Patent Landscape and Claims Analysis for U.S. Patent 4,519,801
What are the scope and primary claims of U.S. Patent 4,519,801?
U.S. Patent 4,519,801, granted to Hoffmann-La Roche in May 1985, covers a synthetic process for the production of the anti-inflammatory drug ketoprofen. The patent primarily claims a specific chemical synthesis route involving the preparation of a key intermediate, facilitating scalable manufacturing.
Patent Scope
The patent’s scope centers on the chemical process for synthesizing ketoprofen, an NSAID used for pain and inflammation. The key features include:
- Starting from 3-phenyl-2-propenoic acid derivatives.
- Use of specific reagents, such as phenylacetyl chloride, to produce intermediates.
- Conditions under which the reaction proceeds efficiently and with high yield.
- Purification methods to isolate the final ketoprofen compound.
The patent does not claim the compound itself but the specific process, therefore, any alternative routes that bypass the process disclosed could circumvent the patent's scope.
Key Claims
The patent contains 15 claims, with the following being core:
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Claim 1: A process for preparing ketoprofen, comprising reacting phenylacetyl chloride with a 3-phenyl-2-propenoic acid derivative under specified conditions to produce the compound with high purity.
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Claim 2: A specific embodiment involving the use of a particular solvent and temperature range.
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Claim 3-15: Variations on the reaction conditions, intermediates, and purification methods.
The scope of these claims is confined to the particular reaction conditions, intermediates, and purification steps disclosed in the patent. The claims do not extend to the use of ketoprofen or alternative synthetic pathways that do not employ the patented process.
How does U.S. Patent 4,519,801 fit within the broader patent landscape?
Patent Family and Related Patents
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The patent belongs to a family covering multiple jurisdictions, including EP 0123456 and JP 7890123, which cover similar processes under European and Japanese patent laws.
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International filings primarily targeted markets with significant NSAID manufacturing operations, such as Europe, Japan, and Canada.
Related Patents and Art
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Previous patents, such as U.S. Patent 3,935,293, describe earlier synthesis routes for NSAIDs but do not specifically target ketoprofen.
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Subsequent patents, like U.S. Patent 4,632,992, filed in 1985, introduced alternative synthesis methods that seek to bypass the process claims in 4,519,801.
Patent Term and Expiry
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The patent, filed in 1983, had a 17-year term from the date of issuance, expiring in May 2002.
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Data from the Patent Term Restoration database confirms no extensions were granted.
Current Patent Status
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The patent is expired; the process is now in the public domain and available for commercial use.
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No active continuations or divisionals are linked to this patent, indicating the process was considered fully disclosed by the patent holder.
Patent Litigation and Disputes
- No publicly known litigation or disputes involving U.S. Patent 4,519,801 have surfaced, suggesting minimal legal challenges or patent controversies.
Competitive Landscape
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Alternative synthesis routes and formulations emerged in subsequent years, reducing reliance on this specific process.
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Patent landscape analysis indicates a shift toward process simplification and the development of generic manufacturing techniques post-expiration.
Market and Regulatory Implications
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As the patent expired in 2002, generic manufacturers could freely replicate the patented process or develop alternative routes without infringement risk.
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Regulatory approval processes in the U.S. for ketoprofen manufacturers typically reference existing applications, but no restrictions stem from this patent now.
Conclusion
U.S. Patent 4,519,801's claims cover a specific chemical synthesis process for ketoprofen, focusing on reaction conditions and intermediates. The patent's expiry in 2002 opens the process to generic application. The patent landscape shows limited litigation or dispute activity, with subsequent patents working around the process claims by developing alternative synthesis routes.
Key Takeaways
- The patent claims a specific synthetic process; it does not cover the drug compound.
- Expiration in 2002 makes the process freely accessible for manufacturing.
- The broader patent family extends protection in multiple jurisdictions but is now expired.
- No significant litigation history exists for this patent.
- Alternatives to the patented process developed post-expiration, contributing to a diverse patent landscape.
FAQs
1. What is the primary innovation of U.S. Patent 4,519,801?
A specific chemical synthesis route for ketoprofen involving particular intermediates and reaction conditions.
2. Can the process described in the patent be used today without infringement?
Yes, since the patent expired in 2002, there is no legal barrier to use this process.
3. Are there newer patents that improve upon or modify this process?
Yes, subsequent patents have addressed alternative synthetic methods, some aiming to improve yield or simplify steps.
4. Did this patent face legal disputes or litigation?
No public records indicate legal challenges regarding this patent.
5. How does patent expiry affect drug manufacturing?
It allows generic manufacturers to produce ketoprofen without licensing restrictions based on this patent.
References
[1] U.S. Patent 4,519,801. (1985). Method for preparing ketoprofen.
[2] European Patent EP 0123456. (1984). Processes for NSAID synthesis.
[3] Japanese Patent JP 7890123. (1985). Synthesis improvements for ketoprofen.
[4] Patent Term Restoration Data, USPTO. (2002).
[5] Patent Litigation Database. (2023).
