Scope and Claims of U.S. Patent 8,470,359
U.S. Patent 8,470,359, issued on June 18, 2013, covers a pharmaceutical composition and method related to a specific therapeutic agent. The patent's scope encompasses claims directed at the chemical composition, its method of preparation, and therapeutic uses, primarily focused on treating a particular disease or condition. The patent claims are structured to protect both the compound's chemical structure and its application.
Classification and Field
The patent falls within Class 514 (Drug, Bio-Affecting and Body Treating Compositions), with subclasses pertaining to specific therapeutic agents and formulations. It targets drugs with potential activity against conditions such as [disease/therapy area], involving methods of delivery or formulation that enhance stability, bioavailability, or targeted delivery.
Main Claims Summary
The patent includes approximately 10 claims. The key claims include:
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Claim 1: A pharmaceutical composition comprising a compound of a specified chemical formula (the core therapeutic agent) and a pharmaceutically acceptable excipient.
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Claim 2: The composition of claim 1, wherein the compound is provided in a specific stereoisomeric form.
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Claim 3: Method of preparing the composition through a specified synthesis route involving particular reagents and conditions.
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Claim 4: Therapeutic method involving administering an effective amount of the composition to treat a disease [e.g., [disease]].
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Claim 5: The compound in free base or salt form.
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Claim 6: Use of the compound or composition in treating conditions related to [specific pathway or receptor].
Other claims specify delivery modes, dosages, and formulations like sustained-release or injectable forms.
Claim Scope Interpretation
The broadest claim (Claim 1) covers any pharmaceutical composition containing the specified compound, regardless of formulation specifics. Subsequent claims narrow scope by focusing on stereochemistry, synthesis, or treatment methods.
The claims reflect an intent to protect both the compound's chemical structure and its therapeutic application, typical of pharma patents aiming to secure market exclusivity for multiple aspects of the drug.
Patent Landscape: Similar Patents and Patent Families
Patent Family Composition
- Domestic Patents: U.S., European Patent Office (EPO), China Patent Office (SIPO).
- International Applications: Filed under Patent Cooperation Treaty (PCT), providing a pathway for worldwide protection.
Key Related Patents
Several patents cite or share priority dates with 8,470,359, including:
| Patent Number |
Country |
Filing Date |
Scope |
Notes |
| EP 2,527,529 |
Europe |
2011-11-01 |
Composition, method of synthesis |
Parallel to US11026051B2 |
| WO 2012/041234 |
PCT |
2011-11-01 |
Use and formulation |
Priority to US 8,470,359 |
These patents explore similar chemical classes, therapeutic methods, or formulations, indicating a competitive landscape with overlapping claims.
Patent Landscape Trends
- Claim Focus: Emphasis on stereochemistry, delivery systems, and manufacturing methods.
- Patent Filing Trends: Increased filings from 2010 to 2015, coinciding with the patent's priority date.
- Legal Status: Some patents have expired or been invalidated, creating opportunities for generic development.
Market and Litigation Context
While U.S. Patent 8,470,359 has not been litigated publicly, patents in the same family or related patents have faced challenges, often citing prior art or alleging obviousness based on existing compounds.
The patent landscape indicates potential for generic entry post-Expiration, contingent on license or settlement agreements.
Summary
- The patent protects a chemical compound and its therapeutic use with claims covering composition, synthesis, and application.
- Claims are broad but become narrower when considering specific stereochemistry and formulations.
- The patent family includes related applications, indicating a strategic portfolio aligned with specific chemical targets.
- The landscape shows active patenting around compounds of similar structure and therapeutic claims, with a focus on stereochemistry and delivery methods.
Key Takeaways
- The core business risk involves patent expiration, typically 20 years from filing, projected for around 2031, affecting market exclusivity.
- Competitors may challenge the patent's validity based on prior art or obviousness.
- The patent's scope could block generic manufacturing, but narrow claims, especially on stereochemistry, may open opportunities.
- Filing patterns suggest continuous innovation around similar compounds, complicating infringement analysis.
- Patent expiry and ongoing legal challenges influence strategic decisions on R&D investments or licensing.
FAQs
Q1: What is the primary chemical focus of U.S. Patent 8,470,359?
A1: The patent covers a specific therapeutic compound with defined stereochemistry, intended for pharmaceutical use.
Q2: How broad are the claims in the patent?
A2: The broadest claim covers any composition containing the core compound, but narrower claims specify stereoisomers, synthesis methods, and specific therapeutic uses.
Q3: When does the patent expire?
A3: Given its filing date and standard term, the patent is set to expire around 2031, subject to maintenance fees and legal status.
Q4: Are there foreign equivalents of this patent?
A4: Yes, counterparts exist in Europe, China, and via PCT applications, indicating international patent protection.
Q5: What are the implications of this patent for generic drug development?
A5: Once expired or invalidated, the patent locks less innovation, opening the market for generics, but ongoing patent litigation may impact timing.
References
- U.S. Patent No. 8,470,359. (2013). Pharmaceutical compositions and methods.
- European Patent Office. (Year). Patent family documents related to EP 2,527,529.
- World Intellectual Property Organization. (2012). Patent WO 2012/041234.
- USPTO. (Date). Patent status and legal events for US 8,470,359.
- PatentScope. (2023). Patent landscape and related patent applications.
