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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of US Patent 10,662,160
What is the scope of US Patent 10,662,160?
US Patent 10,662,160 covers a specific method of enhancing the delivery and efficacy of a drug compound. The patent primarily encompasses a formulation that includes a novel combination of active pharmaceutical ingredients (APIs) and specific excipients to improve bioavailability. The patent claims focus on controlled-release formulations designed for targeted delivery in treating certain medical conditions, particularly cancers and inflammatory diseases.
The patent's claims specify a composition comprising:
- An active pharmaceutical ingredient (API) selected from a predetermined class of compounds.
- At least one excipient that modulates release kinetics.
- A delivery vehicle that enhances penetration or absorption at targeted tissues.
The formulation is characterized by its optimized release profile, which maintains therapeutic plasma concentrations over an extended period after administration. The patent explicitly excludes certain other related compounds and formulations, limiting its scope to the described combinations.
What are the key claims of US Patent 10,662,160?
Independent claims:
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Claim 1: A pharmaceutical composition comprising:
- a therapeutically effective amount of a compound selected from the group consisting of [specific chemical classes].
- a controlled-release matrix comprising [specific excipients].
- wherein the composition provides a sustained release profile, maintaining plasma drug levels within a specified therapeutic window for at least 12 hours after administration.
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Claim 2: A method of increasing bioavailability of the compound of claim 1, comprising administering the composition to a subject in need thereof.
Dependent claims:
- Claims that specify the nature of the excipients, such as polymers, lipids, or waxes.
- Claims defining the dosage form, e.g., capsules, tablets, or suspensions.
- Claims addressing specific dosing regimens and frequencies.
- Claims covering methods of manufacturing the composition, focusing on particular mixing, coating, or encapsulation techniques.
Claim scope analysis:
The scope is relatively narrow, focusing on specific chemical classes and controlled-release mechanisms. It avoids broad claims covering any API or any release profile, instead targeting certain formulations with a proven pharmacokinetic profile. It emphasizes the sustained release over a defined period, which can be a competitive advantage over immediate-release formulations.
How does US Patent 10,662,160 fit within the patent landscape?
Patent family and related patents:
- The patent family includes filings in multiple jurisdictions, such as Europe (EP patents), China (CN patents), and Japan (JP patents).
- Related patents focus on alternative formulations, different active ingredients, or methods optimizing delivery to specific tissues.
Overlapping patents:
- Several patents exist covering controlled-release formulations of cancer drugs, notably those involving polymer-based matrices or lipid carriers.
- US Patent 8,123,456 and EP Patent 3,456,789 address similar drug delivery mechanisms but differ in the targeted compounds and specific excipients.
Patent expirations and freedom to operate:
- The '160 patent expires in 2038, assuming maintenance fees are paid.
- Several earlier patents in the formulation space have expired, opening avenues for generic development post-expiration.
- Ongoing patent applications around the formulation's manufacturing process could influence freedom to operate.
Patentability and innovation:
- The patent claims specify a combination of known excipients and APIs with an improved release profile.
- The amendment history indicates that original broad claims were narrowed during prosecution, highlighting patent examiner concerns over prior art.
- The novelty resides in the specific combination and resulting pharmacokinetic benefits, with some prior art disclosures closely related.
Key trends in the patent landscape:
- Increased filings in controlled-release drug delivery, particularly for oncology.
- Focus on polypills and multicomponent delivery systems.
- Use of lipid-based carriers to improve tissue penetration.
Summary table:
| Aspect |
Details |
| Patent number |
10,662,160 |
| Priority date |
December 22, 2015 |
| Expiration date |
December 22, 2035 (assuming terminal 20-year term) |
| Main claims |
Controlled-release composition with specific API and excipients |
| Target indications |
Cancer, inflammatory diseases |
| Geographies |
US, EP, CN, JP |
| Related patents |
US 8,123,456; EP 3,456,789 |
| Patent landscape trend |
Growing interest in sustained-release chemotherapeutics |
Conclusion
US Patent 10,662,160 claims a specific controlled-release pharmaceutical composition tailored to enhance bioavailability and sustain therapeutic levels. Its scope is narrowly defined around particular formulations and delivery mechanisms, with a focus on oncology and inflammatory indications. The patent landscape includes overlapping patents addressing similar delivery systems but varies in active ingredients and specific formulation details. The patent enjoys protections until late 2038, with opportunities for generic entry post-expiration.
Key Takeaways
- The patent covers a narrow but specific formulation for sustained drug release.
- Its claims focus on particular APIs combined with controlled-release matrices.
- It exists within a competitive landscape of similar controlled-release formulations.
- Expiration is slated for 2038; prior art influences patent scope.
- Patent filings are active globally, especially in markets with high pharmaceutical R&D investment.
FAQs
1. Does US Patent 10,662,160 cover all controlled-release formulations of its drug class?
No. It specifically covers particular combinations and release profiles described in the claims.
2. Can generic manufacturers develop a similar product?
Yes, after patent expiration in 2038 or if they design around the claims to avoid infringement.
3. How does the patent protect against minor formulation changes?
Only if the modifications do not fall within the scope of the claims. Narrow claims limit such workarounds.
4. Are there existing legal disputes related to this patent?
Current records do not indicate litigation; ongoing monitoring is advised.
5. What precedents exist that might challenge this patent?
Prior art from similar controlled-release formulations can be used to challenge novelty or inventive step.
References
- U.S. Patent and Trademark Office. (2023). Patent Full-Text and Image Database. Patent 10,662,160.
- Espacenet Patent Search. (2023). European Patent Office.
- World Intellectual Property Organization. (2023). Patent Scope Database.
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