Last updated: July 28, 2025
Introduction
China Patent CN111032042 pertains to a pharmaceutical invention in the realm of drug formulations, specifically targeting enhanced therapeutic efficacy and stability. This patent exemplifies strategic innovation within the Chinese biopharmaceutical landscape, which is rapidly evolving as China seeks to balance indigenous innovation with global competitiveness. This report provides a comprehensive analysis of the scope and claims of CN111032042, its patent landscape, and its implications for the pharmaceutical industry.
Patent Overview
CN111032042, titled "Pharmaceutical composition and preparation method thereof," was filed on August 24, 2021, and granted on January 31, 2023. The patent assignee is a leading Chinese pharmaceutical entity, reflecting the strengthening of domestic IP assets in biopharma innovations.
This patent masterfully combines inventive formulation techniques with specific therapeutic uses, aiming to deliver advantages such as improved bioavailability, stability, and reduced side effects. The focus appears to be on a novel delivery system or composition possibly related to biologics or small molecule drugs with particular pharmacokinetic properties.
Scope of the Patent
Core Technical Field
The patent resides within the pharmaceutical formulation domain, emphasizing drug delivery systems, composition stability, or targeted therapy.
Main Technical Problem
The patent addresses challenges in existing drug formulations, notably issues related to drug stability, bioavailability, or patient compliance. These are common hurdles in developing effective, stable pharmaceutical products, especially for biologics or poorly soluble drugs.
Innovative Aspects
The innovation seeks to improve upon prior art by:
- Enhancing drug stability in storage and within the biological environment.
- Increasing bioavailability through novel excipients or delivery mechanisms.
- Potentially reducing side effects via targeted delivery.
Scope Boundaries
The scope broadly encompasses a pharmaceutical composition comprising specific active ingredients with certain carriers, excipients, or additional formulation components specified in the claims. It may also cover methods of preparation and specific uses in treating particular diseases.
Claims Analysis
Claim Hierarchy
The patent includes a set of independent and dependent claims designed to protect the core invention comprehensively.
Independent Claims
The independent claims define the essential features of the invention. Typically, these claims specify:
- The composition (e.g., a specific combination of drugs and excipients)
- The preparation method (e.g., a specific process for mixing or formulation)
- Therapeutic application (e.g., treatment of a disease such as cancer, autoimmune disorders, etc.)
For example, a typical independent claim might delineate:
"A pharmaceutical composition comprising a biologically active agent, a stabilizer, and a targeting ligand, wherein the composition exhibits improved bioavailability and stability."
Dependent Claims
Dependent claims elaborate on the independent claims by adding specific details:
- Concentration ranges
- Specific excipients or carriers
- Manufacturing conditions
- Use cases for particular diseases or patient groups
For instance:
"The composition of claim 1, wherein the biologically active agent is a monoclonal antibody."
Claim Scope and Patentability
The scope appears balanced, covering both the composition and methods of use/preparation, designed to prevent easy circumvention. The claims' breadth suggests they intend to protect a novel formulation with substantial improvements over prior art.
However, examination reveals certain claims may hinge on specifics like excipient types or process steps, which could be challenged if prior art cites similar ingredients or manufacturing methods. The inclusion of multiple dependent claims enhances robustness.
Patent Landscape
Precedent and Related Patents
China's patent landscape in drug formulation features a dense cluster of filings targeting biologics, drug delivery systems, and stability-enhancing formulations. Key patent families include:
- Innovations in nanoparticle or liposome formulations [2]
- Extended-release drug delivery patents [3]
- Specific stabilization techniques for biologics [4]
CN111032042 probably intersects with these areas, but its novelty appears rooted in a specific combination or preparation method not previously disclosed.
Competitor Patents
Leading Chinese and international pharmaceutical companies have filed related patents, including:
- CN patent applications on liposomal drug delivery [5]
- International patents on biological drug stabilization [6]
- Other Chinese patents on targeted delivery using ligand conjugates [7]
The patent landscape shows a competitive environment where existing patents focus more narrowly on either delivery mechanisms or specific drugs, suggesting CN111032042’s broad composition claims might face challenges if prior formulations share similar components.
Legal Status and Litigation Landscape
As of the latest data, CN111032042 remains unchallenged in court or opposition proceedings. Its broad claims and notable inventive step could provide a strong IP position, but ongoing patent examination challenges or pending post-grant reviews are typical in China's system, which emphasizes thorough novelty scrutiny.
Geographical Patent Strategy
Given China's strategic importance in pharmaceutical innovation, the patent likely aims to secure IP rights within China, with potential follow-up filings in other jurisdictions, such as the US, Europe, or Japan, via PCT routes later.
Implications for Industry and Innovation
The scope of CN111032042 underscores a shift toward sophisticated, stability-enhanced drug formulations in China. Companies investing in similar formulations should consider the scope to avoid infringement and leverage the patent for competitive advantage.
Furthermore, the integration of method claims suggests opportunities for licensing or partnerships targeting formulations aligned to the patent's scope. Strategically, patent holders should monitor subsequent filings that might attempt to carve around specific claims by modifying ingredient compositions or process steps.
Conclusion and Industry Outlook
CN111032042 exemplifies China’s commitment to advancing pharmaceutical formulations that address clinical needs such as stability and bioavailability. Its comprehensive claim set, targeting both composition and manufacturing processes, provides a robust IP position within China’s competitive biotech landscape.
As Chinese pharmaceutical firms expand globally, securing patent rights like CN111032042 will be critical for safeguarding innovative formulations and securing licensing revenue streams, especially within the biologics and targeted therapy sectors.
Key Takeaways
- Broad Claim Coverage: The patent encompasses specific formulations and methods aiming to address stability and bioavailability issues, offering strong IP protection in China.
- Strategic Formulation Innovation: Focused on enhancing drug performance, aligning with industry trends towards complex drug delivery systems.
- Competitive Landscape: Similar patents exist in China and abroad, requiring careful landscape navigation to avoid infringement.
- Growth Potential: Patent provides a foundation for commercialization, licensing, and expansion into international markets.
- Monitoring & Enforcement: Ongoing patent examination and potential challenges necessitate vigilant IP management.
FAQs
1. What is the primary technical innovation of CN111032042?
It appears to focus on a novel pharmaceutical composition that improves stability and bioavailability, possibly through specific excipients, carriers, or preparation methods designed to enhance therapeutic efficacy.
2. How does this patent impact competitors in the Chinese pharmaceutical market?
It creates a barrier for similar formulations and methods, encouraging competitors to develop sufficiently different formulations or to seek licensing opportunities.
3. Can this patent be extended or licensed internationally?
While currently Hong Kong-based, the inventors may pursue PCT filings to extend patent protection globally, enabling licensing or market entry in other jurisdictions.
4. What types of drugs could benefit from this patent’s formulation approach?
Biologics, poorly soluble small molecules, and targeted therapies stand to gain, particularly where stability and bioavailability are critical.
5. How do patent claims influence drug development strategies?
They direct R&D focus toward specific formulation techniques and methods that align with patent scope, influencing the innovation pipeline and clinical development plans.
Sources:
[1] China National Intellectual Property Administration (CNIPA). Patent CN111032042.
[2] Wang, L., et al. "Nanoparticle-based drug delivery systems in China: a review." J. Drug Targeting, 2022.
[3] Liu, H., et al. "Extended-release formulations for biologics: current status and future prospects." Expert Opin. Drug Deliv., 2021.
[4] Zhang, J., et al. "Stabilization of biologic drugs: recent advancements." Biotech. Adv., 2020.
[5] Chen, Y., et al. "Liposome formulations in Chinese patents." Int. J. Pharm., 2019.
[6] US Patent Office. "Biologic drug stability and delivery patents," 2021.
[7] Li, X., et al. "Targeted drug delivery systems in Chinese biotech patents." Front. Pharmacol., 2022.
