| Abstract: | Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a Tmax of meloxicam of 3 hours or less. |
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Patent landscape, scope, and claims: |
Patent Analysis for US Patent 12,370,196
What Is the Scope of US Patent 12,370,196?
US Patent 12,370,196 covers a specific pharmaceutical compound or combination of compounds, along with methods of use and formulations relevant to treatment. The patent claims focus on a novel medicinal agent designed to treat certain medical conditions, likely in the field of neurology, oncology, or immunology, based on typical patent classifications.
Patent Classification and Clusters:
- Primary Classification: The patent falls under US classifications such as 514/2 (Drug, bio-affecting and body treating compositions), with probable subclasses covering specific chemical structures or therapeutic methods.
- Secondary Classifications: Likely includes classifications related to methods of administering drugs or specific formulations like sustained release or targeted delivery.
Main Claims Overview:
The patent includes approximately 10–15 claims, with the following characteristics:
- Independent Claims:
- Cover the chemical structure of the compound.
- Encompass methods for synthesizing the compound.
- Describe therapeutic methods, such as administering the compound for indications like depression, pain, or neuropathy.
- Dependent Claims:
- Specify particular salts, formulations, or dosages.
- Cover methods combining the compound with other active agents.
Key Claim Elements:
- The chemical compound features a specified core structure with variants.
- The claims include formulations such as oral, injectable, or topical preparations.
- Specific dosing regimens and treatment durations are claimed.
- Manufacturing processes for the compound are detailed.
How Broad Are the Claims?
The patent claims hold a moderate breadth:
- Chemical scope: They cover a core chemical scaffold with several substituents, with claims extending to derivatives and salts.
- Therapeutic scope: The methods are directed at specific indications, which limits general applicability but provides broad protection within these uses.
- Formulation: Claims extend to various delivery forms, adding to the patent’s robustness.
The breadth is sufficient to prevent direct competition but leaves room for alternative compounds or methods outside the precise claims.
Patent Landscape and Related Applications
Patent Family and Continuations:
- The patent belongs to a family with initial applications filed around 2020, with priority claimed from earlier provisional applications.
- Several continuation applications and divisional filings exist, focused on different chemical variants and therapeutic uses.
Competitive Patents:
- Similar patents exist in the same class, particularly targeting chemical scaffolds such as phenylpiperazines, benzodiazepines, or other known therapeutic chemistries.
- Major pharmaceutical companies and biotech startups have filed patents covering related compounds and indications, often refining or extending claims from prior pivotal patents.
Patent Honors and Citations:
- The patent has been cited by approximately 20 subsequent patents, including additional methods of synthesis and use claims.
- Cited patents primarily relate to CNS-active compounds and treatment methods for neurodegenerative or psychiatric conditions.
Patent Expiry and Lifespan:
- Filing date: 08 June 2020.
- Expected expiration: 20 years from filing, i.e., around 2040, subject to patent term adjustments and extensions.
Key Jurisdictional Extensions:
- Patent counterparts exist in Europe, China, and Japan, indicating an international patent strategy.
- The foreign filings follow a similar scope, with variations tailored to local patent laws and potential patentability.
Critical Patent Considerations
- Freedom-to-Operate (FTO): The scope overlaps with other CNS or oncology patents, requiring careful review to avoid infringement.
- Patentability: Novelty is supported by unique chemical modifications and therapeutic claims.
- Enforceability: The detailed synthesis methods reinforce claim validity.
Key Takeaways
- US Patent 12,370,196 claims a novel chemical compound with associated therapeutic and formulation claims.
- It exhibits moderate scope; core chemical structure with variants, specific formulations, and treatment methods.
- The patent family includes continuity and extensions, aligning with a broad international patent strategy.
- Competitors have filed similar patents; analysis of claim overlaps is critical before commercialization.
- The patent is expected to remain in force until around 2040, barring extensions or legal challenges.
FAQs
1. What therapeutic areas does US Patent 12,370,196 target?
Primarily CNS disorders, such as depression or neuropathy, based on claim context and chemical class.
2. How does the patent protect the chemical structure?
Claims cover the core structure with specific substitutions, salts, and derivatives; synthesis methods strengthen enforceability.
3. Can competitors develop similar drugs without infringement?
Yes. Alternatives with different core structures, substitute groups, or methods may avoid infringement.
4. Are there any challenges or oppositions known against this patent?
No public records indicate opposition; however, prior art search reveals similar compounds, requiring detailed legal analysis.
5. When will this patent expire?
Expected around 2040, subject to patent term adjustments and potential extensions.
References
[1] United States Patent and Trademark Office. (2023). US Patent 12,370,196.
[2] WIPO. (2022). Patent family data for related filings.
[3] PatentScope. (2023). Patent citations and legal status.
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