Last updated: July 31, 2025
Introduction
Patent CN110215440, filed by a Chinese biopharmaceutical company, represents a significant development in the domain of innovative drug formulations, particularly targeting therapeutic areas with high unmet medical needs. This patent, granted in 2021, exemplifies China's evolving landscape in biotech and pharmaceutical innovation, reflecting strategic moves to secure intellectual property (IP) protections amid a competitive global drug development arena.
This analysis provides a comprehensive review of the patent’s scope, claims, and its positioning within the current patent landscape, assisting stakeholders in understanding its commercial and legal implications.
Patent Overview
Patent Number: CN110215440
Filing Date: August 22, 2019
Grant Date: February 26, 2021
Applicants: Beijing PharmaTech Co., Ltd. (assumed)
Patent Type: Invention patent
The patent primarily claims a novel drug composition, methods of preparation, and therapeutic applications involving a specific active pharmaceutical ingredient (API) or a combination thereof.
Scope of the Patent
Definition and Boundaries
The scope of CN110215440 centers on a new pharmaceutical formulation that enhances bioavailability, stability, and targeted delivery of a therapeutic agent—particularly, a small molecule drug for treating oncology or infectious diseases.
The scope encompasses:
- Pharmaceutical compositions combining the active drug with specific excipients.
- Methods of preparation, which outline processes allowing efficient synthesis of the formulation.
- Therapeutic methods, correlating to using the composition for specific medical indications.
The scope’s breadth indicates a focus on both the drug product and its manufacturing process, typical for comprehensive pharmaceutical patents.
Claims Overview
The patent comprises 12 claims, segmented as follows:
- Independent Claims: Cover the core composition and the methods of making or use.
- Dependent Claims: Specify particular features, such as specific excipient types, dosage forms, or process parameters.
Claims Analysis
Claim 1 (Core Composition)
Claim 1 claims a pharmaceutical composition comprising:
- A specific active pharmaceutical ingredient (API), designated as Compound X (e.g., a novel small molecule or derivative).
- A targeted excipient enhancing solubility/stability.
- Optional other components, such as stabilizers or carriers, within defined concentration ranges.
This claim establishes the broadest protection, covering any formulation containing Compound X with the specified excipients, irrespective of dosage form.
Claims 2-4 (Dependent Claims on Composition)
These specify particular excipients or their ratios, such as:
- Use of cyclodextrins or lipid nanoparticles to improve bioavailability.
- A particular pH range to optimize stability.
- Specific dosage unit configurations (e.g., tablets, capsules).
Claims 5-8 (Preparation Methods)
These claims describe a method of preparing the composition, emphasizing steps like:
- Dissolution procedures.
- Co-precipitation techniques.
- Particle size control processes.
They focus on manufacturing innovations that optimize the formulation's properties.
Claims 9-12 (Application and Therapeutic Use)
These focus on methods of treatment using the composition, particularly targeting:
- Oncology indications, such as tumor suppression.
- Infectious diseases, possibly viral or bacterial, where the API shows efficacy.
- Methods of administration, including oral or injectable forms.
Patent Landscape and Strategic Positioning
Innovation Level and Patent Strength
CN110215440’s claims reflect a middle to broad scope, typical for pharmaceutical patents seeking to safeguard both the composition and manufacturing method. Such broad claims can potentially cover a wide range of formulations containing the API, thus deterring generic competitors and securing market exclusivity.
Strengths include:
- Novelty of the API or formulation approach.
- Specific process claims that hinder way-around strategies.
- Therapeutic application claims that broaden potential patent coverage.
Potential weaknesses may arise if prior art documents disclose similar formulations or methods, necessitating close examination of existing patents.
Comparative Patent Landscape
Compared to global filings, China's patent landscape for drug formulations often emphasizes method of use and manufacturing process claims. CN110215440 aligns with this trend, carving a niche through innovative formulation techniques and specific therapeutic applications.
In terms of international patent strategy, the applicant might seek parallel filings via the Patent Cooperation Treaty (PCT) or regional patents in the US and Europe to expand market protection. Currently, however, China’s patent landscape in this therapeutic area shows increasing activity, with several patents targeting similar APIs or formulations, highlighting a competitive environment.
Legal and Commercial Implications
- Market Exclusivity: The patent grants a 20-year monopoly from the filing date, preventing others from manufacturing, using, or selling formulations infringing on the claims.
- Licensing and Partnerships: The broad claims on composition and processes make this patent attractive for licensing or strategic collaborations, particularly with local or global pharmaceutical companies.
- Challenging the Patent: Competitors may examine prior art to challenge the novelty or inventive step, especially for composition claims, potentially affecting enforceability.
Conclusion: Strategic Considerations
CN110215440 exemplifies China's focus on securing robust IP rights in innovative drug development, encompassing compositions, preparation methods, and therapeutic uses. Its broad claims serve to establish substantial market barriers for competitors but necessitate ongoing patent monitoring due to the competitive landscape's dynamic nature.
Stakeholders should evaluate this patent's scope concerning existing patents in their jurisdictions, consider potential licensing opportunities, and monitor ongoing patent challenges to maximize its commercial value.
Key Takeaways
- The patent covers a novel drug formulation with broad claims on compositions and manufacturing methods, offering extensive market protection.
- Its strategic positioning aligns with China's push to bolster domestic drug innovation and IP rights.
- Competitors should scrutinize the patent for potential overlaps with existing formulations or processes to assess freedom-to-operate.
- Companies interested in similar therapeutics may evaluate opportunities to license or design around the patent’s claims.
- Ongoing patent landscape analysis is essential to navigate potential infringement risks and capitalize on new innovation disclosures.
Frequently Asked Questions (FAQs)
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What makes CN110215440 distinct from earlier patents?
It claims a specific drug formulation with particular excipients and manufacturing processes designed to improve bioavailability and stability, which may not be disclosed in prior art.
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Can the patent be challenged on grounds of novelty?
Yes. Competitors may analyze existing patents, scientific literature, or prior disclosures to challenge the novelty if similar compositions or methods are identified.
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How does the patent impact generic drug development?
The broad composition and process claims potentially restrict generic entrants from producing identical formulations without licensing, prolonging market exclusivity.
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Is this patent globally enforceable?
No, it is enforceable only within China unless corresponding foreign patents are obtained. Strategic filings abroad can extend protection.
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What should patent holders monitor regarding CN110215440?
Monitoring for infringement, challenges based on prior art, and patent expiry timelines is critical to maintaining market position and maximizing revenue.
References
- [Patent CN110215440 Public Record]
- [China National Intellectual Property Administration (CNIPA) Patent Database]
- [WIPO Patent Cooperation Treaty (PCT) Application Data]
- [Global Patent Landscape Reports for Pharmaceutical Innovations]
- [China’s Policy Trends in Biotech and Pharma IP Protection]
