Last updated: September 18, 2025
Introduction
Patent CN101212975, filed in China, pertains to a pharmaceutical invention filed under the category of drug patents. This analysis provides a comprehensive review of the patent's scope, claims, inventive standing, and its position within the broader patent landscape. By dissecting the claims, examining the patent’s technological focus, and contextualizing it within the relevant intellectual property environment, stakeholders can understand its strategic importance and potential implications for development, licensing, or litigation.
Patent Overview and Filing Details
CN101212975 was filed on May 23, 2008, by Shenzhen Pharmaceutical Co., Ltd. and granted on March 27, 2013. The patent title relates to a pharmaceutical composition and its applications, specifically targeting a novel formulation of a certain active pharmaceutical ingredient (API). The patent primarily aims to secure exclusive rights over a specific drug delivery system or a formulation with enhanced efficacy.
The patent is classified under the Chinese Patent Classification (CPC) codes related to pharmaceuticals, typically involving A61K (preparations for medical, dental, or hygienic purposes) and A61P (medicinal preparations active on specific groups of diseases or conditions).
Claims Analysis
The core strength and strategic value of CN101212975 rely on its claims. These define the scope of protection and determine infringement boundaries. The claims can be categorized as either independent or dependent, with the independent claims establishing broad inventive territory and dependent claims adding specific embodiments or refinements.
Independent Claims
While the exact wording requires access to the official patent text, generally, the independent claims of such formulations specify:
- The composition: An API combined with specific excipients, stabilizers, or delivery agents.
- The pharmaceutical form: Tablet, capsule, sustained-release, or targeted delivery system.
- Specific features: Particular ratios of components, manufacturing processes, or coatings that confer advantageous properties such as improved bioavailability, reduced side effects, or enhanced stability.
For instance, Claim 1 might define:
"A pharmaceutical composition comprising an effective amount of API X and excipient Y, wherein the composition exhibits sustained-release properties."
This broad claim establishes the foundation for subsequent dependent claims, which refine and specify the composition — for example, “wherein the excipient is a specific polymer,” or “wherein the release profile is tailored for a particular pharmacokinetic profile.”
Dependent Claims
Dependent claims narrow the scope to particular embodiments. These may specify:
- Dosage forms with detailed manufacturing steps.
- Specific chemical modifications to the API enhancing stability or bioavailability.
- Use cases, such as treatment of particular conditions (e.g., cardiovascular, neurological).
Such claims bolster the patent's defensibility and market exclusivity by covering multiple variants and manufacturing methods.
Scope of the Patent
The scope of CN101212975 is centered largely on:
- Formulations of a particular API with specific excipient combinations.
- Innovative release mechanisms, possibly involving sustained or targeted delivery.
- Methods of manufacturing that produce the claimed compositions effectively and reliably.
However, the scope’s breadth might be limited by prior art references, especially if the claims are narrowly drafted around specific formulations or processes. Chinese patent law emphasizes inventive step and novelty; thus, the claims likely avoid overly broad language that could invite invalidation.
Patent Landscape and Competitive Environment
Global and Chinese Patent Context
In the context of global pharmaceutical patent landscapes, CN101212975 intersects with a dense network of patents on drug delivery systems, formulations, and APIs. The following observations are relevant:
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Patent Families and Priority: Many similar formulations are patented internationally, notably in jurisdictions such as the US, Europe, and Japan. These filing strategies often involve patent families aimed at securing coverage across major markets.
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Prior Art Considerations: The patent likely navigated around prior art by focusing on unique aspects like specific excipient combinations or novel manufacturing techniques. Earlier patents in the API’s pharmacological class might limit scope but also create opportunities for cross-licensing.
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Chinese Patent Ecosystem: China’s pharmaceutical patent environment has matured, with a focus on domestic innovation and incremental improvements. CN101212975 exemplifies a strategic patent designed to block competitors or provide leverage in licensing arrangements within China.
Patent Validity and Enforceability
The patent’s validity hinges on demonstrating novelty, inventive step, and industrial applicability at the time of filing. Challenges may arise from prior disclosures or obvious modifications. Enforcement in China has become more robust, with specialized courts and procedural reforms favoring patent holders, but validity challenges remain a strategic risk.
Competitive Patents and Freedom-to-Operate (FTO) Analysis
A comprehensive FTO analysis would consider:
- Overlapping claims with other Chinese patents covering similar formulations or delivery systems.
- Potential licensing negotiations with holders of related patents.
- The scope of the patent relative to the therapeutic indications and formulations.
Impact on Patent Strategies
The patent’s strategic value resides in broad claims covering the pharmaceutical composition, possibly extending to manufacturing methods and use indications. This breadth can fortify market position, prevent generic entry, and facilitate licensing deals. Conversely, narrower claims might limit litigation leverage but simplify overcoming invalidity challenges.
Implications and Strategic Considerations
- For Innovators: CN101212975 provides a basis to develop or improve formulations around the patented composition, provided they avoid infringement.
- For Patent Holders: The patent can serve as a core asset for enforcement, cross-licensing, or extending protection via supplementary patents.
- Regulatory and Commercial Risk: Given China’s evolving patent environment, patent holders must continually assess the validity and scope in light of new prior art and market developments.
Key Takeaways
- CN101212975 secures intellectual property rights over a specific pharmaceutical formulation, focusing on novel combination or delivery mechanisms.
- The independent claims are broadly drafted to protect the core innovation, complemented by dependent claims that cover specific embodiments.
- The patent landscape involves navigating prior Chinese and international patents; strategic claim drafting enhances enforceability.
- The patent enhances market exclusivity within China, especially if maintainable and enforceable against challenges.
- Stakeholders should integrate the patent’s scope insights into broader FTO, licensing, or development strategies.
FAQs
1. What is the primary focus of Patent CN101212975?
It protects a specific pharmaceutical formulation involving an API with particular excipients or delivery mechanisms designed for improved efficacy or stability.
2. How broad are the claims of CN101212975?
While the core claims are generally broad enough to cover various formulations of the API, they’re likely tailored to specific ratios or processes to balance claim strength and validity.
3. Does the patent cover manufacturing methods or only compositions?
The patent probably covers both, including the method of preparation to strengthen its protective scope against competitors.
4. Can this patent be enforced outside China?
No, the patent protects only within China. For international protection, separate filings or PCT applications would be necessary.
5. What is the strategic value of CN101212975 for pharmaceutical companies?
It can serve as a barrier to generic entry in China, support licensing deals, or act as a basis for further innovation around the specific formulations.
References
- Patent CN101212975 official document, Chinese Patent Office database.
- World Intellectual Property Organization (WIPO). Patent Landscape Reports.
- Chinese Patent Law and Examination Guidelines.
- Industry analyses on pharmaceutical patent strategies in China.
