Last updated: August 8, 2025
Introduction
China patent CN104177468, titled "Pharmaceutical Composition for Treating Cancer," represents a significant development within China's burgeoning biotechnology and oncology patent landscape. This patent, filed by a leading pharmaceutical entity, underscores strategic R&D efforts aiming to address unmet medical needs in cancer therapy. This analysis examines the patent's scope and claims and contextualizes its landscape within China's intellectual property ecosystem for pharmaceuticals.
Patent Overview: CN104177468
Filing and Publication Details:
- Application Number: CN201210062XXXX
- Filing Date: January 2012
- Publication Date: August 2014
- Priority Date: January 2012
The patent pertains to a pharmaceutical composition, primarily comprising a therapeutic agent targeting tumor cells, possibly including combinations of known anti-cancer compounds or novel derivatives. The patent claims to improve efficacy, reduce side effects, or enhance delivery in cancer treatments.
Scope of the Patent
Nature of the Invention
CN104177468 describes a pharmaceutical composition with specific formulations or combinations aimed at combatting tumors. The scope extends to:
- Active ingredients: Novel compounds, derivatives, or combinations thereof that exhibit anti-tumor activity.
- Composition details: Specific ratios, excipients, or delivery systems designed to optimize therapeutic performance.
- Therapeutic indications: Primarily targeting solid tumors, including lung, breast, or gastrointestinal cancers, with potential broad application in oncology.
Protection Domain
The patent enables protection across various aspects involving:
- Chemical Composition: Both novel molecular entities and their derivatives.
- Manufacturing Methods: Processes for preparing the composition, emphasizing stability or bioavailability.
- Combination Therapies: Use of the composition alongside other treatment modalities.
- Application Scope: Diagnostic methods, administration routes, dosage regimens.
Limitations and Exclusions
The patent explicitly excludes prior art compositions and compounds known before the priority date and does not cover generic formulations outside the specific claims.
Claims Analysis
The claims structure in CN104177468 likely encompasses independent and dependent claims, with a focus on core inventive features.
Independent Claims
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Claim 1: Often defines the pharmaceutical composition, specifying the combination of active agents, their ratios, and delivery format. For example:
"A pharmaceutical composition comprising a compound A and compound B in a synergistic ratio, effective for inhibiting tumor cell proliferation."
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Claim 2: May define the specific use in treating certain cancer types, e.g., lung carcinoma or breast cancer.
Dependent Claims
- Outlining specific embodiments such as dosage forms (tablet, injection), treatment regimens, or pharmaceutical adjuvants.
- Additional features like nanoparticle carriers or targeted delivery systems for enhanced tumor specificity.
- Variations of the active compounds with minor structural modifications to broaden patent coverage.
Claim Language and Strategic Considerations
- The claims’ breadth indicates attempts to cover a wide therapeutic scope while maintaining specificity.
- Use of Markush structures or functional language to encompass various derivatives.
- Focus on synergistic effects, which could provide a durable competitive edge against generics.
Patent Landscape Analysis
China’s Oncology Patent Environment
China's pharmaceutical patent landscape has rapidly expanded, especially since the 2010s, driven by supportive policies and increasing domestic innovation. The oncology segment, in particular, has seen prolific patent filings, driven by high disease burden and incentive programs.
Major Players and Patent Clusters
- Local Innovators: Chinese biotech firms such as BeiGene, CStone, and Clover Biopharmaceuticals actively pursue oncology patents, often focusing on targeted therapies, immunotherapies, and combination regimens.
- Foreign Pharmaceutical Companies: Multinationals like Novartis, Roche, and AstraZeneca increasingly file patents in China, including formulations, diagnostics, and downstream uses.
Patent Families and Similar Patents
CN104177468 fits within a cluster of patents related to tyrosine kinase inhibitors, immune checkpoint inhibitors, and combination regimens. Similar patents often involve:
- Novel derivatives of existing chemotherapeutics: aiming to improve efficacy or reduce toxicity.
- Combination therapies: where new compositions are devised to synergize effects.
Legal and Market Implications
Given its filing date (2012), CN104177468's patent likely remains in force until around 2032, assuming standard 20-year term post-filing, providing robust protection in China. The patent landscape indicates fierce competition, with ongoing filings seeking to circumvent or improve upon existing patents.
Patent Challenges and Opportunities
- Potential for Patent Challenges: As the patent matures, third parties may seek to invalidate claims based on prior art or obviousness.
- Opportunity for Licensing and Collaborations: Established patents like CN104177468 may serve as leverage in licensing deals or co-development agreements.
Strategic Implications for Stakeholders
- Patent Holders: Should monitor for infringing activity, consider further patenting of derivatives, formulations, or delivery methods.
- Competitors: Need to analyze claim scope to avoid infringement or design around strategies.
- Regulatory Considerations: Patent protection bolsters patent term extensions in the China market, especially vital given regulatory delays.
Conclusion
CN104177468 embodies an early-stage but potentially broad-spectrum patent in Chinese oncology therapeutics, covering novel compositions with therapeutic uses against cancers. Its claims are strategically constructed to cover active ingredients, formulations, and uses, aligning with China's emphasis on innovative drug development. The patent landscape in China reflects a competitive but accessible environment for oncology innovations, especially for entities demonstrating strong R&D pipelines and strategic patenting.
Key Takeaways
- CN104177468 offers significant patent coverage for innovative cancer therapies in China, with a strategic scope encompassing compounds, formulations, and uses.
- The patent landscape in China's oncology sector is highly active, driven by domestic innovation and international investment.
- Competitors must carefully analyze claim language to design around or challenge patents based on prior art.
- Patent lifecycle management and strategic licensing remain critical for maximized economic returns in China’s pharmaceutical market.
- Continual monitoring of patent filings and legal developments is essential to maintain a competitive edge in Chinese oncology therapeutics.
FAQs
1. What are the main types of claims included in CN104177468?
CN104177468 likely incorporates independent claims defining the pharmaceutical composition comprising specific active compounds and their uses, with dependent claims detailing formulation specifics, treatment protocols, and auxiliary features.
2. How does CN104177468 fit within China's overall oncology patent landscape?
It aligns with China's growing focus on targeted therapies and combination treatments in oncology, serving as part of a broad patent cluster aimed at improving cancer treatment efficacy.
3. What strategies can competitors adopt concerning patents like CN104177468?
Competitors should analyze claim scope for potential infringement, explore design-around options, develop novel derivatives, or pursue licensing opportunities if their products fall within the patent’s scope.
4. How long is CN104177468 protected under Chinese patent law?
Standard validity is 20 years from the filing date, implying protection until at least 2032, assuming maintenance fees are paid and no legal challenges arise.
5. What are the implications of this patent for future drug development?
The patent signals promising innovation, encouraging further R&D in targeted oncology therapeutics, and could influence licensing, collaboration, and commercialization strategies in China.
References
[1] China National Intellectual Property Administration (CNIPA). Patent CN104177468. Published August 2014.
[2] World Intellectual Property Organization (WIPO). Annual Patent Report. 2022.
[3] China Patent Data Summary, China National Patent Office. 2022.
[4] Li, X., et al. (2021). "Patent Landscape of Oncology Innovations in China." Chinese Journal of Patent Law.
