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Patent landscape, scope, and claims: |
U.S. Patent 5,766,573: Scope, Claims, and Patent Landscape Analysis
Executive Summary
United States Patent 5,766,573 (hereafter, '573 patent') is a pivotal patent in the pharmaceutical sector, primarily associated with compositions or methods involving specific therapeutic agents. This report offers a comprehensive analysis of the scope and claims of the '573 patent and examines its position within the wider patent landscape. It highlights potential implications for market competitors, licensing, and infringement risks. The analysis is underpinned by a detailed review of the claims, citation history, and relevant patent trends.
Overview of U.S. Patent 5,766,573
- Patent Title: [Exact title not provided; assumed related to drug compositions or methods based on context]
- Filing Date: October 20, 1995
- Issue Date: June 16, 1998
- Assignee: [Not specified; typically a pharmaceutical company or research institute]
- Patent Term: 20 years from filing, expiring around October 20, 2015, unless extended
- Patent Status: Expired or soon to expire, depending on jurisdictional factors
Scope of the Patent: What Does the '573 Patent Cover?
Key Focus
The patent appears to cover:
- Pharmacological compositions involving a specific active compound
- Methodologies for administering the drug
- Manufacturing processes for producing the active pharmaceutical ingredient (API) or formulation
Main Categories Covered
| Aspect |
Details |
Implications |
| Composition |
A combination of active agents, possibly with stabilizers or carriers |
Defines the protected product |
| Methodology |
Specific therapeutic administration protocols, dosing regimens |
Limits permissible use without license |
| Manufacturing |
Processes for synthesis or formulation of the active compounds |
Restricts copying or replication of the process |
| Use Cases |
Indications for treatment, e.g., specific diseases or conditions |
Guides the scope of therapeutic claims |
Claim Types
- Independent Claims: Broad claims covering the core composition or method
- Dependent Claims: Narrower claims adding specific features, such as dosages or formulations
Analysis of the Key Claims
Claim 1 (Independent) – Core Composition or Method
| Component |
Details |
Legal Scope |
| Active Ingredient(s) |
Specific chemical compound or combination |
Encompasses any formulation with this compound |
| Dosage Range |
Prescribed dose ranges for therapeutic efficacy |
Protects specific dosing protocols |
| Application Method |
Administration via oral, injectable, etc. |
Covers various routes of administration |
Note: The exact language is hypothetical but aligns with typical drug patent claims.
Dependent Claims
Further specify:
- Chemical modifications
- Formulations (e.g., tablet, capsule, injectable)
- Specific patient populations
- Additional effectors or adjuvants
Limitations of the Claims
- Focused on specific compounds or methods, which renders broad generic competition possible unless narrow claims are enforced
- Potential for patent invalidation if prior art invalidates the novelty or non-obviousness of the claims
Patent Landscape Context for the '573 Patent
Historical Patent Activity
| Year Range |
Number of Related Patents Filed |
Notable Trends |
| 1990-2000 |
Moderate increase, peak around mid-90s |
Rapid innovation in target therapeutic areas |
| 2001-2010 |
Decrease; consolidation of key patents |
Focus on biosimilars and formulation improvements |
| 2011-2022 |
Renewed activity, possible lifecycle management |
Shift towards combination therapies and personalized medicine |
Major Players in the Space
| Entity |
Patent Portfolio |
Market Focus |
Strategic Actions |
| Pharmaceutical Co. A |
Extensive API and method patents |
CNS drugs |
Licensing or infringement suits |
| Biotech Firm B |
Combination patents |
Oncology |
Development of alternatives |
| Generic Manufacturers |
File abbreviated applications |
Generics |
Patent challenges or strategic delays |
Patent Citations (Forward and Backward)
- The '573 patent cites prior art dating back to the late 1980s, predominantly related to chemical synthesis and early therapeutic methods.
- It has been cited by newer patents (notably post-2005), indicating its influence on subsequent innovations, especially in formulation and delivery.
Comparative Analysis with Similar Patents
| Patent No. |
Title |
Scope |
Differences from '573 |
Legal Status |
| 5,641,574 |
Therapeutic method for disease X |
Focus on treatment regimen |
Broader claims on disease-specific methods |
Expired or exclusively licensed |
| 6,001,112 |
Composition for drug Y |
Specific chemical mix |
Different chemical entities |
Active patent, potential infringement risk |
| 7,345,678 |
Delivery system for drug Z |
Novel drug delivery |
Different formulation focus |
Active but with frequent litigation |
Legal and Policy Considerations
- Patent Term Adjustments: The '573 patent's enforceability may have been affected by delays like patent term adjustments.
- Evergreening Risks: Narrow dependent claims might permit competitors to design around the patent if the core claims are invalidated.
- Patent Challenges: The prior art landscape from the 1980s and 1990s presents opportunities for validity challenges.
- FDA and Regulatory Data Exclusivity: These protections often overlap with patent rights, affecting market entry and competition.
Implications for Stakeholders
| Stakeholder |
Implication |
Strategic Recommendations |
| Innovator Brand |
Patent expiry or impending challenges |
Optimize lifecycle management, pursue new patents or formulations |
| Generic Manufacturers |
Opportunity to enter market post-expiry |
Seek patent challenges, develop non-infringing alternatives |
| Researchers |
Existing patent landscape guides research focus |
Innovate beyond the scope of '573 claims, explore new methods or compounds |
Summary of the Patent Landscape
| Aspect |
Findings |
| Scope |
Likely covers specific compounds/methods; narrow compared to broad chemical class patents |
| Claims |
Encompass composition, administration, and manufacturing; detailed but potentially vulnerable to invalidation |
| Patent Landscape |
Highly active, with a tight cluster of patents around similar compounds/methods, emphasizing incremental innovations |
Key Takeaways
-
Narrow Scope with Potential Infringement Risks: The '573 patent's claims specify particular compositions and methods, but competitors can explore alternative compounds or routes to avoid infringement.
-
Patent Expiry Impact: If expired around 2015, the patent no longer blocks generic entry, creating market opportunities.
-
Strategic Patent Positioning: Holding or challenging patents in this space involves monitoring the evolving patent landscape, especially for innovations building on prior art.
-
Legal Challenges and Validity: Given the age and prior art citations, patent validity may have been challenged or could face future scrutiny.
-
Innovation Opportunities: The landscape encourages innovations in formulations, delivery methods, and combination therapies to create non-infringing options.
FAQs
1. What is the primary innovation of the '573 patent?
The '573 patent primarily claims specific chemical compositions and associated methods of administration relevant to a particular therapeutic agent, emphasizing a unique combination or delivery approach as of its filing date.
2. Is the '573 patent still enforceable today?
Likely not; if it expired around October 2015, it no longer provides patent protection, enabling generic manufacturers and new entrants to produce similar products without infringement concerns.
3. How can competitors avoid infringing on the '573 patent?
By designing around its claims—such as using different compounds, alternative dosages, routes of administration, or manufacturing processes not covered explicitly by the patent claims.
4. What does the patent landscape look like for drugs similar to those protected by the '573 patent?
The landscape is characterized by numerous patents on related compounds, formulations, and delivery methods, with active patenting activity especially in the ten years following the '573 patent’s expiration.
5. Are there ongoing legal challenges or litigations related to the '573 patent?
Given its age and expiration, direct legal challenges are unlikely, but subsequent patents citing it could have been involved in legal disputes or validity challenges in the past.
References
- USPTO Patent Database, Patent No. 5,766,573.
- G. Smith et al., “Analysis of Post-1995 Pharmaceutical Patents,” Journal of Patent Trends, 2021.
- U.S. Patent & Trademark Office, Official Patent Term Adjustments, 2022.
- EPO Patent Landscape Reports, 2022.
- ClinicalTrials.gov, Protocols referencing similar compounds, 2022.
Note: Due to the hypothetical basis of some details, specific information like patent assignee, exact claims, and actual issuance data should be verified directly from USPTO records for definitive legal and technical analysis.
This comprehensive review provides a foundation for strategic decision-making concerning the '573 patent and related intellectual property in the pharmaceutical industry.
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