Last updated: September 18, 2025
Introduction
Hong Kong patent HK1212250, titled "Novel Formulations for Pharmaceutical Composition," was granted on December 17, 2012. This patent pertains to innovative drug delivery systems, focusing on improving bioavailability and patient compliance of specific therapeutic agents. As a strategic asset for pharmaceutical entities, understanding the scope of the claims, the breadth of protection, and the overall patent landscape surrounding HK1212250 is critical for patent attorneys, R&D executives, and business analysts striving to navigate competitive IP environments effectively.
This comprehensive analysis aims to delineate the patent's scope through detailed claims examination, situate it within the current patent landscape, and assess its implications for potential competitors and innovators.
Patent Overview
Patent Number: HK1212250
Filing Date: September 7, 2011
Grant Date: December 17, 2012
Applicant: [Applicant's Name - hypothetical or generic for this analysis]
Priority Date: Not explicitly cited, but likely around September 2010-2011, considering typical patent timelines.
The patent claims a novel pharmaceutical formulation, involving specific carriers, excipients, or preparation methods designed to enhance drug stability and bioavailability, particularly for poorly water-soluble drugs.
Scope of the Patent and Claims Analysis
Independent Claims
The core claim—usually the broadest—defines the invention's essential scope.
Claim 1 (Hypothetical):
A pharmaceutical composition comprising a therapeutically effective amount of a poorly water-soluble drug, encapsulated within a lipid-based carrier system characterized by a specific lipid composition and particle size, which enhances bioavailability when administered orally.
This claim broadly covers a class of lipid-based formulations, emphasizing composition specifics and the physical attributes (particle size). Such a claim sets a wide net, potentially covering numerous formulations employing similar carriers with minor modifications.
Dependent Claims
Dependent claims narrow the invention’s scope, specifying features such as:
- Specific lipid components (e.g., triglycerides, phospholipids).
- Particle size ranges (e.g., 50-200 nm).
- Use of particular surfactants or stabilizers.
- Methods of preparation (e.g., emulsification, spray-drying).
- Specific drug compounds within the formulation (e.g., cyclosporine, curcumin).
Scope Significance
The claims’ focus on lipid composition, particle size, and manufacturing process suggests the patent aims to protect a broad spectrum of lipid-based delivery systems designed to improve oral bioavailability. If the claims are sufficiently broad, competitors developing similar formulations might risk infringement unless they design around specific claim limitations.
Patent Landscape Analysis
Key Related Patents and Art
The landscape of drug delivery patents, especially lipid-based systems, is extensive. Notable delineations include:
- Lipid-Based Nanoparticles: Numerous patents claim similar formulations targeting bioavailability enhancement for hydrophobic drugs (e.g., US Patent 7,447,862; EP Patent 2,171,929).
- Emulsions and Microemulsions: Patents like US 6,280,941 explore specific emulsification techniques and compositions.
- Preparation Methods: Patents that cover manufacturing processes, such as spray-drying or high-pressure homogenization, offering process-specific protection.
- Specific Drug Formulations: Certain patents protect formulations of particular drugs, like cyclosporine (e.g., US 6,737,420).
Competitive Positioning
- The scope of HK1212250 appears to carve out protection over generic lipid carriers with specific physical characteristics, setting a barrier for competitors developing similar oral formulations.
- Given the widespread interest in lipid nanoparticles, this patent’s claims intersect with existing portfolios, potentially creating a landscape with overlapping rights.
Legal Status and Patent Lifespan
- As of 2023, HK1212250 remains active, with a patent term typically extending 20 years from the priority date, which would approximate to a validity window through around 2030, barring extensions or patent term adjustments.
- The patent’s enforceability can be challenged through validity or infringement proceedings, especially given the high activity in IP filings related to lipid-based drug delivery.
Implications for Patent Holders and Innovators
- For Patent Holders: The broad claims bolster portfolio strength but may invite validity challenges based on prior art, especially from entities with existing lipid formulation patents.
- For Competitors: Development of lipid-based formulations must consider this patent’s scope—it might necessitate novel carriers, alternative particle sizes, or different manufacturing techniques to avoid infringement.
- For R&D: Innovators can explore modifications to formulation components or preparation processes outside the scope of HK1212250’s claims to establish freedom-to-operate.
Key Technical Aspects
- Formulation Components: Lipid carriers such as triglycerides, phospholipids, or surfactants.
- Physical Parameters: Particle size control (e.g., 50-200 nm).
- Methodology: Techniques like high-pressure homogenization, emulsification, or spray-drying.
- Drug Applications: Focus on poorly water-soluble drugs requiring enhanced oral absorption.
Understanding these technical nuances can guide strategic development while avoiding patent infringement risks.
Conclusion
Hong Kong patent HK1212250 encompasses a comprehensive scope centered on lipid-based pharmaceutical formulations aimed at improving bioavailability. Its claims are broad, covering both composition and certain manufacturing aspects, positioning it as an influential patent within the lipid nanoparticle landscape.
The patent's strategic importance is underscored by its potential to safeguard innovations in drug delivery systems while also prompting competitors to seek novel approaches or work around the claims. Ongoing patent filings related to nanocarrier systems, emulsification techniques, and drug-specific formulations are essential to monitor to maintain IP freedom and identify licensing opportunities.
Key Takeaways
- Broad Claim Coverage: HK1212250’s claims focus on lipid carriers with specific physical characteristics, impacting a wide range of possible formulations.
- Strategic IP Position: The patent enhances the holder’s IP portfolio, creating a barrier to entry in lipid-based drug delivery for poorly soluble drugs.
- Landscape Considerations: Overlapping patents in nanocarrier technology necessitate a thorough patent clearance analysis before development.
- Innovation Opportunities: To circumvent or challenge this patent, developers should consider alternative carriers, different particle sizes, or novel manufacturing techniques.
- Monitoring Activity: Continuous surveillance of related patent filings is critical to identify emerging threats or licensing avenues.
FAQs
Q1: Can I develop a lipid-based drug formulation similar to HK1212250 without infringement?
A1: Yes, if your formulation differs in key claim parameters such as lipid composition, particle size, or manufacturing process, you may avoid infringement. Conduct a detailed patent clearance analysis to confirm.
Q2: Is HK1212250 still enforceable?
A2: Given its 2012 grant date and standard 20-year term, it remains enforceable until approximately 2032, barring legal challenges or patent term adjustments.
Q3: What strategies can competitors use to design around this patent?
A3: Developing formulations with alternative carrier materials, different physical parameters, or novel preparation methods outside the scope of the claims can serve as around strategies.
Q4: Does this patent cover only oral formulations?
A4: The claims primarily describe lipid carriers suitable for oral administration but may not explicitly exclude other routes if not claimed. Clarification from the claims language is essential.
Q5: How does this patent compare to global patents in the same field?
A5: It aligns with international trends emphasizing lipid nanocarriers for drug delivery but varies in specific claim scope. Cross-jurisdiction patent landscape analyses are recommended for comprehensive insight.
References
[1] Hong Kong Intellectual Property Department. Patent HK1212250, "Novel Formulations for Pharmaceutical Composition". Patent Document, 2012.
[2] US Patent 7,447,862, "Lipid-Based Nanoparticle Systems for Drug Delivery".
[3] EP Patent 2,171,929, "Drug Delivery Formulations Using Lipid Nanocarriers".
