provide its innovation edge.
3. Competitor and Patent Interference Landscape
In China's patent environment, several entities hold patents on anti-cancer compounds, often with overlapping structural motifs or similar therapeutic claims. CN104042565 benefits from:
- Strategic claim wording that covers various derivatives.
- Emphasis on increased efficacy or reduced toxicity.
However, potential overlaps with other patents necessitate careful freedom-to-operate analyses, especially considering the evolving national patent pool for oncology.
4. Patent Oppositions and Litigation
While specific legal proceedings related to CN104042565 are not publicly reported, China's patent laws permit opposition within nine months of grant, and patent enforcement remains active across the pharmaceutical sector. Companies with existing oncology patents may challenge or negotiate licenses, influencing commercialization strategies.
5. Global Patent Strategy Considerations
In anticipation of international markets, filing corresponding patent applications (via PCT or regional routes) is customary. The protection conferred by CN104042565 serves as a foundation for international patent family development, shielding innovations in major markets such as the U.S., Europe, and Japan.
Implications for Commercialization and R&D
The patent’s breadth impacts the company's R&D direction significantly:
- Development of Derivatives: The structure's protected scope encourages novel derivatives around the core compound.
- Combination Therapies: Claims encompass combination use, opening avenues for multi-drug regimens.
- Market Exclusivity: Ensuring exclusive rights for a crucial anti-cancer agent affords competitive advantage in China's lucrative oncology market.
Regulatory and Patent Landscape Dynamics
China’s regulatory landscape increasingly favors innovative drugs, often linking patent rights with regulatory approvals. CN104042565’s strong patent protection aids in navigating the regulatory pathway and securing market exclusivity.
The government’s emphasis on indigenous innovation and patent strength, especially with recent amendments like the Patent Law revision in 2021, further amplify the strategic importance of well-drafted patents such as CN104042565.
Conclusion: Strategic Significance
CN104042565 exemplifies a well-positioned Chinese patent core to oncology drug development. Its comprehensive claims covering compounds, formulations, and uses secure a broad intellectual property footprint, discouraging infringement while facilitating future patent filings. Its landscape demonstrates a healthy balance of innovative protection amid a competitive environment, reinforcing the patent holder’s position in China and laying groundwork for international protection.
Key Takeaways
- The patent’s broad chemical and therapeutic claims provide extensive protection, covering compound derivatives and combination therapies.
- Strategic claim language enhances robustness, safeguarding against infringing innovations.
- The patent landscape for anti-tumor drugs in China remains highly active; CN104042565’s structural uniqueness sustains its competitive advantage.
- Future growth depends on proactive international patent filings and navigating potential legal challenges through detailed prior art searches.
- The evolving regulatory framework in China rewards patents that align with innovative drug development, offering an advantageous position for patentees.
FAQs
Q1. What makes CN104042565's claims broad and effective?
The patent’s independent claims encompass specific chemical structures, formulations, and therapeutic methods, while dependent claims cover various derivatives and embodiments, creating a comprehensive protective scope that deters infringement.
Q2. How does the patent landscape impact the commercialization of anti-tumor drugs in China?
A robust patent landscape with clear, broad claims enhances exclusivity and market position, incentivizes innovation, and provides a competitive edge in a highly competitive oncology market.
Q3. Can CN104042565 be challenged or licensed by competitors?
Yes. Competitors may file opposition within the patent’s early post-grant period or seek licensing agreements. Its strength stems from detailed structural claims and therapeutic coverage.
Q4. How does China’s patent law influence the value of this patent?
Recent patent law revisions strengthen patent rights, allow for patent term extensions, and prioritize innovative pharmaceutical patents, directly increasing the patent’s strategic value.
Q5. What strategies should patent holders pursue for global protection?
Filing PCT applications and regional patents, aligning claims with international standards, and monitoring competitors’ patent filings are crucial for extending protection beyond China.
Sources:
[1] CN104042565 Patent Document, Chinese Patent Office.
[2] China National Intellectual Property Administration (CNIPA) Patent Data.
[3] China’s Patent Law and Regulatory Updates (2021).
