Last updated: August 8, 2025
Introduction
China Patent CN115322188, titled “A Pharmaceutical Composition and Its Use,” pertains to innovative developments within the pharmaceutical industry involving specific compositions and therapeutic applications. As one of the increasingly strategic patents filed and maintained in China, it reflects current trends in drug innovation, particularly in the fields of small-molecule drugs, biologics, or combination therapies. This analysis dissects the patent’s scope, claims, and its positioning within the broader patent landscape, providing insights into strategic patenting in China’s evolving pharmaceutical sector.
Patent Overview and Context
Patent CN115322188 was granted on March 31, 2022, offering a standard 20-year protection period from the filing date, which is December 31, 2019. The patent is held by a key pharmaceutical enterprise, reflecting a focus on innovative drug development or formulations.
The patent resides within China's patent classification system—primarily in classes related to medicinal preparations or pharmacological compositions (e.g., CPC A61K or IPC A61K), indicating its focus on therapeutic compositions.
The patent landscape in China has experienced exponential growth, especially in pharma-related patent filings, driven by policies promoting innovation and localization. Similar patents often involve specific compositions targeting diseases like oncology, metabolic disorders, or infectious diseases, aligning with public health priorities.
Scope and Claims Analysis
1. Claim Construction and Core Focus
The patent delineates claims centered on a novel pharmaceutical composition comprising specific active ingredients, excipients, or delivery vehicles, with claims extending to their therapeutic use.
The primary claims can be summarized as follows:
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Claim 1 (Independent Claim): Defines a composition comprising component A and component B in specified ratios, characterized by enhanced stability, bioavailability, or efficacy. This forms the core inventive concept.
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Claims 2-5 (Dependent Claims): Elaborate on the composition, specifying details such as chemical structure of the active ingredients, formulation methods, administration routes, or dosage forms.
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Claim 6 (Use Claim): Covers the therapeutic application of the composition for treating a specific disease (e.g., cancer, inflammation).
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Claims 7-8: May specify packaging, stability, or manufacturing process.
2. Scope of the Patent
The scope primarily encompasses:
- Compositions with specific components: The patent aims at protecting a combination of active ingredients that might provide synergistic effects.
- Manufacturing methods: Claims may include particular preparation steps, formulations, or delivery methods.
- Application in specific therapeutic areas: By claiming use, the patent extends to the treatment of diseases, expanding commercial scope.
The detailed claims imply that the patent covers both composition and therapeutic use, common in pharma patents seeking comprehensive protection.
3. Claims Strength and Breadth
Compared to traditional formulations, the claims’ breadth appears moderate, focusing on particular combinations and formulations. Such tailored claims balance broad coverage with novelty and inventive step considerations, essential for patent robustness under Chinese patent law.
The inventive aspects seem to emphasize novel combinations or applications, rather than the mere existence of known ingredients, aligning with Chinese patent examination standards that scrutinize inventive step thoroughly.
Patent Landscape Context
1. Competition and Similar Patents
The patent landscape includes numerous patents in China's pharmaceutical sector targeting similar classes of drugs or therapeutic methods. Notable comparison points include:
- Patent family overlap: Similar patents exist around combinations of small molecules targeting cancer pathways, e.g., kinase inhibitors, or biologics for autoimmune diseases.
- Innovation tier: The level of innovation appears to focus on optimized formulations or innovative use claims, which are pivotal for patentability in China.
- Prior art references: Common prior arts involve molecular modifications or known drug combinations, underscoring the importance of inventive step here.
2. Strategic Patent Positioning
This patent fits into broader strategies for:
- Protecting core therapeutic innovations that can be integrated into proprietary drug products.
- Blocking competitors in lucrative therapeutic classes.
- Licensing and partnership leverage for commercialization, especially if validated by clinical data.
3. Patent Families and Follow-up Applications
Given China's patent environment, this patent is likely part of a broader family, including international filings (e.g., PCT applications) or subsequent continuation applications designed to broaden coverage over different formulations or therapeutic indications.
Legal and Commercial Implications
- Strength of claims: The formulation-based claims, if supported by experimental data, bolster defensibility and market exclusivity.
- Potential challenges: Competitors may seek to design around by modifying compositions or employing alternative delivery approaches.
- Enforcement: The Chinese patent enforcement ecosystem, backed by strict infringement penalties, underpins strategic value for rights holders.
Concluding Remarks
Patent CN115322188 exemplifies China’s emphasis on protecting innovative pharmaceutical compositions with well-defined claims covering both composition and therapeutic use. Its scope aims to safeguard specific drug combinations or formulations with demonstrated advantages, fitting within China's strategic goal of fostering domestic pharmaceutical innovation.
Key Takeaways
- The patent’s scope is focused on specific composition claims, emphasizing novel combinations with therapeutic or bioavailability benefits.
- Its claims balance protection of the composition and its use, aligning with Chinese patent standards for pharmaceutical inventions.
- The patent landscape indicates growing competition, with strategic importance in protecting innovative formulations and use claims.
- Maintaining a broad, well-supported patent portfolio in China is vital for market dominance and blocking competitors.
- Future patent filings may expand on this patent through additional claims, methods, or indications.
FAQs
1. What types of inventions are typically protected under Chinese pharmaceutical patents like CN115322188?
They generally cover new drug compositions, formulations, manufacturing processes, and therapeutic uses, focusing on innovations that improve efficacy, stability, or delivery.
2. How does Chinese patent law evaluate the inventive step in drug patents?
Chinese patent examiners require that innovations demonstrate novelty, inventive step, and industrial applicability. For pharma, this often involves demonstrating surprising efficacy or manufacturing advantages over prior art.
3. Can competitors develop similar drugs based on the CN115322188 patent?
While they can develop alternative compositions or delivery methods, any infringement action depends on the scope of the claims and whether their products fall within patent protection.
4. What is the significance of claiming therapeutic use in addition to composition claims?
U.S. and Chinese patent laws recognize method or use claims as separate protections. This expands patent scope to include specific indications, increasing commercial exclusivity.
5. How do Chinese patent landscapes influence drug development strategies?
Chinese patents incentivize innovation while fostering follow-up filings for broader coverage. Companies often file multiple overlapping patents to secure comprehensive rights and defend against infringement.
References
[1] China National Intellectual Property Administration (CNIPA). Patent document CN115322188.
[2] WIPO. Patent Cooperation Treaty (PCT) filings and strategies.
[3] Zhang, Y., et al. "Analysis of Pharmaceutical Patent Strategies in China," Journal of Intellectual Property Law, 2021.
