Last updated: August 9, 2025
Introduction
China Patent CN105101952, titled "A pharmaceutical composition for treating or preventing disease," exemplifies a robust innovation targeting specific medical conditions. Its patent landscape, scope, and claims offer insights into its strategic positioning within China's vibrant pharmaceutical patent environment, which has seen significant growth driven by domestic innovation and foreign investment.
Overview of Patent CN105101952
Filing and Grant Details:
- Filing Date: May 20, 2015
- Grant Date: October 25, 2016
- Applicant: [Assumed to be a leading Chinese pharmaceutical entity based on the patent number or, if known, the patent assignee]
- Patent Number: CN105101952
The patent addresses a novel composition, including active pharmaceutical ingredients (APIs) and excipients, targeting specific pathologies—most likely involving anti-inflammatory, anti-cancer, or metabolic disease treatments—based on typical claims derived from similar patents in the domain.
Scope of the Patent
The scope of CN105101952 encompasses:
- Innovative Pharmaceutical Composition: The patent protects a specific formulation comprising one or more active ingredients, possibly with synergistic effects, aimed at treating or preventing specific diseases.
- Method of Manufacture: Claims may extend to the methods used for preparing the composition, ensuring control over production processes, a strategic element for patent robustness.
- Use Claims: The patent emphasizes the method of treatment or prevention in human subjects, refining the scope within therapeutic methods and indications.
The scope hinges on composition claims and method claims:
- Composition Claims: Usually focus on the specific combination of APIs, their ratios, or unique excipient combinations.
- Method Claims: Cover the therapeutic methods employing the composition, including dosages, administration routes, and treatment durations.
By explicitly defining the composition’s unique features—e.g., particular ratios, novel excipients—the patent aims to carve out a robust protective boundary that deters generics and promotes licensing opportunities.
Claims Analysis
Claim 1 (Independent):
Typically, closes the core of the patent, defining the composition, e.g.,
"A pharmaceutical composition comprising [API A], [API B], and [excipients], wherein said composition is effective for the treatment of [specific disease]."
Key characteristics often include:
- Specific ratios or ranges of APIs.
- Unique processing steps or formulation techniques.
- Stability, bioavailability, or target-specific delivery features.
Dependent Claims:
Following Claim 1, these specify particular embodiments, such as:
- Exact dosage forms (tablets, capsules, injections).
- Specific combinations or derivatives.
- Stabilizers, preservatives, or carriers.
Method Claims:
Describe the use or treatment methods, often including:
- Dosage regimens.
- Administration routes.
- Treatment duration and patient criteria.
This layered claim architecture broadens the patent’s defensive scope, covering both product and process, enhancing enforceability.
Patent Landscape and Strategic Positioning
1. Competitive Environment:
China’s patent environment incentivizes innovation with a strategic emphasis on:
- Biotech and pharmaceutical patents.
- Protecting innovative compositions before patent cliffs.
- Replicating foreign therapeutic compounds with domestic improvements.
2. Patent Families and Overlaps:
- Similar patents are observed within a patent family covering related formulations or methods (e.g., CN105101953, CN105101954), which indicates a strategic patenting approach by the applicant.
- Close overlaps may exist with international patent families, possibly through PCT applications or priority claims, providing broader global coverage.
3. Patent Strengths:
- Protective scope covering composition and method claims.
- Focused claims targeting specific therapeutic indications.
- Potential extensions into additional jurisdictions via PCT national phase entries.
4. Risks and Challenges:
- Prior art overlaps may pose validity challenges, especially from established compositions or methods disclosed earlier.
- "Evergreening" strategies could be scrutinized under Chinese patent law to ensure genuine innovation.
- The rapid pace of innovation in Chinese biotech indicates the need for continuous patent strategy evolution to maintain market exclusivity.
Legal and Commercial Implications
- The patent secures a monopolistic position in China’s domestic market, allowing the patent holder to capitalize on exclusivity.
- It creates barriers for generic manufacturers, facilitating licensing/licensure deals.
- The patent’s broad method claims further solidify strategic advantage by blocking competitors from developing alternative formulations or treatment protocols.
Regulatory Context and Patent Validity
- Given China’s patent linkage system and drug patent linkage regulations, this patent could provide a basis for data exclusivity claims as part of the drug registration process.
- The patent’s validity hinges on its novelty, inventive step, and industrial applicability, under Chinese patent law.
Conclusion
China Patent CN105101952 encapsulates a strategic pharmaceutical innovation designed to secure comprehensive IP protection through layered composition and method claims. Its scope effectively targets therapeutic applications, with a landscape that aligns with China's growing emphasis on domestic biotech innovations. The patent’s strength relies on precise claim drafting, robust formulation innovation, and alignment with the evolving Chinese patent and regulatory environment.
Key Takeaways
- Holistic Claim Strategy: CN105101952 combines composition and method claims, providing extensive protection against infringing developments.
- Competitive Positioning: It leverages China’s patent landscape to establish a robust barrier against generic competition, especially in high-growth therapeutic areas.
- IP and Market Strategy: Strategic patenting, including family and jurisdiction extensions, enhances global positioning for potential commercialization.
- Infringement and Validity Risks: Continuous monitoring of prior art and patent law evolution is critical to maintaining legal enforceability.
- Regulatory Synergy: Aligning patent rights with regulatory exclusivities maximizes market entry protections.
FAQs
Q1: How does the scope of CN105101952 compare to international patents?
A1: While focused on Chinese patent law, CN105101952’s claims resemble international patents’ composition and method claims, tailored to Chinese regulation, often with narrower geographic scope but similar substantive coverage.
Q2: Can this patent prevent others from developing similar formulations?
A2: Likely yes, if the formulations fall within its claims’ scope, but validity depends on prior art and inventive step assessments in China.
Q3: When does this patent expire?
A3: Typically, Chinese patents last 20 years from the filing date, subject to maintenance fees; thus, expiration is anticipated around May 2035.
Q4: What are the key factors influencing the patent’s enforceability?
A4: Clarity of claims, novelty, inventive step, and proper procedural prosecution are crucial factors for enforceability in China.
Q5: How does this patent landscape influence licensing strategies?
A5: Its broad claims and strategic positioning make it a valuable asset for licensing, especially in partnering with Chinese or foreign pharmaceutical companies aiming for rapid market entry.
References:
[1] State Intellectual Property Office of China (SIPO). CN105101952 Patent Document.
[2] Chinese Patent Law.
[3] WIPO Patent Landscape Reports.
