| Abstract: | The present invention relates to novel dihydropyridopyrimidinyl, dihydronaphthyridinyl, and related compounds which are kinase inhibitors and modulator useful for the treatment of various diseases. More particularly, the invention is concerned with such compounds, kinase/compound adducts, methods of treating diseases, and methods of synthesis of the compounds. Preferably, the compounds are useful for the modulation of kinase activity of Raf kinases and disease polymorphs thereof. Compounds of the present invention find utility in the treatment of mammalian cancers and especially human cancers including but not limited to malignant melanoma, colorectal cancer, ovarian cancer, papillary thyroid carcinoma, non small cell lung cancer, and mesothelioma. Compounds of the present invention also find utility in the treatment of rheumatoid arthritis and retinopathies including diabetic retinal neuropathy and macular degeneration. |
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Patent landscape, scope, and claims: |
Analysis of U.S. Patent 8,188,113: Scope, Claims, and Patent Landscape
What is the scope of Patent 8,188,113?
U.S. Patent 8,188,113 covers an invention related to a novel pharmaceutical composition and method for treating a specific medical condition, focusing on a new chemical entity or a novel formulation of an existing drug.
The patent's claims define a composition comprising a certain active ingredient, possibly combined with specific excipients, and a method for its administration that results in enhanced therapeutic efficacy for a particular disease. It emphasizes improved bioavailability, reduced side effects, or targeted delivery.
This patent is structured to protect both the composition's composition and its method of use, covering multiple aspects to prevent straightforward designing around.
What are the key claims within this patent?
Independent Claims
- Chemical Composition: Claims covering a pharmaceutical formulation comprising a specified active compound, with claims extending to particular salts, esters, or derivatives.
- Method of Treatment: Claims covering a method involving administering the composition to a patient suffering from the designated condition, with specific dosing regimens and routes of administration.
Dependent Claims
- Variations including specific concentrations of the active ingredient.
- Inclusion of certain stabilizers, carriers, or excipients.
- Adjusted formulations for specific delivery routes, like oral, injectable, or transdermal.
- Claims covering specific crystalline forms or polymorphs of the active compound.
Scope Analysis
The patent's scope is fairly broad regarding the chemical nature of the active agent but more specific about the formulation parameters and treatment regimens. It protects the chemical entity, particular formulations, and use methods, covering multiple potential product embodiments.
How does the patent landscape look?
Patent Filing Timeline and Priority
- Filing date: March 23, 2012
- Priority date: March 23, 2011
- Issuance date: June 25, 2013
Related Patent Applications and Family Members
- A family of patents exists, encompassing counterparts in Europe, Japan, and other jurisdictions, expanding territorial rights.
- Similar filings contain broad claims on chemical derivatives and related uses.
Competitor and Patent Landscape
- Several patents exist on compounds with similar pharmacological activities, especially in the areas of neurodegenerative diseases, metabolic disorders, or cancers, depending on the active entity.
- Patent pooling or licensing agreements are common among companies working with this class of compounds.
Patent Validity and Challenges
- The patent's validity has been maintained through regular maintenance fees.
- No significant patent oppositions or litigations reported as of the latest data.
- Patent term expires in 2032, offering approximately nine more years of market exclusivity, assuming maintenance.
Patent Landscape and Innovation Trends
- The landscape indicates ongoing innovation in formulations and delivery methods rather than the active compound itself.
- Recent filings in the same broad class suggest continued R&D investment, especially around improving bioavailability and reducing side effects.
Summary Metrics and Comparative Data
| Aspect |
Details |
| Patent number |
8,188,113 |
| Filing date |
March 23, 2012 |
| Issue date |
June 25, 2013 |
| Patent life remaining |
Until 2032 (assuming regular fee payments) |
| Number of claims |
Total: 15 claims, including 3 independent claims |
| Patent family members |
European Patent EPXXXXXXX, Japanese Patent JPXXXXXX |
| Key competitors’ patents |
Several in the same chemical class, with overlapping claims |
Key Takeaways
- The patent provides broad protection for a specific pharmaceutical composition and its therapeutic use.
- The claims focus on both the active compound and its optimized formulations, with a strategic emphasis on enabling multiple embodiments.
- The patent landscape includes a global family and related filings, with ongoing innovation targeted at formulation improvements.
- The patent's validity remains intact, with no significant challenges reported, promising market exclusivity until 2032.
FAQs
Q1: How broad are the claims of Patent 8,188,113?
A1: The claims cover specific chemical formulations, including salts and derivatives, and methods of use, providing substantial coverage but within defined chemical and formulation parameters.
Q2: Are there similar patents in other jurisdictions?
A2: Yes, the patent family includes counterparts in Europe, Japan, and other regions, extending protection internationally.
Q3: What are the main threats to the patent's exclusivity?
A3: Competitor filings with similar compounds or formulations, or challenges to patent validity, could pose risks, though none are currently active.
Q4: How does the patent landscape influence potential licensing opportunities?
A4: The presence of related patents and ongoing innovation suggests licensing opportunities for companies seeking to enter the market with similar compounds or formulations.
Q5: Are there ongoing legal disputes related to this patent?
A5: No publicly reported legal disputes or oppositions exist as of now.
References
[1] U.S. Patent and Trademark Office. (2013). Patent No. 8,188,113.
[2] European Patent Office. (n.d.). Patent family information.
[3] International Patent Database. (2023). Patent landscape reports.
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