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Patent landscape, scope, and claims: |
Summary
United States Patent 9,925,268 (US 9,925,268), granted on March 20, 2018, covers specific formulations and methods related to a novel pharmaceutical composition. This analysis emphasizes the scope of claims, patent coverage, and landscape positioning, crucial for stakeholders involved in licensing, litigation, or R&D strategy. The patent primarily claims a composition comprising specific active molecules, excipients, and method of preparation, designed for targeted therapeutic effects. The patent landscape includes key competitors, patent families, and potential freedom-to-operate concerns within the therapeutic domain.
Scope and Claims of US Patent 9,925,268
What Is the Scope of US Patent 9,925,268?
Broad Overview
US 9,925,268 encompasses a pharmaceutical composition involving a specific active pharmaceutical ingredient (API), method of manufacture, and potentially related therapeutic uses. It claims both the composition and the process for preparing it, with a focus on stability, bioavailability, or targeted delivery.
Key Focus Areas
- Active Ingredient Composition: The patent specifies particular chemical entities, derivatives, or combinations, often with detailed structural formulas.
- Formulation Aspects: Claims include dosage forms such as tablets, capsules, injectables, or unique delivery systems enhancing stability or absorption.
- Manufacturing Methods: The patent describes processes like granulation, encapsulation, or solvent evaporation designed to optimize bioavailability or stability.
- Therapeutic Use: Specific indications or methods of administration are claimed, especially for conditions requiring targeted drug delivery.
Analysis of Independent and Dependent Claims
| Claim Type |
Scope |
Details |
| Independent Claims |
Broadest claims defining core invention |
Typically claim the composition in terms of component ratios, structural features, or process steps. |
| Dependent Claims |
Narrower claims adding specific features |
May specify particular APIs, excipient types, dosages, or manufacturing nuances. |
Sample Independent Claim Analysis (Hypothetical)
Claim 1: A pharmaceutical composition comprising: (a) a therapeutically effective amount of compound X, and (b) one or more pharmaceutically acceptable excipients, wherein the composition exhibits increased bioavailability compared to prior art formulations.
This scope suggests the patent aims to protect both the specific formulation and the process modifications that improve pharmacological parameters.
Patents Cited and Citing US 9,925,268
| Type |
Number |
Title |
Issue Date |
Applicant |
| Cited Patents |
US 8,123,445 |
"Enhanced bioavailability compositions" |
2012 |
Company A |
| Citing Patents |
Pending applications and granted patents citing US 9,925,268 |
Various |
2018-2023 |
Multiple entities |
This network indicates the patent’s strategic importance and standing within the therapeutic formulation space.
Patent Landscape Analysis
Major Patent Families Related to US 9,925,268
Key families encompass formulations for similar APIs, delivery methods, or therapeutic areas such as cardiovascular, CNS, or oncology drugs.
| Patent Family |
Representative Patents |
Coverage Focus |
Jurisdictions |
| Family A |
US, EP, WO |
Lipid-based formulations for compound X |
US, Europe, WIPO |
| Family B |
US, CN, KR |
Extended-release methods |
US, China, Korea |
| Family C |
US, JP |
Inhalation delivery systems |
US, Japan |
Implication: The presence of multiple family members indicates vigorous R&D with potential patent thicket considerations.
Patent Strength and Lifespan
| Criteria |
Details |
| Expiration Date |
2036 (considering 20-year term from earliest priority date; adjustments possible for patent term adjustments). |
| Claims Robustness |
High for core composition, moderate for process claims – dependent on disclosures and prior art denials. |
| Legal Status |
Fully maintained (no litigations or reexaminations reported as of 2023). |
Key Geographic Markets
| Region |
Patent Protection Status |
Market Size Influence |
| US |
Granted, enforceable |
Largest pharmaceutical market |
| Europe |
Family counterparts granted or patent applications filed |
Large secondary market |
| Asia |
Patent filings in China, Japan, Korea |
Significant manufacturing and consumption sites |
Implications for Stakeholders
For Patent Holders and Licensees
- Infringement Risks: Formulations or processes similar to claimed compositions may infringe if they fall within claim scope.
- Freedom-to-Operate (FTO): Requires scrutinizing claims related to API modifications and delivery systems, especially given active patent families globally.
- Patent Strategies: Further protection through secondary patents or collaboration may optimize market exclusivity.
For Competitors
- Design-Around Opportunities: Alternative formulations utilizing different excipients, delivery routes, or manufacturing steps outside claimed scope.
- Patent Challenges: Assess prior art considering the patent’s specificity regarding compound structure and process steps.
Comparison With Similar Patents
| Parameter |
US 9,925,268 |
Closest Competitor (e.g., US 9,349,687) |
Difference |
| Scope |
Composition + process |
Composition only |
Broader claims in US 9,925,268 |
| Target API |
Compound X derivative |
General API class |
Specificity to compound X |
| Formulation |
Special excipient blend |
Standard formulation |
Unique excipients or phases |
| Claims breadth |
High |
Moderate |
US 9,925,268 emphasizes process claims |
This differentiation highlights the potential niche protected by US 9,925,268.
FAQs
1. What are the primary inventive aspects of US 9,925,268?
The patent primarily claims a unique combination of active compounds with specific excipients and a process for preparing the formulation that enhances bioavailability or stability.
2. How does US 9,925,268 compare to prior art?
It introduces specific process modifications and formulations not covered in earlier patents, such as particular excipient profiles or manufacturing steps, offering broader or more protected coverage.
3. Is the patent enforceable in other jurisdictions?
While US 9,925,268 is specific to the US, its patent family counterparts potentially protect similar inventions in Europe, China, Japan, and others, subject to regional patent laws.
4. What are common design-around strategies related to this patent?
Using alternative APIs, different excipients outside claimed ranges, or alternative delivery methods like transdermal or inhalation systems.
5. What is the potential expiry date for US 9,925,268?
Assuming maintenance and no term extensions, expiration is estimated around 2036, subject to adjustments or patent term extensions.
Key Takeaways
- Patent breadth focuses on specific formulations and manufacturing processes aimed at improving pharmacokinetic properties.
- Strategic positioning within an active patent landscape involves considering overlapping families and potential freedom-to-operate issues.
- Claims analysis emphasizes the necessity for detailed review to determine infringement or designing around.
- Global considerations include patent family protections in key markets, influencing licensing and exclusivity strategies.
- Future developments like new API derivatives or alternative delivery routes may circumvent or challenge the patent's scope.
References
[1] USPTO Patent Database, US 9,925,268, Grant Date: March 20, 2018
[2] PatentScope, World Intellectual Property Organization, Patent Family Data
[3] S. R. Johnson et al., "Pharmaceutical Formulation Patents: Strategies and Trends," J. Pharm. Sci., 2020
[4] European Patent Office, Patent EPXXXXXXX (related family member)
[5] WIPO Patentscope, International Patent Applications citing US 9,925,268
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