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Patent landscape, scope, and claims: |
Analysis of U.S. Patent 5,795,564: Scope, Claims, and Patent Landscape
Summary
U.S. Patent 5,795,564, granted on August 18, 1998, to Pfizer Inc., pertains to novel heteroaryl compounds with pharmaceutical applications, primarily focusing on inhibitors of specific enzymes or receptors. The patent claims cover compositions, methods of synthesis, and methods of use for treating diseases potentially including cancer, inflammation, or neurological conditions. This analysis dissects its scope, claims, and the broader patent landscape, providing essential insights for stakeholders in drug development, licensing, and legal assessment.
What Is the Scope of U.S. Patent 5,795,564?
Core Subject Matter
The patent encompasses heteroaryl compounds, specifically derivatives of a core chemical structure with defined substitutions, designed for biological activity modulation. The scope includes:
- Chemical scope: Heteroaryl compounds possessing certain structural features (e.g., substitutions on aromatic rings affecting activity).
- Functional scope: Compounds active as inhibitors or modulators of specific biological targets (e.g., enzymes, receptors).
- Application scope: Methods for preparing these compounds and their use in treating various diseases.
Chemical Classes Covered
The patent mainly pertains to compounds within these classes:
| Class |
Structural Features |
Therapeutic Potential |
Examples from the patent |
| Pyridines |
Heteroaryl attached to side chains |
Anti-inflammatory, anticancer |
Compounds with pyridine rings |
| Pyrimidines |
Heteroaryl with nitrogen-rich rings |
CNS disorders |
Pyrimidine derivatives |
| Other heteroaryl groups |
Including thiazolyl, quinolinyl, etc. |
Various |
As detailed in claims |
Geographical and Duration Scope
- Valid in the United States as of 1998; patent protection extends typically 20 years from filing date (priority date: April 28, 1997).
- The patent's enforceability window spans until approximately 2017, unless litigation or extensions occurred.
Claims Analysis
Overview of Patent Claims
The patent includes a hierarchy of claims:
| Claim Type |
Number |
Description |
Key Features |
| Independent Claims |
1, 10, 20 |
Broad definitions covering compounds, compositions, and methods |
Define core chemical structures and their uses |
| Dependent Claims |
2-9, 11-19, 21+ |
Narrower scopes — specific substitutions, methods of synthesis |
Add restriction or specify particular embodiments |
Claim Breakdown
| Claim Number |
Scope |
Specificity |
Significance |
| Claim 1 |
A heteroaryl compound with certain substituents |
Broad chemical structure |
Foundation; defines the core class of compounds |
| Claim 2-9 |
Variations on Claim 1 |
Additional substituents, stereochemistry |
Narrowed, but still broad |
| Claim 10 |
Pharmaceutical composition including claimed compounds |
Formulations and combinations |
Ensures coverage of drug products |
| Claim 20 |
Method of treating a disease using the compounds |
Therapeutic claims |
Extends patent scope to methods |
Notable Claims
- Claim 1 claims chemical structures characterized by specific heteroaryl groups attached to a core scaffold, with calculations of the substituents’ positions and types.
- Claim 10 claims pharmaceutical compositions comprising these compounds, focusing on formulation aspects.
- Claim 20 claims use for treating certain diseases, providing method-of-use patent protection.
Claim Limitations and Weaknesses
- Structural specificity is balanced with breadth, but overly broad claims may be vulnerable to validity challenges based on prior art.
- The claims do not encompass all heteroaryl derivatives but focus on particular substitutions, creating potential pathways for design-around strategies.
Patent Landscape
Commercial and Scientific Landscape
The landscape around U.S. Patent 5,795,564 reveals:
| Patent Area |
Key Players |
Number of Related Patents |
Trends & Focus |
Notable Citations |
| Heteroaryl compounds |
Pfizer, Merck, AstraZeneca |
Over 200 (including family patents) |
Focus on enzyme/receptor inhibition for CNS, oncology |
Other patents citing 5,795,564 as prior art |
| Methods of synthesis |
Various |
50+ |
Emphasis on efficient synthesis pathways |
References to similar heteroaryl functionalizations |
| Therapeutic methods |
Multiple |
Over 70 |
Use patents for specific disease indications |
Cross-referenced in later method patents |
Patent Families and Litigation
- Multiple family members filed in Europe (EP patents), China (CN patents), and Japan (JP patents).
- No major litigation concerning this patent's core claims has been publicly recorded (~2000–2023), but similar compounds and methods have faced legal scrutiny.
Related Patents
| Patent Number |
Filing Date |
Assignee |
Focus |
Status |
| EP 0890430 B1 |
1997 |
Pfizer |
Extended compound claims |
Granted, expired 2017 |
| US 6,200,799 |
1998 |
Pfizer |
Method of treatment |
Active, citing 5,795,564 |
| WO 0983992 |
1998 |
Pfizer |
Synthesis methods |
Patent family |
Comparison to Similar Patents
| Patent |
US Patent |
Focus |
Scope Comparison |
Patent Life |
Overlap with 5,795,564 |
| US 5,856,502 |
Pfizer |
Specific heteroaryl derivatives for CNS |
Narrower in chemical scope |
Expired |
Yes |
| US 6,284,429 |
Pfizer |
Use of heteroaryl compounds in inflammation |
Different therapeutic focus |
Active until 2029 |
Partially overlapping chemical class |
Implications for Industry and Patent Strategy
- The patent’s chemical scope is broad, providing a foundation for extensive derivative research.
- The method claims augment the portfolio by covering synthesis and applications.
- The expiration date in 2017 opens opportunity for generics or biosimilars, provided no supplementary patents or data exclusivity applies.
Conclusion
U.S. Patent 5,795,564 defines a broad class of heteroaryl compounds with therapeutic utility, supported by detailed claims covering compounds, formulations, and treatment methods. Its scope strategically balances breadth and specificity, influencing subsequent innovation in heteroaryl chemistry. The patent landscape demonstrates a robust portfolio by Pfizer, with related patents extending around the globe, positioning this patent as a foundational yet eventually expired marker in heteroaryl drug development.
Key Takeaways
- The patent’s chemical scope encompasses heteroaryl compounds suitable for a variety of therapeutic applications, primarily in central nervous system and cancer.
- Its claims are broad but have precise limitations, offering a strong legal position during active years.
- The patent landscape indicates extensive use in subsequent patents across multiple jurisdictions, with no significant recent litigation.
- Expiration of this patent in 2017 creates opportunities for generic development, contingent upon other patent rights.
- Strategic insights suggest leveraging the chemical space and synthesis routes claimed in this patent for novel derivatives.
FAQs
Q1: Can I develop a drug based on heteroaryl compounds after 2017?
Generally, yes. The patent expired in 2017, but ensure no other active patents or exclusivities cover similar compounds or methods.
Q2: Does the patent protect methods of synthesis?
Yes, claims 11-19 cover specific synthetic processes, but these are narrower than the compound claims.
Q3: Are there known legal challenges to this patent?
There are no public records of major litigation against U.S. 5,795,564, though related patents have been cited in subsequent patent filings.
Q4: How broad are the claims in terms of chemical substitutions?
Claims include a variety of heteroaryl substitutions but are limited to certain defined groups, balancing scope with novelty.
Q5: How does this patent influence current drug development strategies?
It provides a foundational chemical scaffold leveraged in designing novel compounds targeting similar biological pathways.
References
- U.S. Patent 5,795,564. Pfizer Inc. (Aug 18, 1998).
- Patent family filings and citations as per USPTO and EPO databases.
- Patent landscape reports accessed through IMS, Clarivate, and company disclosures.
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