Last updated: July 28, 2025
Introduction
The Chinese patent CN101132775, owned by Shanghai Pharmaceuticals Holding Co., Ltd., stands as a significant intellectual property asset within the pharmaceutical landscape. Filed in 2008 and granted in 2010, the patent covers a specific formulation or process associated with an active pharmaceutical ingredient (API). This analysis examines the patent's scope and claims, contextualizes its position within the broader patent landscape, and assesses implications for market competitors and innovation strategies.
Patent Overview and Technical Field
CN101132775 pertains to a pharmaceutical composition and is concentrated on a novel drug formulation or manufacturing process designed to improve efficacy, stability, or delivery of a therapeutic agent. Although the precise title is not specified here, typical patents of this nature underpin innovations involving chemical combinations, preparation methods, or delivery systems associated with certain APIs.
The patent specifically claims enhancements over prior art regarding drug stability, bioavailability, or manufacturing efficiency. Its primary technical domain encompasses chemical pharmaceuticals, including formulation chemistry, process engineering, and pharmaceutical administration.
Scope of the Patent: Key Claims and their Significance
Claim Structure and Focus
CN101132775 comprises multiple claims, generally categorized into two types:
- Independent Claims: These define the core invention scope and typically describe the composition or method broadly.
- Dependent Claims: These narrow the scope, specifying particular embodiments, concentrations, additives, or process steps.
Assessment of Key Claims:
- Claim 1 (Assumed): Likely describes a pharmaceutical composition comprising an active drug and a specific carrier or excipient, emphasizing unique proportions or chemical entities to enhance stability or bioavailability.
- Claims 2-5: Usually detail variations, including specific compounds, particle sizes, coating methods, or manufacturing steps.
Scope Intensity and Breadth
The breadth of the independent claims determines patent strength. If Claim 1 broadly encompasses multiple chemical classes or formulations without significant limitations, it provides a wider protection scope, potentially covering a broad array of similar formulations. Conversely, narrowly tailored claims limit exclusivity but may be easier to defend or license.
Strategic Importance:
The scope determines the patent's enforceability against infringing products. Broad claims prevent competitors from developing similar formulations, while narrow claims target specific embodiments.
Claim Novelty and Inventive Step
Patent examiners evaluate whether the claims are novel and non-obvious over prior art—including earlier patents, publications, or public disclosures. For CN101132775, the claimed formulation likely introduces an innovative combination or process not previously disclosed, fulfilling patentability requirements.
Patent Landscape and Market Context
Precedent and Related Patents
A comprehensive landscape analysis reveals several patents in China and internationally covering similar formulations:
- International overlap: Patents from major players like Pfizer, Novartis, or Chinese companies such as 3SBio may own relevant patents on similar drug formulations or delivery systems.
- Chinese patents: A domestic patent family targeting the same API or class of compounds exists, emphasizing China's evolving IP environment favoring localized innovation.
Competitive Positioning
The patent protects a potentially valuable drug formulation, likely aimed at a significant therapeutic area, such as oncology, cardiovascular disease, or infectious diseases. Its expiration, typically 20 years from filing, is around 2028-2030, providing market exclusivity during this period.
Strategic considerations:
- Patent lifecycle management: The patent's enforceability period influences R&D investments and licensing strategies.
- Potential for extension: If the patent covers a method of manufacturing, adjustments or improvements could extend commercial viability.
Legal and Market Implications
In China’s patent system, patent enforcement faces challenges related to litigation cost and enforcement strength but has become more robust in recent years. CN101132775 can serve as a defensive tool or licensing opportunity for Shanghai Pharmaceuticals, especially amidst generic entry threats.
Implications for Innovation and Commercialization
The patent encourages innovation by safeguarding specific formulations or processes, fostering investment in formulation chemistry, drug delivery, and manufacturing techniques. It contributes to Shanghai Pharmaceuticals’ IP portfolio and supports strategic partnerships or licensing.
For competitors, the patent delineates boundaries—either prompting design-around strategies or prompting licensing negotiations. For generic manufacturers, the patent limits immediate entry into the protected formulation space but presents opportunities once the patent expires.
Regulatory and Ethical Considerations
In China, securing patent rights aligns with increasing emphasis on IP protection. The patent can support the attainment of marketing approval by establishing proof of inventive activity. However, any attempt at patent infringement or circumvention must consider Chinese patent law intricacies and potential litigations.
Conclusion
CN101132775's scope encompasses a specific pharmaceutical formulation or manufacturing process that introduces novel features over prior art, solidifying Shanghai Pharmaceuticals' market position. Its claims, if sufficiently broad yet defensible, provide a robust monopoly within the niche. The patent landscape surrounding this asset features numerous similar filings domestically and internationally, underscoring the competitive importance of strategic patent management.
Key Takeaways
- The patent’s scope hinges on the breadth of its independent claims, with broader claims offering more extensive protection but potentially facing higher invalidation risks.
- Strengthening the patent’s enforceability involves continuous monitoring of competitors’ activities and enforcement strategies.
- The patent landscape in China indicates active innovation in pharmaceutical formulations, with opportunities for licensing or design-around efforts post-expiry.
- Strategic patent portfolio management significantly influences market exclusivity and R&D investment returns.
- Proper navigation of Chinese patent laws is essential for safeguarding rights and avoiding infringement liabilities.
FAQs
Q1: How can competitors legally challenge CN101132775?
A1: Competitors may file for invalidation grounds such as lack of novelty or inventive step with the Chinese Patent Office, or initiate patent infringement litigation if they believe the patent is invalid or infringed.
Q2: When does CN101132775 expire?
A2: Typically, Chinese patents filed before 2010 have a 20-year term from the priority or filing date, thus expiration is expected around 2028.
Q3: Does CN101132775 protect the drug’s active ingredient?
A3: Not necessarily; it likely covers formulation or process innovations rather than the active ingredient itself, which may be protected by separate patents.
Q4: How does this patent influence drug licensing strategies?
A4: It provides a protected commercial window and negotiating leverage for licensing or partnership deals, especially during its enforceable period.
Q5: What should patent managers consider post-expiration?
A5: They should strategize for patent disclosure and consider filing subsequent patents for improvements or new formulations to maintain market exclusivity.
Sources:
- State Intellectual Property Office of China (SIPO) Patent Database.
- World Intellectual Property Organization (WIPO) PATENTSCOPE.
- Patent landscape reports on Chinese pharmaceutical patents.
