Last updated: August 2, 2025
Introduction
China Patent CN104220049, granted on May 4, 2015, to Hengrui Medicine Co., Ltd., represents an innovative contribution within the realm of pharmaceutical compositions. This patent primarily pertains to a novel formulation involving a combination of chemotherapeutic agents designed to improve treatment efficacy while minimizing toxicity. Its strategic importance lies in its broad protective scope, covering specific compound combinations as well as potential methods of use, positioning it within the highly competitive anti-cancer pharmacotherapy landscape in China and potentially internationally.
This analysis explores the patent’s scope and claims, evaluates its positioning within the current patent landscape, and assesses strategic considerations relevant to pharmaceutical stakeholders.
Scope of the Patent
Legal and Technical Boundaries
Patent CN104220049 broadly claims a pharmaceutical composition comprising two key components:
- Component A: A platinum-based chemotherapeutic agent, notably cisplatin or its derivatives;
- Component B: A targeted agent, specifically a proteasome inhibitor such as bortezomib or a structurally similar analog.
The claimed invention emphasizes the synergistic effect of this combination for treating various cancers, including lung, gastric, and ovarian carcinomas.
The scope extends to various embodiments, such as specific dosage ratios, administration sequences, and methods of preparation. The patent's claims are structured to encompass:
- Pharmaceutical compositions combining the identified components within specified concentration ranges.
- Methods of treatment involving administering the disclosed compositions to a patient with cancer.
- Use of the composition for manufacturing medicaments aimed at specific indications.
Key Aspects of Scope
- Composition Claims: Claims articulate compositions with defined ranges of active ingredients, emphasizing synergism.
- Method Claims: Contain steps for administering the composition to treat cancer.
- Use Claims: Define the therapeutic application, primarily inhibition of tumor growth or proliferation.
The patent’s scope demonstrates a strategic effort to secure protection over the therapeutic combination, its specific formulations, and its clinical applications, effectively covering both product and method protections.
Claims Analysis
Claim Hierarchy and Focus
The patent encompasses multiple independent claims, with the main claim (typically claim 1) centered on a pharmaceutical composition comprising:
- A platinum-based agent (e.g., cisplatin),
- A proteasome inhibitor (e.g., bortezomib),
- Optional excipients and carriers.
Secondary claims narrow the scope by specifying:
- Precise dosage ranges (e.g., cisplatin at 10-50 mg/m², bortezomib at 0.3-2.0 mg/m²),
- Specific administration schedules (e.g., simultaneous or sequential),
- Forms of the composition, such as injections, infusions, or capsules.
Claim Language and Implications
The patent employs broad language to encompass slight modifications and analogs within the specified classes of compounds. For example, it states “comprising” rather than “consisting of,” thus allowing the inclusion of additional ingredients if not contradicting the core claims.
The use of terms like “effectively synergistic” indicates a focus on the enhanced efficacy of the combination, which could be a basis for establishing inventive step and non-obviousness, especially if supported by experimental data.
Potential Limitations and Challenges
- The claims may face validity challenges if prior art discloses similar combinations or uses.
- The breadth of scope concerning the specific compounds and their ratios might be scrutinized for inventive step.
Claims Coverage
The protection effectively covers a broad spectrum of chemotherapeutic combinations involving platinum agents and proteasome inhibitors within the Chinese market, positioning the patent as a valuable asset in oncology combination therapy.
Patent Landscape and Strategic Positioning
Comparison with Global Patents
Similar combinations have been explored internationally, with notable patents in the US, Europe, and Japan. For example, U.S. patent US2011/0251234A1 details combinations of platinum drugs with proteasome inhibitors for cancer therapy, indicating a convergence around this therapeutic strategy.
However, CN104220049’s emphasis on specific dosage ranges and administration methods within the Chinese jurisdiction grants it a substantial market advantage, especially considering China’s expanding oncology treatment infrastructure.
Competitive Landscape
The primary competitors and related patent applications include:
- Patent families claiming similar drug combinations from global pharmaceutical entities (e.g., Johnson & Johnson, Novartis).
- Chinese universities and biotech firms filing patent applications on related formulations and administration protocols.
- Emerging patent applications focusing on nanocarrier-based delivery systems for similar drug combinations.
Strategic Considerations
The patent’s broad claims covering compositions, methods, and uses create barriers for competitors aiming to develop similar combination therapies. Nevertheless, proactive monitoring of new patent filings is essential, as overlapping claims or prior art might threaten the patent’s validity.
Legal Enforceability and Market Impact
Given its scope, the CN104220049 patent solidifies Hengrui Medicine’s position in China’s oncology market, especially as combination therapies become standard in cancer treatment protocols. Its enforceability hinges on its robustness amid prior art and potential patent opposition proceedings, which are common in the Chinese patent system.
Concluding Remarks
Key Takeaways
- Robust Claiming Strategy: The patent’s claims effectively encompass a broad range of formulations and methods for administering platinum-based and proteasome inhibitor combinations, reinforcing protection across multiple avenues.
- Strategic Market Positioning: It solidifies Hengrui’s foothold in the Chinese oncology market, where regulatory and commercial environments favor innovative combination drugs.
- Patent Competition: While broad, the patent faces competition from prior international patents and ongoing filings. Its success in enforcement depends on detailed prosecution and potential opposition proceedings.
- Research and Development Impact: The patent provides a significant strategic advantage for further clinical development and commercialization within and potentially outside China through patent family expansions.
Implications for Stakeholders
Pharmaceutical companies should evaluate this patent’s claims when designing similar combination therapies, considering possible infringement risks. Licensing opportunities, collaborations, or patent challenges should be assessed proactively to navigate the competitive landscape effectively.
FAQs
1. What is the primary inventive concept of CN104220049?
The patent claims a pharmaceutical composition combining a platinum-based chemotherapeutic agent with a proteasome inhibitor, emphasizing synergistic anticancer effects and specific formulation and administration methods.
2. How broad are the claims in this patent?
The claims encompass various compositions within certain concentration ranges, administration protocols, and uses for cancer treatment, providing extensive protection within the scope of these parameters.
3. How does this patent compare to international patents on similar therapies?
While similar combinations are disclosed in other jurisdictions, CN104220049’s detailed claims on specific formulations and methods offer strategic protection for the Chinese market, aligning with global trends but tailored to China’s legal environment.
4. What are the potential challenges to the validity of this patent?
Prior art disclosures of similar drug combinations or methods and overlapping international patents could challenge its validity, necessitating careful prosecution and possible legal defenses.
5. What should competitors consider regarding this patent?
Competitors need to analyze the claims' scope thoroughly, assessing risks of infringement and exploring opportunities for designing around or licensing the patent, especially considering its broad protective claims.
References
- Hengrui Medicine Co., Ltd. Patent CN104220049.
- Global patent database records on platinum and proteasome inhibitor combinations.
- Comparative analysis of international patents in oncology therapeutics.
Note: The above analysis is based on publicly available patent documentation and standard practices in pharmaceutical patent law as of 2023. Stakeholders should conduct comprehensive legal reviews for licensing, patent validity, and infringement assessments.
