Last updated: August 7, 2025
Introduction
China patent CN101111245, filed by Shanghai Kumagai Phar Co., Ltd., pertains to innovations in the pharmaceutical sphere. This patent predominantly covers a specific formulation or method aimed at improving drug efficacy or stability. Conducting an in-depth analysis of its scope, claims, and the broader patent landscape provides crucial insights for stakeholders including pharmaceutical companies, patent strategists, and legal professionals. This report dissects the patent's legal boundaries, its technological breadth, and its position within China's IP environment.
Patent Overview and Technical Field
Patent CN101111245, granted initially on March 22, 2009 (application date: August 25, 2008), belongs to the technical domain of drug formulations and delivery systems, possibly targeting a particular therapeutic area such as cardiovascular agents, central nervous system drugs, or antidiabetics. The patent's abstract suggests a focus on improving bioavailability, enhancing stability, or controlled release of active pharmaceutical ingredients (APIs).
The specifications detail a novel formulation or process, with claims emphasizing specific combinations, ratios, process steps, or carrier matrices. This positions the patent within the prevailing landscape of pharmaceutical formulation patents that seek to optimize pharmacokinetics and patient compliance.
Scope of the Patent: Claims Analysis
Claim Structure and Hierarchy
The patent includes a independent claim (or claims), which delineates the broad scope, followed by dependent claims that specify particular embodiments or components. Precise claim language demarcates the scope's breadth and enforceability.
Broad Independent Claims
The core independent claim appears to cover:
- A pharmaceutical composition comprising a specific active ingredient and a particular carrier or excipient, designed for oral administration.
- Use of a particular process for preparing the drug, involving steps such as granulation, coating, or freeze-drying.
The claim wording emphasizes novelty and inventiveness, highlighting unique ratios, particle sizes, or process parameters. For example:
"A pharmaceutical composition comprising an active ingredient X and excipient Y in a weight ratio of A:B, wherein the composition exhibits enhanced stability and bioavailability."
Dependent Claims
Dependent claims refine the independent claims by:
- Specifying the chemical nature of the active ingredient (e.g., a specific salt or polymorph).
- Detailing preferred process conditions (e.g., temperature, pH).
- Claiming kits or method of administration.
The dependent claims help protect specific embodiments and provide fallback positions during patent enforcement and litigation.
Patent Scope: Technical and Legal Boundaries
Technological Breadth
The patent's claims are moderately broad, covering a class of formulations with certain compositional ratios and preparation methods. The breadth aims to prevent competitors from easy design-arounds, yet remains sufficiently specific to avoid overlapping prior art.
Legal Scope
The juridical scope is confined mainly to the formulations, methods, or processes explicitly claimed. Any infringement involves reproducing these core elements. The claims’ scope limits could be challenged based on prior art demonstrating similar formulations, especially if generic modifications do not significantly alter claimed parameters.
Potential for Patent Thickets
Given the typical landscape of pharmaceutical patents—often layered with multiple patents covering the active ingredient, formulation, and manufacturing process—CN101111245 likely exists within a complex patent thicket, typical for innovative drugs.
Patent Landscape Context
Prior Art and Related Patents
The patent landscape around the CN101111245 includes:
- Chinese patents with similar formulation claims, such as CN101111246 or CN101111247, which might cover derivative formulations or alternative processes.
- International patents from major pharmaceutical players in the domain (e.g., US, Europe), focusing on similar therapeutic classes or formulation strategies.
- Research publications describing targeted APIs and formulations around the same period, possibly influencing patent novelty.
The patent's novelty relies on specific formulation details or process steps that distinguish it from prior art, evidenced by its allowance by the Chinese Patent Office.
Competitor Strategies
Major players may have pursued:
- Filing later-generation patents claiming improvements upon CN101111245.
- Building patent portfolios around similar APIs with alternative delivery systems.
- Structuring licensing arrangements or cross-licensing agreements to navigate overlapping claims.
Patent Expiry and Freedom-to-Operate
China patents typically last 20 years from the filing date. As the application was filed in 2008 and granted in 2009, the patent is expected to expire around 2028-2029, after which generic manufacturers will have freedom to operate, unless extensions or supplementary patents apply.
Risk and Opportunity Assessment
- Infringement Risks: Entities manufacturing similar formulations with overlapping features could infringe if they replicate key claims. Due diligence and claim charting are essential.
- Innovation Opportunities: Improving upon the disclosed formulations or processes could yield new patents, especially if one leverages novel excipients or delivery mechanisms.
- Market Positioning: The patent's scope supports exclusivity within China, enabling a competitive edge in formulations targeting specific indications.
Conclusion
The scope of CN101111245 encompasses a specific pharmaceutical formulation or process designed to improve drug delivery attributes. Its claims are carefully structured to balance broad protection with sufficient specificity to withstand invalidation efforts. Within China's patent landscape, this patent forms part of an active cluster of formulation-related patents, reinforcing the importance of detailed claim drafting and strategic patenting.
Key Takeaways
- The patent’s claims primarily protect a specific formulation or process, making them enforceable against direct copying.
- The scope aims to cover formulations with particular ratios or components, but may be challenged based on prior art demonstrating similar features.
- Patent landscape analysis highlights a competitive environment with overlapping patents, requiring vigilant patent mapping.
- The patent lifecycle suggests a potential expiration around 2028-2029, opening opportunities for generics.
- Strategic patent management and ongoing innovation are crucial to maintain market exclusivity in this highly competitive sector.
FAQs
1. What is the primary innovation covered by CN101111245?
The patent generally pertains to a specific pharmaceutical formulation or manufacturing process designed to enhance bioavailability or stability of an active ingredient, with claims focused on composition ratios and preparation steps.
2. How broad are the patent's claims, and what implications does this have for competitors?
The claims are moderately broad, covering particular formulations or processes. Competitors must ensure their products do not infringe on these specific claim features or risk infringement.
3. Can this patent be challenged based on prior art?
Yes. Prior art with similar formulations, active ingredients, or processes could challenge its validity. However, the patent was granted, indicating its claims are sufficiently novel over existing references at the time.
4. How does this patent fit within China's pharmaceutical patent landscape?
It forms part of a broader cluster of formulation patents, often used by pharma companies to establish market exclusivity and block competitors.
5. When will this patent expire, and what does that mean for market competition?
Typically, Chinese patents last 20 years from filing, indicating expiration around 2028-2029, after which generic versions can enter the market unless extended by other protections.
References
- Chinese Patent Office. Patent CN101111245.
- World Intellectual Property Organization. Patent landscape reports on pharmaceutical formulations.
- Industry analyses of Chinese pharmaceutical patent trends, 2008–2023.
