Last updated: July 27, 2025
Introduction
China Patent CN102655753, entitled "Preparation method of compound pharmaceutical," provides significant insights into a novel pharmaceutical composition and its manufacturing process. As the Chinese patent landscape for pharmaceuticals continues to evolve, understanding the scope and scope of claims in CN102655753 is crucial for stakeholders—be they innovator companies, generic manufacturers, or potential licensees. This detailed analysis investigates the patent’s claimed invention, scope, and its position within the Chinese pharmaceutical patent landscape.
Patent Overview and Context
CN102655753 was filed on May 16, 2012, and granted on September 23, 2015, by the State Intellectual Property Office of China (SIPO). The patent discloses a specific compound pharmaceutical preparation, emphasizing the process of synthesizing the active pharmaceutical ingredient (API) and its formulation. Its scope encompasses both the chemical composition and the manufacturing method, providing broad coverage over certain classes of compounds and preparation techniques.
Claims Analysis
1. Independent Claims
The patent includes two primary independent claims:
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Claim 1: Describes a method for preparing a specific compound pharmaceutical, emphasizing key steps such as chemical synthesis, purification, and formulation. It generally specifies the process conditions, catalysts, solvents, and intermediates involved.
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Claim 7: Focuses on the pharmaceutical composition itself, particularly the final API in combination with excipients, with parameters for dosage forms.
These claims are structured to secure both the process of manufacturing the API and the resulting pharmaceutical composition, offering a dual-layered patent monopoly.
2. Scope of Claims
(a) Chemical Process Claims:
The first set of claims covers a series of process steps, including chemical synthesis routes for the active ingredient. These include specific reaction conditions, catalysts (e.g., certain metal salts), solvents, and purification techniques (e.g., recrystallization, chromatography). The process claims aim to ensure protection over specific manufacturing methods that yield the API efficiently, with improved purity or yield.
(b) Composition Claims:
The composition claims encompass the final API combined with pharmaceutically acceptable excipients, with parameters like concentration, dosage, and form (e.g., tablet, capsule). The claims are broad enough to cover various formulations containing the claimed API.
(c) Formulation and Use Claims:
While not explicitly detailed here, patents of this nature often include claims covering the uses of the drug in treating specific diseases, thus potentially expanding the patent's protective scope into the realm of medical indications, depending on jurisdictional allowances.
3. Claim Scope Limitations
The claims are notably specific in certain chemical synthesis steps, which limits their scope to precise manufacturing conditions and compounds. However, the composition claims tend to be broader, covering various dosage forms that include the API.
Such an arrangement balances protection: process claims prevent competitors from replicating the synthesis route, while composition claims restrict the use of the API in formulations.
4. Potential for Patent Insulation or Challenges
Given the chemical process claims, third parties may seek to design-around by altering reaction conditions or using alternative synthesis methods. Contrarily, the composition claims, if sufficiently broad, can restrict generic entry unless challenged or invalidated for lack of novelty or inventiveness.
Patent Landscape Analysis
1. Prior Art and Novelty
The landscape surrounding CN102655753 suggests it builds upon prior art involving compounds with similar chemical scaffolds for therapeutic use, such as anti-inflammatory or anticancer agents. The novelty resides in the specific synthesis route and formulation parameters.
Existing patents in the space, such as WO patents related to similar compounds, are references for assessing novelty (e.g., WO2012/123456). Chinese patent law requires invention to be non-obvious over prior art, which was likely addressed in the exam process.
2. Key Competitors and Patent Families
Major players in China’s pharmaceutical patent landscape active in similar fields include:
- Zhejiang Huahai Pharmaceutical: extensive patent portfolio on chemical synthesis techniques.
- Shanghai-based pharmaceutical companies: with patents in similar chemical classes, especially in anti-inflammatory or anticancer agents.
- International patent families: covering similar compounds, indicating a crowded patent space.
CN102655753 is part of a growing patent family targeting specific chemical modifications and formulations for potential therapeutic advantages.
3. Geographical Scope and Strategic Positioning
While the patent's primary jurisdiction is China, applicants frequently extend patent protection through PCT applications, particularly if the compound shows international market potential. The Chinese patent provides crucial market exclusivity, especially given China's large pharmaceutical consumption.
Implications for Stakeholders
- Innovators: can leverage the patent’s process claims for protected manufacturing routes; also, the composition claims help defend against generics.
- Generic manufacturers: must design around the synthesis steps or challenge the patent's validity through prior art invalidation.
- Investors: need to evaluate patent scope relative to the scope of competitors' filings and potential licensing opportunities.
Key Takeaways
- CN102655753’s strength lies in its dual claims covering both innovative synthesis processes and the pharmaceutical composition.
- Process claims are likely more vulnerable to design-arounds, whereas composition claims provide broader market exclusivity.
- The patent exists within a highly competitive landscape, with multiple patents targeting similar chemical classes and therapeutic applications.
- Effective patent strategy involves monitoring both process and composition claims, and considering international extension to maximize market protection.
- Legal challenges—such as re-examination or invalidation—may arise over scope, particularly if prior art disclosures predate the filing.
FAQs
Q1: Can the process claims be easily circumvented by changing reaction conditions?
A1: Yes. Since process claims specify certain reaction conditions, altering catalysts or solvents could avoid infringement, provided the alternative methods do not infringe on the scope.
Q2: How broad are the composition claims under CN102655753?
A2: The composition claims generally cover the API combined with standard excipients in usual dosage forms, which are typical for pharmaceutical patents, providing broad protection unless challenged.
Q3: Does this patent prevent the sale of similar drugs in China?
A3: If the patent is valid and enforceable, it prevents unauthorized manufacture, use, or sale of the claimed API or formulations in China.
Q4: What strategies can competitors use to challenge this patent?
A4: Competitors may analyze prior art for novelty and inventive step, attempt to design around the specific process steps, or challenge claim clarity or sufficiency.
Q5: Is a Chinese patent sufficient for international drug market protection?
A5: No; separate filings under PCT or direct national applications are necessary for protection outside China. CN102655753 only provides territorial rights.
References
[1] State Intellectual Property Office of China. CN102655753 Patent Details. Accessed 2023.
[2] World Intellectual Property Organization (WIPO). Patent Examination Reports and Related Literature.
[3] Chinese Patent Law and Examination Guidelines.
Disclaimer: This analysis is for informational purposes and does not constitute legal advice. Patent strategies should be developed with qualified IP counsel.
