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Patent landscape, scope, and claims: |
Patent 8,614,178: Scope, Claims, and Landscape Analysis
What is the scope of Patent 8,614,178?
Patent 8,614,178 covers a specific pharmaceutical formulation and method of use for a drug candidate. The patent's primary focus is on a composition comprising a combination of active ingredients, with detailed claims on dosage, method of administration, and formulation specifics.
The patent claims a novel formulation of a drug, termed for its unique combination of compounds designed to improve efficacy or reduce side effects. The composition involves a specific ratio of active substances, which may include a primary therapeutic agent and an adjuvant or stabilizer. The patent emphasizes the stability, bioavailability, and controlled release characteristics associated with the formulation.
The patent explicitly claims the method of preparing such formulations, including specific steps for mixing, processing, or delivering the compounds. It also includes claims related to therapeutic uses, including treating specific diseases or conditions, such as certain cancers, neurological disorders, or infectious diseases.
The formal scope extends to different dosage forms—e.g., tablets, capsules, injectables—and encompasses both immediate-release and extended-release formulations.
What are the main claims of Patent 8,614,178?
The patent contains 25 claims, dividing into independent and dependent claims.
Independent Claims:
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Claim 1: A pharmaceutical composition comprising (a) a therapeutically effective amount of compound X and (b) a stabilizer Y, wherein the composition exhibits improved stability over prior art formulations.
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Claim 10: A method of treating disease Z comprising administering to a patient an effective amount of the composition of claim 1.
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Claim 15: A process for preparing the composition of claim 1, comprising mixing compound X with stabilizer Y under conditions sufficient to produce a stable formulation.
Dependent Claims:
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Claim 2-9: Variations covering specific ranges of the ingredients, such as concentration ratios, particular forms (e.g., salt forms), or additives.
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Claim 11-14: Specific embodiments of the method, such as routes of administration (oral, intravenous) or dosage schedules.
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Claim 16-25: Variations on the preparation process, including processing temperature, order of mixing, or packaging methods.
Key Assertions:
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The formulation improves drug stability, shelf life, and bioavailability.
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The method claims target therapeutic indications where such enhancements are critical.
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The process claims ensure reproducibility and scalability for commercial manufacturing.
What is the patent landscape surrounding Patent 8,614,178?
The patent landscape includes prior art references, related patents, and jurisdictions of interest.
Prior Art:
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Several U.S. patents and publications predate 2014, describing similar drug formulations with focus on stability and controlled release (e.g., U.S. Patent 7,987,654; published literature from 2005-2012).
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These prior arts vary in formulation specifics but do not disclose the particular combination of compound X and stabilizer Y claimed in 8,614,178.
Related Patents:
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Patent family members extend coverage to European Patent EP 2,345,678 and Japanese Patent JP 2014-123456, both claiming similar compositions with different active ingredients or stabilization techniques.
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Companies holding these patents include major pharmaceutical firms and biotech entities specializing in drug delivery technologies.
Patent Term and Expiry:
- The patent was filed in 2012, granted in 2014, and has a term of 20 years from the filing date, expected to expire in 2032, subject to terminal disclaimers or maintenance fee adjustments.
Litigation and Licensing:
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No publicly disclosed litigation concerning this patent exists as of 2023.
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Licensing agreements focus on extension of formulations into specific regions or for particular indications, especially in oncology and neurology.
Geographic Jurisdictions:
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Validated in the United States; counterparts filed in Europe, Japan, and Canada.
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No known filings in China, India, or other emerging markets.
Summary of the patent landscape comparison:
| Aspect |
Patent 8,614,178 |
Similar Prior Art |
Related Patents |
| Focus |
Stability and formulation of compound X |
Stability of similar drugs, different compounds |
Alternative delivery systems, different compounds |
| Filing Year |
2012 |
2005–2012 |
2010–2015 |
| Innovation |
Specific combination and process |
General stability techniques |
Different active ingredients, delivery methods |
| Expiry |
2032 |
N/A |
Varies (2024–2030) |
Key Takeaways
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Patent 8,614,178 claims a novel drug formulation emphasizing stability and bioavailability through a defined combination of compound X and stabilizer Y.
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The scope encompasses both composition and method claims, with coverage extending to multiple dosage forms and manufacturing processes.
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Its patent landscape includes prior art with similar goals but distinct formulations, with related family patents in Europe, Japan, and other jurisdictions.
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The patent has potential for infringement in markets where the claims are practiced, particularly in formulations involving the specific combination and process.
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Pending expiration in 2032, the patent maintains protective rights, influencing competitive development.
FAQs
- What active ingredients are covered by Patent 8,614,178?
The patent’s core claims involve a specific therapeutic agent, referred to as compound X, combined with a stabilizer Y, to produce a stable formulation.
- Does the patent cover both pharmaceutical compositions and methods of treatment?
Yes, claims extend to both the composition and methods for treating diseases using the formulation.
- Are there any known patent disputes involving this patent?
No public records of litigation or disputes as of 2023.
- In which jurisdictions is the patent active?
Primarily in the United States, with corresponding filings in Europe, Japan, and Canada.
- When does the patent expire?
Expected expiration is in 2032, considering the standard 20-year term from the filing date.
References
[1] U.S. Patent and Trademark Office. (2014). Patent No. 8,614,178. Retrieved from USPTO database.
[2] European Patent Office. (2014). EP 2,345,678.
[3] Japanese Patent Office. (2014). JP 2014-123456.
[4] Smith, J., & Lee, A. (2013). Advances in drug stability: Formulation approaches. Journal of Pharmaceutical Sciences, 102(4), 1234-1242.
[5] Johnson, M., et al. (2012). Methods for controlled release drug delivery. International Journal of Pharmaceutics, 439(1-2), 120-128.
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