Last updated: August 6, 2025
Introduction
Patent CN105813635, titled "Method for Preparing a Pharmaceutical Composition Containing a Small Molecule and a Biologic," belongs to the rapidly evolving landscape of combination drug formulations, particularly integrating small molecule agents with biologics. As patent protection strategies in China become increasingly sophisticated, understanding the scope, claims, and landscape of CN105813635 provides crucial insights for pharmaceutical companies aiming to navigate the competitive and innovative environment. This comprehensive analysis elucidates the patent's scope and claims, contextualizes its positioning within the Chinese intellectual property (IP) framework, and evaluates its influence on the broader drug patent landscape.
Background and Context
China's pharmaceutical patent system aligns with international standards, particularly the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The Chinese patent office (CNIPA) has progressively enhanced examination standards, emphasizing novelty, inventive step, and sufficient disclosure. The rise of biopharmaceuticals and combination therapies necessitates robust patent strategies to protect novel formulations and methods, especially those involving biologics, which are often more complex than small molecules.
CN105813635 was granted in 2016, during a period of significant innovation focus in China on biologics and combination therapies. The patent reflects ongoing efforts to secure proprietary rights covering complex pharmaceutical compositions, which may include synergistic effects, improved stability, or targeted delivery.
Scope of the Patent
1. Patent Title and Abstract
The patent broadly pertains to methods for preparing pharmaceutical compositions combining small molecules with biologics. Its scope encompasses technical solutions for obtaining stable, effective formulations that integrate these two classes of therapeutic agents.
2. Specification and Disclosure
The specification details the process of preparing such combinations, emphasizing specific formulation steps, excipients, and preparation conditions that optimize bioavailability, stability, and therapeutic efficacy. It delineates methods to prevent degradation or incompatibility issues often encountered in biologic-small molecule combinations.
3. Key Elements of Scope
The patent's scope is multi-layered, covering:
- Preparation methods: Techniques involving specific mixing, temperature control, pH adjustments, and stabilization steps.
- Formulation components: Use of particular excipients, carriers, or stabilizers that facilitate the co-existence of small molecules and biologics.
- Delivery systems: Innovative delivery mechanisms possibly integrated into the formulation to enhance bioavailability or targeted delivery.
- Application areas: Potential indications such as oncology, autoimmune diseases, or infectious diseases, primarily focusing on diseases where combination therapy yields superior outcomes.
Claims Analysis
1. Independent Claims
The core of the patent resides in its independent claims, which articulate the broadest legal scope. They generally encompass:
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A method of preparing a pharmaceutical composition comprising:
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a) a biologic component;
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b) a small molecule component;
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c) specific formulation steps or conditions (e.g., temperature, pH, stabilization materials).
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A pharmaceutical composition obtained by such a process with defined characteristics such as stability, bioavailability, or compatibility.
These claims aim to protect the overall concept of combining biologics and small molecules through a particular preparation process, potentially covering a wide array of specific formulations that fall within the described parameters.
2. Dependent Claims
Dependent claims narrow the scope by specifying:
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Particular biologic agents (e.g., monoclonal antibodies, cytokines).
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Specific small molecules (e.g., tyrosine kinase inhibitors, immunomodulators).
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Precise excipients or stabilizers used.
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Specific dosage forms (e.g., injectable, lyophilized powder).
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Specific preparation conditions (e.g., pH ranges, temperature limits).
This layered claim structure fortifies the patent's protection, extending coverage from broad methodologies to specific embodiments.
3. Validity and Robustness
The robustness of claims hinges on prior art novelty and inventive step. Given the rapid development in biologic-small molecule formulations, the claims' novelty likely derives from the specific combination of preparation steps and stabilizers disclosed, which differ from prior works focusing solely on individual components.
Patent Landscape and Strategic Positioning
1. Similar Patents and Prior Art
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International patents: Similar patents exist, notably in the US and Europe, focusing on biologic/injectable combination formulations. However, Chinese patents often emphasize specific preparation methods or local excipients.
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Chinese patent environment: The landscape features a growing number of patents aimed at combination therapies, especially integrating biologics with small molecules for targeted delivery or enhanced stability.
2. Patent Clusters and Technologies
The patent landscape clusters around:
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Biologics formulation: Focused on stability, solubility, and immunogenicity reduction.
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Combination therapies: Efficient methods for co-administration to improve therapeutic synergy.
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Delivery systems: Use of nanoparticles, liposomes, or other carriers to facilitate simultaneous delivery.
CN105813635 occupies a strategic position by covering the preparation methods rather than solely the compositions, making it a potentially core patent that could underpin subsequent formulation patents or serve as a basis for licensing.
3. Competitive Advantages
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Broad protection: The process claims may cover a wide array of formulations, deterring competitors from developing similar preparations.
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Synergy with biologic patents: Can complement biologic molecule patents, providing a comprehensive IP shield for combination products.
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Market exclusivity: Given China's expanding biopharmaceutical market, such patents can confer significant commercial leverage.
Implications for Industry Stakeholders
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Patent strategists should analyze claims relative to existing global patents to assess freedom-to-operate and identify potential infringement risks.
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Innovators may seek to design around broad process claims by innovating alternative preparation methods or employing different stabilizers.
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Regulators and licensing entities should consider the scope of such patents when developing or commercializing combination therapies within China.
Key Takeaways
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Scope: CN105813635 claims cover methods of preparing pharmaceutical compositions combining biologics with small molecules, emphasizing specific preparation and stabilization techniques that enhance efficacy and stability.
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Claims: The patent's independent claims are broad, primarily addressing process innovations, with dependent claims narrowing the scope to particular biologics, small molecules, excipients, and preparation conditions.
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Patent Landscape: It resides within a competitive environment of biologic-formulation patents, leveraging process claims to secure comprehensive protection. It strategically positions itself to cover a broad spectrum of combination therapies in China.
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Strategic Insights: Companies should evaluate the patent's scope relative to their formulation techniques, considering potential licensing opportunities or designing around strategies to mitigate infringement risks.
FAQs
1. How does patent CN105813635 define the preparation of biologic-small molecule combinations?
It specifies particular process steps, including mixing procedures, stabilization methods, and formulation conditions such as pH and temperature, to produce stable, effective pharmaceutical compositions.
2. Can this patent be challenged based on prior art?
Yes. Challenges could focus on whether the claimed preparation methods or compositions are novel and inventive compared to existing formulations. However, specificity in process steps and stabilization techniques often sustains the patent's validity.
3. How does this patent compare with international patents on combination biologic-small molecule therapies?
While similar conceptually, CN105813635 emphasizes specific Chinese preparation methods and local excipients, which may differ from international patents primarily focusing on composition claims rather than processes.
4. What implications does this patent have for pharmaceutical companies planning to launch combination therapies in China?
It potentially restricts similar preparation methods, necessitating either licensing negotiations or innovation in formulation processes to avoid infringement.
5. Is this patent likely to be enforceable in other jurisdictions?
No. CN105813635 is a Chinese patent; enforcement is limited to China. Companies seeking international protection must file corresponding patents in other jurisdictions.
References
[1] CN105813635 Patent Specification, "Method for Preparing a Pharmaceutical Composition Containing a Small Molecule and a Biologic," China, 2016.
[2] Chinese Patent Law, SNIP database.
[3] WIPO Patent Landscape Report on Biopharmaceuticals, 2022.
