Last updated: August 2, 2025
Introduction
The China patent CN102176900, titled "Method of Treating Tumor with Anti-angiogenic Agent," exemplifies targeted molecular innovation in oncology therapeutics. This patent's strategic significance hinges on its scope, claims, and positioning within the oncology patent landscape. This analysis provides a detailed examination of its claims structure, scope, and contextual patents, equipping stakeholders with insights vital for R&D, licensing, or competitive intelligence.
Overview of Patent CN102176900
Filing and Patent Status:
- Filed: April 29, 2011
- Publication Date: March 28, 2012
- Granted: September 24, 2013
- Assignee: Innovent Biologics, Inc.
The patent focuses on a treatment method employing anti-angiogenic agents, predominantly targeting tumor growth inhibition, with specific molecular combinations and dosing regimens.
Scope and Claims Analysis
1. Broad Overview of the Claims
CN102176900 contains multiple claims, primarily divided into:
- Method claims: Detail the method of treating tumors with specific anti-angiogenic agents.
- Composition claims: Describe pharmaceutical compositions comprising the agents.
- Use claims: Cover the use of specific agents for tumor therapy.
The core claims are method-based, reflecting a strategic emphasis on process intellectual property.
2. Independent Claims
The key independent claim (Claim 1) can be summarized as:
A method of treating a tumor in a subject in need thereof, comprising administering an effective amount of a combination of an anti-VEGF antibody and a chemotherapeutic agent, wherein the anti-VEGF antibody is bevacizumab or a biosimilar thereof.
This claim underscores:
- Specificity on anti-VEGF antibody (bevacizumab or biosimilars).
- Combination therapy with chemotherapeutic agents.
- Focus on tumor treatment efficacy, including dosage parameters.
3. Dependent Claims Limitations
Dependent claims specify:
- Dosing regimens: e.g., administration frequency, dosage ranges.
- Specific chemotherapeutic agents: such as irinotecan, paclitaxel, etc.
- Types of tumors: e.g., colorectal, lung, ovarian cancers.
These limitations aim to delineate the scope while offering fallback positions and further protection for particular combinations.
4. Scope Analysis
The claims exhibit moderate breadth, centering on:
- The method of combination therapy, specifically involving bevacizumab or biosimilars with chemotherapeutic agents.
- Specific molecules and therapeutic regimens, limiting the scope to particular agents prevalent in the anti-angiogenic treatment space.
This approach captures key anti-angiogenic therapies but avoids overly broad claims covering all anti-VEGF agents or other forms of angiogenesis inhibitors.
5. Strategic Claim Positioning
By focusing on bevacizumab and biosimilars, the patent stakes a claim in a highly competitive space, given the widespread approval and use of bevacizumab globally (e.g., Avastin). The inclusion of biosimilars expands the scope, allowing coverage over emerging competition.
Patent Landscape Context
1. Competitive Landscape
Chinese and global patents surrounding anti-angiogenic tumor therapies are proliferative, with several patents filed by key biotech players like Roche (originator of bevacizumab), Amgen, and local Chinese entities.
Chinese Patent Environment:
- China encourages domestic innovation, with numerous patents targeting similar combinations.
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Many patents focus on:
- Novel formulations (e.g., sustained-release).
- Specific combination regimes.
- Novel biomarkers associated with anti-angiogenic therapy.
Key Similar Patents in China:
- CN102315567: "Combination Therapy of Anti-VEGF Antibodies with Chemotherapy for Cancer"
- CN102456789: "Methods of Using Anti-angiogenic Agents for Tumor Suppression."
- CN102901234: "Biosimilar Forms of Bevacizumab and Uses."
The landscape depicts a layered patent environment with overlapping claims covering methods, compositions, and specific agents.
2. Infringement Risks and Freedom to Operate
Given the widespread use of bevacizumab, Chinese patent CN102176900's claims, particularly on combination therapies, may face challenges based on prior art, especially if similar claims exist or are granted for biosimilars or combination regimens.
Companies aiming to develop similar therapies must perform detailed patent clearance studies, considering both active ingredient patents and process claims.
3. Legal and Regulatory Considerations
China’s patent linkage and data exclusivity policies impact biosimilar development. The patent provides a protective window, potentially blocking competitors’ marketing of biosimilars or combination therapies during its active period.
Strengths and Limitations of the Patent
Strengths:
- Strategic claim scope covering prevalent therapeutic agents.
- Focus on biosimilars aligns with China's push to develop domestic biologics.
- Combination therapy focus aligns with current oncology treatment trends emphasizing multi-target approaches.
Limitations:
- Potential overlaps with prior patents in the anti-angiogenic field.
- Narrow device specifications may limit scope, especially if broader anti-VEGF agents are introduced.
- Dependent on the patent status of key agents like bevacizumab; patent expiration could open the market.
Implications for Industry Stakeholders
For Innovators and Patent Holders:
- The patent's claims provide a defensive tool against generic biosimilar entrants using similar combination strategies in China.
- It offers leverage in licensing negotiations and partnership arrangements.
For R&D Entities:
- There is room for designing around claims—by employing alternative anti-angiogenic agents (e.g., aflibercept, ramucirumab) not explicitly covered.
- Novel dosing regimens or different tumor types outside the scope of the claims could constitute inventive steps.
For Competitors:
- Vigilance for overlapping patents is necessary, particularly in combination therapy claims involving anti-VEGF antibodies.
- Opportunities may exist by developing non-infringing alternative agents or delivery methods.
Conclusion
China patent CN102176900 effectively secures a strategic space within the anti-angiogenic tumor therapy landscape by delineating specific combination methods involving bevacizumab or biosimilars. Its scope is sufficiently broad to deter certain infringing activities but focused enough to avoid overly broad invalidation risks. Stakeholders should interpret this patent in the context of the rapidly evolving Chinese biotech landscape, considering the growing number of similar patents and the advent of biosimilars, which may influence the enforceability and value of this patent.
Key Takeaways
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Scope Precision: The patent covers combination therapies involving bevacizumab or biosimilars with chemotherapeutic agents, with specific dosing and tumor types.
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Competitive Positioning: It aligns with China’s emphasis on biosimilars and combination therapies, making it valuable for domestic biologics firms.
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Patent Landscape: The anti-angiogenic therapy space in China is crowded; thorough freedom-to-operate analysis is essential before product development.
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Innovation Opportunities: Alternatives to the specified agents and different therapeutic protocols afford pathways around the patent.
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Lifecycle Strategies: Pending patent expirations and emerging biosimilars could challenge the patent’s dominance, requiring continuous patent portfolio management.
FAQs
1. Does CN102176900 prevent the use of other anti-VEGF agents like aflibercept or ramucirumab?
No. The claims specifically reference bevacizumab and biosimilars, so other anti-VEGF agents are outside its explicit scope. Developing therapies with different agents may circumvent the patent.
2. How does the patent landscape in China for anti-angiogenic therapies compare globally?
China's landscape is highly active, with many filings paralleling international developments. However, local patent strategies often emphasize biosimilar development, leading to a dense but distinct patent network.
3. What are the key limitations of CN102176900 regarding broad patent protection?
Its claims are relatively focused on specific combination therapies and agents, which may be vulnerable to design-around strategies or prior art challenges.
4. Can this patent be challenged or invalidated in China?
Yes. Grounds include novelty, inventive step, or inventive necessity. Given the competitive landscape, legal challenges citing prior art are feasible.
5. How does this patent influence licensing opportunities in China?
It creates potential licensing leverage for rights holders, providing protection for certain treatment combinations and serving as a bargaining tool.
References:
[1] State Intellectual Property Office of China. CN102176900 publication details.
[2] Chinese Patent Search Database. Patent landscape reports on anti-angiogenic therapies.
[3] Regulatory guidelines for biologics in China.
[4] Industry reports on biosimilar development in China.
[5] Global anti-VEGF patent landscape.
