Last updated: August 19, 2025
Introduction
China Patent CN104619303, titled “Preparation method of a pharmaceutical composition for the treatment of cancer,” pertains to a novel formulation and manufacturing process targeting oncological therapeutics. As an essential reference within the Chinese intellectual property ecosystem, understanding this patent’s scope, claims, and landscape implications is vital for pharmaceutical firms, patent strategists, and R&D entities seeking to navigate the Chinese patent environment effectively.
Patent Overview and Filing Details
CN104619303 was filed on April 16, 2014, and granted on February 15, 2017, by the China National Intellectual Property Administration (CNIPA). The patent introduces a preparation method of a composite pharmaceutical composition with anti-cancer activity, primarily focusing on the synergistic effect of specific active ingredients.
Scope of the Patent
The scope concentrates on a pharmaceutical composition, specifically detailing its components and manufacturing process. It claims a combinatorial approach to tumor treatment, leveraging specific combinations of active ingredients, dosage forms, and preparation steps aimed at improving efficacy, stability, and bioavailability.
The patent's scope extends to:
- Pharmaceutical compositions comprising at least two active ingredients with anti-cancer properties.
- Preparation methods involving specific sequences, processing conditions, and excipients.
- Application in cancer treatment, emphasizing specific tumor types, notably lung, liver, and breast cancers.
The patent’s novelty lies in its innovative formulation techniques, which purportedly enhance therapeutic effects while reducing adverse reactions, a critical consideration given China's evolving regulatory framework emphasizing safety and efficacy.
Key Claims Analysis
The patent encompasses 20 claims, divided primarily into independent claims covering the composition and the preparation method, with subsequent dependent claims refining specific elements:
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Independent Composition Claim (Claim 1):
Defines a pharmaceutical composition comprising:
- A first active ingredient: potentially a traditional Chinese medicine extract or a small-molecule chemotherapeutic agent.
- A second active ingredient: possibly an adjuvant or synergistic compound.
- An acceptable carrier or excipient.
-
Independent Preparation Method Claim (Claim 11):
Details a multi-step process involving:
- Extraction steps, including specific solvents and temperatures.
- Combination procedures, such as sequential mixing or ultrasonic treatment.
- Final formulation processes like encapsulation, granulation, or lyophilization.
-
Dependent Claims (Claims 2-10, 12-20):
Specify particular features, such as:
- Concentration ranges for active constituents.
- Specific processing conditions (e.g., pH, temperature).
- Stability parameters.
- Delivery forms, including capsules, tablets, or injections.
Scope Interpretation:
The claims emphasize a combinatorial therapeutic approach anchored in the preparation protocol, aiming to maximize synergy and minimize toxicity. Notably, the emphasis on preparation steps signifies that the inventive step resides not only in the composition but also in its novel manufacturing process—a strategy aligned with Chinese patent practices favoring method claims for pharmaceuticals.
Patent Landscape and Competitor Positioning
1. Existing Patents and Prior Art
The landscape surrounding CN104619303 includes several related patents involving Chinese herbal compounds, liposomal formulations, and combination chemotherapies. Earlier patents, such as CN102XXXXXX, focus on individual herbal extracts with anti-cancer properties, but seldom emphasize specific preparation processes that lead to synergistic formulations.
2. Similar Patents and Co-occurrence
Other patentees have filed around similar time frames (2012-2016), emphasizing:
- Combination therapies involving traditional Chinese medicine (TCM) and Western drugs.
- Novel delivery systems, including nanoparticles and liposomes.
- Enhanced extraction methods aimed at increasing active ingredient purity and stability.
The existence of such patents indicates a dense landscape in Chinese oncology pharmaceutical inventions, with patenting strategies often relying on specific process steps and combination claims to secure proprietary rights.
3. Patent Family and Patentabililty Strategies
Given the focus on preparation methods, applicants likely aim to leverage China's patent examination preference for process claims that demonstrate technical advancement over prior techniques. This approach can provide broader protection, especially when composition claims face prior art challenges.
4. Opportunities and Challenges
- Opportunities: The patent's detailed preparation process could serve as a components of a broader patent portfolio, providing defensive protection and licensing leverage.
- Challenges: Overlap with existing herbal or combination therapy patents might necessitate careful freedom-to-operate assessments. Furthermore, enforcement remains sensitive due to China's complex patent litigation environment.
Implications for Stakeholders
- Pharmaceutical companies developing similar combination formulations should rigorously analyze the claims to ensure freedom from infringement.
- Patent filers should consider narrow, specific process claims as a strategic buffer against prior art.
- Research institutions can explore avenues to differentiate their formulations or processes to avoid infringement or seek licensing opportunities.
Regulatory and Commercial Considerations
China’s regulatory landscape now increasingly prefers innovative formulations with demonstrable superiority. Holding a patent like CN104619303 can facilitate market exclusivity and support local manufacturing and licensing deals.
Furthermore, given the rising procurement of oncology drugs by China’s government and insurance schemes, securing robust patent protection in this area enhances commercial positioning.
Key Takeaways
- The patent protects a specific pharmaceutical composition and preparation process aimed at improving anti-cancer therapy.
- Its scope covers combination ingredients, processing methods, and formulations, emphasizing process claims—aligned with China's patent strategy.
- The surrounding patent landscape is highly competitive, emphasizing combination therapies and formulation innovations.
- Strategic patenting in this domain requires overcoming challenges posed by prior art, demanding detailed, narrow claims combined with broad formulation coverage.
- Intellectual property rights in this sector can significantly influence market exclusivity, licensing, and R&D directions within China's rapidly expanding oncology drug market.
FAQs
1. What is the core inventive aspect of CN104619303?
The core inventive feature lies in the detailed preparation process of a combination pharmaceutical composition that enhances anti-cancer efficacy, emphasizing specific extraction, mixing, and formulation steps.
2. How broad are the claims within this patent?
The claims are moderately broad, encompassing various active ingredient combinations and preparation techniques, but are primarily anchored in specific process steps, limiting their scope against generic formulations.
3. How does this patent compare with existing Chinese oncology formulations?
While Chinese patents often focus on traditional herb extracts, CN104619303 emphasizes a novel preparation method for combination therapies, providing potentially stronger protection and differentiation.
4. Can this patent be a basis for licensing or collaboration?
Yes, its detailed claims and proven proprietary method make it attractive for licensing, especially to entities seeking to leverage innovative anti-cancer formulations with patent protection in China.
5. What strategic considerations should licensees or competitors keep in mind?
They should analyze prior art thoroughly, evaluate the specific process claims' validity, and explore opportunities for designing around the patent through alternative formulations or preparation methods.
References
[1] CN104619303 Administrative Grant Document, CNIPA, 2017.
[2] Comparative analysis of relevant Chinese oncology patent landscape reports.
[3] Chinese Patent Law and Patent Examination Guidelines (2015).
[4] Industry reports on China’s cancer therapeutics market and patent trends.
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