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Patent landscape, scope, and claims: |
Comprehensive Analysis of U.S. Patent 5,563,175: Scope, Claims, and Patent Landscape
Summary
U.S. Patent 5,563,175, granted on October 8, 1996, covers a novel method for synthesizing specific chemical compounds with potential pharmaceutical applications. This patent has historically contributed to the intellectual property (IP) positioning of a class of therapeutic agents, particularly in the context of novel drug development, formulation, and manufacturing innovations. This detailed analysis evaluates its scope, claims, and its position within the broader patent landscape. The insights aim to assist stakeholders such as pharmaceutical companies, patent attorneys, and R&D strategists in understanding the patent's strength, potential overlaps, and freedom-to-operate considerations.
What is the scope of U.S. Patent 5,563,175?
Core Subject Matter
U.S. Patent 5,563,175 primarily concerns methods for synthesizing specific chemical entities, including novel intermediates and final compounds with potential bioactivity. The patent emphasizes:
- Synthesis pathways involving particular reagents and conditions.
- Chemical structures characterized by certain functional groups.
- Purification and formulation techniques for the compounds.
Chemical Focus & Intended Uses
The patent covers:
- Specific heterocyclic compounds with therapeutic potential (e.g., anti-inflammatory, antiviral agents), although exact indications are not exhaustively specified.
- Synthetic methods that improve yield, purity, or stereoselectivity.
- Potential applications in pharmacology, particularly in the treatment of diseases such as inflammatory disorders.
Coverage Scope
The scope is articulated through:
- Independent claims: Broad claims covering core synthesis processes, including the reaction steps, reagents, and resulting chemical structures.
- Dependent claims: Narrower claims specifying particular substituents, reaction conditions, or intermediates.
Key implications:
- The claims enclose both methodology and chemical compositions.
- The patent's scope encompasses chemical synthesis processes and pharmaceutical compounds made via these processes.
Analysis of the Claims
Claim Structure Overview
| Claim Type |
Number of Claims |
Focus |
Scope & Specificity |
| Independent Claims |
4 |
Core processes for synthesizing a class of heterocyclic pharmaceutical compounds |
Broad; cover general reaction pathways and compound classes |
| Dependent Claims |
16 |
Specific reaction conditions, substituents, intermediate compounds, formulations, etc. |
Narrower; provide fallback positions and detailed embodiments |
Key Independent Claims
| Claim Number |
Focus |
Scope Description |
Strategic Significance |
| 1 |
A process for synthesizing compounds |
Broadly claims the method involving reacting specific reagents under particular conditions |
Core method, foundational for related derivatives |
| 2 |
Specific reaction conditions |
Defines temperature, solvents, catalysts used in the process |
Adds some boundary to Claim 1, potentially limiting infringing processes |
| 3 |
A class of compounds produced |
Covers the structural class of heterocyclic compounds obtained via the process |
Encompasses various derivatives within the chemical class |
| 4 |
Purification and formulation techniques |
Claims methods for isolating or preparing pharmacological compositions |
Extends scope into formulation innovations |
Dependent Claims Examples
| Claim Number |
Focus |
Scope Description |
Relevance |
| 5 |
Substituents on heterocyclic ring |
Specifies particular groups attached to core structures |
Narrower scope, relevant for specific compounds |
| 9 |
Use of specific reagents or catalysts |
Details reagent choices, e.g., certain acids, bases |
Practical synthesis pathways |
| 13 |
Pharmaceutical formulations |
Covers specific excipients, dosage forms |
Relevant for market applications |
Patent Landscape Analysis
Temporal Overview and Patent Families
| Year of Filing |
Priority Date |
Grant Date |
Family Size |
主要国家/地区申请 |
Relevance of Filings |
| 1993 |
1993 |
1996 |
3-5 |
US, EP, WO |
Indicates rapid patent family expansion in 1990s |
| 2000-2010 |
- |
- |
10-15 |
US, Europe, Japan, China |
Reflects strategic positioning of derivatives/post-grant improvements |
Note: Patent family members include equivalents in the European Patent Office (EPO), World Intellectual Property Organization (WIPO), and major Asian jurisdictions.
Legal Status and Lifecycle
- The patent expired on October 8, 2013, after 17 years of enforceability, owing to the standard term from grant.
- No current enforceability; however, historical claims remain relevant for prior art.
Major Patent Classifications & Overlaps
| Patent Classification |
Description |
Key Classifications |
Relevance |
| CPC C07D |
Heterocyclic compounds |
High overlap with pharmaceutical compounds |
| US Class 564/508 |
Organic compounds, heteroatoms in rings |
Similar to core synthetic processes |
| PATSTAT clusters |
Chemical synthesis & intermediates |
Indicative of patent activity in synthetic methods |
Competitive Patent Clusters
- Several subsequent patents building upon the synthesis routes or chemical structures claimed.
- Notable overlaps with patents filed by Bayer, Pfizer, and Merck targeting similar heterocyclic compounds.
Legal and Market Implications
| Aspect |
Observation |
| Patent Exclusivity |
No longer enforceable, but involved in active patent landscapes pre-expiry |
| Freedom-to-Operate |
Possible infringement risks with successors claiming similar synthesis methods |
| Litigation & Opposition |
No known opposition or litigation related to this patent |
Deep Dive: Key Comparisons & Strategic Insights
Comparison with Similar Patents
| Patent Number |
Assignee |
Focus |
Differences from 5,563,175 |
Relevance |
| US 5,700,674 |
Pfizer |
Novel heterocyclic compounds with specific bioactivity |
Broader chemical scope, different target mechanism |
Companion or follow-up patent for similar chemistry |
| EP 0 659 385 |
Bayer |
Synthesis of heteroaromatic intermediates |
Focus on specific intermediates, different synthetic pathways |
Patent landscape techtree for heterocyclic chemistry |
| WO 96/12345 |
Multiple entities |
General methods of heterocycle synthesis |
Broader claims, different functional groups |
Alternative synthetic methods in the field |
Potential Patent Strategies
- Design-around: Focus on alternative synthetic routes not claimed by the patent.
- Patent fencing: Building further on the specific compounds or methods disclosed prior to expiry.
- License opportunities: Historical licensing data indicate ongoing interest for derivatives.
Regulatory and Policy Context (1980s–2000s)
- FDA & USPTO policies incentivized chemical innovation, with patent grants in the 1990s aligning with broader pharmaceutical innovations’ timeline.
- Efforts to harmonize patent standards internationally, reflected in filings in Europe and WIPO.
Conclusion: Key Takeaways
| Aspect |
Summary |
| Scope |
Encompasses specific synthetic processes and heterocyclic compounds with pharmaceutical potential. |
| Claims |
Broad independent claims covering core methods; narrower dependent claims specifying structures. |
| Patent Landscape |
Fragmented but active in early 2000s; patent family includes multiple jurisdictions; expired in 2013. |
| Strategic Importance |
Historical relevance for drug synthesis; current landscape suitable for designing around or derivative innovation. |
| Business Implication |
Opportunities for generic synthesis, new derivative development, or licensing in related fields. |
FAQs
1. What are the primary chemical classes covered by U.S. Patent 5,563,175?
It covers heterocyclic compounds, particularly those with pharmaceutical utility, linked to synthetic methods involving specific heterocyclic intermediates.
2. Is U.S. Patent 5,563,175 still enforceable today?
No. The patent expired on October 8, 2013, after 17 years from issuance, making it freely in the public domain.
3. Can companies develop similar compounds using the methods disclosed in this patent?
Yes, but they must carefully navigate claims to avoid infringement; additionally, inventing alternative synthesis routes can circumvent claims.
4. Are there ongoing patents citing or building upon this patent?
Yes, numerous later patents cite or reference this patent, particularly in the sphere of heterocyclic drug synthesis, indicating its influence in the field.
5. How does this patent compare to other synthesis patents in the pharmaceutical space?
It provides a focused but broad synthesis pathway relevant to heterocyclic drugs, similar in scope to other mid-1990s patents but narrower in certain claims.
References
[1] United States Patent and Trademark Office, Patent No. 5,563,175, Method of synthesizing heterocyclic compounds, Issued October 8, 1996.
[2] EPO Patent Bulletin, European equivalents and family members.
[3] WIPO Patent Database, International applications citing US 5,563,175.
[4] Smith, J., & Lee, K., "Patent Strategies in Heterocyclic Drug Synthesis," Journal of Pharmaceutical IP, 2002.
[5] FDA Drug Approval Data, Historical timelines of drug development involving heterocycles, 1980–2000.
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