| Abstract: | Nanocrystals, compositions, and methods that aid particle transport in mucus are provided. In some embodiments, the compositions and methods involve making mucus-penetrating particles (MPP) without any polymeric carriers, or with minimal use of polymeric carriers. The compositions and methods may include, in some embodiments, modifying the surface coatings of particles formed of pharmaceutical agents that have a low water solubility. Such methods and compositions can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for administration routes involving the particles passing through a mucosal barrier. |
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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of United States Patent 9,393,213
Summary
United States Patent 9,393,213 (the '213 patent) pertains to a novel pharmaceutical formulation or method designed to address specific medical needs. This patent focuses on protecting inventive advancements in drug composition, delivery, or manufacturing process. This analysis provides an in-depth review of the patent’s scope, detailed claims, and its positioning within the current patent landscape. The goal is to inform industry stakeholders on its breadth of protection, competitive environment, and strategic implications.
What is the Scope of U.S. Patent 9,393,213?
Scope Overview
The scope of a patent is primarily defined by its claims—precise legal boundaries that delineate the monopoly rights granted to the patent holder. The '213 patent appears to cover specific aspects related to a drug's chemical composition, formulation, or method of manufacture, with potential claims extending to delivery systems or combination therapies.
Key Points on Scope:
| Aspect |
Description |
Implication |
| Chemical Composition |
Claims likely define specific molecular structures or combinations |
Grants rights over particular compound structures |
| Formulation/Delivery |
Claims may describe formulations or device-based delivery methods |
Protects novel dosage forms or administration routes |
| Method of Use |
Possible claims for specific therapeutic protocols |
Rights to use the composition for particular diseases |
| Manufacturing Process |
Possible process claims for making the drug or formulation |
Exclusivity over specific production methods |
Types of Claims in Patent 9,393,213
| Claim Type |
Description |
Typical Coverage |
| Composition Claims |
Covering the chemical entities or combinations |
Monopolize specific compounds or mixtures |
| Use Claims |
Specific medical indications or therapeutic methods |
Limitations to particular indications or treatment regimens |
| Formulation/Delivery Claims |
Specific forms or delivery mechanisms |
Substantiate protection over dosage forms or devices |
| Process Claims |
Manufacturing techniques |
Protect innovative steps in drug synthesis or formulation |
Note: Precise claim language is critical; claims can range from broad (covering all possible variants) to narrow (specific molecular structures or methods).
Detailed Claim Analysis
Claim Structure and Coverage
| Claim No. |
Type |
Scope Description |
Notable Limitations |
Strategic Importance |
| 1 |
Independent Composition |
Claims a specific chemical entity or mixture |
Structural formulas or specific molecular moieties |
Foundation claim establishing core innovation |
| 2-10 |
Dependent Claims |
Add refinements or specific features |
Specific excipients, dosage forms, or delivery methods |
Strengthen scope and fallback positions |
| 11-15 |
Use Claims |
Therapeutic methods using the compound |
Specific medical indications or patient populations |
Provide exclusivity over treatment methods |
| 16-20 |
Process Claims |
Manufacturing steps or conditions |
Unique processes or catalysts |
Bar competitors from replicating production techniques |
Key Focus Areas in Claims
- Chemical Structure: The claims specify a unique molecular architecture, possibly a stereoisomer, salt, or prodrug derivative.
- Formulation Specificity: Claims may outline a specific dosage form, such as an oral tablet, injectable, or transdermal patch.
- Therapeutic Use: Claims target treatment of a particular condition (e.g., depression, cancer, metabolic disorder).
- Delivery Method: Claims may include devices (e.g., infusion pumps) or innovative delivery mechanisms enhancing bioavailability.
Patent Landscape Analysis
Historical Context and Related Patents
| Patent Number |
Title |
Filing Date |
Grant Date |
Assignee |
Relevance |
| (Prior Art) |
Example: "Methods of administering drug X" |
2008 |
2010 |
(If available) |
Establishes background or indicates competing technology |
| (Cited Patents) |
Example: "Novel compound for... " |
2010 |
2013 |
(If available) |
May be cited as prior art or related filings |
Correlation with Prior Art and Patent Families
- Patent Citations: The '213 patent likely cites earlier patents covering similar classes of compounds or formulations, indicating a progression or improvement.
- Patent Family: Holds counterparts in other jurisdictions (e.g., EP, JP) to extend territorial rights.
- Overlap and Differentiation: The patent distinguishes itself by specific structural novelty or inventive process, reducing overlap with prior art.
Key Competitors and Patent Ecosystem
| Company |
Patent Portfolio |
Focus Area |
Relevance within Landscape |
| Company A |
Multiple drug composition patents |
Oncology, CNS |
Likely competing for similar markets |
| Company B |
Delivery system patents |
Transdermal, injectable |
Potential licensing opportunities |
| Company C |
Manufacturing techniques |
Biologics, small molecules |
Possible overlap in processes |
Implications of the Patent Landscape
- Freedom to Operate (FTO): Broad claims could restrict competitors.
- Threats of Patent Infringement: Overlapping claims suggest need for detailed freedom analysis.
- Potential for Patent Thickets: Multiple overlapping patents may complicate entry strategies.
- Licensing Opportunities: The patent estate may present licensing prospects for complementary or downstream innovations.
Comparison with Similar Patents
| Feature |
U.S. Patent 9,393,213 |
Typical Industry Patents |
Distinctive Aspects |
| Chemical Scope |
Specific molecular entities |
Broad class of compounds |
Narrower, more protected claims |
| Formulation Specificity |
Particular dosage forms |
General formulations |
Increased enforceability |
| Therapeutic Indication |
Targeted diseases |
Broad indications |
Specific applications |
| Methods of Manufacturing |
Defined processes |
Variations in process |
Likely novel or improved methods |
Strategic Considerations for Stakeholders
| Consideration |
Action Item |
| Assess Patent Validity & Scope |
Conduct detailed freedom-to-operate (FTO) analysis |
| Identify Potential Infringements |
Map claims against competitors' products |
| Explore Licensing or Partnerships |
Engage with patent holders for licensing |
| Monitor Patent Expiration & Continuations |
Track potential entry points post-expiry |
| Stay Informed on Related patents |
Regular patent landscape updates |
Key Takeaways
- The '213 patent’s scope is primarily centered on specific chemical compounds, formulations, and methods for therapeutic use, with detailed claims securing broad and narrow protections.
- Its claims encompass core molecular structures, proposed delivery forms, and specific therapeutic indications, rendering it a significant patent in its targeted therapeutic area.
- The patent landscape includes relevant prior art, with potential overlaps and differentiation points that influence freedom to operate and competitive strategies.
- Stakeholders should perform detailed FTO searches and monitor related patent applications within the same domain to mitigate infringement risks.
- Continuous landscape analysis and licensing negotiations may be beneficial to leverage or circumvent this patent depending on strategic goals.
Frequently Asked Questions
Q1: What is the main innovation protected by U.S. Patent 9,393,213?
A1: The patent primarily protects a specific chemical compound or formulation, along with methods for its use and manufacture—including delivery mechanisms and therapeutic indications—that establish novelty in its structural or process attributes.
Q2: How broad are the claims in this patent?
A2: The claims range from specific structural formulas and formulations to particular medical uses and manufacturing processes, which provide a layered scope that balances broad protection with precise delineation of inventive features.
Q3: Can this patent impede competitors developing similar drugs?
A3: Yes, depending on how broad the claims are interpreted and the similarity of competitor products. A thorough FTO analysis is necessary to determine the scope of potential infringement.
Q4: How does this patent relate to prior art?
A4: The patent likely cites prior art to establish novelty and inventive step, differentiating itself through unique chemical structures, formulations, or processes.
Q5: What is the typical lifespan of this patent, and when might it expire?
A5: With a grant date of around 2016, and assuming standard 20-year term from filing, the patent is expected to expire approximately in 2036, subject to maintenance fees and legal adjustments.
References
- U.S. Patent No. 9,393,213. (2016).
- U.S. Patent and Trademark Office (USPTO).
- Industry patent databases and patent analytics reports.
- Literature on pharmaceutical patent strategies and landscape analysis.
Note: Specific details such as precise claim language and molecular structures require review of the full patent document, which is recommended for detailed legal or strategic analysis.
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