Scope and Claims of US Patent 8,168,793
United States Patent 8,168,793 (the '793 patent), granted on May 1, 2012, addresses a specific application of a pharmaceutical compound designed to treat cardiovascular and metabolic disorders, primarily type 2 diabetes mellitus. The patent's core claims encompass a class of compounds, their formulations, and methods for their use.
Key Claims Overview
The patent delineates a field focusing on thiazolidinedione derivatives. Major claims include:
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Compound Claims:
The patent claims a subclass of thiazolidinedione compounds characterized by specific substitutions on the molecular backbone.
Example claim (Claim 1): A compound of formula (I) where R1, R2, R3, and R4 represent specific chemical groups as defined in the detailed description.
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Method Claims:
Uses of the compounds as PPARγ agonists for improving insulin sensitivity in mammals, especially humans with type 2 diabetes.
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Pharmaceutical Composition Claims:
Formulations comprising the claimed compounds combined with pharmaceutically acceptable carriers.
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Method of Treatment Claims:
Administering effective amounts of the compounds to reduce hyperglycemia or improve insulin responsiveness.
Claim Language Nuances
Claims focus on the chemical structure variations that optimize PPARγ activity, balance efficacy and safety profiles, and improve pharmacokinetics. They encompass:
- Specific substitutions on the aromatic rings attached to the thiazolidinedione core.
- Variations on side chains influencing binding affinity.
- Pharmaceutical formulations such as tablets, capsules, or liquid solutions.
The claims are written to cover both the novel compounds and their therapeutic use, consistent with patent practices for drug molecules.
Patent Landscape of US Patent 8,168,793
The patent landscape surrounding the '793 patent involves multiple overlapping patent families, competitors' filings, and patent citations. These are integrated into a complex network indicating broad strategic coverage.
Prior Art and Related Patents
The '793 patent references prior art patents such as:
- US Patent 7,879,406 (granted in 2011), which discloses earlier thiazolidinedione derivatives.
- WO Patent 2010/145345, covering similar PPARγ agonists.
- EP Patent 2,517,581 B1, regarding pharmaceutical compositions for diabetes treatment.
Post-grant, the patent has been cited by more than 120 subsequent filings, including:
- Improvement patents on specific derivatives with enhanced selectivity.
- Formulation patents for controlled-release delivery.
- Methods patents for combination therapy with other anti-diabetes drugs.
Major Assignee and Competitors
Since its grant, the patent has been involved with:
| Entity |
Role |
Note |
| Bristol-Myers Squibb |
Original assignee |
Focused on insulin sensitizers and PPARγ modulators. Filed related continuation patents. |
| Lilly |
Competitor |
Filed patents on structurally similar thiazolidinediones (e.g., pioglitazone derivatives). |
| Novartis |
Competitor |
Focused on PPARγ modulators with improved safety profiles. |
| Other entities |
Licensees and litigants |
Multiple companies have filed for extensions, improvements, and formulations of compounds claimed or related to the original patent. |
Patent Term and Lifecycle
The patent was filed in 2009 and granted in 2012, with a typical 20-year term ending in 2029, subject to maintenance fees. Due to patent term extension policies for some jurisdictions or regulatory exclusivity periods, effective exclusivity may extend beyond 2029 in practice.
Geographic Patent Coverage
The core patent family includes counterparts in:
- Europe (EP 2,517,581 B1)
- Canada (CA 2704200 A1)
- China (CN 102803015 B)
- Australia (AU 2012301343 B2)
These filings confirm broad global coverage for the relevant compound class.
Implications for R&D and Market Entry
The scope of claims enables the assignee to protect specific chemical subclasses and their medical uses, but the patent landscape shows active development by multiple competitors. The existence of numerous related patents indicates a crowded innovation space, requiring careful freedom-to-operate analyses for new drugs derived from this patent family.
The expiration date in 2029 suggests potential patent expiry around 2030 unless extended or subject to regulatory exclusivity. Knowledge of the landscape allows strategic planning for generic entry or licensing negotiations.
Key Takeaways
- The '793 patent covers specific thiazolidinedione derivatives and their use as PPARγ agonists for diabetes.
- Claims emphasize molecular modifications that influence therapeutic properties.
- The patent landscape is crowded, with multiple filings focused on structural variants and formulations.
- Major pharmaceutical companies have strategic filings related to this patent series.
- The patent will likely remain an influential intellectual property right until its expiration in 2029.
FAQs
1. What is the primary therapeutic focus of the '793 patent?
It targets compounds used to treat type 2 diabetes by activating PPARγ, improving insulin sensitivity.
2. How broad are the claims in this patent?
Claims cover a class of structurally related thiazolidinedione derivatives, their formulations, and therapeutic uses, with specific chemical substitution patterns.
3. Are there blocking patents from competitors in this space?
Yes. Multiple patents by Lilly, Novartis, and others cover similar compound classes and formulations, forming a crowded patent landscape.
4. How does patent expiration affect market exclusivity?
The patent expires in 2029, with potential extensions or regulatory exclusivities possibly prolonging market protection.
5. What is the strategic importance of this patent's landscape?
It defines freedom to operate, influences licensing decisions, and impacts generics' entry timing.
References
- USPTO Patent No. 8,168,793.
- Patent family filings and citations from Lens.org and WIPO PATENTSCOPE.
- Market and patent landscape reports from Clarivate, IAM, and patent analytics companies.
