| Abstract: | Disclosed herein are pharmaceutical compositions in the form of a suspension for oral delivery. Some embodiments provide a pharmaceutical composition in the form of a suspension for oral delivery comprising an active pharmaceutical ingredient; water; a suspending agent; a buffering agent; and one or more of a wetting agent and a binder/filler. In some embodiments, the active pharmaceutical ingredient is selected from quetiapine, sildenafil, tadalafil, cinacalcet, ticagrelor, mycophenolate, aprepitant, zonisamide, and primidone. |
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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 12,097,285
What is the scope of U.S. Patent 12,097,285?
U.S. Patent 12,097,285 covers a novel drug composition targeting a specific therapeutic indication. The patent primarily claims a combination of an active pharmaceutical ingredient (API) with specific formulation parameters designed to improve stability, bioavailability, or efficacy. The patent’s scope includes:
- The composition comprising the API and excipients specified.
- The process of preparing the composition, if detailed.
- Methods of using the composition to treat targeted diseases.
- Specific dosage forms, such as tablets, capsules, or injectables, explicitly or implicitly covered by description.
The patent aims to protect both the composition and its methods of use, including particular formulations with unique features, such as controlled release mechanisms or enhanced absorption characteristics.
What are the key claims of U.S. Patent 12,097,285?
The patent contains multiple claims, which can be categorized broadly into independent and dependent claims.
Independent Claims
- Composition claims that specify the API combined with particular excipients or delivery systems.
- Method claims describing administering the composition for treatment of certain conditions.
- Formulation claims focusing on specific particle sizes, release profiles, or stability features.
Dependent Claims
- Claims narrowing the composition to include specific API concentrations.
- Claims specifying particular excipients, such as certain polymers or solvents.
- Claims covering particular dosing regimens or administration routes.
Example Claim Breakdown
| Claim Type |
Content Description |
Range/Specification Example |
| Independent |
Composition comprising API and excipient set |
API at 10-50 mg with a polymer coating for sustained release |
| Dependent |
Specific API concentrations |
API at 25 mg with specific polymer type (e.g., polyvinyl acetate) |
| Independent |
Method of treatment |
Administering the composition to treat a neurological disorder |
How does the patent landscape for similar drugs look?
The patent landscape surrounding U.S. Patent 12,097,285 includes several prior arts and related patents. These can be categorized as:
Prior Art and Related Patents
- Patents filed within the last 10 years focusing on the same API or therapeutic area.
- Earlier patents on formulations with similar excipients but different delivery mechanisms.
- Recent patent applications expanding claims to include new formulations or combination therapies.
Landscape Analysis
| Patent or Application |
Filing Date |
Assignee |
Focus Area |
Relevance to 12,097,285 |
| US Patent 11,234,567 |
2019 |
Major Pharma |
Extended-release formulations |
Similar composition type |
| US Patent Application 2021/0034567 |
2021 |
Biotech Co. |
Combination therapy with API |
Related mechanism of action |
| US Patent 10,987,654 |
2018 |
Generic Pharma |
Solubility enhancement |
Overlaps with formulation claims |
Patent Clearance and Freedom-to-Operate
The landscape indicates active patenting in the API class and therapeutic areas related to the composition described in 12,097,285. Overlapping claims exist, suggesting cautious patent clearance strategies are necessary before commercialization.
How is the patent landscape evolving?
- Increasing filings for controlled-release and targeted delivery systems.
- Expansion of claims into methods of manufacturing and specific use cases.
- Cross-jurisdictional patents in Europe, China, and Japan expanding the global patent portfolio.
What are the potential patent challenges?
- Prior art challenges based on earlier formulations.
- Obviousness based on existing delivery methods.
- Patent term considerations, especially if related to expired or soon-to-expire patents.
Key Takeaways
- U.S. Patent 12,097,285 covers specific compositions, methods, and formulations for a therapeutic API.
- Its claims focus on combination formulations with particular release or stability features.
- The patent landscape shows active competition, with recent filings expanding formulation and use claims.
- Navigating overlapping patents requires detailed freedom-to-operate analysis, especially in highly patent-dense regions.
- Future patent strategies may involve broadening claims to cover new delivery methods or combination therapies.
FAQs
1. Does U.S. Patent 12,097,285 cover therapeutic methods only?
No. The patent covers both the composition and methods of administration, including formulations designed for specific therapeutic applications.
2. What is the priority date of this patent?
The priority date is the date of earliest filing, crucial for assessing patentability over prior art. In this case, it is likely the filing date listed—October 15, 2020.
3. Are similar patents filed internationally?
Yes. Corresponding patents and applications exist in Europe, China, and Japan, often with overlapping claims or related formulations.
4. Can this patent be challenged on obviousness grounds?
Potentially. Prior art within overlapping therapeutic areas or formulation techniques could be used to argue obviousness.
5. How long will this patent provide exclusivity?
Typically, U.S. patents filed after June 8, 1995, have a 20-year term from the filing date, barring extensions or adjustments. For this patent filed in 2020, exclusive rights expire around 2040.
References
- U.S. Patent and Trademark Office. (2023). Patent 12,097,285. Retrieved from https://patents.google.com/patent/US12097285B2
- WIPO Patent Scope. (2023). Patent family data and international filings. Retrieved from https://patentscope.wipo.int/
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