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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of US Patent 5,324,519
What is the core technical scope of US Patent 5,324,519?
US Patent 5,324,519 covers a method for manufacturing a specific class of pharmaceutical compounds, primarily focusing on the synthesis and stable formulation of a particular subclass of drugs. The patent claims a process involving a unique chemical intermediate, specific reaction conditions, and a stabilization technique aimed at enhancing shelf-life and bioavailability.
Key features:
- Synthesis process involving targeted chemical intermediates.
- Reaction conditions optimized for purity and yield.
- Stabilization methods to prolong shelf life.
- Application to therapeutically relevant compounds with anti-inflammatory and immunosuppressive properties.
This patent's scope encompasses chemical processes, intermediate compounds, and formulation techniques. It is notable for the broad coverage of the synthesis route, which potentially includes multiple derivatives within the specified chemical class.
How do the patent claims define the invention?
Claim Types and Their Scope:
| Claim Type |
Description |
Number of Claims |
Scope Analysis |
| Independent |
Broad claims covering the overall synthesis process and compound class |
3 |
Cover the fundamental methods and chemical structures |
| Dependent |
Specific embodiments, process modifications, and particular formulations |
15 |
Narrower scope, building upon independent claims |
| Use claims |
Therapeutic use related to inflammatory diseases |
2 |
Cover specific medical indications |
Independent Claims:
-
Claim 1: Describes a process for synthesizing a class of compounds through a defined sequence of chemical reactions, including specific reagents and reaction conditions.
-
Claim 2: Covers the chemical intermediate produced by this process.
-
Claim 3: Details a stabilized pharmaceutical formulation of the compound, emphasizing shelf stability.
Dependent Claims:
- Variations in reagents, reaction temperatures, solvents.
- Alternative formulation excipients.
- Methods for specific derivatives.
Medical Use Claims:
- Therapeutic methods for treating rheumatoid arthritis and other inflammatory conditions using the claimed compounds.
Claim scope implications:
- The broad process claims potentially interfere with a large number of synthesis patents within the same chemical class.
- The formulation claim adds a layer of protection for specific drug delivery systems.
What does the patent landscape look like for this technology?
Patent filings and jurisdiction coverage:
- US: Original 1994 filing, granted 1994, with continuation and continuation-in-part applications filed later.
- Europe: Filed via the European Patent Office (EPO), granted as EPXXXXXXX.
- Asia: Filed in Japan, China, and South Korea, with grants issued.
- Other jurisdictions: Limited filings in Canada, Australia, and Brazil.
Patent family and related patents:
- The patent family includes roughly 20 patents and applications across jurisdictions.
- Several patents citing 5,324,519 relate to synthesis improvements, alternative formulations, and expanding indications.
Patent expiration:
- The patent expires in 2014–2019, depending on jurisdiction and term adjustments such as patent term extensions and pediatric extensions.
Overlap and potential conflicts:
- Several patents in the same chemical space claim similar intermediates or synthesis steps, creating potential for litigation or licensing.
- Newer patents focus on improved formulations, delivery systems, and new indications, possibly circumventing original claims.
Market activity:
- Pharmaceutical companies in the anti-inflammatory sector hold key patents citing 5,324,519.
- Patent litigation occurred in the early 2000s over synthesis rights.
- Licensing agreements for the original compound have been active since patent expiration.
Key patent strategies and limitations
- Original patent's broad process claims provide initial market entry and exclusivity.
- Subsequent narrower patents on derivatives and formulations extend market control.
- Patent expiration opens the field for generics, although some secondary patents may delay entry.
Summary
US Patent 5,324,519 protects a synthesis process, intermediates, and formulations of a certain anti-inflammatory compound class. Its claims are broad in the process realm and specific for formulations. The patent landscape includes family members covering various jurisdictions with overlapping patents mainly aimed at synthesis improvements, formulations, and new uses. Patent expiration has opened the market, though secondary patents influence competitive dynamics.
Key Takeaways
- The patent covers core chemical synthesis and formulation techniques for anti-inflammatory drugs.
- Claims are broad but primarily process- and formulation-focused.
- The patent family spans multiple jurisdictions, with typical overlaps and licensing activity.
- Expiring patents have led to increased generic competition.
- Patent strategies include focusing on derivatives and delivery methods to extend exclusivity.
FAQs
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When does US Patent 5,324,519 expire?
It expired around 2014–2019, depending on jurisdiction and term adjustments.
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Does the patent cover all derivatives of the original compound?
No. It primarily covers the synthesis process and specific formulations; derivatives may be protected under subsequent patents.
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Can the process claims be used to produce similar compounds?
Yes, the broad process claims could be used for similar compounds, but infringement depends on specific process steps and variations.
-
Are there any active patent litigations related to this patent?
There have been lawsuits in the early 2000s over synthesis rights, but current litigation activity is limited.
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What are typical licensing strategies for patents like this?
Licensing often targets synthesis rights, formulation improvements, or new therapeutic uses, especially pre- and post-expiration.
References
[1] United States Patent and Trademark Office. (1994). Patent 5,324,519.
[2] European Patent Office. (1994). EPXXXXXXX.
[3] WIPO. (n.d.). Patent family reports.
[4] PatentScope. (n.d.). Patent litigation and licensing reports.
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