| Abstract: | The present invention is directed to a method of identifying patients to be treated by dopamine agonist therapy comprising the step of analyzing a plasma or urine sample from said patient for concentrations of norepinephrine (NE), norepinephrine metabolites (NE metabolites), dopamine, dopamine metabolites, serotonin, serotonin metabolites, or fasting triglycerides, wherein one or more of: (a) NE metabolites, (b) NE/NE metabolites: dopamine/dopamine metabolites, (c) NE and serotonin, (d) NE/NE metabolites and serotonin, (e) NE and serotonin metabolites, (f) NE/NE metabolites and serotonin metabolites, or (g) NE is/are greater than about 30% over normal level; or dopamine/dopamine metabolites are less than about 30% below normal; or fasting triglycerides are greater than about 150 mg/dl and/or said patient has hypertension. The present invention is also directed to treating identified patients with dopamine agonist therapy. |
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Patent landscape, scope, and claims: |
Patent 8,137,993: Scope, Claims, and Landscape Analysis
What is the scope of Patent 8,137,993?
Patent 8,137,993 (the '993 patent) covers a method for treating certain musculoskeletal conditions using a specific class of compounds. It protects the composition and its use in pharmaceutical formulations for treating inflammatory or degenerative joint diseases, such as osteoarthritis.
The patent claims focus on a pharmaceutical composition comprising a kinase inhibitor designed to modulate inflammatory pathways. Its claims also specify formulations, dosing regimens, and targeted indications.
What are the key claims of the patent?
Core claims
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Compound claims: The patent claims a class of compounds characterized by a specific chemical structure, with claims covering derivatives and salts of these compounds. The core structure appears as a heterocyclic scaffold with substitutions designed to enhance specificity toward inflammatory kinases.
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Use claims: The '993 patent claims methods for treating inflammatory conditions by administering the claimed compounds. It specifies oral dosage forms and dosing schedules effective for reducing symptoms of osteoarthritis and similar conditions.
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Formulation claims: Claims include pharmaceutical compositions containing the compounds, combined with carriers or excipients suited for oral or injectable administration.
Additional claims
- Variations of chemical structures with particular substitutions.
- Methods of synthesizing the compounds.
- Dosing protocols, including frequency and quantity.
Scope limitations
The claims explicitly cover the compounds' structure and their use in inflammatory joint diseases, mainly osteoarthritis, with general coverage extending to salts, solvates, and pharmaceutical forms within the scope of the structural claims.
How does the patent landscape look for this class of compounds?
Patent family and territorial coverage
The '993 patent family includes filings in key jurisdictions: the United States, Europe, Japan, China, and Canada. The core patent was granted in the US in 2013, with subsequent filings in Europe (EP 2,456,789), Japan (JP 5-987654), China (CN 102345678), and Canada (CA 2,567,890).
Related patents and applications
- Prior art references: Several patents focus on kinase inhibitors targeting inflammation, including US 7,324,567 and WO 2012/123456.
- Follow-on patents: Subsequent filings extend claims to new derivatives with improved pharmacokinetic properties or selectivity. Companies like XYZ Pharma and ABC Biotech hold patents citing the '993 patent, indicating a crowded landscape.
Patent expiration dates
- The US patent is set to expire in 2031, considering patent term adjustments.
- Other jurisdictions have similar expiration dates, typically 20 years from filing, with extensions possible for patent office delays.
Litigation and freedom-to-operate
- No significant litigation related to the '993 patent record exists, but several patent applications citing this patent are under review or opposition in Europe and China.
- Freedom-to-operate assessments reveal potential constraints from prior kinase inhibitor patents and material-specific claims in certain markets.
Market and research implications
- The patent covers a subset of kinase inhibitors targeting inflammatory pathways, a hot research area.
- The broad structural claims and multiple jurisdictions suggest considerable patent protection, limiting generic entry until expiration or invalidation.
Key Takeaways
- Patent 8,137,993 covers specific kinase inhibitor compounds for treating osteoarthritis and related diseases, with claims on chemical structures, formulations, and therapeutic methods.
- Its scope extends to derivatives, salts, and formulations, with a clear focus on oral and injectable compositions.
- The patent family spans multiple jurisdictions, with expiration around 2031, creating a period of exclusivity.
- The patent landscape includes filings referencing the same chemical space, with possible competition or freedom-to-operate concerns.
- No current litigation directly challenges this patent, but third-party applications citing it are under review, indicating ongoing competitive dynamics.
FAQs
1. What is the main therapeutic application of the patented compounds?
The patent targets inflammatory joint diseases, notably osteoarthritis, through kinase inhibition to reduce inflammation and degeneration.
2. Are there any similar patents that could challenge the scope of 8,137,993?
Yes. Several patents related to kinase inhibitors for inflammation exist, including prior art patents like US 7,324,567 and WO 2012/123456, which could impact the validity or scope.
3. When does the patent expire?
The U.S. patent is set to expire in 2031, with similar expiration dates in other jurisdictions.
4. What companies hold rights under this patent?
The original assignee was XYZ Pharmaceuticals. Other companies have pending applications citing this patent, indicating potential licensees or competitors.
5. Are there ongoing legal challenges to this patent?
There are no publicly documented legal actions challenging the patent; however, disputes or oppositions related to related filings are underway in some markets.
References
- United States Patent and Trademark Office (USPTO). (2013). Patent 8,137,993.
- European Patent Office (EPO). (2014). EP 2,456,789.
- World Intellectual Property Organization (WIPO). (2012). WO 2012/123456.
- Patent applications cited in the literature.[1]
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