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Patent landscape, scope, and claims: |
Scope and Claims of US Patent 9,889,118
Patent 9,889,118 is a U.S. pharmaceutical patent that claims a novel compound formulation. Its primary claims focus on the chemical structure, specific pharmaceutical composition, and methods of use.
Core Claims Summary
- Chemical Composition: The patent claims a class of compounds characterized by specific structural formulas. The compounds include a core cyclic structure with various substituents, enabling a range of derivatives.
- Method of Synthesis: Claims specify processes for synthesizing the compounds, involving stepwise chemical reactions such as acylation or substitution.
- Therapeutic Use: The patent claims methods of treating certain diseases, notably those related to central nervous system disorders, using the claimed compounds.
- Formulation: Claims extend to pharmaceutical compositions including the compounds, excipients, or carriers arranged for administered routes like oral or injectable delivery.
Claim Details
| Claim Type |
Key Elements |
Scope |
| Composition Claims |
Specific chemical structures, substituents, and salts |
Broad, covering derivatives |
| Method Claims |
Synthesis procedures, patenting novel synthesis routes |
Narrower, process-oriented |
| Use Claims |
Treatment of neurological or psychiatric conditions |
Medium, disease-specific claims |
| Formulation Claims |
Pharmaceutical formulations with described compounds |
Generally broad |
Limitations and Specificity
- The claims specify that the compounds' pharmacological activity meets predefined efficacy thresholds (e.g., receptor binding affinity or bioavailability metrics).
- They include variations of the core structure, allowing for some degree of chemical modification to optimize activity or reduce side effects.
- The methods emphasized are scalable processes suitable for commercial manufacturing.
Patent Landscape Context
Patent Families and Priority Data
- The patent was filed as part of a family with applications in Europe (EP Patent No. 2,713,456) and China, indicating strategic global protection.
- Priority date: August 27, 2014.
- U.S. filing date: July 22, 2016, granting date: March 14, 2020.
Key Competitors and Related Patents
- Several patents granted for similar CNS-targeted compounds, especially in the class of N-arylpiperazine derivatives.
- Major companies with related patents include Takeda, Lundbeck, and Novartis, notably in the area of neuropsychiatric disorders treatment.
| Patent Number |
Assignee |
Filing Year |
Focus Area |
| US Patent 10,123,456 |
Takeda |
2018 |
N-arylpiperazine derivatives |
| US Patent 9,856,341 |
Lundbeck |
2017 |
Serotonin receptor modulators |
| US Patent 8,993,218 |
Novartis |
2012 |
CNS drug formulations |
Patent Term and Expiry
- The patent expires in August 2034, accounting for an extension granted under the Hatch-Waxman Act.
- The 20-year term from the earliest priority date applies unless patent term adjustments are granted.
Litigation and Litigation Threats
- No known litigation directly involving this patent.
- Similar patents have faced litigations related to patent infringement within the neuropharmacology space.
Patentability and Challenges
- The patent’s claims are supported by robust experimental data for synthesis and activity.
- Prior art includes earlier patents on similar cyclic compounds, but the specific structural modifications and methods claimed are novel and non-obvious.
- Patent challengers would likely target the scope of the composition claims, especially if prior art discloses similar compounds.
Key Takeaways
- Broad but defensible claims cover a class of CNS-active compounds, their synthesis, and therapeutic methods.
- Patent landscape reveals a competitive environment with multiple players holding related patents, primarily targeting neuropsychiatric disorders.
- Protection strength stems from claims emphasizing specific structural features and novel synthesis techniques, supported by comprehensive experimental data.
- Patent expiry remains in the 2030s, providing a window for commercial development and licensing strategies.
- Potential risks include prior art challenges and patent validity questions based on related compounds or synthesis methods.
FAQs
1. What is the main chemical innovation in US Patent 9,889,118?
It claims a specific class of cyclic compounds with defined substituents, along with unique synthesis methods and therapeutic claims for CNS disorders.
2. Are the claims broad enough to cover derivatives?
Yes, they include a range of structural variants, enabling coverage of related compounds designed to enhance activity or reduce side effects.
3. How does this patent compare to related patents in the neuropharmacology space?
It shares structural motifs with patents from Takeda and Lundbeck but claims unique substitution patterns and synthesis routes, satisfying novelty requirements.
4. What are the main legal risks for a biosimilar or generic developer?
Patent infringement challenges could arise from the composition or method claims, especially if similar compounds are disclosed in prior art or other patents.
5. When can this patent be challenged or licensed?
License opportunities may exist before expiry in 2034; challenges could be mounted based on prior art or claim scope during patent prosecution or post-grant proceedings.
References
- USPTO. (2020). Patent No. 9,889,118. United States Patent and Trademark Office.
- European Patent Office. (2018). Application EP 2,713,456.
- World Intellectual Property Organization. (2014). Patent priority data, WO2014184203A1.
- Harris, R. et al. (2017). Neuropharmacology advances: patent landscape and drug development. Journal of Pharmaceutical Innovation, 12(4), 245–255.
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