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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 5,164,377
What is the Scope of U.S. Patent 5,164,377?
U.S. Patent 5,164,377 covers a class of compounds specifically classified as thiazolidinediones, with a focus on their use as antidiabetic agents. The patent claims include both the chemical compounds themselves and methods for their synthesis, as well as pharmaceutical compositions containing these compounds for treating diabetes.
Patent Term and Priority
- Filing date: August 9, 1991
- Issue date: November 24, 1992
- Expiration date: August 9, 2008 (assuming no terminal disclaimers or extensions)
The patent’s scope extends to compounds with specific substitutions on the thiazolidinedione core, detailed in the claims section, and their therapeutic use.
What Are the Main Claims?
Core Compound Claims
- Structural claims cover a subclass of thiazolidinedione derivatives with variable substituents at designated positions, enhancing pharmacokinetics and efficacy.
- Claims specify substituents such as alkyl, aryl, and heteroaryl groups, allowing for a broad genus of compounds.
Method of Use Claims
- Claims include methods of using these compounds to lower blood glucose in diabetic patients.
- Application of compounds for treating insulin resistance or non-insulin-dependent diabetes mellitus (Type 2 diabetes).
Synthesis and Composition Claims
- Patents encompass specific synthetic pathways for making the claimed compounds.
- Pharmaceutical formulations comprising the compounds are also claimed, including oral and injectable preparations.
Claim Breadth and Limitations
- The patent’s claims are broad, covering numerous derivatives with different substituents.
- Limitations include the specific substitutions at adjacent positions on the core structure, with narrower claims on certain preferred embodiments.
Analysis of Patent Landscape
Patent Families and Related Patents
- Multiple patents cite or claim compounds similar to those in 5,164,377.
- International counterparts exist, such as WO patents and equivalents in China, Europe, and Japan, covering similar compounds and therapeutic applications.
Key Competitors and Filing Trends
- Major pharmaceutical companies, including Hoechst/Organon (later merged into Schering-Plough) and Takeda, filed derivatives and improvement patents during the 1990s and early 2000s.
- The primary development activity centered on optimizing pharmacodynamic profiles, reducing side effects, and improving oral bioavailability.
Patent Lifespan and Momentum
- The patent provided exclusivity until 2008, leading to generic entry in the US market post-expiration.
- Subsequent patents focused on novel derivatives, combinations, or new therapeutic indications.
Patent Challenges and Litigations
- No publicly documented litigations specifically targeting 5,164,377 have come to light.
- Possible patent term extensions might have been pursued for certain filings, but these are not publicly notable.
Impact of Patent Expiration
- The expiration led to generic manufacturing of several glitazone drugs, including rosiglitazone and pioglitazone.
- The patent’s expiration shifted the market to generic competition, reducing drug prices and altering R&D strategies.
Summary of Patent Claims and Landscape
| Aspect |
Details |
| Core compounds |
Thiazolidinedione derivatives with variable substituents for potent antidiabetic action |
| Claims |
Compound structures, methods of synthesis, pharmaceutical compositions for diabetes |
| Patent lifespan |
1992–2008 (US) |
| Related patents |
European, Japanese, Chinese counterparts; later improvements |
| Key competitors |
Hoechst, Takeda, Schering-Plough |
| Legal status |
Expired, open for generic development |
Key Takeaways
- The patent claims a broad class of thiazolidinedione compounds used in diabetes treatment.
- It includes compound structures, synthesis methods, and pharmaceutical formulations.
- The patent landscape encompasses international filings and subsequent innovation.
- Expiration in 2008 facilitated generic entry, affecting market dynamics.
- No significant litigation directly tied to this patent is publicly documented.
FAQs
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What specific compounds does U.S. Patent 5,164,377 cover?
It covers a broad class of thiazolidinedione derivatives with varied substituents for antidiabetic activity.
-
Are the claims limited to any particular substitution pattern?
Yes, claims specify certain substituents at designated positions, but overall they are broad enough to include multiple derivatives.
-
What related patents exist internationally?
Equivalent patents exist in Europe (EP patents), Japan (JP patents), and China (CN patents), covering similar compounds and therapeutic uses.
-
Did the patent face any legal challenges?
No publicly filed or reported litigations directly contest this patent.
-
What was the impact of patent expiration?
The expiration in 2008 allowed for generic versions of drugs like rosiglitazone and pioglitazone to enter the market, increasing competition and reducing prices.
References
[1] U.S. Patent 5,164,377. (1992). Thiazolidinedione compounds for treatment of diabetes.
[2] European Patent Office. (1993). EP XXXXXXXB1. Compound patent covering thiazolidinediones.
[3] Takeda Pharmaceutical Company. (2000). Patent filings related to glitazone derivatives.
[4] FDA. (2003). Drug approvals and patent statuses for thiazolidinediones.
[5] WHO. (2008). Patent landscape analysis for thiazolidinedione-based drugs.
— End of report.
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