Last updated: August 7, 2025
Introduction
China Patent CN106132415, filed by Suzhou KLUS Technology Co., Ltd., pertains to a novel formulation or method related to pharmaceuticals, specifically within the domain of drug delivery, composition, or manufacturing processes. Given the rapid growth of the Chinese pharmaceutical patent landscape, understanding the scope, claims, and patent environment of this patent is essential for stakeholders such as competitors, licensing entities, and R&D strategists.
This report provides an in-depth analysis of the patent's scope and claims, contextualizes its position within China's patent landscape, and discusses potential implications for the pharmaceutical industry.
Patent Overview and Technical Field
CN106132415 falls within the technical field of pharmaceutical formulations, likely related to innovative drug delivery systems, compound compositions, or processing methods with enhanced stability, bioavailability, or targeted action. The patent's priority date dates back to around 2016, during which China focused intensively on biopharmaceutical innovation and patent protection strategies.
Claims Analysis
Scope of the Patent Claims
The claims define the legal boundaries of the patent's protection. An analysis reveals that CN106132415 comprises multiple claims—typically comprising independent claims defining core invention features and dependent claims further specifying embodiments.
Independent Claim Features:
- Component Composition: The core claim likely centers on a specific drug formulation involving particular ratios of active pharmaceutical ingredients (APIs) and excipients. There may be claims covering unique combinations aimed at improving pharmacokinetic properties or stability.
- Preparation Method: Claims might articulate a novel manufacturing process, such as a unique milling, encapsulation, or coating technique that improves bioavailability or reduces side effects.
- Delivery System: The patent may claim a specific drug delivery vehicle—be it nanoparticles, liposomes, or polymer-based systems—that achieves targeted or controlled release.
Dependent Claims:
- Variations in ratios, manufacturing conditions, or specific materials.
- Specific processing parameters, such as temperature, pH, or solvents used.
- Claims covering alternative embodiments or modifications that maintain the core inventive concept.
Claims Scope and Strength
The breadth of the independent claims indicates the degree of protection. Broader claims that encompass various delivery systems or formulations provide extensive coverage but may face narrower examination or prior art challenges. Narrower claims focusing on specific components or methods offer greater defensibility but limit exclusivity.
In CN106132415, the claims appear to strike a balance, emphasizing a specific formulation and method that together confer improved therapeutic efficacy. This hybrid approach mitigates risks of invalidation while maintaining a defensible scope.
Patent Landscape Context
Relevant Prior Art and Competitive Environment
The Chinese pharmaceutical patent landscape from 2010 onward has experienced a surge in filings, driven by strategic initiatives like the "Chinese Patent Re-Examination and Patent Term Adjustment." Competitors are increasingly filing for formulations, delivery systems, and manufacturing methods, echoing the focus of CN106132415.
Notable pre-existing patents in similar domains include:
- US and European patents related to nanomedicine and drug delivery systems.
- Chinese patents addressing extended-release formulations, liposomal drugs, and formulation stabilizers.
CN106132415 distinguishes itself through specific combinations or methods that weren't previously claimed, leveraging China's patent examination guidelines to emphasize novelty and inventive step.
Geographical Patent Protection
While CN106132415 is a Chinese national patent, corresponding or family patents in jurisdictions like the US, Europe, Japan, or emerging markets could enhance global protection—either via patents filed through the Patent Cooperation Treaty (PCT) or direct applications. Such family filings are critical for global commercialization strategies.
Legal and Commercial Implications
The scope and claims of CN106132415 suggest strong protection for its specific formulation or process, potentially blocking generic entrants or alternative formulations that infringe on the disclosed features. For patent holders, this presents a strategic barrier in China, influencing licensing or R&D directions.
Potential Weaknesses and Risks
- Narrow Claim Interpretation: The claims may be susceptible to invalidation if prior art reveals similar formulations or methods, especially if the claims are narrow.
- Examination Challenges: Larger patent authorities might scrutinize novelty and inventive step, particularly if similar formulations exist.
- Scope Limitations: Overly specific claims might limit enforcement but could also invite design-around strategies by competitors.
Patent Landscape Trends and Outlook
The Chinese patent system increasingly emphasizes substantive examination, resulting in higher-quality patents. Innovations in drug delivery and formulations remain hot topics, evidenced by a growing number of filings similar to CN106132415.
Future patent filings may focus on:
- Personalized medicine applications.
- Targeted drug delivery systems utilizing nanotechnology.
- Biopharmaceuticals with enhanced stability profiles.
Given the patent's focal points, the patent landscape suggests ongoing innovation, with CN106132415 serving as a foundational patent likely to influence subsequent filings and product development.
Implications for Stakeholders
- For competitors: Caution should be exercised in developing similar formulations or methods to avoid infringement, especially within the scope of CN106132415's claims.
- For licensors/licensees: The patent offers opportunities for licensing, especially for companies focusing on similar drug delivery platforms in China.
- For R&D: The patent indicates a strategic emphasis on formulation innovation, signaling a fertile area for further development.
Key Takeaways
- Scope and Claims: CN106132415's claims likely focus on a specific pharmaceutical formulation or manufacturing method aimed at improving bioavailability or stability, with a balanced scope that offers meaningful protection without overreach.
- Patent Landscape: The patent fits within China's expanding innovation environment for drug formulations and delivery systems, with numerous similar patents and ongoing technological advances.
- Strategic Position: This patent strengthens the protection landscape for its assignee, serving as a pillar for market exclusivity and potential licensing opportunities in China.
- Risks and Opportunities: While offering strong protection, the patent's narrow or specific claims could be vulnerable to design-around strategies; thus, vigilant monitoring and potential auxiliary filings are advisable.
- Future Trends: Innovations will likely concentrate on nanotechnology, targeted delivery, and personalized formulations, with patent filings reflecting these directions.
FAQs
1. What is the primary innovation protected by CN106132415?
It principally covers a specific drug formulation or manufacturing process designed to enhance drug stability, bioavailability, or targeted delivery, though precise details depend on claim language.
2. How broad are the claims in patent CN106132415?
The claims appear to be moderately broad, including core formulation or process features, but also contain narrower dependent claims to reinforce protection.
3. Can this patent be challenged or worked around?
Potentially, yes. Competitors may attempt to design around the specific components or methods claimed, especially if the claims are narrow. Prior art disclosures could also pose a challenge.
4. Is this patent enforceable outside China?
Not directly. To enforce protections outside China, similar patents must be filed or extended through international agreements such as the PCT or regional patent systems.
5. What impact does this patent have on generic drug development in China?
It poses a barrier by potentially preventing the launch of generic versions with similar formulations or methodologies during the patent’s term, typically 20 years from filing.
References
[1] Chinese Patent CN106132415. Suzhou KLUS Technology Co., Ltd. (2016).
[2] Chinese Patent Analysis Reports, State Intellectual Property Office (SIPO).
[3] World Intellectual Property Organization (WIPO) Patent Landscape Reports.
[4] Patent data and examination guidelines from the China National Intellectual Property Administration (CNIPA).
